UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
OF THE SECURITIES EXCHANGE ACT OF 1934
For the month of September 2022
(Commission File No. 001-40241)
LAVA Therapeutics N.V.
(Translation of registrant’s name into English)
Yalelaan 60
3584 CM Ultrecht, The Netherlands
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101 (b) (1):
Yes ☐ No ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101 (b) (7):
Yes ☐ No ☐
LAVA Therapeutics, N.V.
Exclusive License Agreement
LAVA Therapeutics N.V. (“LAVA”), entered into an exclusive license agreement, dated as of September 23, 2022 (the “Agreement”), with Seagen Inc. (“Seagen”), pursuant to which LAVA granted a worldwide exclusive license to Seagen to develop, manufacture, and commercialize LAVA-1223, an advanced preclinical asset that utilizes LAVA’s proprietary Gammabody™ technology to target epidermal growth factor receptor (EGFR)-expressing solid tumors. Seagen will pay LAVA a one-time, upfront license fee of $50 million. In addition, Seagen will pay LAVA development, regulatory and commercialization milestone payments of up to approximately $650 million upon achievement of certain specified milestones as well as royalties ranging from the single digits to the mid-teens on net sales of the licensed product. LAVA may exercise a one-time, buy-up option to increase the royalty rate percentages for such royalties upon payment of a one-time fee within a designated period of time following receipt of certain clinical data for the licensed product. In the event LAVA elects to exercise such buy-up option, the amount of certain of the development milestones will be subject to certain percentage decreases.
Under the terms of the Agreement, Lava will provide a limited amount of initial supply of LAVA-1223 to support Seagen’s clinical development of the product. Seagen is also granted an opportunity to exclusively negotiate rights to apply LAVA's proprietary Gammabody platform on up to two additional tumor targets. The Agreement contains customary representations, warranties and covenants by both parties, as well as customary provisions relating to indemnification, confidentiality and other matters.
The foregoing description of the terms of the Agreement is qualified in its entirety by reference to the full text of the Agreement, which is filed as Exhibit 10.1 to this Report on Form 6-K, and incorporated herein by reference.
Press Release
On September 26, 2022, the Company issued a press release announcing entry into the Agreement. A copy of this press release is filed herewith as Exhibit 99.1.
Investor Presentation
On September 30, 2022, the Company updated its corporate presentation, which it made available on its website. A copy of the presentation is furnished herewith as Exhibit 99.2.
INCORPORATION BY REFERENCE
This Report on Form 6-K and Exhibits 10.1 and 99.1 to this Report on Form 6-K shall be deemed to be incorporated by reference into the registration statement on Form S-8 (File no. 333-256655) and registration statement on Form F-3 (File no. 333-264246) of LAVA Therapeutics N.V. (including any prospectuses forming a part of such registration statements) and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
EXHIBIT LIST
Exhibit |
| Description |
10.1* | | Exclusive License Agreement, dated September 23, 2022, by and between Seagen Inc. and Lava Therapeutics N.V. |
99.1 | | |
99.2 | | |
* | | Certain identified information has been excluded from this Exhibit because it is not material and is the type that the Company treats as private or confidential. The omissions have been indicated by “[***]”. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereto duly authorized.
| LAVA Therapeutics, N.V. | |
| (Registrant) | |
| | |
Date: September 30, 2022 | By: | /s/ Stephen Hurly |
| Stephen Hurly | |
| Chief Executive Officer and Director | |
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
List of Exhibits and Schedules:
Exhibit AAdditional Targets License Terms
Schedule 1.97Lava-1223 Compound
Schedule 1.110Lava Patents
Schedule 4.1Research Plan
Schedule 5.1.1Technology Transfer
Schedule 5.2.2(b)Lava CTA Sections
Schedule 5.3[***]
Schedule 6.1Manufacturing Technology Transfer
Schedule 6.4(a)Initial Supply
Schedule 6.4(b)Principal Terms of Initial Supply Agreement
Schedule 6.4(c)Existing Materials
Schedule 9.2.1Press Release
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
Schedule 11.2.1
Schedule 11.2.7
Schedule 11.2.11(a)
Schedule 11.2.11(b)
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
EXCLUSIVE LICENSE AGREEMENT
This Exclusive License Agreement (“Agreement”) is entered into as of September 23, 2022 (the “Effective Date”), by and between Seagen Inc., a Delaware corporation located at 21823 30th Drive SE, Bothell, WA 98021, USA (“Seagen”) and Lava Therapeutics N.V., a Netherlands public limited company (naamloze vennootschap) having an address at Yalelaan 60, 3584 CM Utrecht, the Netherlands (“Lava”). Lava and Seagen may be referred to in this Agreement individually as a “Party” or collectively as the “Parties.”
BACKGROUND
WHEREAS, Seagen is a global biotechnology company with expertise in researching, developing and commercializing targeted therapies to treat cancer;
WHEREAS, Lava is a biotechnology company that has a proprietary Gammabody™ platform and expertise relating to the discovery and development of bispecific and multi-specific T-cell engagers (collectively, “msTCEs”) directed to certain targets;
WHEREAS, Lava owns or controls certain patents and other intellectual property relating to the Lava-1223 Compound (as defined herein); and
WHEREAS, Seagen wishes to obtain from Lava an exclusive license in the Territory to Develop, Manufacture and Commercialize Licensed Compounds and Licensed Products (in each case as defined herein), and Lava is willing to grant such a license to Seagen, in accordance with the terms and conditions set forth herein.
NOW THEREFORE, in consideration of the mutual covenants and agreements contained herein, and other good and valuable consideration, the sufficiency of which is hereby acknowledged by both Parties, the Parties agree as follows:
Whenever used in this Agreement with an initial capital letter, the terms defined in this Article 1 and elsewhere in this Agreement, whether used in the singular or plural, shall have the meanings specified.
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
of the Acquisition. For clarity, an “Acquiror” of a Party shall exclude the Party and all of its Affiliates existing immediately prior to the consummation of the Acquisition.
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
any of the foregoing) and any other requirements of any applicable Governmental Authority that govern or otherwise apply to a Party’s activities in connection with this Agreement.
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
practicing any intellectual property rights that are licensed under this Agreement, except to the extent such Know-How, Patent Rights, Materials or other rights (a) are actually used in the performance of activities under this Agreement by the acquired Party or Acquiror; or (b) were otherwise licensed or sublicensed (as applicable) by such Third Party to such acquired Party, or Affiliates of such Party, prior to such Acquisition. For clarity, Lava shall, during the Term, be deemed to Control all Know-How, Patent Rights, Materials and other rights that have, at any time, been licensed or assigned to Lava pursuant to the [***] Agreement.
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
“Distributor” shall not be considered a Sublicensee for purposes of this Agreement even if (sub)licenses are granted to such Distributor for purposes of conducting its resale activities.
