NAYA Biosciences to Present Translational Insights to Support Phase I/IIa Clinical Trials for its GPC3-Targeting NK Engager Bispecific Antibody at the 2024 Annual Meeting of the Society for Immunotherapy of Cancer (SITC)
NAYA Biosciences (NASDAQ: NAYA) announced two presentations at the 2024 SITC Annual Meeting in Houston, focusing on their GPC3-targeting NK engager bispecific antibody NY-303. The first presentation demonstrates NY-303's ability to reverse resistance to PD-1 checkpoint blockade, converting 'cold' tumors to 'hot' ones, making them susceptible to immunotherapy. The second presentation showcases a Graph AI model analyzing GPC3 gene expression and NK cell tumor infiltration's influence on hepatocellular carcinoma survival rates. These insights support the planned Phase I/IIa clinical trials in H1 2025.
NAYA Biosciences (NASDAQ: NAYA) ha annunciato due presentazioni al 2024 SITC Annual Meeting di Houston, focalizzandosi sul loro anticorpo bispecifico NY-303, che mira a GPC3 e attiva le cellule NK. La prima presentazione dimostra la capacità di NY-303 di invertire la resistenza al blocco del checkpoint PD-1, convertendo i tumori 'freddi' in 'caldi', rendendoli suscettibili all'immunoterapia. La seconda presentazione mette in evidenza un modello di Graph AI che analizza l'espressione genica di GPC3 e l'influenza dell'infiltrazione delle cellule NK sui tassi di sopravvivenza del carcinoma epatocellulare. Questi dati supportano i trial clinici di Fase I/IIa previsti per il primo semestre del 2025.
NAYA Biosciences (NASDAQ: NAYA) anunció dos presentaciones en la Reunión Anual SITC 2024 en Houston, centrándose en su anticuerpo bispecífico NY-303, que se dirige a GPC3 y activa las células NK. La primera presentación demuestra la capacidad de NY-303 para revertir la resistencia al bloqueo del checkpoint PD-1, convirtiendo tumores 'fríos' en 'calientes', haciéndolos susceptibles a la inmunoterapia. La segunda presentación muestra un modelo de Graph AI que analiza la expresión génica de GPC3 y la influencia de la infiltración de células NK en las tasas de supervivencia del carcinoma hepatocelular. Esta información apoya los ensayos clínicos de Fase I/IIa planeados para la primera mitad de 2025.
NAYA 바이오사이언스 (NASDAQ: NAYA)는 휴스턴에서 열린 2024 SITC 연례 회의에서 GPC3를 표적으로 하는 NK engager 이중 특이성 항체 NY-303에 초점을 맞춘 두 가지 발표를 발표했습니다. 첫 번째 발표는 NY-303이 PD-1 체크포인트 차단제에 대한 저항을 역전시키는 능력을 보여주며, '차가운' 종양을 '뜨거운' 종양으로 전환시켜 면역 요법에 민감하게 만듭니다. 두 번째 발표는 GPC3 유전자 발현과 NK 세포 종양 침투가 간세포 암종 생존율에 미치는 영향을 분석하는 Graph AI 모델을 보여줍니다. 이러한 통찰력은 2025년 상반기에 예정된 1상/2a 임상 시험을 지원합니다.
NAYA Biosciences (NASDAQ: NAYA) a annoncé deux présentations lors du Congrès Annuel SITC 2024 à Houston, axées sur leur anticorps bispécifique NY-303 ciblant le GPC3. La première présentation démontre la capacité de NY-303 à inverser la résistance au blocage du checkpoint PD-1, transformant les tumeurs 'froides' en 'chaudes', les rendant ainsi sensibles à l'immunothérapie. La seconde présentation présente un modèle de Graph AI analysant l'expression génique de GPC3 et l'influence de l'infiltration des cellules NK sur les taux de survie du carcinome hépatocellulaire. Ces informations soutiennent les essais cliniques de Phase I/IIa prévus pour le premier semestre 2025.
NAYA Biosciences (NASDAQ: NAYA) gab zwei Präsentationen auf dem 2024 SITC Jahrestreffen in Houston bekannt, die sich auf ihren GPC3-zielenden NK-Engager-Bispezifischen Antikörper NY-303 konzentrieren. Die erste Präsentation zeigt die Fähigkeit von NY-303, die Resistenz gegen den PD-1-Checkpoint-Blockade umzukehren und 'kalte' Tumore in 'heiße' Tumore zu verwandeln, wodurch sie für die Immuntherapie anfällig werden. Die zweite Präsentation stellt ein Graph AI-Modell vor, das die GPC3-Genexpression und den Einfluss des NK-Zell-Tumorinfiltrations auf die Überlebensraten bei hepatozellulärem Karzinom analysiert. Diese Erkenntnisse unterstützen die geplanten klinischen Studien der Phase I/IIa im ersten Halbjahr 2025.
