Kiromic BioPharma Adds University of Arizona Cancer Center as Fifth Site for Phase 1 Deltacel-01 Trial

Kiromic BioPharma, Inc. (OTCQB: KRBP), a clinical-stage biotherapeutics company, has announced that the University of Arizona Cancer Center (UACC) has been activated as the fifth clinical trial site for its Deltacel-01 Phase 1 trial. This trial is evaluating Deltacel™ (KB-GDT-01), Kiromic's allogeneic, off-the-shelf Gamma Delta T-cell (GDT) therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC) who have not responded to standard treatments. The UACC is one of the 57 NCI-Designated Comprehensive Cancer Centers in the United States.

Dr. Ricklie Ann Julian, an Assistant Professor of Medicine at UACC, will serve as the Principal Investigator at this site. Pietro Bersani, CEO of Kiromic BioPharma, expressed enthusiasm about the partnership with UACC, noting that it will facilitate the enrollment of the next cohort of patients and potentially yield encouraging results in the trial’s expansion phase. The site initiation visit at UACC has already been completed, and patient enrollment is expected to commence shortly.

The University of Arizona Cancer Center stands out as a significant institution in cancer research and treatment. It is the sole NCI-Designated Comprehensive Cancer Center headquartered in Arizona and among the 57 such centers across the nation. The center's mission is to lessen the cancer burden in Arizona, focusing on underserved populations like Hispanics and Native Americans. With multiple research and education offices statewide, UACC serves as a regional resource and national model for addressing cancer risks, improving treatment through transdisciplinary discoveries, training talented scientists and providers, and engaging communities to enhance health equity.

The UACC has a clinical affiliation with Banner – University Medicine in Tucson and operates local outpatient clinics. Founded by physician Sydney Salmon, who served from 1976 until 1999, the UACC received its first NCI Cancer Center Support Grant in 1978 and achieved comprehensive cancer center designation in 1990.

The Deltacel-01 Phase 1 trial is an open-label study evaluating the safety and tolerability of Gamma Delta T-cell infusions combined with low-dose radiotherapy in patients with stage 4 NSCLC. The trial involves patients receiving two intravenous infusions of Deltacel™ alongside four courses of localized, low-dose radiation over a 10-day period. The primary goal of the trial is to assess safety, while secondary objectives include measuring objective response, progression-free survival, overall survival, time to progression, time to treatment response, and disease control rates.

Deltacel™ (KB-GDT-01) is an investigational gamma delta T-cell therapy currently featured in the Deltacel-01 Phase 1 trial for treating stage 4 metastatic NSCLC. This allogeneic product consists of unmodified, donor-derived gamma delta T cells and is Kiromic’s leading candidate in its GDT platform. Designed to harness the natural potency of GDT cells to target solid cancers, Deltacel™ focuses initially on NSCLC, which accounts for approximately 80% to 85% of all lung cancer cases. Data from two preclinical studies have shown Deltacel™ to be safe and effective when combined with low-dose radiation.

Kiromic BioPharma, Inc. is a clinical-stage biotherapeutics company utilizing its proprietary DIAMOND® artificial intelligence (AI) 2.0 target discovery engine to develop and commercialize cell therapies focused on immuno-oncology. The company is working on a multi-indication allogeneic cell therapy platform that leverages the natural potency of Gamma Delta T-cells to target solid tumors. Kiromic’s DIAMOND® AI integrates data science with target identification to significantly reduce the time and financial costs typically associated with drug development. The company is headquartered in Houston, Texas.