This week, we speak to Artiva Biotherapeutics’ CEO, Fred Aslan, M.D.

The company has demonstrated the potential for efficacy and safety with natural killer (NK) cells in two cancer clinical trials. In August, the company announced FDA clearance for an IND for lupus – marking a first for an allogeneic, off-the-shelf NK or CAR-T cell therapy in autoimmune disease.

AlloNK (also known as 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 is investigating AlloNK in a phase 1/2 multicenter clinical trial to assess the safety and clinical activity of AlloNK alone and in combination with the anti-CD20 monoclonal antibody, rituximab, in patients with relapsed or refractory B-cell-non-Hodgkin lymphoma (B-NHL). Artiva is also investigating the safety and clinical activity of AlloNK in combination with rituximab in patients with lupus nephritis. 

In addition, Artiva is collaborating with Affimed in a phase 2, open-label, multi-center, multi-cohort study, testing a combination therapy, comprised of AlloNK and the innate cell engager AFM13, for the treatment of patients with relapsed/refractory CD30-positive lymphomas. Artiva selects cord blood units with the high affinity variant of the CD16 receptor and a KIR-B haplotype for enhanced product activity. 

Using the company’s cell therapy manufacturing 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 activating NK receptors, without the need for engineering. AlloNK is being administered in the outpatient setting over multiple doses and multiple cycles.

Artiva’s pipeline also includes AB-201, an anti-HER2 CAR-NK cell therapy candidate for the treatment of HER2-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 also entered into therapeutic NK cell collaborations with Merck Sharp & Dohme.