SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
For the month of November, 2022
Commission File Number: 001-36619
Im Neuenheimer Feld 582,
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of 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): ☐
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): ☐
ENTRY INTO A MATERIAL DEFINITIVE AGREEMENT
On November 1, 2022, Affimed GmbH, a subsidiary of Affimed N.V. (together with Affimed GmbH, Affimed or the Company) entered into a collaboration agreement (the Agreement) with Artiva Biotherapeutics, Inc. (Artiva) for the clinical development and commercialization of a combination therapy, for any uses in humans or animals, comprising Affimeds product consisting of an innate cell engager referred to as AFM13 (the Affimed Product) and Artivas product containing an NK cell referred to as AB-101 (the Artiva Product). As of the effective date of the Agreement, the following indications are included in the joint development plan: CD30+ Hodgkin Lymphoma and Peripheral T-Cell Lymphoma. While the collaboration is initially limited to the United States, the parties will, upon Affimeds request, in good faith discuss an expansion to certain other territories.
Artiva has granted Affimed, with respect to the clinical development of the combination therapy an exclusive, and with respect to the promotion of the combination therapy under the Agreement a non-exclusive, non-transferable (except to affiliates and successors in interest), royalty-free and non-sublicensable (with certain exceptions) license under Artiva patents and know-how. Affimed has granted Artiva a non-exclusive, non-transferable (except to affiliates and successors in interest), royalty-free license and non-sublicensable (with certain exceptions) license under Affimed patents and know-how for use in the clinical development of the combination therapy under the Agreement.
Under the terms of the Agreement and the development plan agreed between the parties, Affimed will be primarily responsible for the development of the combination therapy, the conduct of the relevant clinical trials and the preparation and filing of regulatory materials during the clinical development. Artiva will support Affimed in the development, in particular through the supply of the Artiva Product and certain other products to be used in the clinical trials. Affimed will have the sole right and responsibility to promote the combination therapy according to a jointly aligned promotion plan.
Each party must use commercially reasonable efforts to perform the tasks assigned to it under the Agreement and the development plan. Affimed must also use commercially reasonable efforts to file an IND for the combination therapy and dose first patients within certain timeframes. In addition, each party must use commercially reasonable efforts to obtain and maintain regulatory approvals required to commercialize its product as part of the combination therapy. Each party must also use commercially reasonable efforts to supply its respective product in the quantities required for the clinical trials according to a jointly agreed clinical demand plan (which forms part of the development plan) as well as for commercialization according to jointly agreed commercial demand projections (which will be updated on a rolling quarterly basis during the commercial phase).
During the term of the Agreement, and subject to certain exceptions, neither party nor its affiliates is allowed to clinically develop or commercialize any product or therapy comprising its product in the territory for any indication which is included in the development plan under the Agreement. In addition, during the term of the Agreement, and subject to certain exceptions, Affimed may not combine the Affimed Product with other NK cells, and Artiva may not clinically develop or commercialize the any product that directly and specifically binds to CD30.
The financial terms of the Agreement foresee that Affimed shall be responsible for all costs associated with the development of the combination therapy (including all clinical trial costs), except that Affimed and Artiva shall each bear 50% of the costs and expenses incurred in connection with the performance of any confirmatory clinical trial required by the FDA. Artiva shall be solely responsible for all costs incurred by Artiva for the supply of AB-101 and certain other products used in the clinical trials. In addition, under the Agreement, the parties agree to make payments to each other to achieve a proportion of 67%/33% (Affimed/Artiva) of revenues generated by both parties from commercial sales of each partys product as part of the combination therapy (such payment obligations to expire country-by-country upon expiry of collaboration patents and data exclusivity or upon biosimilar market entry).
Each party will own intellectual property that solely constitutes an improvement or enhancement to its respective background intellectual property. Other inventions generated in the performance of the development under the Agreement will be jointly owned by Affimed and Artiva. The clinical data generated in connection with the clinical trials under the Agreement shall be jointly owned, provided that prior to publication of such data, both parties are subject to certain usage restrictions of such data outside the collaboration.
