The FDA has cleared the investigational new drug application for AB-201.
The FDA has cleared Artiva Biotherapeutics’ investigational new drug (IND) application for the chimeric antigen receptor NK (CAR-NK) cell therapy AB-201 for the potential treatment of solid tumors.1
“AB-201 is the first systemically administered, CAR-NK cell therapy candidate targeting the most prevalent HER2-positive cancer indications, including breast and gastric carcinomas,” Fred Aslan, MD, chief executive officer, Artiva, said in a statement.1 “Our Manufacturing-First strategy and highly scaled AlloNK platform has now demonstrated the ability to produce both non-engineered and CAR-NK product candidates for off-the-shelf use in the outpatient setting, with the potential to treat thousands of patients from single umbilical cord blood donors.”
AB-201 is developed using Artiva’s AlloNK platform and proprietary CAR design. The therapy uses a novel, high affinity anti-HER2 antibody converted to scFv structure to confer highly specific tumor targeting. It also uses Artiva’s costimulatory structure and IL-15 expression to enhance activity and persistence of CAR-NK cells. Artiva plans to initiate a clinical study of AB-201 in patients with HER2-postiive solid tumors at multiple sites throughout the US in the first half of 2023.
AB-201 previously demonstrated anti-tumor activity in HER2-positive tumor models in multiple preclinical studies. The NK cell is derived from umbilical cord blood preselected for advantageous attributes including a high affinity CD16 receptor variant and a KIR-B haplotype. The therapy is designed to maintain high expression of CD1 and activate innate cell tumor engaging receptors for a dual targeting approach. The company is able to manufacture the therapy at very large scale with cryopreservation n infusion-ready media to facilitate repeat clinical administration in the clinic.
“There is a significant unmet need for effective therapies in the treatment of HER2-positive tumors, and AB-201 has demonstrated compelling preclinical anti-tumor activity,” Edith Perez, MD, Professor of Medicine, Mayo Clinic, and member, Board of Directors, Artiva, added to the statement.1
Earlier this year, Artiva announced an agreement with Merck to evaluate combinations of AB-201with tri-specific NK-cell engagers.2 The agreement builds off an original 2021 collaboration.
“We have established a fantastic working relationship with Merck over the last year and we are happy to expand our collaboration to include the combination of our AlloNK platform NK cells with tri-specific NK-cell engager candidates,” Peter Flynn, PhD, cofounder and Chief operating officer, Artiva.2