SARASOTA, Fla. and MIAMI - NAYA Biosciences (NASDAQ: NAYA), a $3.9 million market cap portfolio company specializing in oncology, autoimmune diseases, and women's health, announced today its plan to introduce a novel PD-1 x VEGF bifunctional antibody into its pipeline. The company's stock has shown strong momentum with a 10.85% gain over the past week, according to InvestingPro data. This new therapeutic candidate is designed to target hepatocellular carcinoma (HCC) and other solid tumors.
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. With an impressive InvestingPro Financial Health Score of 3.24 (rated as GREAT), NAYA appears well-positioned to execute its development strategy. 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.
The new antibody, named 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, aiming to improve T-cell infiltration and immune response while disrupting tumor vasculature. 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 is a NASDAQ-listed company with a hub & spoke model that facilitates the acquisition, development, and partnering of assets. Its portfolio also includes NY-338, targeting multiple myeloma and autoimmune diseases, and NY-600, for metastatic castration-resistant prostate cancer treatment.
This expansion of NAYA's oncology pipeline comes as the PD(L)1 market is expected to surpass $50 billion in 2025, according to IQVIA. Trading at $0.87 per share, investors can access detailed financial analysis and additional insights through InvestingPro, which offers exclusive metrics and investment tips for NAYA Biosciences. The information disclosed is based on a press release statement from NAYA Biosciences.
In other recent news, INVO Bioscience has completed its merger with NAYA Biosciences, an oncology and autoimmune disease specialist. This strategic move unites INVO's fertility business with NAYA's clinical-stage assets, aiming to leverage combined resources for enhanced growth and innovation. The newly formed entity, which will operate under the name NAYA Biosciences, will include a leadership team comprising of INVO's CEO Steve Shum and CFO Andrea Goren, and NAYA's founder Dr. Daniel Teper as President and CEO of the new NAYA Therapeutics subsidiary.
The merger has also resulted in a combined company portfolio which includes a bispecific antibody targeting GPC3 for hepatocellular carcinoma patients, and a CD38-targeting bispecific antibody with potential applications in multiple myeloma and autoimmune diseases. The transaction did not require the approval of INVO's stockholders and post-merger, INVO's equity holders will own approximately 17.75% of the combined company.
In addition to the merger, INVO Bioscience has secured a Merchant Cash Advance of $265,000 to support its working capital and general corporate functions. The company has also extended its merger agreement with NAYA Biosciences to October 14, 2024, with NAYA set to purchase 27,500 shares of Series A Preferred Stock for $137,500 upon completion of the merger. These are among the recent developments in INVO Bioscience's business operations.
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