Artiva NK Cell Therapy AlloNK/ Affimed Innate Cell Engager Combo Gets Fast Track Designation


The companies plan to evaluate the combination therapy in patients with HL in the phase 2 LuminICE-203 clinical trial.

The FDA has granted fast track designation to Artiva Biotherapeutics’ natural killer (NK) cell therapy AlloNK (AB-101) as part of a combination therapy with Affimed’s innate cell engager AFM13 for the treatment of relapsed/refractory (r/r) Hodgkin lymphoma (HL).1

The companies plan to evaluate the combination therapy in the phase 2 LuminICE-203 clinical trial (NCT05883449), which is not yet recruiting as of June 1, 2023, but received investigational new drug (IND) application clearance earlier this year. LuminICE-203, which will aim to enroll approximately 154 patients, will include both patients with r/r HL and patients with CD30-positive peripheral T-cell lymphoma.

AFM13 has previously been evaluated in combination with a cord blood-derived NK cell therapy in the phase 1/2 AFM13-104 clinical trial (NCT04074746), which is listed as active, but no longer recruiting patients, as of June 15, 2023. The trial, which is sponsored by MD Anderson Cancer Center, included patients with CD30-positive HL and non-HL who were heavily pretreated. Affimed has reported results from this trial that included an overall response rate (ORR) of 94%, a complete response rate (CRR) of 71%, and a well-managed safety profile at the recommended phase 2 dose in patients with late-stage, multi-refractory disease. Furthermore, the company noted that among 31 patients with r/r HL, the ORR was 97% and the CRR was 77%.

“Our clinical data of AFM13 in combination with allogeneic NK cells has shown outstanding efficacy and a well-managed safety profile in late-stage, multi-refractory, patients with r/r Hodgkin and non-HL,” Wolfgang Fischer, PhD, the chief operating officer at Affimed, said in a statement.1 “The FDA fast track designation is a testament to the powerful potential our combination approach may deliver for these patients in high need, and we remain committed to working closely with the FDA to expedite development of this important therapy.”

Earlier this year, in January, Artiva received fast track designation from the FDA for a different combination therapy consisting of AlloNK and the monoclonal antibody rituximab for the treatment of r/r B-cell NHL (B-NHL).2 This combination therapy is currently being evaluated in a phase 1/2 multicenter clinical trial (NCT04673617) in patients with r/r B-NHL who have progressed beyond 2 or more prior lines of therapy including chimeric antigen receptor (CAR)-T therapy. The study, which is also evaluating AlloNK as a monotherapy and as a combination therapy with both bendamustine and rituximab, is recruiting at multiple clinical sites across the US and has an estimated enrollment of 108 participants.

“We are excited to announce this advantageous regulatory designation as we continue our clinical evaluation of the AB-101/rituximab combination in the treatment of relapsed/refractory B-cell NHL, including in patients who have failed prior CAR-T treatment,” Thorsten Graef, MD, chief medical officer, Artiva, said in a January 2023 statement.1 “We are encouraged by the early clinical data we are seeing with AB-101 and look forward to expanding its evaluation in this indication as well as with additional biologic therapy combinations through internal and partnered clinical programs.”

More recently, in August 2023, Artiva received clearance of an IND from the FDA for a clinical trial evaluating AlloNK in combination with rituximab for the treatment of patients with systemic lupus erythematosus and active lupus nephritis.3 Artiva noted that no allogeneic NK or CAR-T therapy has previously received IND clearance for evaluation in an autoimmune disease indication.

1. Affimed receives FDA fast track designation for AFM13 in combination with AlloNK® for the treatment of patients with relapsed or refractory Hodgkin lymphoma. News release. Affimed N.V. September 12, 2023. Accessed September 18, 2023.
2. Artiva Biotherapeutics receives FDA fast track designation for AB-101. News release. Artiva Bitoehrapeutics. January 31, 2023. Accessed September 18, 2023.
3. Artiva Biotherapeutics announces FDA clearance of IND for AlloNK cell therapy candidate in combination with rituximab in lupus nephritis. News release. Artiva Biotherapeutics, Inc. August 16, 2023. Accessed September 18, 2023.
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