NY-500 / NAYA Therapeutics - LARVOL DELTA

NAYA Therapeutics Enters into Definitive Agreements to Regain Full Rights to Next-Generation Cancer Immunotherapies As It Advances Towards Clinical Milestones (ACCESSWIRE) - "NAYA Therapeutics...has regained its status as a privately-held company, separating from its recent merger with INVO Bioscience. This strategic decision enables NAYA Therapeutics to optimize its portfolio development strategy for value maximization and market attractiveness as it advances towards clinical development milestones for its portfolio of first and potential best-in-class candidates....Enrollment of HCC patients for Phase I/II clinical trials of NY-303, which shows unique potential to unlock the biology of checkpoint inhibitor non-responders, is expected in 2025. Next, we are aiming to initiate Phase I/II clinical trials of NY-500, positioned to be the first PD-1/VEGF to market in HCC, in 2026. Finally, NY-338, which shows a differentiated profile to daratumumab and T-cell engagers, is anticipated to commence enrolling patients in its Phase I/II clinical trials in multiple myeloma in 2026."

Commercial • Trial status • Hepatocellular Cancer • Multiple Myeloma

NAYA Biosciences Announces Development of NY-500, a Novel AI-Optimized PD-1 x VEGF Bifunctional Antibody (GlobeNewswire) - "NAYA Biosciences...announced that it is expanding its bifunctional antibody pipeline to include a novel PD-1 x VEGF tetravalent bifunctional antibody for the treatment of hepatocellular carcinoma (HCC) and other solid tumors....NY-500 has a differentiated molecular design, leveraging both NAYA’s proprietary FLEX format and AI-optimization, and is expected to enter monotherapy phase 1/2a clinical trials in early 2026 for the treatment of hepatocellular carcinoma (HCC) & other solid tumors."

New molecule • New P1/2 trial • Hepatocellular Cancer • Solid Tumor