NAYA Biosciences to Present GPC3-Targeting NK Engager Antibody Data at 2024 SITC Annual Meeting

SARASOTA, Fla. and MIAMI, Oct. 31, 2024 – NAYA Biosciences (NASDAQ: NAYA), a life science company focused on oncology, autoimmune diseases, and fertility treatments, disclosed new insights into its GPC3-targeting NK engager bispecific antibody NY-303. This information supports the upcoming phase I/IIa clinical trials set for the first half of 2025. Additionally, a predictive AI model for hepatocellular carcinoma (HCC) survival rates will be presented at the 2024 Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in Houston, Texas, from November 6-10.

NAYA will share translational research data indicating that NY-303 can overcome resistance to PD-1 checkpoint inhibitors, transforming tumors from “cold” to “hot,” thus making them more receptive to immunotherapy. This data will be presented through posters at the SITC meeting.

The first poster will reveal how NY-303 reverses resistance to PD-1 checkpoint blockade in HCC by inhibiting Wnt-GPC3-beta-catenin signaling. This session will be presented by Armin Rath, PhD, on November 9, 2024. The second poster, to be presented by Abhik Seal, PhD, of Lynx Analytics, on November 8, 2024, will demonstrate how Graph AI can analyze the impact of GPC3 gene expression and NK cell tumor infiltration on HCC survival rates.

The initial data from these presentations will be accessible on the SITC website starting November 5th at 9 am EST. Subsequently, the posters will be available on NAYA Biosciences' website.

NY-303 is pioneering in leveraging a bispecific antibody to activate NK cells by targeting GPC3, an oncofetal protein on liver cancer cells, and NKp46, a receptor on NK cells. This mechanism transforms the tumor environment, making liver cancer cells vulnerable to immunotherapy. This innovative approach offers hope for liver cancer patients, particularly those with limited treatment options and poor survival rates, as well as other GPC3-expressing tumors like lung squamous cell carcinoma, ovarian cancer, and pediatric cancer.

Current liver cancer treatments, including surgery, liver transplantation, targeted drugs, and immunotherapies like checkpoint inhibitors, provide limited success, especially in advanced stages. With a global five-year survival rate of about 20%, more effective therapies are critically needed.

NY-303 presents a new therapeutic avenue by harnessing the immune system to specifically target tumor cells and engage NK cells. This strategy aims to deliver potent anti-cancer effects with a potentially safer profile, minimizing the side effects associated with chemotherapy and other traditional treatments. Moreover, it addresses the challenge of tumors that do not respond to existing immunotherapies.

For HCC patients, NY-303 could significantly enhance outcomes by providing a precise, targeted method to eliminate cancer cells. This is crucial given the high recurrence rates and difficulties in treating advanced liver cancer. As part of the next generation of immunotherapies, NY-303 could redefine treatment possibilities and offer renewed hope to patients facing this challenging diagnosis.

HCC, the most common form of primary liver cancer, typically arises in individuals with chronic liver diseases such as hepatitis B or C, cirrhosis, and Metabolic Dysfunction-Associated SteatoHepatitis (MASH). With over 900,000 new cases annually, HCC is a major global health issue, ranking as the sixth most common cancer worldwide. In the United States, the incidence of HCC has been rising steadily. Due to late detection, survival rates for HCC are often low, with a five-year survival rate around 20%, varying significantly based on the stage at diagnosis. Early-stage HCC can see improved survival rates with surgical resection or liver transplantation, while advanced stages have much poorer outcomes. Globally, survival rates are similarly low, influenced by healthcare access and screening programs. Recent advances in immunotherapy, such as immune checkpoint inhibitors, offer new hope for advanced HCC patients, but new treatment approaches remain essential to improve survival and quality of life.

NAYA Biosciences is committed to developing breakthrough treatments in oncology, autoimmune diseases, and fertility. Their expanding portfolio includes NY-303 for HCC, NY-338 for multiple myeloma and autoimmune diseases, and INVOcell®, an FDA-approved fertility device. NY-303 is cleared for phase 1/2a monotherapy trials in early 2025, offering a unique approach targeting non-responders to the current immunotherapy standard of care.