NAYA Biosciences (NASDAQ: NAYA) is set to broaden its oncology portfolio with the introduction of NY-500, a novel PD-1 x VEGF bifunctional antibody. This strategic move aims to target hepatocellular carcinoma (HCC) and other solid tumors, leveraging the company's proprietary FLEX antibody platform and a collaboration with MabSilico, an AI and deep technology firm.
NY-500: A Dual-Targeting Approach
NY-500 is designed to simultaneously target PD-1, an immune checkpoint, and VEGF, a key factor in blood vessel formation. This dual-targeting mechanism seeks to enhance T-cell infiltration and immune response within the tumor microenvironment while disrupting the tumor's blood supply. The approach is inspired by recent clinical data showcasing the effectiveness of similar antibodies, such as ivonescimab, which outperformed pembrolizumab in lung cancer trials.
Dr. Daniel Teper, President of NAYA Biosciences, highlighted the potential of this AI-optimized candidate to exhibit synergistic dual-targeting activity, potentially leading to improved clinical responses in solid tumors.
Clinical Development and Pipeline Expansion
NY-500 is anticipated to enter phase 1/2a clinical trials as a monotherapy in early 2026. In addition to NY-500, NAYA is actively developing 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. Preliminary data suggests that NY-303 may convert tumors to a state more receptive to immunotherapy.
NAYA's Broader Portfolio
NAYA Biosciences operates under a hub & spoke model, focusing on the acquisition, development, and partnering of assets. The company's portfolio also includes NY-338, targeting multiple myeloma and autoimmune diseases, and NY-600, for metastatic castration-resistant prostate cancer treatment.
Market Context
The expansion of NAYA's oncology pipeline occurs against the backdrop of a rapidly growing PD(L)1 market, projected to exceed $50 billion in 2025, according to IQVIA.
