NAYA Biosciences Announces Development of NY-500, a Novel AI-Optimized PD-1 x VEGF Bifunctional Antibody
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.
NAYA Biosciences (NASDAQ: NAYA) ha annunciato l'espansione della sua pipeline di anticorpi bifunzionali con NY-500, un nuovo anticorpo bifunzionale tetravalente PD-1 x VEGF per il trattamento del carcinoma epatocellulare (HCC) e di altri tumori solidi. L'azienda sta sviluppando NY-500 utilizzando la sua piattaforma proprietaria di anticorpi FLEX e ottimizzandola attraverso una partnership di intelligenza artificiale con MabSilico.
I recenti dati clinici con ivonescimab, un anticorpo simile PD-1 x VEGF, hanno dimostrato una superiorità rispetto a Keytruda® nel trattamento del cancro polmonare non a piccole cellule. NAYA prevede di avviare studi clinici per NY-500 all'inizio del 2026.
Inoltre, NAYA sta sviluppando NY-303, un anticorpo bifunzionale che mira a GPC3, attualmente in fase di studi clinici di fase 1/2 per pazienti con HCC non rispondenti alla terapia PD-1 +/- VEGF. Dati recenti presentati al SITC hanno mostrato la capacità di NY-303 di invertire la resistenza al blocco del checkpoint PD-1. Gli studi clinici di fase 1/2a per NY-303 dovrebbero iniziare nel 2025.
NAYA Biosciences (NASDAQ: NAYA) anunció la expansión de su pipeline de anticuerpos bifuncionales con NY-500, un novedoso anticuerpo bifuncional tetravalente PD-1 x VEGF para el tratamiento del carcinoma hepatocelular (HCC) y otros tumores sólidos. La compañía está desarrollando NY-500 utilizando su plataforma propietaria de anticuerpos FLEX y optimizándolo a través de una asociación de IA con MabSilico.
Datos clínicos recientes con ivonescimab, un anticuerpo similar PD-1 x VEGF, han demostrado superioridad sobre Keytruda® en el tratamiento del cáncer de pulmón no microcítico. NAYA espera iniciar ensayos clínicos para NY-500 a principios de 2026.
Además, NAYA está desarrollando NY-303, un anticuerpo bifuncional dirigido a GPC3, actualmente en ensayos clínicos de fase 1/2 para pacientes con HCC que no responden a la terapia PD-1 +/- VEGF. Datos recientes presentados en el SITC mostraron la capacidad de NY-303 para revertir la resistencia al bloqueo del checkpoint PD-1. Se espera que los ensayos clínicos de fase 1/2a para NY-303 comiencen en 2025.
NAYA Biosciences (NASDAQ: NAYA)는 간세포 암종(HCC) 및 기타 고형 종양 치료를 위해 새로운 PD-1 x VEGF 4가 자기작용 항체 NY-500의 바이폴리컬 항체 파이프라인 확장을 발표했습니다. 이 회사는 자사의 독점 FLEX 항체 플랫폼을 사용하여 NY-500을 개발하고 있으며, MabSilico와의 AI 파트너십을 통해 최적화하고 있습니다.
ivonescimab와 같은 PD-1 x VEGF 항체와 관련된 최근 임상 데이터는 비소세포 폐암 치료에서 Keytruda®보다 우수성을 입증했습니다. NAYA는 2026년 초에 NY-500에 대한 임상 시험을 시작할 계획입니다.
또한, NAYA는 GPC3를 표적하는 항체 NY-303을 개발 중이며, 현재 PD-1 +/- VEGF 치료에 반응하지 않는 HCC 환자를 위한 1/2상 임상 시험 중입니다. SITC에서 발표된 최근 데이터는 NY-303이 PD-1 체크포인트 차단에 대한 내성을 역전시킬 수 있는 능력을 보여주었습니다. NY-303에 대한 1/2a 단계 임상 시험은 2025년에 시작될 예정입니다.
NAYA Biosciences (NASDAQ: NAYA) a annoncé l'expansion de son pipeline d'anticorps bifonctionnels avec NY-500, un nouvel anticorps bifonctionnel tétravalent PD-1 x VEGF pour traiter le carcinome hépatocellulaire (CHC) et d'autres tumeurs solides. L'entreprise développe NY-500 en utilisant sa plateforme propriétaire d'anticorps FLEX et l'optimise grâce à un partenariat d'IA avec MabSilico.