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
Third Parties, the cost of materials (including taxes and duties thereon) procured by Lava for, or provided by Lava to, Third Parties in connection with such Third Parties’ services, and services provided by Third Parties, but excluding any (a) capital expenditures and financing costs, and (b) employee salaries and benefits.
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
the foregoing) for approval to conduct Clinical Trials of a pharmaceutical or biological product filed with or submitted to a Regulatory Authority in conformance with the requirements of such Regulatory Authority.
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
Net Sales shall be determined from the applicable Selling Party’s books and records maintained in accordance with the Selling Party’s Accounting Standards consistently applied. Transfers of Licensed Product between or among Seagen, its Affiliates and Sublicensees for subsequent resale shall not be included in Net Sales, but the subsequent end sale shall be included in Net Sales. [***].
If a Licensed Product is sold as a Combination Product in a country, Net Sales of the Licensed Product will be calculated by multiplying the total Net Sales of the Combination Product by the fraction A/(A+B), where A is the average per unit price of the Licensed Product when sold separately in finished form in such country, and B is the sum of the average per unit price in the applicable country of all Additional Actives in each case when sold separately in finished form in such country. If, in a particular country: (a) the Licensed Product is not sold separately in finished form in such country, or (b) one or more of the Additional Actives are not sold separately in finished form in such country, the adjustment to Net Sales shall be determined by the Parties in good faith to reasonably reflect the fair value of the contribution of the Licensed Product in the Combination Product to the total market value of such Combination Product.
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
Laws or by a Regulatory Authority in such country that prevents the Regulatory Approval or marketing of any Biosimilar Product of such Licensed Product in such country, including reference product exclusivity under Section 351(k)(7)(C) of the Public Health Service Act and any foreign equivalents.
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
in such country, and (c) termination or expiration of Regulatory Exclusivity for such Licensed Product in such country.
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
For purposes of this Section 2.3, [***]
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
Party Know-How, Patent Rights or other rights, the “After-Acquired Lava IP”), then Lava will use commercially reasonable efforts to secure, [***], a sublicense to Seagen under the After-Acquired Lava IP that is substantially similar in scope to the license grant in Section 2.1.1, and will keep Seagen reasonably informed as to the status of any such negotiations, provided that Lava will not obtain an exclusive license to such After-Acquired Lava IP that is [***] without Seagen’s prior written consent. In addition, Lava will promptly notify Seagen in writing if it becomes aware of any Third Party Know-How, Patent Rights or other rights other than After-Acquired Lava IP that [***].
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
have the authority to (a) modify or amend the terms and conditions of this Agreement, (b) waive either Party’s compliance with, or determine that either Party has or has not fulfilled, the terms and conditions of this Agreement, or (c) determine any issue in a manner that would conflict with, expand, or reduce the express terms and conditions of this Agreement.
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
reimbursement of such excess amount to Seagen and Seagen shall reimburse Lava for such excess amount in accordance with this Section 4.4. In addition, at least [***]days prior to the end of any Calendar Quarter during the Research Term, Lava shall report to Seagen its non-binding estimated Research Costs for which it will seek to be reimbursed for such Calendar Quarter (which shall be based on the estimated actual amounts for the first two (2) months of such Calendar Quarter and the forecasted amounts for the last month of such Calendar Quarter).
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
Party CMOs, for the Manufacture and supply of all Licensed Compounds and Licensed Products in the Field in the Territory. Lava shall, itself or through one or more Third Party CMOs, Manufacture in accordance with GMP and supply to Seagen the unlabeled vials of (a) the Lava-1223 Product (“GMP Drug Product”) and (b) diluent (“GMP Diluent”), in each case ((a) and (b)) as more fully described and in the quantities set forth in Schedule 6.4(a) hereto (the “Initial Supply”) and intended to support Phase 1 Clinical Trials. Within [***] after the Effective Date, the Parties shall negotiate in good faith and execute an agreement consistent with the terms set forth on Schedule 6.4(b) hereto with respect to the Initial Supply (such agreement, together with the related quality agreement, the “Initial Supply Agreement”). Seagen shall pay Lava for the supply of the Initial Supply in accordance with the Initial Supply Agreement. For the avoidance of doubt, Lava’s Manufacture and supply obligations for GMP Drug Product and GMP Diluent shall be limited to only the unlabeled vials specifically set forth on Schedule 6.4(a). In addition, Lava will transfer to Seagen its then-existing inventory of non-GMP drug substance, drug product and diluent as set forth on Schedule 6.4(c) hereto (the “Existing Materials”), provided that Lava may retain quantities of such Existing Materials as are reasonably necessary to complete Lava’s obligations under the Research Plan. Following completion of its obligations under the Research Plan, Lava will transfer to Seagen the remaining inventory of the Existing Materials. Until such transfer is complete, Lava shall continue to support the shelf-life conditions of the Existing Materials.
# | Development Milestone Event | Development Milestone |
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
Payment (USD) | ||
1 | [***] | [***] |
2 | [***] | [***] |
3 | [***] | [***] |
4 | [***] | [***] |
5 | [***] | [***] |
6 | [***] | [***] |
7 | [***] | [***] |
8 | [***] | [***] |
9 | [***] | [***] |
10 | [***] | [***] |
11 | [***] | [***] |
12 | [***] | [***] |
13 | [***] | [***] |
14 | [***] | [***] |
15 | [***] | [***] |
| Total | [***] |
As used in a Development Milestone Event, the term “First Indication” means the first Indication to achieve such Development Milestone Event, even if such Indication is the second Indication to be Developed, and the terms “Second Indication” and “Third Indication” shall be interpreted in the same manner. Each of the foregoing Development Milestone Payments in this Section 7.2 shall be payable a maximum of [***] hereunder regardless of the number of times the applicable Development Milestone Event is achieved. For the avoidance of doubt, the aggregate maximum amount payable by Seagen hereunder pursuant to this Section 7.2 is [***].
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
Sales Milestone Event | Sales Milestone Payment (USD) |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
Total | [***] |
Each of the foregoing Sales Milestone Payments in this Section 7.3 shall be payable a maximum of [***] hereunder regardless of the number of times the applicable Sales Milestone Event is achieved. For the avoidance of doubt, the aggregate maximum amount payable by Seagen hereunder pursuant to this Section 7.3 is [***].
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
Product less than or equal to [***] | |
For that portion of aggregate annual Net Sales of the applicable Licensed Product greater than [***] and less than or equal [***] | [***] |
For that portion of aggregate annual Net Sales of the applicable Licensed Product greater than [***] and less than or equal to [***] | [***] |
For that portion of aggregate annual Net Sales of the applicable Licensed Product greater [***] | [***] |
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
days such payment is delinquent (provided that if the payment is disputed, such interest shall be calculated from the time that the dispute is resolved), compounded monthly.
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
Unless an audit is ongoing with respect to such period, the Parties shall be released from any liability or accountability with respect to said calculations for such Calendar Year.
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
Any combination of features or disclosures shall not be deemed to fall within the foregoing exclusions merely because individual features are published or available to the general public or in the rightful possession of the receiving Party unless the combination itself and principle of operation are published or available to the general public or in the rightful possession of the receiving Party.
