NAYA Biosciences Develops AI-Optimized PD-1 x VEGF Antibody NY-500

NAYA Biosciences, a company focused on advancing treatments for oncology, autoimmune disorders, and women's health, is broadening its bifunctional antibody offerings by introducing a new PD-1 x VEGF tetravalent bifunctional antibody. This innovative approach is aimed at treating hepatocellular carcinoma (HCC) and other solid tumors. The company is utilizing its proprietary FLEX antibody platform, enhanced in collaboration with MabSilico, an AI and deep technology enterprise, to fast-track the development of promising therapeutic candidates.

Dr. Daniel Teper, President of NAYA Biosciences, expressed enthusiasm for the addition of the AI-optimized PD-1 x VEGF therapeutic candidate to their existing array of advanced bifunctional antibodies. The distinct bifunctional format employed by NAYA displays potential for dual-targeting activity, potentially unlocking clinical responses in solid tumors. NY-500, the PD-1 x VEGF antibody, is designed to focus on hepatocellular carcinoma and other tumors with significant unmet medical needs. Encouraging clinical results from ivonescimab, the leading PD-1 x VEGF antibody, have demonstrated superiority over Keytruda® in non-small-cell lung cancer, hinting at a transformative impact on PD-(L)1 therapeutic candidates.

In addition to NY-500, NAYA is advancing NY-303, a GPC3-targeting bifunctional antibody, through a phase 1/2 clinical trial for HCC patients unresponsive to current PD-1 and VEGF therapies. Data recently shared at the Society for Immunotherapy of Cancer showcased NY-303's potential to counteract resistance to PD-1 checkpoint inhibitors, converting tumors from a "cold" state to a "hot" state, thereby making them receptive to immunotherapy once more. The monotherapy Phase 1/2a clinical trials for NY-303 have received regulatory approval to commence in 2025.

NY-500, with its tetravalent bifunctional design, targets PD-1, a critical immune checkpoint, and VEGF, which influences angiogenesis. This dual-targeting strategy has demonstrated a capacity to enhance T-cell infiltration and immune response while disrupting tumor blood vessels. Ivonescimab's recent success over pembrolizumab in lung cancer trials underscores the promise of PD-1 x VEGF antibodies. NY-500, benefiting from NAYA's FLEX format and AI-optimization, is scheduled to enter monotherapy phase 1/2a clinical trials in early 2026 for hepatocellular carcinoma and other solid tumors. With the PD(L)1 market projected to exceed $50 billion in 2025, this development comes at a pivotal time.

NAYA Biosciences operates as a life science portfolio company, bringing innovative treatments to patients. Employing a hub-and-spoke model, the company effectively manages resources to acquire, develop, and partner assets, optimizing returns by integrating scalable commercial revenues with innovative clinical-stage therapies. NAYA’s growing asset portfolio includes NY-303, targeting HCC non-responders; NY-338, a CD38 x NKp46 bifunctional antibody for multiple myeloma and autoimmune diseases; NY-500, and NY-600, a PSMA x NKp46 antibody for metastatic Castration Resistant Prostate Cancer.

With an expanding lineup of advanced therapeutic candidates, NAYA Biosciences continues to position itself at the forefront of transformative medical treatments, seeking to provide breakthrough solutions for critical health challenges.