Les données cliniques récentes concernant ivonescimab, un anticorps PD-1 x VEGF similaire, ont montré une supériorité par rapport à Keytruda® dans le traitement du cancer du poumon non à petites cellules. NAYA vise à initier des essais cliniques pour NY-500 début 2026.
En outre, NAYA développe NY-303, un anticorps bifonctionnel ciblant GPC3, actuellement en essais cliniques de phase 1/2 pour des patients atteints de CHC qui ne répondent pas aux thérapies PD-1 +/- VEGF. Les données récentes présentées lors du SITC ont montré la capacité de NY-303 à inverser la résistance au blocage du point de contrôle PD-1. Les essais cliniques de phase 1/2a pour NY-303 devraient commencer en 2025.
NAYA Biosciences (NASDAQ: NAYA) hat die Erweiterung seiner Pipeline für bifunktionale Antikörper mit NY-500 angekündigt, einem neuartigen tetravalenten bifunktionalen Antikörper PD-1 x VEGF zur Behandlung von hepatocellulärem Karzinom (HCC) und anderen soliden Tumoren. Das Unternehmen entwickelt NY-500 mit seiner proprietären FLEX-Antikörperplattform und optimiert es durch eine KI-Partnerschaft mit MabSilico.
Aktuelle klinische Daten mit ivonescimab, einem ähnlichen PD-1 x VEGF-Antikörper, haben eine Überlegenheit gegenüber Keytruda® bei der Behandlung von nicht kleinzelligem Lungenkrebs gezeigt. NAYA plant, Anfang 2026 klinische Studien für NY-500 zu starten.
Darüber hinaus entwickelt NAYA NY-303, einen bifunktionalen Antikörper, der auf GPC3 abzielt, der sich derzeit in klinischen Studien der Phase 1/2 für HCC-Patienten befindet, die nicht auf PD-1 +/- VEGF-Therapien ansprechen. Aktuelle Daten, die auf dem SITC präsentiert wurden, zeigten, dass NY-303 in der Lage ist, die Resistenz gegen die PD-1-Checkpoint-Blockade umzukehren. Die klinischen Studien der Phase 1/2a für NY-303 sollen 2025 beginnen.
- 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
- Clinical trials for NY-500 not starting until 2026
- Company currently has no marketed products in this therapeutic area
Insights
The development of NY-500 represents a significant strategic advancement in NAYA's oncology pipeline. The bifunctional antibody approach, combining PD-1 and VEGF targeting, shows particular promise based on recent clinical validation from competitors. The reference to ivonescimab's superiority over
The AI optimization through MabSilico partnership could potentially accelerate development timelines and improve molecular design, though the 2026 clinical trial timeline suggests a relatively standard development pace. The existing phase 1/2 trial of NY-303 in HCC provides important platform validation and potential combination strategies.
For non-technical readers: Think of NY-500 as a dual-action cancer drug that both helps the immune system recognize cancer cells (PD-1) and cuts off their blood supply (VEGF). It's like combining two proven weapons against cancer into one more powerful treatment.
The scientific rationale behind NY-500 is compelling. The tetravalent design suggests enhanced binding capabilities compared to traditional antibodies. Targeting both PD-1 and VEGF simultaneously addresses two critical aspects of tumor biology - immune evasion and angiogenesis. The focus on HCC is strategic, as this indication has shown modest response rates to current checkpoint inhibitors.
The company's NY-303 data showing conversion of "cold" to "hot" tumors is particularly noteworthy, as this represents a key challenge in immunotherapy resistance. The potential for sequential or combination therapy between NY-303 and NY-500 could create multiple treatment options for HCC patients.
For non-specialists: "Cold" tumors are like fortresses that hide from the immune system, while "hot" tumors are visible and vulnerable to attack. NAYA's drugs aim to make hidden tumors visible while also cutting off their resources.
• 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
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NAYA Investor & Media Contact
Anna Baran-Djokovic
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+1-305-615-9162
anna@nayabiosciences.com
FAQ
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