Virginia Oncology Associates Joins Phase 1 Deltacel-01 Trial as Second Site

Kiromic BioPharma has announced the successful completion of treatment by the third participant in its Phase 1 Deltacel-01 clinical trial. The company has also confirmed that Virginia Oncology Associates, PC, in Norfolk, Virginia, has been added as the second site for the ongoing trial, which is assessing the safety and efficacy of Deltacel™ (KB-GDT-01), an allogeneic Gamma Delta T-cell (GDT) therapy for non-small cell lung cancer (NSCLC) patients.
Pietro Bersani, CEO of Kiromic BioPharma, expressed enthusiasm about the addition of Virginia Oncology Associates to the trial, noting their reputation for excellence in cancer research and care. The site's initiation process is complete, with patient enrollment anticipated to commence in April. Dr. Gary Simmons, a seasoned investigator in oncology and CAR T-cell therapy studies, will lead the site.
The third patient in the Deltacel-01 trial concluded their treatment at the Beverly Hills Cancer Center on February 21. Kiromic anticipates releasing initial data on safety, tolerability, and preliminary efficacy for this patient and the second participant by the end of March.
The Deltacel-01 trial, an open-label study, involves administering two infusions of Deltacel alongside four sessions of low-dose radiation to patients with stage 4 NSCLC over a 10-day period. The primary goal of the trial is to assess the safety of the treatment, with secondary endpoints including objective response rate, progression-free survival, overall survival, and other disease control metrics.
Deltacel, part of Kiromic's GDT platform, is an experimental therapy made up of unmodified donor-derived gamma delta T cells. It is designed to leverage the inherent strength of GDT cells to target solid tumors, with an initial focus on NSCLC, which accounts for 80% to 85% of all lung cancer cases. Preclinical studies have shown promising safety and efficacy when Deltacel is used in conjunction with low-dose radiation.
Virginia Oncology Associates is a practice specializing in cancer and blood disorder diagnosis and treatment, offering a range of services including medical and radiation oncology, gynecologic oncology, hematology, and clinical research.
Kiromic BioPharma is a clinical-stage biotherapeutics company that utilizes its DIAMOND® AI 2.0 technology for the development and commercialization of cell therapies, particularly in immuno-oncology. The company's AI-driven approach aims to streamline the drug development process, reducing both time and costs.

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