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
Notwithstanding the foregoing, in the event that a Party is required to make a disclosure of the other Party’s Confidential Information pursuant to Section 8.3.3-8.3.4, it will, except where impracticable, promptly inform the other Party of the disclosure that is being sought in order to provide the other Party an opportunity to challenge or limit the disclosure obligations, and, if requested by the other Party, cooperate in all reasonable respects with the other Party’s efforts to obtain confidential treatment or a protective order with respect to any such disclosure, at the other Party’s expense. In any such event, each Party agrees to take all reasonable action to minimize disclosure of the other Party’s Confidential Information. Any information disclosed pursuant to this Section 8.3 shall remain the Confidential Information of the disclosing Party subject to the terms of this Article 8.
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
prior written consent, nor shall the waiver of privilege or immunity resulting from the conduct of one Party be deemed to apply against any other Party.
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
(c)it shall not, without Seagen’s prior written consent, (i) terminate any Lava Existing In-License Agreement, or until the Initial Supply is accepted by Seagen, any [***] Agreement or [***] Agreement, (ii) modify or amend, or waive any of its rights under, any Lava Existing In-License Agreement, or until the Initial Supply is accepted by Seagen, the [***] Agreement or [***] Agreement, in each case in a manner that could reasonably be expected to adversely affect any of Seagen’s rights or obligations under this Agreement, or (iii) assign or otherwise transfer or novate to any Third Party any Lava Existing In-License Agreement, or until the Initial Supply is accepted by Seagen, any [***] Agreement or [***] Agreement (or agree to do any of the foregoing); |
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
Compound or Licensed Product by Seagen, its Affiliates or Sublicensees (or any Third Party acting on their behalf), (b) the gross negligence or willful misconduct of any Seagen Indemnitee in connection with this Agreement, or (c) the breach by Seagen of this Agreement; except, in each case (a)-(c), (i) to the extent such Losses arise out of any conditions set forth in Sections 12.2(a)-(d) for which Lava is obligated to indemnify any Seagen Indemnitee under Section 12.2, or (ii) the gross negligence or willful misconduct of any Lava Indemnitee.
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
in its entirety or on a country-by-country basis for any or no reason upon [***] days’ prior written notice to Lava; provided, however, that if Seagen terminates this Agreement in its entirety pursuant to this Section 13.2 at any time following Lava’s exercise of the Buy-Up Option and prior to [***], Seagen shall refund to Lava on the termination date of this Agreement the Buy-Up Fee plus the aggregate amount of reductions in Development Milestone Payments made to Lava pursuant to Section 7.5.3 attributable to such exercise.
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
(whether a court, a patent office, or an arbitral tribunal) any claim in any Lava Patent as being invalid, unenforceable or otherwise not patentable, then Lava may give notice to Seagen that Lava will terminate this Agreement unless such challenge is withdrawn, abandoned or terminated (as appropriate) with prejudice within [***] days from the date of such notice. If Seagen or its Affiliate (as the case may be) does not withdraw, abandon or terminate (as appropriate) with prejudice such challenge within such [***] day period, Lava may terminate this Agreement. In the event that Lava notifies Seagen in writing that any Sublicensee has directly taken any action, or has knowingly provided financial or other assistance (including direct legal or technical advice) to any Third Party, to challenge in a court or administrative proceeding any claim in any Lava Patent as being invalid, unenforceable or otherwise not patentable, then Seagen shall terminate such Sublicensee’s sublicense in its entirety, unless such action by such Sublicensee is withdrawn within [***] days after Lava’s notice to Seagen thereof. This Section 13.8 does not apply to any counterclaim filed by Seagen or any of its Affiliates or Sublicensees as a defendant in defense of claims filed or initiated by Lava or any of its Affiliates, or otherwise in connection with an assertion of a cross-claim or a counter-claim or with respect to any response by Seagen or any of its Affiliates or Sublicensees to compulsory discovery, subpoenas or other requests for information in a judicial or arbitration proceeding.
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
to Lava for such Affiliate’s performance), or (ii) in the entirety in connection with the transfer or sale of all or substantially all of Seagen’s and its Affiliates’ assets or business related to the subject matter of this Agreement, whether by merger, acquisition, operation or law or otherwise, and (b) Lava may, without the written consent of Seagen, assign this Agreement and Lava’s rights and obligations hereunder (i) in whole or in part to an Affiliate of Lava (provided that Lava shall remain liable to Seagen for such Affiliate’s performance), or (ii) in the entirety in connection with the transfer or sale of all or substantially all of Lava’s and its Affiliates’ assets or business related to the Lava Platform, whether by merger, acquisition, operation or law or otherwise. A Party shall notify the other Party in writing of any assignment of this Agreement by such Party within [***] days thereof. Any attempted assignment not in accordance with this Section 14.1 shall be void. Any permitted assignee shall assume all assigned obligations of its assignor under this Agreement.
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
in each case to the appropriate addresses or e-mail addresses set forth below (or to such other addresses and e-mail addresses as a Party may designate by notice):
If to Lava: | LAVA Therapeutics N.V. |
Philadelphia, PA 19106
USA
Attention: General Counsel
E-mail: agarabedian@lavatherapeutics.com
With a copy to (which shall not constitute notice) to:
Ballard Spahr LLP
1735 Market Street, 51st Floor
Philadelphia, PA 19103
Attention: Brian D. Doerner, Esq.
E-mail: doerner@ballardspahr.com
If to Seagen: | Seagen, Inc. |
21823 30th Drive SE
Bothell, WA 98021
USA
Attention: [***]
E-mail: [***]
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
country or jurisdiction would be covered by a Valid Claim within the Lava Patents. Lava shall fully and promptly cooperate with Seagen’s efforts to obtain and maintain any such registration, including by promptly executing any forms or other documents submitted to Lava by Seagen from time to time in order to effect such registration in a country or jurisdiction.
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
[Signature Page follows]
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
IN WITNESS WHEREOF, the Parties intending to be bound have caused this Agreement to be executed by their duly authorized representatives.
LAVA Therapeutics N.V. | Seagen Inc. |
| |
By: /s/ Stephen Hurly | By: /s/ Roger Dansey |
Name: Stephen Hurly | Name: Roger Dansey |
Title: CEO | Title: Chief Medical Officer |
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
EXHIBIT A
Additional Targets License Terms
[***]
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
Schedule 1.97
Lava-1223 Compound
[***]
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
Schedule 1.110
Lava Patents
[***]
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
Schedule 4.1
Research Plan
[***]
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
Schedule 5.2.2(b)
Lava CTA Sections
[***]
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
Schedule 6.4(a)
Initial Supply
[***]
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND IS INFORMATION THAT THE COMPANY TREATS AS PRIVATE OR CONFIDENTIAL.
