On December 11, 2023 NAYA Biosciences Inc. ("NAYA"), a company which has recently signed a definitive merger agreement with INVO Bioscience to establish an expanded, publicly-traded life science company dedicated to increasing patient access to breakthrough treatments in fertility, oncology, and regenerative medicine, reported that new data for its CD38-targeted Flex-NK Bispecific Antibody (NY-338, formerly CYT-338) for the treatment of Multiple Myeloma (MM) was published as an abstract in the 2023 American Society of Hematology (ASH) (Free ASH Whitepaper)’s (ASH) (Free ASH Whitepaper) meeting supplement of Blood, in the "Multiple Myeloma: Prospective Therapeutic Trials" section (Press release, NAYA Biosciences, DEC 11, 2023, View Source [SID1234638459]).
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"NAYA is building a portfolio of differentiated clinical-stage oncology therapeutics, starting with two FLEX-NK bispecific antibodies acquired from Cytovia Therapeutics," commented NAYA CEO Dr. Daniel Teper. "We are excited about this new data for our CD38-targeted antibody, which aims to address limitations with the current standard-of-care and offer new options for multiple myeloma patients."
"The synergistic engagement of NK cells through NKp46 greatly enhances the immunotherapeutic effects of FLEX-NK bispecific antibodies, reducing NK cell fratricide, maintaining NK cell levels, and enhancing potency including reversal of NK cell dysfunction," added Ola Landgren, MD, PhD, co-author of the abstract and Professor of Medicine, Chief of the Myeloma Division, and Leader of the Experimental Therapeutics Program at the University of Miami’s Sylvester Comprehensive Cancer Center. "The data supports initiation of clinical trials to evaluate this promising new therapy and makes it a potential best-in-class anti-CD38 therapeutic for multiple myeloma."
Despite the clinical success of the first anti-CD38 targeted monoclonal antibody, daratumumab, approved for the treatment of multiple myeloma (MM), significant challenges remain such as CD38 antigen loss/internalization and/or natural killer (NK) cell fratricide resulting in resistance to treatment over time. The data presented for NY-338 demonstrates a differentiated profile from daratumumab, with best-in-class potential, and supports the initiation of clinical trials in 2024. Specifically, the conclusions show that the unique NKp46 activation mechanism provided by NY-338 for reducing NK cell fratricide and maintaining NK cell levels together with the enhanced potency including reversal of NK cell dysfunction makes it an attractive best-in-class anti-CD38 therapeutic against MM compared to daratumumab. These results support the development of CYT-338 in both monotherapy and combination with other complementary immunotherapy agents being developed or approved for MM. A first-in-human Phase 1 study targeting patients with relapsed/refractory MM is in development in the U.S.