Kiromic BioPharma Adds UPMC as Fourth Deltacel-01 Trial Site

Kiromic BioPharma, Inc., a clinical-stage biotherapeutics company, announced the activation of UPMC in Pittsburgh, Pennsylvania as the fourth clinical trial site for its Deltacel-01 Phase 1 trial. This trial is focused on evaluating Deltacel™ (KB-GDT-01), an allogeneic, off-the-shelf Gamma Delta T-cell (GDT) therapy, in patients diagnosed with stage 4 metastatic non-small cell lung cancer (NSCLC).

UPMC is a globally recognized healthcare system, employing some of the nation's leading clinicians and medical researchers. The UPMC Hillman Cancer Center stands as Western Pennsylvania’s only National Cancer Institute-designated Comprehensive Cancer Center.

The principal investigator for Deltacel-01, Dr. Jason J. Luke, will also serve as the principal investigator at the UPMC site. Dr. Luke holds the position of Associate Professor of Medicine at the University of Pittsburgh and UPMC Hillman Cancer Center, where he also serves as Associate Director for Clinical Research and Director of the Immunotherapy and Drug Development Center.

Pietro Bersani, Chief Executive Officer of Kiromic, expressed his enthusiasm for the participation of Dr. Luke and UPMC in advancing their potentially transformative therapy. Dr. Luke is a renowned expert in immuno-oncology, having led clinical trials of various immunotherapies across multiple cancer types. His extensive experience in early-phase drug development for solid tumors has significantly shaped the Deltacel-01 trial. Bersani is optimistic that Deltacel will continue to demonstrate positive outcomes in treating this deadly disease. He also mentioned plans to activate another clinical trial site later this quarter, with patient enrollment at UPMC expected to commence this summer.

In addition, Kiromic has reported favorable preliminary safety and tolerability data from the fourth patient enrolled in the Deltacel-01 trial, with early efficacy data for this patient anticipated by the end of May. The company plans to enroll the fifth and sixth patients in May and June, respectively.

The Deltacel-01 Phase 1 trial aims to evaluate the safety and tolerability of Gamma Delta T Cell infusions in combination with low-dose radiotherapy in patients with stage 4 NSCLC. Patients will receive two intravenous infusions of Deltacel™ and four sessions of low-dose, localized radiation over a 10-day period. The primary objective 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 (GDT) therapy currently in the Phase 1 trial stage for treating stage 4 metastatic NSCLC. This allogeneic product comprises unmodified, donor-derived gamma delta T cells and is the lead candidate in Kiromic’s GDT platform. Deltacel™ is designed to harness the natural potency of GDT cells to target solid tumors, initially focusing on NSCLC, which accounts for approximately 80% to 85% of all lung cancer cases. Preclinical studies have shown Deltacel™ to have favorable safety and efficacy profiles when combined with low-dose radiation.

Kiromic BioPharma, headquartered in Houston, Texas, is committed to advancing cell therapies for immuno-oncology through its proprietary DIAMOND® artificial intelligence (AI) 2.0 target discovery engine. The company is developing 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 aims to significantly reduce the time and costs associated with drug development.