Exhibit 10.1
Schedule 6.4(b)
Principal Terms of Initial Supply Agreement
[***]
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
Schedule 6.4(c)
Existing Materials
[***]
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
Schedule 9.2.1
Press Release
[***]
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
Schedule 11.2.1
Representations and Warranties of Lava
[***]
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
Schedule 11.2.7
Representations and Warranties of Lava
[***]
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
Schedule 11.2.11(a)
Representations and Warranties of Lava
[***]
CERTAIN CONFIDENTIAL INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND REPLACED WITH “[***]” BECAUSE IT IS NOT MATERIAL AND WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
Schedule 11.2.11(b)
Representations and Warranties of Lava
[***]
Exhibit 99.1
Seagen and LAVA Therapeutics Announce Exclusive Worldwide License Agreement to Advance LAVA-1223, a Preclinical Gamma Delta Bispecific T Cell Engager for EGFR-Expressing Solid Tumors
BOTHELL, Wash. and UTRECHT, The Netherlands and PHILADELPHIA, Sept. 26, 2022 (GLOBE NEWSWIRE) -- Seagen Inc. (Nasdaq: SGEN), a world leader and pioneer in antibody-drug conjugate (ADC) therapies, and LAVA Therapeutics N.V. (Nasdaq: LVTX), a clinical-stage immuno-oncology company focused on developing its proprietary Gammabody™ platform of bispecific gamma delta T cell engagers, today announced an exclusive license agreement in which Seagen will work to develop, manufacture and commercialize LAVA-1223. LAVA-1223 is an advanced preclinical asset that utilizes LAVA’s proprietary Gammabody™ technology to target epidermal growth factor receptor (EGFR)-expressing solid tumors.
Under the terms of the agreement, Seagen will receive an exclusive global license for LAVA-1223 and pay LAVA $50 million upfront; up to approximately $650 million in potential development, regulatory and commercial milestones; and royalties ranging from the single digits to the mid-teens on future sales. The agreement also provides Seagen with the opportunity to exclusively negotiate rights to apply LAVA's proprietary Gammabody™ platform on up to two additional tumor targets.
“Seagen is committed to driving innovation to improve the lives of people with cancer, and this agreement represents the company’s entry into a novel class of therapeutics that are designed to overcome the challenges of standard T cell engagers by leveraging the activity of a distinct T cell subset,” said Roger Dansey, M.D., interim CEO and Chief Medical Officer, Seagen. “This exclusive license from LAVA provides Seagen with the opportunity to harness its expertise in developing first-in-class targeted cancer therapies, along with the company’s global development and commercialization capabilities.”
LAVA-1223 employs a targeted approach that is designed to amplify natural tumor recognition by directing gamma delta T cells to the EGFR+ tumor to kill target cells and trigger immune activation while minimizing impact to normal antigen-expressing tissue. Activating the adaptive immune system with this approach has the potential to provide durable immune responses with the possibility of enhancing patient survival.
“LAVA is pioneering the development of gamma delta bispecific antibodies to treat cancer, and we are pleased to work with Seagen in this pursuit. The combination of LAVA’s proprietary Gammabody platform and deep bispecific expertise, with Seagen’s leadership in developing targeted therapies for cancer and commercialization infrastructure, makes this an ideal partnership to advance novel therapies for patients,” said Stephen Hurly, President and Chief Executive Officer of LAVA Therapeutics. “This agreement enables LAVA to further validate its platform in a second solid tumor product candidate, bringing us closer toward our goal of generating effective Gammabody medicines for cancer patients. We look forward to working with Seagen to develop potential next generation cancer treatments.”
About LAVA-1223
LAVA-1223 is a potential first-in-class therapy designed specifically to target and activate Vg9Vd2 (gamma delta) T cells in the presence of epidermal growth factor receptor (EGFR)-expressing tumor cells. EGFR is a well-validated target that is over-expressed in multiple solid tumor types including colorectal cancer, lung cancer and head and neck cancer.
About Seagen
Seagen is a global biotechnology company that discovers, develops and commercializes transformative cancer medicines to make a meaningful difference in people’s lives. Seagen is headquartered in the Seattle, Washington area, and has locations in California, Canada, Switzerland and the European Union. For more information on our marketed products and robust pipeline, visit www.seagen.com and follow @SeagenGlobal on Twitter.
About LAVA Therapeutics
LAVA Therapeutics N.V. is a clinical-stage immuno-oncology company utilizing its proprietary Gammabody™ platform to develop a portfolio of bispecific gamma delta T cell engagers for the potential treatment of solid and hematological malignancies. The Company utilizes bispecific antibodies engineered to selectively kill cancer cells by triggering Vg9Vd2 (Vgamma9 Vdelta2) T cell antitumor effector functions upon cross-linking to tumor-associated antigens. For more information, please visit www.lavatherapeutics.com, and follow us on LinkedIn, Twitter and YouTube.
Seagen Forward-Looking Statements
Certain statements made in this press release are forward-looking, such as those, among others, relating to the therapeutic potential of LAVA-1223 and the Gammabody™ platform, including possible efficacy, safety and therapeutic uses, as well as clinical development plans.
Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include, without limitation, the possibility that clinical trials may fail to establish sufficient efficacy; that adverse events or safety signals may occur; that adverse regulatory actions or other setbacks could occur in clinical trials even after promising results in earlier clinical trials or preclinical studies; that setbacks in development could occur as a result of the difficulty and uncertainty of pharmaceutical product development; and other factors. More information about the risks and uncertainties faced by Seagen is contained under the caption “Risk Factors” included in the company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2022 filed with the Securities and Exchange Commission. Seagen disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
LAVA’s Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements, including with respect to the company’s anticipated growth and clinical development plans, including the timing of clinical trials. Words such as “anticipate,” “believe,” “could,” “will,” “may,” “expect,” “should,” “plan,” “intend,” “estimate,” “potential” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on LAVA’s expectations and assumptions as of the date of this press release and are subject to various risks and uncertainties that may cause actual results to differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the preclinical data, clinical development and scope of clinical trials, and the potential use of our product candidates to treat various tumor targets. Many factors, risks and uncertainties may cause differences between current expectations and actual results including, among other things, the timing and results of our research and development programs and preclinical and clinical trials, our ability to obtain regulatory approval for and commercialize our product candidates, our ability to leverage our initial programs to develop additional product candidates using our Gammabody™ platform, and the failure of LAVA’s collaborators to support or advance collaborations or our product candidates. The COVID-19 pandemic may disrupt our business and that of the third parties on which we depend, including delaying or otherwise disrupting our clinical trials and preclinical studies, manufacturing and supply chain, or impairing employee productivity. In addition, there may be adverse effects on our business condition and results from general economic and market conditions and overall fluctuations in the United States and international equity markets, including deteriorating market conditions due to investor concerns regarding inflation and hostilities between Russia and Ukraine. LAVA assumes no obligation to update any forward- looking statements contained herein to reflect any change in expectations, even as new information becomes available.