- NY-303 demonstrates ability to reverse immunotherapy resistance
- Phase I/IIa clinical trials planned for H1 2025
- Development of predictive AI model for HCC survival rates
- None.
Abstracts demonstrate reversal of resistance to PD1 checkpoint blockade and predictive AI model of HCC survival rate
SARASOTA, Fla. and MIAMI, Oct. 31, 2024 (GLOBE NEWSWIRE) -- NAYA Biosciences (“NAYA”) (NASDAQ: NAYA), a life science portfolio company dedicated to bringing breakthrough treatments to patients in oncology, autoimmune diseases, and fertility, today announced that it is presenting novel insights into the mode of action of its GPC3-targeting NK engager bispecific antibody NY-303 to support phase I/IIa clinical trials in H1 2025 as well as into a predictive AI model of HCC survival rate at the 2024 Annual Meeting of the Society for Immunotherapy of Cancer (SITC) taking place November 6-10 in Houston, Texas.
The company will present translational research data demonstrating that NY-303 can reverse resistance to PD-1 checkpoint blockage and turn tumors from a “cold” into a “hot” status, making the tumors susceptible to immunotherapy again.
The second poster presented at the SITC 2024 annual meeting will demonstrate how Graph AI can leverage analysis of the influence of GPC3 gene expression and NK cell tumor infiltration on hepatocellular carcinoma survival rates.
Details on the poster presentations are as follows:
Title: Reversal of resistance to PD-1 checkpoint blockade in Hepatocellular Carcinoma by NY-303, a GPC3 NK cell engager, inhibiting Wnt-GPC3-beta catenin signaling.
Abstract Number: 8098
Session Date: Saturday, Nov. 9, 2024
Presenter: Armin Rath, PhD, NAYA Biosciences
Title: Leveraging Graph AI to analyze the influence of GPC3 Gene expression and NK-Cell tumor infiltration on Hepatocellular Carcinoma survival rates
Abstract Number: 8718
Session Date: Friday, Nov. 8, 2024
Presenter: Abhik Seal, PhD, Lynx Analytics
The initial data from these abstracts will be available on the SITC website starting on November 5th at 9 am EST. Additionally, the posters will be accessible on the NAYA Biosciences website following the live presentation.
About NY-303
NY-303 is a first-in-class therapeutic candidate that leverages the engagement and activation of natural killer (NK) cells using a bispecific antibody targeting both GPC3, an oncofetal protein uniquely expressed on liver cancer cells, and NKp46, a cell surface receptor on natural killer (NK) cells that plays a central role in NK cell activation and the elimination of target cells. The unique mechanism enables NY-303 to turn the tumor form a “cold” into a ‘hot’ stage making liver cancer cells susceptible against immunotherapy to target and destroy cancer cells. This innovative approach is especially promising for patients with liver cancer, such as hepatocellular carcinoma (HCC), who face limited treatment options and poor survival rates but also for other GPC3-expressing tumors like lung squamous cell carcinoma, ovarian cancer, and pediatric cancer.
Currently, liver cancer therapies include surgery, liver transplantation, targeted drugs, and immunotherapies like checkpoint inhibitors, but the prognosis remains grim, especially for advanced-stage disease. With a global five-year survival rate of around
NY-303 represents a new opportunity for liver cancer patients by harnessing the body’s immune system to specifically attack tumor cells and engage NK-cells. Unlike traditional treatments, this therapy is designed to offer potent anti-cancer effects with a potentially safer profile, reducing the side effects often associated with chemotherapy and other conventional treatments and overcoming non-responding tumors against immunotherapies.
For patients with HCC, NY-303 could significantly improve outcomes by offering a more precise, targeted approach to eradicating cancer, which is critical given the high recurrence rates and challenges in treating advanced liver cancer. As part of the next generation of immunotherapies, NY-303 may redefine treatment possibilities and offer renewed hope to those facing this difficult diagnosis.
About HCC
Hepatocellular carcinoma (HCC) is the most common form of primary liver cancer, often developing in individuals with chronic liver conditions like hepatitis B or C, cirrhosis, and Metabolic Dysfunction-Associated SteatoHepatitis (MASH). HCC is a global health challenge, with over 900,000 new cases annually, making it the sixth most common cancer worldwide. The incidence of HCC in the United States has been steadily rising. Survival rates for HCC are often low due to late detection. The five-year survival rate for liver cancer in the United States is around
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 fertility. Our 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 and NKp46 targeting bispecific 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
What did NAYA Biosciences (NAYA) present at SITC 2024?
When will NAYA Biosciences start Phase I/IIa trials for NY-303?