The parties collaboration will be overseen by a joint steering committee (the JSC) with respect to the development and by a joint commercialization committee (the JCC) with respect to the commercialization, each consisting of an equal number of representatives of Affimed and Artiva. If the JSC or JCC is unable to reach an agreement in a particular matter, the dispute shall be escalated to the joint executive committee (the JEC) consisting of two executive members of either party. Affimed will have the final decision-making authority on the JEC, provided that certain matters (including the expansion of the development to additional indications and the adjustment of the protocol) require unanimous vote.
The Agreement will expire if there is no payment obligation under the Agreement in the territory. Either party may terminate the Agreement in its entirety for any uncured (within 60 days after notice) material breach of the Agreement by the other party or upon the other partys insolvency. In addition, Affimed may terminate the agreement if the futility assessment in an already pending trial for the Artiva Product is not passed.
Both parties may (during certain time windows during the development phase, but only before initiation of a confirmatory clinical trial for the combination therapy) opt out of the further development and promotion of the combination therapy. If a party opts out, the other party may continue the development and promotion of the combination therapy, in which case the opting-out party is required to provide certain continued support activities (e.g., supply of its Product), and the revenue ratio applicable to each party shall be adjusted. In addition, if Affimed opts out, Affimed will be compensated for a portion of its costs incurred before the opt-out through a buy down payment from Artiva (which will however not become payable if Affimed opts out after a change of control of Affimed).
The foregoing description of the Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of such document, a copy of which Affimed intends to file as an exhibit to its Annual Report on Form 20-F for the year ended December 31, 2022.
INCORPORATION BY REFERENCE
This Report on Form 6-K shall be deemed to be incorporated by reference into the registration statements on Form F-3 (Registration Number 333-251658), Form F-3 (Registration Number 333-260946) and Form S-8 (Registration Numbers 333-198812) of Affimed N.V. 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 99.1 to this Report on Form 6-K shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934 (the Exchange Act) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act.
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, thereunto duly authorized.
|Date: November 3, 2022||By:||/s/ Adi Hoess|
|Title:||Chief Executive Officer|
|By:||/s/ Angus Smith|
|Title:||Chief Financial Officer|
Description of Exhibit
|99.1||Affimed N.V. Press Release, dated November 3, 2022.|
Affimed and Artiva Biotherapeutics Announce Partnership to Advance
Combination Therapy of Innate Cell Engager (ICE®) AFM13
and Off-the-Shelf Allogeneic NK Cell Therapy AB-101
Companies to combine their clinical programs (AFM13, AB-101) to address high unmet need of CD30-positive lymphoma patients
Affimeds AFM13 in combination with cord blood-derived NK cells demonstrated exceptionally high response rates in relapsed and refractory CD30-positive lymphoma patients
AB-101 is a clinical-stage, cryopreserved, off-the shelf, non-genetically modified, allogeneic cord blood-derived NK cell manufactured at large scale via Artivas AlloNKTM platform as a universal ADCC-enhancing cell therapy
In preclinical studies, the combination of AFM13 and AB-101 demonstrated potent anti-tumor activity
An investigational new drug (IND) submission to the U.S. Food and Drug Administration (FDA) is planned for the first half of 2023
Affimed to receive 67% of the combination therapy revenues, and Artiva to receive 33%
Conference call and webcast scheduled for November 3, 2022 at 10:30 a.m. EDT/15:30 CET
Heidelberg, Germany and San Diego, November 3, 2022 Affimed N.V. (Nasdaq: AFMD) (Affimed), and Artiva Biotherapeutics Inc. (Artiva), both immune-oncology companies focused on developing and commercializing therapies utilizing the innate immune system, today announced a new strategic partnership to jointly develop, manufacture, and commercialize a combination therapy comprised of Affimeds Innate Cell Engager (ICE®) AFM13 and Artivas cord blood-derived, cryopreserved off-the-shelf allogeneic NK cell product candidate, AB-101.
Affimed submitted a pre-IND meeting request for the AFM13 and AB-101 co-administered combination therapy to the FDA requesting feedback on the clinical trial design in relapsed/refractory (r/r) Hodgkin lymphoma (HL) with an exploratory arm evaluating the combination in r/r CD30-positive peripheral T-cell lymphoma (PTCL) and potential path to registration. FDA responded to this request and guided to providing feedback by Q1 2023.