CONTACTS
Seagen Contact:
For Media David Caouette 310-430-3476
dcaouette@seagen.com
For Investors Douglas Maffei, Ph.D. 425-527-4881
dmaffei@seagen.com
LAVA Contact:
For Investors:
ir@lavatherapeutics.com
For IR/Media Argot Partners 212-600-1902
lava@argotpartners.com
| 1 Fighting Cancer with Precision Gammabody ™ Platform Corporate Presentation September 2022 |
| 2 Legal Disclosure: Forward - looking Statements This presentation contains forward - looking statements, including with respect to the company’s anticipated growth and clinical development plans, including the timing of clinical trials .. Words such as “anticipate,” “believe,” “could,” “will,” “may,” “expect,” “should,” “plan,” “intend,” “estimate,” “potential” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward - looking statements .. These forward - looking statements are based on LAVA’s expectations and assumptions as of the date of this presentation and are subject to various risks and uncertainties that may cause actual results to differ materially from these forward - looking statements .. Forward - looking statements contained in this presentation include, but are not limited to, statements about the preclinical data, clinical development and scope of clinical trials, and the potential use of our product candidates to treat various tumor targets .. Many factors, risks and uncertainties may cause differences between current expectations and actual results including, among other things, the timing and results of our research and development programs and preclinical and clinical trials, our ability to obtain regulatory approval for and commercialize our product candidates, our ability to leverage our initial programs to develop additional product candidates using our Gammabody ™ platform, and the failure of LAVA’s collaborators to support or advance collaborations or our product candidates .. The COVID - 19 pandemic may disrupt our business and that of the third parties on which we depend, including delaying or otherwise disrupting our clinical trials and preclinical studies, manufacturing and supply chain, or impairing employee productivity .. In addition, there may be adverse effects on our business condition and results from general economic and market conditions and overall fluctuations in the United States and international equity markets, including deteriorating market conditions due to investor concerns regarding inflation and hostilities between Russia and Ukraine .. LAVA assumes no obligation to update any forward - looking statements contained herein to reflect any change in expectations, even as new information becomes available .. |
| 3 Investment Highlights Clinical - Stage Company Developing Bispecific Gamma Delta T Cell Engagers © LAVA Therapeutics 2022 • Gammabody ™ Platform - Bispecific antibodies linking V 9V 2 T cells to tumor targets to l everage the unique anti - tumor potential of V 9V 2 T cells • Strongly enhance tumor cell killing while retaining tumor specificity • Advantages: Low risk for on - target/off - tumor toxicity, co - activation of suppressor T cells and cytokine release syndrome Approach • Two programs in Phase 1/2a trials, initial data released ASCO 2022, additional data read - outs later in 2022 and 2023 Clinical Stage Company • First investigational products from product concept to clinical trial in 5 years Team that Delivers • $110.7M (Q2 2022) in cash and investments; c ash runway greater than two years • Collaborations with Janssen (J&J) and Seagen Well - funded |
| 4 Differentiated Gammabody ™ Pipeline in Hematologic & Solid Tumor Indications Solid Tumor Hematologic malignancy MM: multiple myeloma CLL: chronic lymphocytic leukemia AML: acute myeloid leukemia PSMA: prostate - specific membrane antigen EGFR: epidermal growth factor receptor mCRPC : metastatic castration - resistant prostate cancer © LAVA Therapeutics 2022 Candidate Target Indication(s) Discovery Preclinical Phase 1 Phase 2 Phase 3 Milestones LAVA - 051 CD1d MM CLL AML • Phase 1 data 2Q 2022 (ASCO) • Additional data in 2H 2022/1H 2023 LAVA - 1207 PSMA mCRPC • Phase 1 data Q1 2023 (ASCO GU) • Phase 2a expansion cohort data 1H 2023 LAVA - 1223 EGFR Solid Tumors • Licensed to Seagen Sept 2022 LAVA - 1266 CD123 Hematologic Malignancies • IND / CTA filing expected YE 2023 LAVA - 1278 CD40 Hematologic Malignancies Janssen Biotech Collaboration undisclosed |
| 5 Established Leadership with Proven Experience in Drug Discovery & Development Ton Adang, PhD CDO Paul Parren, PhD EVP, Head of R&D Hans van der Vliet, MD, PhD CSO Steve Hurly, MSc, MBA President & CEO • 25+ years leadership experience in life sciences industry • Former President & CEO, Sesen Bio, a NASDAQ - listed oncology biotech • Veteran in strategic drug development • 15+ years investment banking experience • Industry leader in antibody science and drug development • Former Head of Preclinical Development & Research, Genmab • Inventor of five marketed therapeutic antibodies, including a bispecific • Vast experience inventing, developing therapeutic antibodies and technologies, including DARZALEX & DuoBody • Medical oncologist, professor at the Department of Medical Oncology, Amsterdam UMC • Inventor of LAVA’s gamma delta T cell engager platform • Extensive experience as clinical investigator Benjamin Winograd, MD, PhD CMO • Expertise in drug development programs in hematology and oncology, including several successful regulatory filings • Former roles at Bristol - Myers Squibb, Pharmacia, Schering - Plough & Celgene • Previous Head of Clinical R&D for Multiple Myeloma, Celgene • Vast experience in drug development • Former roles at Organon, Schering - Plough & Merck/MSD • Leadership positions in Lead Discovery and Project Management (i.e., Merck’s KEYTRUDA) • Extensive global, diversified legal and team building experience; 15+ years practicing law • Most recently Associate General Counsel, Spark Therapeutics (Roche), serving as a strategic advisor for U.S. launch of first gene therapy • Previously at Sandoz (Novartis) and Ballard Spahr LLP as business and transactional attorney Amy Garabedian General Counsel © LAVA Therapeutics 2022 |
| 6 Gamma Delta T Cells Uniquely suited for an anti - cancer T cell engager approach V 9V 2 T Cells |
