Press Release - June 24, 2019
Heidelberg, Germany, June 24, 2019 – Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company committed to giving patients back their innate ability to fight cancer, today announced the presentation of data updates on two clinical studies at the 15th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland.
The data from an oral and a poster presentation featured Affimed’s lead innate cell engager AFM13, a first-in-class tetravalent, bispecific antibody derived from the ROCK® platform that is being developed to treat CD30-positive lymphomas. AFM13 specifically binds to CD30 on tumor cells and to CD16A on innate immune cells, such as NK cells and macrophages.
“The results of the completed Phase 1b study of AFM13 in combination with pembrolizumab in Hodgkin lymphoma and of Columbia University’s study of AFM13 in patients with relapsed or refractory CD30-positive lymphoma with cutaneous presentation substantiate the potential of AFM13 to make a difference in the lives of patients with limited to no treatment options,” said Dr. Leila Alland, Affimed’s Chief Medical Officer. “We look forward to advancing our innate cell engagers in future clinical studies, including our registration-directed study of AFM13 in relapsed and refractory peripheral T cell lymphoma and transformed mycosis fungoides.”
Final results from a completed Phase 1b dose escalation study of AFM13 in combination with pembrolizumab (Keytruda®) in patients with relapsed or refractory Hodgkin lymphoma (HL; NCT02665650) were presented during an oral session by Dr. Stephen M. Ansell, Professor of Medicine at Mayo Clinic Rochester, MN and Chair of Faculty Development and Recruitment, Division of Hematology, Department of Internal Medicine, and International Coordinating Principal Investigator of the study. Overall, the combination of AFM13 and pembrolizumab was well tolerated, with no new or worsening safety signals compared to known safety profiles of each agent alone. At the highest treated dose, the objective response rate (ORR) of 88% (by both independent and investigator assessments) and the complete response (CR) rates of 42% and 46% by investigator and independent assessments, respectively, compared favorably to the historical data of monotherapy pembrolizumab in a similar patient population, with the CR rates approximately double that of pembrolizumab. The estimated progression-free survival (PFS) was 78% and 45% at 6 and 12 months, respectively. Response rates were high amongst the subgroup of patients who were primary refractory to brentuximab vedotin (BV), with 11 of the 13 patients achieving an objective response (ORR 85%, 46% CR rate). A deepening of responses was reported over time in multiple patients, and patients previously transplant-ineligible transitioned to transplant after achieving an objective response with the combination of AFM13 and pembrolizumab.
"Despite advances in the treatment of patients with Hodgkin lymphoma, there remains a need for new treatment options for patients who have failed multiple lines of treatment,” commented Dr. Ansell. “I am encouraged by the results achieved in this study, which showed that the combination of AFM13 and pembrolizumab is well-tolerated and achieved high and deep response rates even in patients who were refractory to brentuximab vedotin.”
New data from an AFM13 Phase 1b/2a study in patients with relapsed or refractory CD30-positive lymphoma with cutaneous presentation (NCT03192202) were presented by Dr. Ahmed Sawas, Assistant Professor of Medicine at the Columbia University College of Physicians and Surgeons and the New York-Presbyterian Hospital, and Principal Investigator of the study. In this study, AFM13 was well tolerated and resulted in a high ORR of 50% (1 CR and 4 PRs) including therapeutic activity post-BV failure. This included 2 of 5 responses in the subset of patients with transformed mycosis fungoides (T-MF), a particularly hard-to-treat disease.
Analysis of tumor biopsies showed increased numbers of NK cells both before and during treatment with AFM13 amongst the patients responding to therapy. This was also associated with markers of NK cell-mediated tumor cell killing. In the peripheral blood, NK cell activation markers were observed amongst the responders, and there were associated decreases in total numbers of circulating NK cells and regulatory T cells.
Overall, the data support the potential of AFM13 as a novel immuno-therapeutic to treat CD30-expressing lymphomas. A registration-directed Phase 2 international multicenter study of AFM13 in refractory peripheral T cell lymphoma (PTCL) and T-MF is planned.
Affimed (Nasdaq: AFMD) is a clinical stage biopharmaceutical 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 cancers. For more information, please visit www.affimed.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 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, expectations regarding 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 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.
Head of Investor Relations
Head of Communications, EU IR