Apimed "Artiva NK Therapy - Ingaijeo Combination Phase 2, FDA Fast Track Designation"

GC Cell licenses AB-101 technology to Artiva

GC Cell announced on the 14th that the combination therapy of the natural killer (NK) cell engager 'AFM13' from its German partner Apimed and the NK cell therapy 'AB-101' from Artiva was designated as a Fast Track by the U.S. Food and Drug Administration (FDA) on the 12th (local time).

GC Cell logo. [Photo by GC Cell]

AB-101 is an allogeneic NK cell therapy derived from umbilical cord blood developed by GC Cell and licensed out to Artiva. This is the second time AB-101 has been designated as Fast Track, following its designation in January for combination therapy with rituximab for non-Hodgkin lymphoma (NHL). Fast Track designation allows for FDA support at each stage of the development process.

AFM13 is an NK cell engager that binds to specific proteins expressed on both cancer cells and immune cells. This molecule acts as a type of bispecific antibody, enhancing the interaction between cancer cells and immune cells.

The Phase 2 clinical trial of the combination therapy of AFM13 and AB-101 is currently underway targeting patients with relapsed or refractory Hodgkin lymphoma and CD30-positive peripheral T-cell lymphoma.

Wolfgang Fischer, Chief Operating Officer (COO) of Apimed, stated, "The combination therapy of AFM13 and allogeneic NK cell therapy has demonstrated excellent efficacy and safety data in patients with refractory Hodgkin and non-Hodgkin lymphoma," adding, "The FDA Fast Track designation is evidence that our combination therapy is essential to address the unmet needs of patients." He also said, "We plan to work closely with the FDA for rapid development."

Apimed has already demonstrated efficacy in the existing Phase 1/2 monotherapy trial of AFM13. In the Phase 2 results presented at the American Society of Hematology last December, the objective response rate (ORR) was 94%, and the complete remission (CR) rate was 71%. Notably, among 31 patients with relapsed/refractory Hodgkin lymphoma, the ORR was 97%, and the CR was 77%.

This content was produced with the assistance of AI translation services.