NK Cell Therapy/Rituximab Combination Fast Tracked for B-cell Non-Hodgkin Lymphoma

AB-101 is also being investigated with the innate cell engager AFM13 for CD30 lymphomas.

The FDA has granted fast track designation to Artiva Biotherapeutics’ cell therapy AB-101 for use in combination with rituximab for the treatment of relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL).1

“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 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.”

AB-101 is an allogeneic, non-genetically modified, cord blood-derived, cryopreserved, antibody-dependent cell-mediated cytotoxicity -enhancing natural killer cell therapy candidate for use in combination with monoclonal antibodies or innate-cell engagers. The cord blood units used are selected to have the high affinity variant of the receptor CD16 and a KIR-B haplotype for enhanced activity. Artiva uses the AlloNK platform to produce thousands of cell therapy doses from a single umbilical cord blood unit.

AB-101 is being evaluated for safety, tolerability, and preliminary efficacy in a phase 1/2 multicenter clinical trial (NCT04673617) alone and in combination with rituximab, an anti-CD20 monoclonal antibody, 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 is recruiting at multiple clinical sites across the US and has a target enrollment of 80 participants.

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Participants will receive AB-101 administered weekly in the outpatient setting over 1-month cycles in up to 4 cycles to assess therapeutic efficacy and durability. The first phase of the study will assess the incidence, severity, and dose relationship of adverse events (AEs) and serious AEs of AB-101 as a monotherapy as well as clinical activity as measured by overall response rate and the recommended phase 2 dose of AB-101 as a combination therapy with rituximab.

“We are committed to our mission of delivering AB-101 as an off-the-shelf cell therapy with an efficacy and tolerability profile suitable for administration and management in the community setting,” Fred Aslan, MD, chief executive officer, Artiva, added to the statement.1 “Given the maturity of our highly scalable manufacturing process, we believe we are well positioned to pursue a first-in-class allogeneic NK cell therapy registration in either non-Hodgkin lymphoma in combination with rituximab, or in Hodgkin lymphoma in combination with Affimed’s AFM13.”

AB-101 is also being evaluated as a combination therapy with Affimed’s Innate Cell Engager AFM13for the treatment of patients with relapsed/refractory CD30-positive lymphomas, as of a November 2022 agreement. In preclinical studies, the combination of AFM13 and AB-101 demonstrated potent anti-tumor activity and Affimedis planning to submit an investigational new drug (IND) for the combination in the first half of 2023.2

1. Artiva Biotherapeutics receives FDA fast track designation for AB-101. News release. Artiva Bitoehrapeutics. January 31, 2023. https://www.businesswire.com/news/home/20230131005475/en/Artiva-Biotherapeutics-Receives-FDA-Fast-Track-Designation-for-AB-101
2. Affimed and Artiva Biotherapeutics announce partnership to advance combination therapy of innate cell engager (ICE®) AFM13 and off-the-shelf allogeneic NK cell therapy AB-101. News release. Affimed. November 3, 2022. https://www.artivabio.com/affimed-and-artiva-biotherapeutics-announce-partnership-to-advance-combination-therapy-of-innate-cell-engager-ice-afm13-and-off-the-shelf-allogeneic-nk-cell-therapy-ab-101/
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