NAYA Biosciences, a NASDAQ-listed company specializing in oncology, autoimmune diseases, and women's health, has announced its plan to introduce a novel PD-1 x VEGF bifunctional antibody, NY-500, into its pipeline. This new therapeutic candidate is designed to target hepatocellular carcinoma (HCC) and other solid tumors, aiming to improve T-cell infiltration and immune response while disrupting tumor vasculature.
The company is utilizing its proprietary FLEX antibody platform and collaborating with MabSilico, a firm specializing in artificial intelligence and deep technology, to enhance the development of this antibody. Dr. Daniel Teper, President of NAYA Biosciences, expressed enthusiasm about the potential of this AI-optimized candidate to exhibit synergistic dual-targeting activity, which could lead to improved clinical responses in solid tumors.
NY-500 is expected to enter monotherapy phase 1/2a clinical trials in early 2026. It targets PD-1, an immune checkpoint, and VEGF, a factor in blood vessel formation. This approach follows recent clinical data indicating the effectiveness of ivonescimab, another PD-1 x VEGF antibody, in outperforming pembrolizumab in lung cancer trials.
In addition to NY-500, NAYA is advancing NY-303, a GPC3-targeting bifunctional antibody, currently in phase 1/2 clinical trials for HCC patients who have not responded to existing PD-1 +/- VEGF therapies. NY-303 has shown promise in converting tumors to a status more receptive to immunotherapy.
NAYA Biosciences' portfolio also includes NY-338, targeting multiple myeloma and autoimmune diseases, and NY-600, for metastatic castration-resistant prostate cancer treatment. The expansion of NAYA's oncology pipeline comes as the PD(L)1 market is expected to surpass $50 billion in 2025, according to IQVIA.
