NAYA Biosciences Announces Initiation of Phase 1/2a Clinical Trial for its GPC3-targeted NK Engager Bispecific Antibody in Patients with Hepatocellular Carcinoma

Core Viewpoint - NAYA Biosciences has received regulatory approval to initiate clinical trials for its GPC3-targeting NK Engager bispecific antibody, NY-303, aimed at treating hepatocellular carcinoma (HCC) in patients who do not respond to first-line immunotherapy [1][2]. Group 1: Clinical Trial Updates - The company has received approval from the Israeli Ministry of Health and institutional review board clearance to start patient enrollment in up to 7 academic centers for the clinical trial of NY-303 [1]. - Patient recruitment for the Phase 1 trial is expected to begin in early 2025 at leading medical centers in Israel, including Hadassah Hospital, Sheba Medical Center, and Sourasky Medical Center [2]. - The Phase 1 trial will focus on dose-escalation, with key endpoints including safety, pharmacokinetics, activity markers, preliminary clinical efficacy, and time-to-progression [2]. Group 2: Mechanism and Efficacy of NY-303 - NY-303 is a first-in-class therapeutic candidate that targets both GPC3, an oncofetal protein on liver cancer cells, and NKp46, a receptor on natural killer cells, aiming to convert tumors from a "cold" to a "hot" state for better immunotherapy response [4]. - The dual targeting mechanism of NY-303 is designed to address the approximately 70% of patients who do not respond to current immunotherapy standards, with the potential to improve outcomes significantly [8]. Group 3: Industry Context and HCC Statistics - Hepatocellular carcinoma (HCC) is a leading cause of cancer death globally, with over 900,000 new cases annually, and the five-year survival rate for liver cancer in the U.S. is around 20% [3][5]. - Current treatment options for liver cancer include surgery, liver transplantation, targeted drugs, and immunotherapies, but the prognosis remains poor, especially for advanced-stage disease [5][6]. - There is a critical need for more effective therapies in the treatment of HCC, as recent advances in immunotherapy have not sufficiently improved survival rates for advanced cases [6].