| 7 V 9V 2 T Cells are Uniquely Positioned to Leverage Innate & Adaptive Immunity V 9V 2 T cells are an abundant, homogeneous effector cell population associated with positive outcomes in cancer patients Adaptive Immunity Innate Immunity Yeung MM, et al. Gut 2000; 47:215 Kimura Y, et al. Cancer Sci 2016; 107:1206 Lo Presti , et al, Front Immunol 2014; 5:1 Wu P, et al. Immunity 2014;40:785 Adams EJ, et al. Annu Rev Immunol 2013; 31:529 Lo Presti E, et al. Cancer Immunol Res 2017; 5:397 Adapted from Dranoff G., Nature Rev. Cancer 2004; 4: 11 - 22 V 2 T cells • Natural ability to recognize and kill tumor cells • Highly cytotoxic • Largest - T cell subset: ~90 - 95% in peripheral blood • Monomorphic TCR: V 2 preferentially pairs with V 9 • Well - defined specificity: phosphoantigen - BTN2A1/3A1 complex • Consistent proinflammatory cytotoxic effector T cell population • Unique antigen presenting ability – potential for durable response • Positive association with outcome in cancer patients Pang DJ, et al. Immunology 2012; 136:283 Adams EJ, et al. Cell Immunol 2015; 296:31 Siegers GM, et al. Mol Ther 2014; 22:1416 © LAVA Therapeutics 2022 |
| 8 T Cells Present in Many Cancers & Correlated With Favorable Prognosis Adapted from Tosolini M et al. Oncoimmunology 2017; 6, e1284723 T cells indicate highest correlation with favorable outcome among all leukocyte subsets analyzed V 9V 2 T cells are present across a wide array of hematological and solid malignancies Abundance of Tumor - Infiltrating Vg9Vd2 T Cells Adapted from Gentles A et al, Nature Medicine 2015; 21:938 - 945 * In vivo/ex vivo data generated using Lava’s - bsTCEs Unweighted [meta - 2] Leukocytes Ranked By Survival Hematological Malignancies Solid Tumors (Abundance) N=5,782 Tumors ■ Favorable ■ Adverse Global Prognostics Associations for 22 Leukocyte Types Across 25 Cancers © LAVA Therapeutics 2022 |
| 9 LAVA’s Proprietary Gammabody ™ Platform Bispecific Gamma Delta T Cell Engagers |
| 10 Systemic Activation of V 9V 2 T Cells Showed Promise • Systemic activation and proliferation via treatment with V 9V 2 T cell - based therapy (synthetic phosphoantigens ( BrHPP ) / aminobisphosphonates ± low - dose IL - 2) Early attempts with V 9V 2 T cell - based therapy showed promise, but efficacy may have been limited by systemic, non - tumor specific activation of V 9V 2 T cells and exhaustion in vivo activation ex vivo activation • Clinical trials with in/ex vivo activation protocols showed promising objective responses and safety • No signs of cytokine release syndrome (CRS) as a result of V 9V 2 T cell activation cell transfer therapy isolation of T cells Tumor Pre - Treatment Post - Treatment Lung metastases of RCC; adoptive transfer Lymphoma; NBP / IL - 2 Kobayashi H et al., Cancer Immunol Immunother 2011; 60: 1075 - 1084 Wilhelm M et al., Blood 2003; 102: 200 - 206 © LAVA Therapeutics 2022 |
| 11 Off - the - Shelf Gammabody ™ Platform: Enhances Innate Tumor Recognition by Directing V 9V 2 T Cells to the Cancer Cells LAVA’s Gammabody ™ adds tumor antigen - specific recognition, while retaining stress signal recognition, to target and activate V 9V 2 T cells to induce both direct tumor cell killing and orchestrate an immunological cascade of anti - cancer responses V 9V 2 T cells recognize stress signals – TCR interacts with pAg - butyrophilin complex Conditionally activate V 9V 2 T cells upon crosslinking with tumor associated antigen (TAA) Gammabody ™ Provides Tumor Recognition to Trigger V 9V 2 T Cell - Mediated Immunity 1 2 Retains recognition of natural stress signals Natural Activation Mechanism V 9V 2 TCR Gammabody ™ TAA butyrophilin V 9V 2 T cell V 9V 2 T cell Tumor cell butyrophilin Tumor cell V 9V 2 TCR 1 pAg pAg © LAVA Therapeutics 2022 |
| 12 Cascade Response – Potential Translation to Favorable Therapeutic Window Efficacy: Safety: In addition to direct tumor cell killing , V 9 V 2 T cells have the potential to orchestrate an immunological cascade response that includes activation of innate and adaptive immune cells in the tumor microenvironment • Potent killing of cancer cells (EC 50 s in the low picomolar range) • No co - activation of immune - suppressive Tregs which dampen antitumor efficacy of cytotoxic T cells • Orchestrate innate and adaptive immune responses, potentially resulting in potent and durable responses • Activity against hematologic malignancies and solid tumors, including immunologically “cold” tumors • Potential for expansion of V 9V 2 T cells can result in an increased number of anti - tumor V 9V 2 T cells in the tumor • Conditional activation with high accuracy • Greatly reduced potential for cytokine release syndrome (CRS); No evidence of CRS in NHP studies Adapted from Dranoff G, Nature Rev Cancer 2004; 4: 11 - 22 Kabelitz D et al., Cell Mol Immunol 2020; 17: 925 – 939 © LAVA Therapeutics 2022 |
| 13 Potent Killing of Cancer Cells in Preclinical Models Highly Potent Durable Dose Dependent and Serial Killing Conditional Activation EGFR Gammabody ™ - Induced Cytotoxicity CD1d Gammabody ™ Triggers Lysis of CCRF - CEM Tumor Cells Killing of Primary Colorectal Cancer Cells by EGFR Gammabody ™ Sustained EGFR Gammabody ™ - Mediated Killing of Tumor Cells by V 9V 2 T Cells de Bruin RC et al., OncoImmunology 2017; 7: e1375641, right bottom Data on file: LAVA Therapeutics N.V. , top row and left bottom © LAVA Therapeutics 2022 |
| 14 Expansion & Cascade Response Without Treg Activation in Preclinical Models Gammabody ™ can induce robust gamma delta T cell expansion and can amplify the anti - tumor immune response via downstream activation of other immune cells while avoiding co - activation of immunosuppressive T cells such as Tregs Expansion No Treg Activation Cascade Response Gammabody ™ - Mediated Expansion of V 9V 2 T Cells no bsTCE CD1d Gammabody ™ CD40 Gammabody ™ A431 Treg EGFR - CD3 TCE EGFR Gammabody ™ PBMC + tumor + tumor + EGFR Gammabody ™ N=4; *: p<0.05, **: p<0.01 © LAVA Therapeutics 2022 Data on file: LAVA Therapeutics N.V. |
