UPDATES
October 30, 2025 – Israel Innovation Authority Grant Awarded
HOPEC Pharma received official approval for an R&D grant from the Israel Innovation Authority following a detailed scientific and technological evaluation of the company’s innovation and research program. The grant supports advanced scientific and translational research accompanying the clinical study, including biomarker discovery, immunological analyses, and mechanistic studies designed to enhance understanding of UPEC-FimON’s mode of action. This endorsement underscores national confidence in HOPEC Pharma’s technology, innovation, and leadership team.
September 7, 2025 – Site Initiation Visit (SIV) at Hadassah Medical Center
The Site Initiation Visit marked a major operational milestone for HOPEC Pharma’s first-in-human study. The visit included full protocol training, safety review, and site readiness verification by the investigators and clinical operations team. All site visuals and study setup activities were conducted in collaboration with RS NESS, HOPEC Pharma’s CRO partner responsible for clinical project management and operational oversight. From this date, patient recruitment officially began at Hadassah Medical Center under Principal Investigator Dr. Vladimir Yutkin, marking the transition from preparation to active clinical enrollment.
September 3, 2025 – Data Safety Monitoring Board (DSMB) Kick-off Meeting
HOPEC Pharma convened the first meeting of its independent Data Safety Monitoring Board (DSMB), composed of leading medical experts from Hadassah Medical Center: Prof. Aron Popovtzer (Chairperson), Prof. Jack Baniel, and Prof. Hila Elinav. The DSMB operates alongside Dr. Moshe Kamar, HOPEC Pharma’s Medical Monitor and Safety Officer, ensuring continuous safety oversight and coordination between the sponsor and the committee. Together, they provide independent supervision of patient safety and data integrity throughout the study, maintaining scientific rigor and compliance with the highest ethical standards.
August 19, 2025 – Clinical Trial Agreement Signed with Hadasit / Hadassah Medical Center
HOPEC Pharma signed a Clinical Trial Agreement (CTA) with Hadasit Medical Research Services, establishing Hadassah Medical Center as the first clinical site for the Phase 1a/1b study. The agreement formalized collaboration with Dr. Vladimir Yutkin and Hadassah’s oncology research infrastructure, enabling initiation of clinical activities under full regulatory compliance.
July 27, 2025 – Helsinki Committee and Ministry of Health Approval
HOPEC Pharma received official approval from the Israeli Ministry of Health and the Helsinki Committee of Hadassah Medical Center, authorizing initiation of its Phase 1a/1b clinical trial in patients with NMIBC refractory to BCG or intravesical chemotherapy. This approval marks the transition of UPEC-FimON from preclinical research to human clinical evaluation.
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