New Preclinical Data being Presented at SITC Underscore Promising Combinations of Affimed's AFM13 and Cytokine-Activated Natural Killer Cells

• Virtual data presentation at The Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting on Wednesday, November 11, 2020

Heidelberg, Germany, November 9, 2020 – Affimed N.V. AFMD, a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today that preclinical data – generated through a collaboration with The University of Texas MD Anderson Cancer Center and Washington University School of Medicine – will be the focus of an oral presentation at the virtual Annual Meeting of the Society for Immunotherapy of Cancer (SITC), identifying promising combinations of Innate Cell Engager (ICE^®) AFM13 with cytokine-activated adult blood or cord blood natural killer (NK) cells against CD30-positive hematological malignancies. Nancy D. Marin, PhD, of Washington University School of Medicine will present these data virtually on Wednesday, November 11, 2020 from 3:45 – 5:15 p.m. EST during the session, "Innate Immunity: The Next Generation of Targets for Anti-Cancer Immunotherapy."

"The current set of preclinical in vitro and in vivo data demonstrate the increased efficacy of AFM13-preloaded cord blood-derived NK cells towards CD30-positive tumor cells," said Arndt Schottelius, M.D. PhD, Affimed's Chief Scientific Officer. "We are excited about these data that laid the groundwork for the ongoing Phase 1 evaluation of this combination to treat patients suffering from CD30+ malignancies."

NK cell-based immunotherapies represent an emerging field of targeting hard-to-treat cancers. To evaluate the potential of innate cell engagers (ICE^®) to trigger NK cell-directed tumor cell killing, the collaborative research analyzed AFM13-mediated tumor cell killing in combination with several NK cell products, including conventional (c)NK cells from healthy donors, NK cells from patients with Hodgkin Lymphoma, cytokine-induced memory-like (ML) NK cells from peripheral blood and preactivated and expanded cord blood (cb) NK cells. Affimed's tetravalent bispecific ICE^® AFM13 binds to CD30, a protein found on tumor cells, as well as CD16A, a molecule found on NK cells and macrophages, triggering the innate immune system to initiate tumor-cell killing. The cbNK cells were then stably pre-loaded with AFM13, enhancing responses to CD30+ lymphomas in vitro and in vivo in immunodeficient NSG mouse models.

AFM13-preloaded cNK cells from healthy donors exhibited superior responses versus those from Hodgkin lymphoma patients suggesting that the source of NK cells impacts tumor cell killing. IL-12, IL-15, and IL-18-induced ML NK cells exhibited enhanced killing of CD30+ lymphoma cells when directed by AFM13, compared to cNK cells. Similarly, AFM13 combined with cord-blood expanded NK cells that were pre-activated with IL-12, IL-15 and IL-18 also exhibited tumor cell killing compared to expanded cb NK cells.

"ICE^® molecules combined with NK cells have the potential to improve tumor cell killing of hard-to-treat cancers," said Dr. Marin from Washington University School of Medicine. "Based on this data, a patient with NK cells rendered dysfunctional could see meaningful benefit when adding cytokine-activated cord blood cells or ML NK cells to enhance the tumor cell killing of AFM13, helping restore functionality to their depleted NKs and innate immune system."

"The use of cbNK cells complexed with AFM13 to target lymphomas expressing CD30 represents a novel approach to immunotherapy. This technique has the potential to be extended to other cancer targets in the future, transforming pre-complex NK cells into de facto CAR NK cells, thus providing a rapid pathway for translating new NK cell therapies into the clinic," said first author Lucila Kerbauy, M.D., who led the work as a postdoctoral fellow at MD Anderson.

The presented data formed the basis of an Investigational New Drug (IND) Application and further substantiate the rationale for combining AFM13 with adoptive NK cell-based therapies,  as is being currently investigated in a Phase I clinical study at MD Anderson (NCT04074746). Additionally, these new data and methodology are also being used in a Phase I study with AFM24 – Affimed's tetravalent, bispecific ICE^® that binds to EGFR on tumor cells and CD16A on innate immune cells – in EGFR-positive advanced solid tumors to characterize NK cell phenotypes in patients (NCT04259450).

For more information visit the SITC website at www.sitcancer.org/2020/home.

About AFM13

AFM13 is a first-in-class CD30/CD16A ROCK^®-derived bispecific innate cell engager (ICE^®) that induces specific and selective killing of CD30-positive tumor cells by engaging and activating natural killer (NK) cells and macrophages, thereby leveraging the power of the innate immune system. AFM13 is Affimed's most advanced ICE^® clinical program, and it is currently being evaluated as a monotherapy in a registration-directed trial in patients with relapsed/refractory peripheral T-cell lymphoma (REDIRECT). The study is actively recruiting and can be found at www.clinicaltrials.gov using the identifier NCT04101331.

About Affimed N.V.

Affimed AFMD is a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer. Affimed's fit-for-purpose ROCK^® platform allows innate cell engagers to be designed for specific patient populations. The company is developing single and combination therapies to treat hematologic and solid tumors. The company is currently enrolling patients into a registration-directed study of AFM13 for CD30-positive relapsed/refractory peripheral T cell lymphoma and into a Phase 1/2a dose escalation/expansion study of AFM24 for the treatment of advanced EGFR-expressing solid tumors. For more information, please visit www.affimed.com.

Affimed Investor and Media Contacts

Alex Fudukidis
Head of Investor Relations
a.fudukidis@affimed.com

Mary Beth Sandin
Head of Marketing and Communications
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