| 15 Gammabody ™ Can Selectively Kill Cancer Cells W hile Sparing Healthy Cells in Hematologic Malignancy and Solid Tumor models • 2:1 ratio ( T cells : Target cells) • Similar CD20 expression levels on C1R neo and B - cells CD20 Gammabody ™ Mediated Killing PSMA Gammabody ™ Mediated Killing Preferential killing of cancer versus healthy cells demonstrated in vitro and ex vivo ; may prevent on - target/off - tumor mediated toxicity and allow for targeting of widely expressed tumor associated antigens **** p<0.001 Prostate Cancer Normal Prostate Medium + PSMA Gammabody ™ + V 9V 2 T cells + V 9V 2 T cells + PSMA Gammabody ™ © LAVA Therapeutics 2022 Data on file: LAVA Therapeutics N.V. |
| 16 Fully Cross - Reactive bsTCEs are Well - Tolerated in Non - Human Primates • Mild to no clinical signs of toxicity • Low cytokine spike, which did not result in CRS • No clinical chemistry abnormalities • No histopathological abnormalities • Gammabody ™ detectable on peripheral blood and lymph node gamma delta T cells NHP data support the potential benign safety profile of LAVA’s Gammabody ™ platform CD1d - , CD20 - targeting surrogate Gammabody TM (without Fc ) were dosed up to 10 mg/kg (4 hr infusion, 4 doses, every 2 days) and biweekly at 1 mg/kg for 1 month EGFR - targeting surrogate Gammabody ™ (without Fc ) was dosed up to 10 mg/kg (4 hr infusion, 4 doses, every 2 days) EGFR - targeting surrogate Gammabody ™ ( Fc - containing ) was dosed up to 23 mg/kg (0.5 hr infusion, 4 weekly doses) © LAVA Therapeutics 2022 Data on file: LAVA Therapeutics N.V. |
| 17 LAVA - 051 Activates T Cells and iNKT Cells by Targeting CD1d for the Treatment of CLL, MM & AML |
| 18 LAVA - 051: First - in - Class Gammabody ™ Targeting CD1d • Principal Mechanism of Action ( MoA ): Targets and activates V 9V 2 T cells in the presence of CD1d - expressing tumor cells • Secondary MoA : Activates iNKT cells against CD1d - expressing tumor cells ‒ Direct cytotoxicity against CD1d - positive tumor cells ‒ Promotes the cytotoxic activity of V 9V 2 T cells and iNKT cells Tumor Cell iNKT Cell V 9V 2 T Cell TCR CD1d β 2 m • Enrollment underway in Phase 1/2a clinical trial ‒ MM, CLL, and, at higher dose levels, AML ‒ Initial data disclosed ASCO 2022 ‒ Additional data expected in 4Q 2022 • Potential accelerated approval pathways available iNKT TCR © LAVA Therapeutics 2022 |
| 19 LAVA - 051: Targeting CD1d for Hematological Cancers CD1d is expressed on tumors cells in a high proportion of patients with CLL, MM & AML CD1d expression (MF index) Isotype Isotype Isotype 0.5 1 2 4 8 16 32 64 128 N=39 N=51 N=85 AML MM CLL © LAVA Therapeutics 2022 Data on file: LAVA Therapeutics N.V. |
| 20 CLL AND MM AML (highest dose levels only) Optional adjustments: • Dosing frequency • Dose level • # cohorts CLL (n=20) MM (n=20) Twice - weekly dosing AML (n=20) LAVA - 051 Phase 1/2a Initiated in Hematological Malignancies Phase 1 first 4 cohorts dose escalation data presented at ASCO 2022; Additional data is expected in 4Q 2022; Dose Escalation Dose Expansion Recommended expansion dose/schedule n = estimated number of patients per indication Goal: Determine preliminary level of activity per disease Goal: Determine recommended dose and schedule based on optimal biological dose or maximum tolerated dose (MTD) © LAVA Therapeutics 2022 |
| 21 Biomarker analysis to validate whether LAVA’s Gammabody ™ platform performs in humans as predicted based on preclinical data LAVA - 051 Phase 1/2a: Extensive Biomarker Analysis Pharmacodynamics Cytokines (IL - 1β, IL - 2, IL - 6, IL - 8, TNF - α, IFN - γ, GM - CSF) B inding of LAVA - 051: V 9V 2 - T cells | CD1d positive tumor cells Activation status & frequency: V 9V 2 - T cells | iNKT cells Induction of activation of V 9V 2 - T cells ex vivo when exposed to CD1d (functional assay) Immune - monitoring ( frequency and activation status of B cells , T cell subsets , NK cells , monocytes, dendritic cells ) Disease assessments Tumor - defining markers/CD1d/BTN3A - MM (peripheral blood, urine, CT scan, bone marrow biopsy) - CLL (peripheral blood, CT scan, bone marrow biopsy) - AML (peripheral blood, bone marrow biopsy) Safety Chemistry / hematology / urine Pharmaco k inetics A nti - D rug A ntibodies © LAVA Therapeutics 2022 |
| 22 LAVA - 051 - Patient characteristics and time on treatment MM/CLL 3/3 Male/Female 5/1 Median age (range) 66 (60 - 75) Prior therapies, median (range) – MM/CLL 5 (4 - 6) 4 (3 - 5) DLT period PD PD PD PD COVID COVID © LAVA Therapeutics 2022 |
| 23 LAVA - 051 - Adverse events NS = not suspected; S = suspected A : Drug hypersensitivity Gr3 reported for CLL patient to allopurinol administered as TLS prophylaxis; allergy to allopurinol con firmed through repeat occurrence to single agent prophylaxis. B : Fever Gr2 reported for CLL patient in conjunction with 'tumor flare’. C : Diverse electrolyte imbalances reported for MM patient: hypercalcemia Gr3 and hypomagnesemia Gr2 reported 2 days following 1s t treatment - discontinuation of calcium carbonate and colecalciferol , all resolved; hypophosphatemia Gr2 reported 14 days following 1st treatment - all resolved; hypokalemia Gr2 reported 21 days followi ng 1st treatment - resolved. D : Neutropenia Gr3 reported for MM patient 14 days following first treatment - readily resolved with one dose of pegfilgrastim .. E : Infusion related reaction Gr2 within 15 minutes of end of infusion; no reappearance during following infusions administered f ollowing clemastine and paracetamol prophylaxis. Data cut - off date of presented data was 2 May 2022 • Overall well tolerated • No CRS • No ICANS • No DLTs Cycle 1 Worst grade per patient TEAE Grade ≥2 0.45 g (N=1) 3 g (N=1) 15 g (N=1) 45 g (N=3) Total (N=6) Relatedness AE NS S NS S NS S NS S Bone pain 1 1 Cancer pain 1 1 Contrast media allergy 1 1 Decreased appetite 1 1 Diarrhea 1 1 Drug hypersensitivity 1 A 1 Dyspnea exertional 1 1 Fatigue 1 1 Hypercalcemia 1 C 1 Hypoalbuminemia 1 1 Hypokalemia 1 C 1 Hypomagnesemia 1 C 1 Hypophosphatemia 1 C 1 Infusion related reaction 1 E 1 Lumbar vertebral fracture 1 1 Motor dysfunction 1 1 Neutropenia 1 1 D 2 Pain in extremity 1 1 Pyrexia 1 B 1 Rhinitis 1 1 © LAVA Therapeutics 2022 |