This clinical agreement follows the parties existing two-year preclinical collaboration to assess combining elements of the companies respective platforms in the generation of targeted, off-the-shelf allogeneic NK cell therapies. As part of the collaboration, the companies evaluated the combination of AFM13 and AB101 in various preclinical models and generated data that supports development of a co-administered combination therapy.
Based on the compelling clinical data we have generated for AFM13 in combination with NK cells, we are committed to finding the fastest path to bringing this potentially life-changing treatment to lymphoma patients, said Dr. Adi Hoess, CEO of Affimed. The allogeneic NK field is still at a nascent stage, and we selected Artiva because of their commercially-viable production process that can support a multicenter clinical trial and potentially enable a path to registration.
We are developing AB-101 as a universal ADCC enhancer when combined with monoclonal antibodies and NK cell engagers, said Dr. Fred Aslan, CEO of Artiva. The data Affimed has generated to date with AFM13 in combination with cord blood-derived NK cells in a patient population with great unmet need is very compelling, and we are excited to partner with Affimed on what could become one of the first approvals for an allogeneic NK cell therapy-based regimen.
AFM13 is currently being investigated in combination with allogeneic cord blood-derived NK cells (CBNK) from The University of Texas MD Anderson Cancer Center. In this investigator sponsored study, data published earlier today for presentation at the 64th ASH Annual Meeting and Exposition demonstrated that all 24 patients in the recommended Phase 2 dose cohort responded (overall response rate of 100%) and showed a complete response rate of 70.8%. The combination was well tolerated with few infusion-related reactions and without cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, or graft versus host disease.
The Affimed-Artiva partnership aims to expedite further development of the combination therapy in CD30-positive lymphoma patients who have exhausted other treatment options. AB-101 has already completed a monotherapy safety cohort in an initial Phase 1 trial and is currently being assessed in combination with the anti-CD20 monoclonal antibody, rituximab, in patients with relapsed or refractory non-Hodgkin lymphoma (NHL). Preclinical results investigating the combination of AFM13 and AB-101 have further demonstrated enhanced anti-tumor activity. The companies plan to file an IND for the program in relapsed/refractory CD30-positive lymphoma patients during the first half of 2023.
Under the terms of the agreement, Affimed and Artiva will pursue the development of the AFM13/AB-101 combination treatment in the United States on a co-exclusive basis. Affimed will lead regulatory activities through Phase 2 and any confirmatory studies. Affimed will be responsible for funding clinical study costs through Phase 2, while Artiva will be responsible for the costs of supplying AB-101 and IL-2 for such studies. If accelerated approval is obtained, the companies will share confirmatory study costs on a 50/50 basis.
Both companies will retain commercialization and distribution rights and book sales for their respective products. Affimed will be responsible for promotional activities and expenses of the combination therapy. Pursuant to the agreement, revenues from the combination will be shared, with Affimed receiving 67% of the combination therapy revenue and Artiva receiving 33%.
Conference call and webcast information
Affimed and Artiva will host a conference call and webcast on November 3, 2022, at 10:30 a.m. EDT / 15:30 CET to discuss this partnership and next steps in the development of AFM13 in combination with AB-101. The conference call will be available via phone and webcast. A live audio webcast of the conference call will be available in the Webcasts section on the Investors page of the Affimed website at https://www.affimed.com/investors/webcasts-and-corporate-presentation/.
To access the call by phone, please use link
https://register.vevent.com/register/BIca92c598dd7a41319b8a09f5f7ce08bf, and you will be provided with dial in details and a pin number.
To avoid delays, we encourage participants to dial into the conference call fifteen minutes ahead of the scheduled start time.
A replay of the webcast will be accessible at the same link for 30 days following the call.
AFM13 is a first-in-class innate cell engager (ICE®) that uniquely activates the innate immune system to destroy CD30-positive hematologic tumors. AFM13 induces specific and selective killing of CD30-positive tumor cells, leveraging the power of the innate immune system by engaging and activating natural killer (NK) cells and macrophages. AFM13 is Affimeds most advanced ICE® clinical program and is currently being evaluated as a monotherapy in a registration-directed trial in patients with relapsed/refractory peripheral T-cell lymphoma (REDIRECT). Additional details can be found at www.clinicaltrials.gov (NCT04101331).
