AFMD - Affimed drops ~26% after plans to prioritize lead asset as a combination therapy

German biotech Affimed N.V. ( NASDAQ: AFMD ) lost ~26% pre-market Monday after announcing plans to focus its lead asset AFM13 as a combination therapy targeting certain cancers related to the immune system.

The announcement comes after the company updated results from an investigator-sponsored phase 1/2 trial for AFM13 in combination with cord blood-derived allogeneic NK cells for recurrent or refractory CD30-positive lymphomas.

AFM13 is an investigational therapy designed to involve the components of the innate immune system, such as natural killer (NK) cells and macrophages, to fight cancer.

The AFM13-104 trial treated 41 patients with relapsed or refractory CD30-positive Hodgkin and Non-Hodgkin lymphoma using AFM13 in combination with Artiva’s AB-101 NK cell product.

As of the data cut, 31 Hodgkin lymphoma patients who received the recommended phase 2 dose (RP2D) had indicated an objective response rate (ORR) of 97% and a complete response (CR) rate of 77%. There were three objective responses, including one CR in four non-Hodgkin lymphoma patients who received RP2D.

For all 35 patients treated at RP2D, the ORR and CR stood at 94% and 71%, respectively. There were no dose-limiting toxicities or incidences of cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, or graft versus host disease.

On Monday, the company also disclosed topline data from its Phase 2 trial for AFM13 monotherapy in patients with advanced stage R/R peripheral t-cell lymphoma (PTCL) indicating primary efficacy measures, ORR of 32.4% and a CR of 10.2%.

For other measures of efficacy, AFM13 as monotherapy indicated a median duration of response (DoR) of 2.3 months, median progression-free survival (PFS) of 3.5 months, and median overall survival (OS) of 13.8 months. The patients had undergone a median of 2.7 prior lines of therapy.

However, given the robust data seen for the drug combo in Hodgkin lymphoma, Affimed ( AFMD ) said it would no longer pursue an accelerated approval AFM13 monotherapy in PTCL and instead focus on its development in combination with Artiva’s AB-101 NK cell product.

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