| 24 LAVA - 051 - Pharmacodynamics • V 9 V 2 T cell activation markers (CD 25 and CD 69 ) consistently upregulated following dosing, in each dose cohort • Maximum measured V 9 V 2 T cell receptor occupancy (RO) increased with higher dose cohorts • iNKT cell activation was assessable, and observed, in one patient (cohort 2 ) • No significant increase in the CRS - related cytokine IL - 6 = dosing = missed dose Dose/ patient ID V 9 V 2 T cell frequency (% of CD3+) % CD25+ V 9 V 2 - T cells Baseline Post - dosing (range) Baseline Post - dosing (max) 0.45 g/03 - 001 0.00 ND ND ND 3 g/02 - 001 0.51 0.31 - 0.74 18.2 51.5 15 g/02 - 002 1.46 0.02 - 1.08 0.9 7.9 45 g/03 - 003 0.41 0 - 0.42 15.2 35.6 45 g/01 - 001 0.45 0 - 0.10 12.5 55.6 45 g/02 - 003 0.05 0 - 0.07 0 50.0 © LAVA Therapeutics 2022 |
| 25 LAVA - 051 – Potential signs of activity 0 25 50 75 100 125 0.01 0.1 1 Treatment days Cell count (x10 9 /L) Lymphocytes Clonal B cells R/R = Relapsed/Refractory; iwCLL = international workshop on C hronic Lymphocytic L eukemia. Permission for photo obtained. MM • High risk MM patient ( 45 g) • 4 prior lines of therapy within 6 years from diagnosis : – Bortezomib, Cyclo , Dex → auto HSCT – Carfilzomib, Lenalidomide, Dex – Pomalidomide, Dex – Daratumumab, Dex • Refractory to last 3 lines of treatment • 23 % reduction in M - protein • Patient stopped due to COVID CLL • Patient with R/R CLL ( 15 g) : temporary enlargement and tenderness of several involved lymph nodes accompanied by grade 2 fever during Cycle 1 ; resembled a tumor - flare reaction • Other causes of enlargement of involved LNs ruled out • Patient assessed as having stable disease per iwCLL criteria ( 2018 ) • Percent of clonal B cells in peripheral blood decreased from 41 .. 8 % at baseline to 8 .. 9 % at the start of Cycle 4 • Patient stopped after Cycle 5 due to COVID © LAVA Therapeutics 2022 |
| 26 Conclusions • LAVA - 051 is the first of a novel class of bispecific T cell engagers with expected broad therapeutic window – Bispecific single domain antibody engaging CD 1 d and V 2 - TCR chain of V 9 V 2 - T cells to mediate potent killing – Low potential for CRS observed in preclinical models and clinical setting when V 9 V 2 - T cells are activated • LAVA - 051 has safely reached 100x the starting dose in CLL and MM – No CRS and no ICANS (ASTCT) – No significant increase in the CRS - related cytokine IL - 6 – Most observed AEs have not been suspected to be related – No DLTs • No ADA’s detected to date • Predictable and linear pharmacokinetics • PD parameters reflect changes as expected per MoA – V 9 V 2 - T cell activation markers (CD 25 and CD 69 ) were consistently upregulated following dosing, in each dose cohort .. – Maximum measured V 9 V 2 - T cell receptor occupancy increased with higher dose cohorts – iNKT cell activation was assessable, and observed, in one patient (cohort 2 ) • Preliminary signs of clinical activity in a CLL patient and MM patient • Trial continuing, including US sites (IND cleared) and evaluation of s.c. dosing ASTCT = American Society for Transplantation and Cellular Therapy ICANS = Immune Effector Cell Associated Neurotoxicity Syndrome DLT = Dose Limiting Toxicity ADA = Anti - Drug Antibody; MoA = Mechanism of Action © LAVA Therapeutics 2022 |
| 27 LAVA - 1207 Activates T Cells by Targeting PSMA for the Treatment of mCRPC |
| 28 LAVA - 1207: Targeting PSMA for Prostate Cancer PSMA + tumor cells LAVA - 1207 VHH - Fc ~80kD V 9V 2 T cells • Specifically targets and mediates activation of V 9 V 2 T cells against PSMA - expressing tumor cells • PSMA is a well - validated tumor target ‒ Mediates PSMA - dependent activation of V 9 V 2 T cells resulting in potent killing of PSMA - positive tumor cells • Fc added to extend half life, silenced to avoid Fc - mediated effector functions • Pre - clinical data support MoA , anti - cancer activity & selectivity • Phase 1 / 2 a trial advancing ; patient recruitment ongoing ‒ Metastatic castration - resistant prostate cancer ( mCRPC ) ‒ Initial Phase 1 data expected in 4 Q 2022 © LAVA Therapeutics 2022 |
| 29 LAVA - 1207 Phase 1/2a in Metastatic Castration - Resistant Prostate Cancer ( mCRPC ) Therapy Refractory mCRPC Optional Adjustments: • Dosing frequency • Dose level • # cohorts Therapy Refractory mCRPC (n=30) Dosing: Every 2 Weeks LAVA - 1207 Phase 1/2a Initiated; Patient Recruitment Underway Dose Escalation Dose Expansion Recommended expansion dose / schedule Goal: Determine preliminary level of activity Goal: Determine recommended dose and schedule based on MTD or optimal biological dose © LAVA Therapeutics 2022 |
| 30 Key Preclinical Programs |
| 31 Potential for LAVA - 1223 Across a Number of EGFR - Expressing Solid Tumors Data on file: LAVA Therapeutics N.V. and Janssen Biotech Inc. 0 20 40 60 80 100 Bladder Breast Colon Glioma Head & Neck NSCLC Ovarian Pancreatic RCC Percentage overexpression range EGFR Expression by Tumor Type (Range) Sustained EGFR Gammabody ™ Mediated Killing of Tumor Cells by V 9V 2 T Cells EGFR Gammabody ™ Concentration (Log10 pM ) © LAVA Therapeutics 2022 |
| 32 LAVA - 1266 Shows Promise for Hematological Malignancies 0.01 0.1 1 10 100 1000 0 20 40 60 80 100 CD123 Gammabody TM Concentration [pM] Specific cell death of primary AML cells (%) EC50 ~ 8 pM 0.01 0.1 1 10 100 1000 0 20 40 60 80 100 CD123 Gammabody TM Concentration [pM] THP-1 cell line cytotoxicity (%) EC50 ~ 3 pM Potent L ysis of AML Cell L ine and P rimary AML Cells by CD123 Gammabody ™ CD123 is Overexpressed in a Wide Range of Hematological Malignancies • AML • B - ALL • Hairy cell leukemia • Hodgkin lymphoma • Blastic plasmacytoid dendritic cell neoplasm • B - cell chronic lymphoproliferative disorders • MDS CD123 expression FSC CD123 expression on AML cells © LAVA Therapeutics 2022 Data on file: LAVA Therapeutics N.V. |
| 33 Milestones |
| 34 • 3L+ mCRPC pts • Adoptive FIH study design, dose escalation • Key data: Safety, initial anti - tumor activity, estimation of therapeutic window • Initial study in relapsed/refractory MM, CLL; relapsed/refractory AML added at biological relevant dose(s) • Adoptive FIH study design, dose escalation • Key data: Safety, initial anti - tumor activity, estimation of therapeutic window 2H22 1H22 Two Lead Programs in Clinic with Near - Term Milestones Cash runway greater than two years Phase 1: Initial Dose Escalation in 4Q 2022 1H23 Additional clinical data in 4Q 2022 Additional clinical data 2H 2023 LAVA - 051 (CD1d) LAVA - 1207 (PSMA) Phase 1 Dose Escalation (ASCO) © LAVA Therapeutics 2022 |
| 35 Corporate Presentation September 2022 |
