NAYA Biosciences Announces Development of NY-500, a Novel AI-Optimized PD-1 x VEGF Bifunctional Antibody
Rhea-AI Summary
NAYA Biosciences (NASDAQ: NAYA) announced the expansion of its bifunctional antibody pipeline with NY-500, a novel PD-1 x VEGF tetravalent bifunctional antibody for treating hepatocellular carcinoma (HCC) and other solid tumors. The company is developing NY-500 using its proprietary FLEX antibody platform and optimizing it through an AI partnership with MabSilico.
Recent clinical data with ivonescimab, a similar PD-1 x VEGF antibody, has demonstrated superiority over Keytruda® in non-small-cell lung cancer treatment. NAYA aims to initiate clinical trials for NY-500 in early 2026.
Additionally, NAYA is developing NY-303, a GPC3-targeting bifunctional antibody, currently in phase 1/2 clinical trials for HCC patients not responding to PD-1 +/- VEGF therapy. Recent data presented at SITC showed NY-303's ability to reverse resistance to PD-1 checkpoint blockage. Phase 1/2a clinical trials for NY-303 are expected to begin in 2025.
Positive
- Development of novel AI-optimized PD-1 x VEGF antibody (NY-500) for cancer treatment
- Similar drug (ivonescimab) showed superiority over market leader Keytruda in NSCLC
- NY-303 demonstrated ability to reverse resistance to PD-1 checkpoint blockage
Negative
- Clinical trials for NY-500 not starting until 2026
- Company currently has no marketed products in this therapeutic area
News Market Reaction
On the day this news was published, NAYA gained 9.74%, reflecting a notable positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
• 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
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
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
anna@nayabiosciences.com
FAQ
When will NAYA Biosciences begin clinical trials for NY-500?
What is the target indication for NAYA's NY-500 antibody?
How does NAYA's NY-303 perform in HCC patients resistant to current treatments?
What technology platform is NAYA using to develop NY-500?
When will NAYA begin Phase 1/2a trials for NY-303?
