Artiva to Evaluate CAR-NK Therapy in Solid Tumors

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.

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“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

REFERENCES

1. Artiva Biotherapeutics announces FDA allowance of IND for AB-201, a HER2-targeted CAR-NK for the treatment of solid tumors. News release. September 20, 2022. https://www.artivabio.com/artiva-biotherapeutics-announces-fda-allowance-of-ind-for-ab-201/
2. Artiva Biotherapeutics announces agreement with Merck to evaluate combinations of NK cells with tri-specific NK-cell engagers. News release. Artiva Biotherapeutics. April 11, 2022. https://www.artivabio.com/artiva-biotherapeutics-announces-agreement-with-merck-to-evaluate-combinations-of-nk-cells-with-tri-specific-nk-cell-engagers/