Affimed Announces Updated AFM13 Clinical Data Presentation at the American Society of Hematology Annual Meeting, Demonstrating Good Tolerability and a High Objective Response Rate in Patients with Recurrent/Refractory CD30-positive Lymphoma

12/7/2020, 4:01 PM (Source: GlobeNewswire)


  • AFM13 monotherapy was well tolerated and reached an Objective Response Rate of 42 percent among heavily pretreated patients with R/R CD30-positive lymphoma with cutaneous presentation
  • Immunological analyses revealed that innate cell engagers modulate NK and T cell populations in peripheral blood and tumors

Heidelberg, Germany, December 7, 2020 – Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced the presentation of a clinical data set on AFM13 at the 62nd American Society of Hematology Annual Meeting and Exposition. Dr. Ahmed Sawas, Assistant Professor of Medicine at Columbia University College of Physicians and Surgeons and the New York-Presbyterian Hospital, and principal investigator presented the updated results of a phase 1b/2a study in patients with CD30-expressing lymphoma with cutaneous involvement.

AFM13 is a bispecific tetravalent Innate Cell Engager (ICE®) targeting CD30 on tumor cells and CD16A on NK cells and macrophages.

2971: 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)

This updated analysis of the AFM13 monotherapy study in patients with relapsed or refractory CD30-positive lymphoma with cutaneous presentation showed an Objective Response Rate (ORR) of 42 percent (6/14) and demonstrated clinical activity after brentuximab vedotin failure in two of four patients. Flow cytometry of peripheral blood revealed decreased circulating NK cell numbers during therapy and tumor biopsies of responders exhibited an increased pre-therapy CD56+ NK cell infiltration versus non-responders. Granzyme B expression was detected in responders, indicating NK cell cytotoxicity. Together, these data suggest that AFM13 may initiate NK cell tumor infiltration and recruit and engage NK cells. In addition, AFM13 was well tolerated.

“The therapeutic need for this heavily pretreated patient group is extremely high. We are therefore happy to see that AFM13 monotherapy was well tolerated and demonstrated a promising ORR,” commented Dr. Ahmed Sawas. “Our biological evaluation is the first to demonstrate that innate cell engagers modulate NK cell populations in patient peripheral blood and tumors, which seems to be associated with patient benefit.”

About Affimed N.V.

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.

FORWARD-LOOKING STATEMENTS

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, the value of our ROCK® platform, our ongoing and planned preclinical development and clinical trials, our collaborations and development of our products in combination with other therapies, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates, our intellectual property position, our collaboration activities, our ability to develop commercial functions, clinical trial data, our results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies, the industry in which we operate, the trends that may affect the industry or us, impacts of the COVID-19 pandemic, the benefits to Affimed of orphan drug designation and the risks, uncertainties and other factors described under the heading “Risk Factors” in Affimed’s filings with the Securities and Exchange Commission. 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.

Investor Relations Contact

Alexander Fudukidis
Head of Investor Relations
E-Mail: a.fudukidis@affimed.com

Media Contact

Mary Beth Sandin
Head of Marketing and Communications
E-Mail: m.sandin@affimed.com


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