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Patrick Soon-Shiong, MD, Chairman and CEO of NantKwest presented a clinical data update in patients who have received off-the-shelf aNK and/or haNK natural killer cell therapy in combination with immunotherapeutic agents in advanced solid tumors. These results demonstrated durable complete responses in 5 out of 35 patients with highly refractory late stage cancers across multiple tumor types. Data presented at the Jefferies Healthcare Conference demonstrated complete responses across phase I combination studies of aNK/haNK with or without N-803, ImmunityBio, Inc.'s IL-15 fusion superagonist in solid tumor cancer patients with highly refractory disease. ImmunityBio, is an affiliated company of NantKwest. These combinations enhance NK and T cell activity and proliferation, and resulted in 14% complete responses across multiple indications, while demonstrating positive safety profiles. In patients with highly refractory and relapsed diseases who have failed multiple rounds of standard-of-care therapy, the responses were durable. All five patients with complete responses remain alive to date, ranging from 4 to 24 months from the onset of response.

NantKwest announced that its strategic partner Viracta Therapeutics presented updated clinical data on its HDAC inhibitor, nanatinostat at the Annual Meeting of the American Society of Clinical Oncology in Chicago, IL, from May 31-June 4. In April 2017, NantKwest announced that it was the lead investor in Viracta's Series B financing round. Concurrent with the financing, NantKwest secured an exclusive license with commercialization rights to nanatinostat for use in combination with natural killer, or NK, cell therapies, including NantKwest's NK cell platforms. Nanatinostat is a Class 1 histone deacetylase, or HDAC, inhibitor currently in phase Ib/II clinical trials. In preclinical studies, nanatinostat has been shown to reactivate silenced transgenes in tumor cells thereby turning them into preferential targets for NK cell killing, while also serving to broadly stimulate a patient's immune system, offering the potential for improved clinical responses in cancer patients. The activity of HDAC inhibitors are believed to be based on the upregulation of natural killer group 2D ligand expression on cancer cells, which serve as "eat-me" signals for NK cells and can drive NK proliferation, activation and cancer cell killing. NantKwest is preparing to initiate clinical trials that include nanatinostat in combination with its haNK and t-haNK cell therapy platforms, which we believe will work synergistically to enhance the efficacy of the company's NK cell therapies and further distinguish us in the market. Interim results presented at the 2019 annual ASCO meeting from the phase Ib portion of the ongoing phase Ib/II clinical trial of nanatinostat was in combination with the antiviral valganciclovir for the treatment of relapsed/refractory Epstein Barr Virus, or EBV,-associated lymphomas. Three doses of the combination were evaluated with responses seen at all dose levels. Both drugs are taken orally and can be administered in an out-patient setting. EBV-associated cancers are known to be an extremely difficult cancer to treat. Early clinical data with the combination of nanatinostat and anti-viral therapy in EBV-associated lymphoma from the phase Ib/II study has provided encouraging efficacy signals. Currently, there are no approved treatments for EBV-associated lymphomas that specifically target the virus. The combination therapy produced an objective response rate of 58%, a complete response rate of 33% and a disease stabilization rate of 75%. Based on these encouraging results, Viracta anticipates advancement of the clinical trial to the phase II stage that will evaluate intermittent dosing of nanatinostat in combination with daily valganciclovir.

NantKwest announced that the company's t-haNK investigational new drug application has cleared FDA review and the program has now transitioned to a first-in-human clinical trial targeting CD19 t-haNK in advanced B-cell lymphoma. "Based on extensive and encouraging preclinical results, we have enhanced our ability to modularly combine this proprietary off-the-shelf t-haNK-based therapy with a wide range of monoclonal antibodies using this multi-targeted approach. We are now ready to transition this innovation in NK cell based therapeutics to a Phase I human clinical trials designed to assess the safety, tolerability and efficacy of CD19 t-haNK cell therapy in advanced b-cell lymphoma. Upon completion of the safety phase, NantKwest intends to combine this CD19 t-haNK cell therapy with other synergistic, immunomodulatory agents as part of an integrative, combination therapy approach that we describe as the NANT Cancer Vaccine to further enhance the synergistic effectiveness of this novel therapeutic intervention," said CEO Patrick Soon-Shiong.