NAYA Biosciences announces development of PD-1 x VEGF antibodies, aiming for clinical trials by early 2026.
Quiver AI Summary
NAYA Biosciences has announced the expansion of its bifunctional antibody pipeline to include a novel PD-1 x VEGF tetravalent antibody, NY-500, targeted at hepatocellular carcinoma (HCC) and other solid tumors. Utilizing NAYA's FLEX antibody platform and AI technology from partner MabSilico, the company aims to enhance its drug development. The PD-1 x VEGF approach has shown promise, outpacing existing immunotherapies like Keytruda in recent clinical trials for non-small-cell lung cancer. NAYA also plans to begin clinical trials for NY-500 in early 2026, alongside ongoing trials for its GPC3-targeting antibody, NY-303, which has demonstrated the ability to overcome resistance in tumors previously unresponsive to immunotherapy.
Potential Positives
- NAYA Biosciences is expanding its pipeline to include the PD-1 x VEGF bifunctional antibody, NY-500, which shows potential to surpass current standard-of-care treatments in oncology, specifically targeting hepatocellular carcinoma (HCC) and other solid tumors.
- The inclusion of AI-optimization through a partnership with MabSilico may accelerate the development of NY-500 and demonstrate NAYA's commitment to innovative approaches in drug development.
- Recent clinical data suggests that PD-1 x VEGF antibodies, like ivonescimab, have outperformed established therapies, which could position NAYA as a competitive player in the lucrative PD(L)1 market projected to exceed $50 billion by 2025.
- NAYA's ongoing development of other bifunctional antibodies, such as NY-303, highlights its diverse and promising oncology pipeline aimed at addressing significant unmet medical needs in cancer treatment.
Potential Negatives
- The announcement of the PD-1 x VEGF bifunctional antibody, NY-500, involves a lengthy timeline with clinical trials expected to start in early 2026, indicating a lag in immediate product development and potential delays in market entry.
- NAYA is facing competition from established therapies and other companies, like Summit Therapeutics with ivonescimab, which has already demonstrated superiority over a leading treatment, leaving NAYA in a challenging position to prove its product's efficacy against entrenched competitors.
- The press release contains a significant number of forward-looking statements, which introduces uncertainty and the risk that actual results may materially differ from projections, possibly impacting investor confidence.
FAQ
What is the significance of the PD-1 x VEGF antibody?
The PD-1 x VEGF antibody, NY-500, has potential to improve treatment outcomes in hepatocellular carcinoma and other solid tumors.
When will NAYA initiate clinical trials for NY-500?
NAYA plans to initiate monotherapy Phase 1/2a clinical trials for NY-500 in early 2026.
How does NY-500 differ from existing treatments?
NY-500 leverages a tetravalent bifunctional design, targeting both PD-1 and VEGF to enhance immune response in tumors.
What are the expected benefits of targeting PD-1 and VEGF together?
Targeting both PD-1 and VEGF may improve T-cell infiltration and disrupt tumor blood supply, enhancing therapeutic efficacy.
What other treatments is NAYA developing for cancer?
NAYA is also developing NY-303, a GPC3-targeting bifunctional antibody, and other candidates for various cancer types.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
Full Release
• PD-1 x VEGF antibodies show potential to surpass checkpoint inhibitors as standard-of-care in multiple oncology indications
• NAYA aiming to initiate clinical trials in early 2026
SARASOTA, Fla. and MIAMI, Jan. 06, 2025 (GLOBE NEWSWIRE) -- NAYA Biosciences (“NAYA”) (NASDAQ: NAYA), a life science portfolio company dedicated to bringing breakthrough treatments to patients in oncology, autoimmune diseases, and women’s health, today 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.
NAYA is leveraging its proprietary FLEX antibody platform and further optimizing its design through a partnership with MabSilico , an artificial intelligence & deep technology-focused company, to accelerate the development of new best-in-class candidates for validated therapeutic targets.
