On March 1, 2024 Kiromic BioPharma, Inc. (OTCQB: KRBP) ("Kiromic" or the "Company") reported that Virginia Oncology Associates, PC (Norfolk, Virginia) has been activated as the second clinical trial site in the Phase 1 Deltacel-01 trial evaluating Deltacel (KB-GDT-01), Kiromic’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with non-small cell lung cancer (NSCLC) (Press release, Kiromic, MAR 1, 2024, View Source [SID1234640701]).

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"Virginia Oncology Associates is known for its excellence in oncology-focused research and patient care, and we are delighted to add them as the second Deltacel-01 clinical trial site. With encouraging preliminary results from the first patient in Deltacel-01, we are proud to expand trial access to more sites with the goal of enhancing enrollment efficiency and data quality," said Pietro Bersani, Chief Executive Officer of Kiromic BioPharma.

The site initiation process at Virginia Oncology Associates has been completed and patient enrollment is expected to begin in April, following receipt of preliminary results from the first three-patient cohort in Deltacel-01. Dr. Gary Simmons, D.O., MSHA, will serve as the principal investigator at this site, and brings to Deltacel-01 extensive experience in clinical studies focused on oncology and on CAR T-cell therapies.

Kiromic also announces that the third patient in Deltacel-01 completed treatment at the Beverly Hills Cancer Center on February 21. Kiromic expects to announce initial safety and tolerability data, as well as preliminary efficacy results, from this patient and from the trial’s second patient by the end of March.

About Deltacel-01

In Kiromic’s open-label Phase 1 clinical trial, titled "Phase 1 Trial Evaluating the Safety and Tolerability of Gamma Delta T Cell Infusions in Combination With Low Dose Radiotherapy in Subjects With Stage 4 Metastatic Non-Small Cell Lung Cancer" (NCT06069570), patients with stage 4 NSCLC will receive two intravenous infusions of Deltacel with four courses of low-dose, localized radiation over a 10-day period. The primary objective of the Deltacel-01 trial is to evaluate safety, while secondary measurements include objective response, progression-free survival, overall survival, time to progression, time to treatment response, and disease control rates.

About Deltacel

Deltacel (KB-GDT-01) is an investigational gamma delta T-cell (GDT) therapy currently in the Deltacel-01 Phase 1 trial for the treatment of stage 4 metastatic NSCLC. An allogeneic product consisting of unmodified, donor-derived gamma delta T cells, Deltacel is the leading candidate in Kiromic’s GDT platform. Deltacel is designed to exploit the natural potency of GDT cells to target solid cancers, with an initial clinical focus on NSCLC, which represents about 80% to 85% of lung cancer cases. Data from two preclinical studies demonstrated Deltacel’s favorable safety and efficacy profile when it was combined with low-dose radiation.