On January 31 2023 Artiva Biotherapeutics, Inc., a clinical stage company whose mission is to deliver highly effective, off-the-shelf, allogeneic natural killer (NK) cell-based therapies, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Artiva’s lead program AB-101 (Press release, Artiva Biotherapeutics, JAN 31, 2023, View Source [SID1234626670]).
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"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," said Thorsten Graef, M.D., Chief Medical Officer of Artiva. "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."
"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," stated Fred Aslan, M.D., Chief Executive Officer of Artiva. "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."
About AB-101
AB-101 is a non-genetically modified, cord blood-derived, allogeneic, cryopreserved, ADCC-enhancing NK cell therapy candidate for use in combination with monoclonal antibodies or innate-cell engagers in the out-patient setting. Artiva selects cord blood units with the high affinity variant of the receptor CD16 and a KIR-B haplotype for enhanced product activity. Using the Company’s AlloNKTM platform, Artiva can generate thousands of doses of pure, cryopreserved, infusion-ready NK cells from a single umbilical cord blood unit while retaining the high and consistent expression of CD16 and other tumor-engaging receptors, without the need for engineering. We believe this makes AB-101 an optimal adjunct therapy to targeted, ADCC-mechanistic biologics.
Artiva is conducting a Phase 1/2 multicenter clinical trial (ClinicalTrials.gov Identifier: NCT04673617) to assess the safety and clinical activity of AB-101 alone and in combination with the anti-CD20 monoclonal antibody, rituximab, in patients with relapsed or refractory B-cell-non-Hodgkin lymphoma (NHL) who have progressed beyond two or more prior lines of therapy including CAR-T therapy. This study is progressing at multiple clinical sites across the U.S. and AB-101 is administered weekly in the out-patient setting over one month cycles and with up to four cycles to assess therapeutic efficacy and durability. Artiva is also collaborating with Affimed N.V. in developing a combination therapy comprised of AB-101 and the Innate Cell Engager AFM13, for the treatment of patients with relapsed/refractory CD30-positive lymphomas.
About Fast Track Designation
Fast Track Designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fulfill an unmet medical need, enabling drugs to potentially reach patients earlier. Clinical programs with Fast Track designation may benefit from early and frequent communication with the FDA throughout the regulatory review process. These clinical programs may also be eligible to apply for Accelerated Approval and Priority Review if relevant criteria are met.