“We are excited to add a novel, AI-optimized PD-1 x VEGF therapeutic candidate to our pipeline of best-in-class bifunctional antibodies,” commented NAYA Biosciences President Dr. Daniel Teper. “NAYA’s bifunctional format has demonstrated the ability for synergistic dual-targeting activity, resulting in the potential to unlock clinical response in solid tumors. NY-500, our PD-1 x VEGF antibody, will target hepatocellular carcinoma (HCC) and other solid tumors with high unmet medical needs. Recent clinical data with ivonescimab , the most advanced PD-1 x VEGF antibody, has shown superiority in non-small-cell lung cancer (NSCLC) compared to Keytruda®, the leading first-line immunotherapy standard-of-care in multiple solid tumors, paving the way for a new generation of PD-(L)1 therapeutic candidates.”
NAYA is also developing a GPC3-targeting bifunctional antibody (NY-303) in a phase 1/2 clinical trial for HCC patients not responding to PD-1 +/- VEGF therapy. NAYA has recently presented data for NY-303 at the Society for Immunotherapy of Cancer (SITC) demonstrating the ability to reverse resistance to PD-1 checkpoint blockage and turn tumors from a “cold” into a “hot” status, making the tumors susceptible to immunotherapy again. Initiation of monotherapy Phase 1/2a clinical trials has been cleared by regulatory authorities and leading academic centers and is expected to start in 2025.
About NY-500 (PD-1 x VEGF Bifunctional Antibody)
NY-500 is a tetravalent bifunctional antibody targeting PD-1, a key immune checkpoint targeted by pembrolizumab (Keytruda®, Merck & Co), and VEGF, a vascular endothelial growth factor targeted by bevacizumab (Avastin®, Genentech Roche) which regulates the production of new blood vessels (angiogenesis). Synergistic effects of simultaneously targeting PD-1 & VEGF have been shown to improve T-cell infiltration into tumors and enhance immune response while disrupting tumor vasculature. Ivonescimab, a PD-1 x VEGF antibody from Summit Therapeutics, recently outperformed pembrolizumab in a head-to-head lung cancer clinical trials. 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. According to IQVIA , the PD(L)1 market is expected to exceed $50 billion in 2025.
About NAYA Biosciences
NAYA Biosciences (NASDAQ: NAYA) is a life science portfolio company dedicated to bringing breakthrough treatments to patients in oncology, autoimmune diseases, and women’s health. Our proven hub & spoke model harnesses the shared resources of a parent company and agility of lean strategic franchises, enabling efficient acquisition, development, and partnering of assets and allowing for optimized return on investment by combining scalable, profitable commercial revenues with the upside of innovative clinical-stage therapeutics.
NAYA’s expanding portfolio of assets currently includes NY-303, a GPC3 x NKp46 bifunctional antibody for the treatment of hepatocellular carcinoma (HCC) with a unique mode of action targeting non-responders to the current immunotherapy standard of care (approximately 70% of the current treatable market) cleared to enroll patients in a Phase 1/2a monotherapy trial in 2025, NY-338, a CD38 x NKp46 bifunctional antibody for the treatment of multiple myeloma and autoimmune diseases with a differentiated safety and efficacy profile, NY-500, a PD-1 x VEGF bifunctional antibody for the treatment of HCC and other solid tumors, and NY-600 a PSMA x NKp46 bifunctional antibody for the treatment of metastatic Castration Resistant Prostate Cancer (mCRPC).
Safe Harbor Statement
This release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The Company invokes the protections of the Private Securities Litigation Reform Act of 1995. All statements regarding our expected future financial position, results of operations, cash flows, financing plans, business strategies, products and services, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include words such as “anticipate,” “if,” “believe,” “plan,” “estimate,” “expect,” “intend,” “may,” “could,” “should,” “will,” and other similar expressions are forward-looking statements. All forward-looking statements involve risks, uncertainties, and contingencies, many of which are beyond our control, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. Factors that may cause actual results to differ materially from those in the forward-looking statements include those set forth in our filings at
www.sec.gov
. We are under no obligation to (and expressly disclaim any such obligation to) update or alter our forward-looking statements, whether as a result of new information, future events or otherwise.
NAYA Investor & Media Contact
Anna Baran-Djokovic
SVP, Investor Relations
+1-305-615-9162
[email protected]
