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NAYA Biosciences Announces Initiation of Phase 1/2a Clinical Trial for its GPC3-targeted NK Engager Bispecific Antibody in Patients with Hepatocellular Carcinoma
SARASOTA, Fla. and MIAMI, Oct. 24, 2024 (GLOBE NEWSWIRE) -- NAYA Biosciences (“NAYA”) (NASDAQ: NAYA), a life science portfolio company dedicated to bringing
About this update from Invo Fertility, Inc.
[{"type":"text","content":"SARASOTA, Fla. and MIAMI, Oct. 24, 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 an update regarding its clinic trial plans. The Company received regulatory approval from the Israeli Ministry of Health in July 2024 and subsequent institutional review board clearance to initiate patient enrollment in up to 7 academic centers for its clinical trial evaluating the safety and efficacy of NY-303, its GPC3-targeting NK Engager bispecific antibody, as a monotherapy for the treatment of hepatocellular carcinoma in patients not responding to first-line immunotherapy. “With the completion of the recent merger, we can now begin our focus on planning for the initiation of clinical trials with our lead GPC3-targeting NK engager bispecific antibody, which is a significant milestone for NAYA Biosciences,” commented NAYA Biosciences President and NAYA Therapeutics CEO Dr. Daniel Teper. “We are passionate about bringing new options to patients not responding to first line immunotherapy and expect that positive Phase I safety and preliminary efficacy data will support accelerated clinical development in HCC as well as exploration in additional solid and pediatric tumors.” The Phase 1 part of the trial will consist of a dose-escalation where patients responding to treatment will continue weekly administration as long as no disease progression is observed. Key endpoints include safety, pharmacokinetics, activity markers, preliminary clinical efficacy, and time-to-progression. NAYA is planning to start patient recruitment in early 2025 at leading medical centers in Israel including Hadassah Hospital, Sheba Medical Center, and Sourasky Medical Center. The Phase 2a part of the trial is anticipated to be expanded to the United States and Europe subject to additional regulatory approvals and will evaluate NY-303 at two dose levels selected in Phase I. Key efficacy endpoints will include objective response rate and progression-free survival. “Hepatocellular carcinoma is a leading cause of cancer death worldwide with a rapidly increasing global trend,” commented NAYA Therapeutics Chief Medical Officer Dan Chiche, MD. “Currently, less than 30% of patients treated with current standa...