Press Release - December 8, 2014
Heidelberg, Germany, December 8, 2014 – Affimed N.V. (Nasdaq: AFMD), a clinical-stage biopharmaceutical company developing targeted cancer immunotherapies, today announced that final clinical analyses of a Phase 1 study with the company’s lead program AFM13 were presented at the American Society of Hematology (ASH) Annual Meeting 2014 in San Francisco, California, in a poster presentation on December 6, 2014. The analyses confirmed results reported to date that AFM13 is well tolerated with a favorable administration profile, demonstrating strong indications of clinical activity through tumor-shrinkage and Natural Killer (NK) cell engagement. AFM13 is a bispecific, tetravalent monoclonal antibody engaging the patient’s NK-cells through the CD16A target to kill CD30+ tumor cells in patients with Hodgkin, T-cell and other kinds of lymphoma.
“There is a high medical need for innovative and, in particular, safe treatment options for patients with Hodgkin lymphoma as they are often exhausted from intensive and toxic chemotherapy,” said Jens-Peter Marschner, M.D., Chief Medical Officer of Affimed. “These first clinical data with our targeted immunotherapeutic provide reason to believe that AFM13 either alone or in combination could contribute to improve the treatment options.”
A Phase 2 proof-of-concept study, conducted by the German Hodgkin Study Group and supported by the Leukemia and Lymphoma Society, is currently in preparation and will commence early 2015. In the Phase 1 study reported at ASH, 28 patients with relapsed/refractory Hodgkin lymphoma (HL) received a salvage treatment with escalating doses (0.01-7.0 mg/kg body weight) of AFM13. AFM13 was administered weekly for 4 weeks in the majority of patients. The study was designed to demonstrate safety and tolerability of the antibody. Secondary endpoints included pharmacokinetics (PK), tumor response and pharmacodynamics (PD).
The clinical data demonstrate that AFM13 is very well tolerated. Adverse events are generally mild to moderate. No relevant hematological or neurological events were observed. PK data confirm that the bispecific TandAb molecule can be administered by regular infusions and does not require continuous infusions. Furthermore, AFM13 showed clear activity and more than half of the patients had tumor shrinkage. AFM13 was also active in brentuximab vedotin failures. In peripheral blood, the portion of activated NK cells increased significantly after each infusion and soluble CD30 was reduced during the treatment period.
The NK-cell TandAb® AFM13 targets CD30 on malignant cells and CD16A on NK-cells. Both targets are bound with high affinity and thereby NK-cells, which represent potent cytotoxic cells of the innate immune system, are directed to the cancer cells and eliminate them. AFM13 is specifically designed to treat CD30-positive malignancies including Hodgkin lymphoma.
Affimed N.V. (Nasdaq: AFMD) is a clinical-stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies. Affimed’s product candidates are being developed in the field of immuno-oncology, which represents an innovative approach to cancer treatment that seeks to harness the body’s own immune defenses to fight tumor cells. The most potent cells of the human defense arsenal are types of white blood cells called Natural Killer cells, or NK-cells, and T-cells. Affimed’s proprietary, next-generation bispecific antibodies, called TandAbs for their tandem antibody structure, are designed to direct and establish a bridge between either NK-cells or T-cells and cancer cells, triggering a signal cascade that leads to the destruction of cancer cells. Affimed has focused its research and development efforts on three proprietary TandAb programs for which it retains global commercial rights.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. 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 are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. These forward-looking statements include, but are not limited to, statements regarding the risk of cessation or delay of any of the ongoing or planned clinical studies and/or development of our product candidates. Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, risks associated with our clinical development activities, regulatory oversight, product commercialization, intellectual property claims, 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.
Adi Hoess, CEO
Phone: +49 6221 65307-0