Press Release - November 4, 2020
Heidelberg, Germany, November 4, 2020 – Affimed N.V., (NASDAQ: AFMD) a clinical stage biopharmaceutical company committed to giving patients back their innate ability to fight cancer, announced today that two abstracts highlighting data related to the company’s lead innate cell engager (ICE®), AFM13, have been accepted for poster presentation at the virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition being held December 5-8, 2020.
AFM13 is a first-in-class tetravalent, bispecific ICE® built on Affimed’s Redirected Optimized Cell Killing (ROCK®) platform – the most clinically advanced technology for designing innate immunity therapies that can be tailored to specific patient populations and tumor types. AFM13 works by binding to CD30 on tumor cells and to CD16A on innate immune cells, engaging the patient’s immune system in fighting cancer through NK cells and macrophages.
Poster presentation 1:
Title: Clinical and Biological Evaluation of the Novel CD30/CD16A Tetravalent Bispecific Antibody (AFM13) in Relapsed or Refractory CD30-Positive Lymphoma with Cutaneous Presentation: A Biomarker Phase Ib/IIa Study (NCT03192202)
Authors: Sawas A., Chen P.-H., Lipschitz M., Rodig S., Vlad G.
Date: December 7, 2020, 7:00 AM-3:30 PM
Final analysis of the AFM13 monotherapy study in patients with relapsed or refractory CD30-positive lymphoma with cutaneous presentation showed a high Objective Response Rate (ORR) of 40 percent with demonstrated therapeutic activity after brentuximab vedotin failure. Response to AFM13 was correlated with an increase in NK cell activation and tumor infiltration, demonstrating that AFM13 modulates the NK cell population and that such changes are associated with patient benefit.
Poster presentation 2:
Title: AFM13 in patients with relapsed or refractory Hodgkin Lymphoma: Final results of an open-label, randomized, multicenter phase II trial
Authors: Momotow J., Sasse S., Plütschow A., Hüttmann A., Basara N., Könecke C., Martin S., Bentz M., Grosse-Thie C., Thorspecken S., De Wit M., Kobe C., Dietlein M., v. Tresckow B., Fuchs M., Borchmann P., Engert A.
Date: December 6, 2020, 7:00 AM-3:30 PM
In this final trial analysis (NCT02321592), evaluating AFM13 in a heavily pretreated patient population with classical Hodgkin lymphoma (n=25), where patients were relapsed/refractory to standard therapies including brentuximab vedotin and PD-1, an objective response rate of 16.6% was observed, including 1 complete and 3 partial responses. Stable and progressive disease was documented in 6 and 14 patients, respectively. The trial was terminated prematurely due to lack of recruitment. Therefore, no statistical analyses were possible, and the report of the results is of descriptive nature. Treatment with AFM13 was well-tolerated.
Full abstracts of the presentations are published in a special online-only issue in the journal Blood, a publication of the American Society of Hematology.
For more details about the ASH Virtual Annual Meeting please visit: https://www.hematology.org/meetings/annual-meeting.
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.
Affimed (Nasdaq: 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.
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