Artiva Biotherapeutics Receives FDA Fast Track Designation for AB-101
31 Jan 2023
Cell TherapyFast TrackImmunotherapyClinical StudyAccelerated Approval
AB-101 is a cord blood-derived, allogeneic, cryopreserved, ADCC-enhancing NK cell therapy candidate for use in combination with monoclonal antibodies or innate-cell engagers
Granted Fast Track designation by U.S. FDA for the treatment of relapsed/refractory non-Hodgkin lymphoma of B cell origin, in combination with rituximab
SAN DIEGO--(BUSINESS WIRE)-- Artiva Biotherapeutics, Inc., a clinical stage company whose mission is to deliver highly effective, off-the-shelf, allogeneic natural killer (NK) cell-based therapies, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Artiva’s lead program AB-101.
“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 pro 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. ArtivaArtiva 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 AlloNK™ 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.
About Artiva Biotherapeutics
Artiva’s mission is to deliver highly effective, off-the-shelf, allogeneic NK cell-based therapies utilizing our Manufacturing-First approach, that are safe and accessible to cancer patients. Artiva’s pipeline includes AB-101, an ADCC enhancer NK-cell therapy candidate for use in combination with monoclonal antibodies or innate-cell engagers. Artiva is currently advancing a Phase 1/2 clinical trial of AB-101 in combination with rituximab for the treatment of relapsed or refractory B-cell lymphomas and is also combining AB-101 with Affimed N.V.’s Innate Cell Engager AFM13 for the treatment of patients with relapsed/refractory CD30-positive lymphomas. Artiva’s pipeline also includes AB-201, an anti-HER2 CAR-NK cell therapy candidate for the treatment of HER2-overexpressing tumorsHER2-overexpressing tumors, such as breast, gastric, and bladder cancers, and for which an IND has been allowed by FDA, and a pipeline of CAR-NK candidates targeting both solid and hematopoietic cancers. Artiva has entered into therapeutic NK cell collaborations with Merck Sharp & Dohme Corp. and with Affimed GmbH. Artiva’s AlloNK™ platform incorporates cell expansion, activation, and engineering technology developed by Artiva’s strategic partner, GC Cell Corporation, a member of the GC family of companies, a leading healthcare company in Korea. Artiva is headquartered in San Diego. For more information, visit .
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