Affimed Reports Safety Profile And Activity For Lymphoma Drug

Affimed Therapeutics reported additional data from the Phase I clinical trial of its investigational lymphoma drug AFM13. The drug demonstrated favorable safety profile and clinical activity in heavily treated patients afflicted with relapsing or refractory Hodgkin’s Lymphoma.

AFM13 is an investigational compound being developed specifically for the treatment of Hodgkin’s Lymphoma. It is a bispecific T and Ab antibody recruiting host natural killer (NK) cells through its CD16A-binding domains to engage and kill CD30-positive malignant cells. AFM13 has received Orphan Drug Designation both in the U.S. and EU.

In the trial, patientsreceiving AFM13 treatment showed a significant increase of activated NK cells in peripheral blood. Clinical activity was also observed over all dose levels and included patients who received prior brentuximab vedotin treatments. AFM13’s cytoxicity was observed to be consistently higher than those of its Fc-enhanced and native anti-CD30 IgGs. Primary endpoints of the trial were tolerability and safety. Secondary endpoints included pharmacokinetics, pharmacodynamics, and clinical efficacy.

Jens-Peter MarschnerCMO of Affimed, said, “The clinical Phase 1 trial met its primary endpoint and demonstrated that AFM13 can be administered safely. Clear activity could be demonstrated with the potential to further maximize the effect by optimizing the dose regimen and extending the treatment duration. These data are promising, in particular because there is no alternative treatment option for patients in this setting. A Phase 2 study investigating an optimized dose regimen will be initiated this year.”

Hodgkin’s Lymphoma is a malignant type of cancer which attacks the lymphatic system. The disease has a yearly incidence of about 9,000 new patients in the U.S. alone. Due to the high unmet medical need to improve quality of life and prolong life of patients afflicted with the disease, the market for Hodgkin’s Lymphoma presents an attractive opportunity. Market size for HL is projected at over $1 billion in the U.S. and EU by 2020.

The company had previously announced a partnership with The Leukemia & Lymphoma Society Partner to co-fund and advance the investigational antibody into Phase II trial evaluation.

Data from the clinical trial were presented at the AACR Annual Meeting 2014.