AB-101 is a cord blood-derived, allogeneic, cryopreserved, ADCC-enhancing NK cell therapy candidate for use in combination with monoclonal antibodies or innate-cell engagers. Artiva selects cord blood units with the high affinity variant of the receptor CD16 and a KIR-B haplotype for enhanced product activity. Artiva can generate thousands of doses of pure, cryopreserved, infusion-ready NK cells from a single umbilical cord blood unit while retaining the high and consistent expression of CD16 without the need for engineering. Artiva is conducting a Phase 1/2 multicenter clinical trial (ClinicalTrials.gov Identifier: NCT04673617) to assess the safety and clinical activity of AB-101 alone and in combination with the anti-CD20 monoclonal antibody, rituximab, in patients with relapsed or refractory B-cell-non-Hodgkin lymphoma (NHL) who have progressed beyond two or more prior lines of therapy.
About Affimed N.V.
Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to give patients back their innate ability to fight cancer by actualizing the untapped potential of the innate immune system. The companys proprietary ROCK® platform enables a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors, enabling a broad pipeline of wholly-owned and partnered single agent and combination therapy programs. The ROCK® platform predictably generates customized innate cell engager (ICE®) molecules, which use patients immune cells to destroy tumor cells. This innovative approach enabled Affimed to become the first company with a clinical-stage ICE®. Headquartered in Heidelberg, Germany, with offices in New York, NY, Affimed is led by an experienced team of biotechnology and pharmaceutical leaders united by a bold vision to stop cancer from ever derailing patients lives. For more about the companys people, pipeline and partners, please visit: www.affimed.com.
Artivas mission is to deliver highly effective, off-the-shelf, allogeneic NK cell-based therapies utilizing our Manufacturing-First approach, that are safe and accessible to cancer patients. Artivas pipeline includes AB-101, an ADCC enhancer NK-cell therapy candidate for use in combination with monoclonal antibodies or innate-cell engagers. Artiva is currently advancing a Phase 1/2 clinical trial of AB-101 in combination with rituximab for the treatment of relapsed or refractory B-cell lymphomas. Artivas pipeline also includes AB-201, an anti-HER2 CAR-NK cell therapy candidate for the treatment of HER2-overexpressing tumors, such as breast, gastric, and bladder cancers, and for which an IND has been allowed by FDA, and a pipeline of CAR-NK candidates targeting both solid and hematopoietic cancers. Artiva has entered into therapeutic NK cell collaborations with Merck Sharp & Dohme Corp. and with Affimed GmbH. Artivas AlloNK platform incorporates cell expansion, activation, and engineering technology developed by Artivas strategic partner, GC Cell Corporation, a member of the GC family of companies, a leading healthcare company in Korea. Artiva is headquartered in San Diego. For more information, please visit www.artivabio.com.
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as anticipate, believe, could, estimate, expect, goal, intend, look forward to, may, plan, potential, predict, project, should, will, would and similar expressions. Forward-looking statements appear in a number of places throughout this release and include statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the potential of AFM13 and AB-101 and the Affimed-Artiva partnership, the value of our ROCK® platform, our ongoing and planned
preclinical development and clinical trials, potential development pathways and commercial results. Actual results may differ for various reasons, including the risks, uncertainties and other factors described under the heading Risk Factors in Affimeds filings with the SEC, as well as the fact that the current clinical data of AFM13 in combination with NK cell therapy is based on AFM13 in combination with allogeneic cord blood-derived NK cells from The University of Texas MD Anderson Cancer Center, as opposed to AB-101, the timing and content of FDA guidance with respect to the AFM13/AB-101 combination, the clinical and commercial viability of AB-101 and the potential for commercial revenue from the collaboration. Given these risks, uncertainties, and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future.
Affimed Investor Relations Contact
Director, Investor Relations
Tel.: +1 (917) 436-8102
Affimed Media Contact
Mary Beth Sandin
Vice President, Marketing and Communications
Tel.: +1 (484) 888-8195
Artiva Investor Contact
Michael E. Faerm
Chief Financial Officer
Artiva Media Contact
Jessica Yingling, Ph.D.
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