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

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

REFERENCES

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/