Kiromic BioPharma Advances Deltacel-01 Trial to Expansion Phase

Kiromic BioPharma, Inc. (OTCQB: KRBP) has announced that it will advance the Deltacel-01 Phase 1 clinical trial to the Expansion Phase. This progression comes after a favorable review from the Deltacel-01 Safety Monitoring Committee (SMC), which met on July 16th to evaluate the safety and efficacy data collected so far. The committee confirmed both positive results and the optimal dose of the treatment.

The Deltacel-01 trial focuses on Deltacel™ (KB-GDT-01), Kiromic’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy. It is being tested in patients suffering from stage 4 metastatic non-small cell lung cancer (NSCLC) who have not responded to standard treatments. The trial is divided into two parts. Part 1 is aimed at determining the optimal dose of Deltacel™. After the SMC's approval, Part 2, known as the Expansion Phase, will further evaluate the effectiveness of the therapy at this optimal dose. Kiromic plans to start enrolling patients for the Expansion Phase in September, increasing the number of participants by nine.

Pietro Bersani, CEO of Kiromic BioPharma, expressed satisfaction with the SMC’s positive review. He emphasized that identifying the optimal dose is a crucial milestone, as it sets the stage for Part 2 of the trial. Bersani believes that this will allow the company to concentrate on assessing the effectiveness of Deltacel™ and further validate their innovative approach using gamma delta T-cells.

Additionally, the fifth patient in the Deltacel-01 trial has completed their 30-day follow-up, showing a favorable safety profile with no dose-limiting toxicities reported. Kiromic expects to present initial efficacy data from this patient’s two-month follow-up in August.

The 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), involves patients with stage 4 NSCLC. These patients will receive two intravenous infusions of Deltacel™, along with four courses of low-dose, localized radiation over a 10-day period. The primary objective of the trial is to evaluate the safety of the treatment. Secondary metrics include objective response, progression-free survival, overall survival, time to progression, time to treatment response, and disease control rates.

Deltacel™ (KB-GDT-01) is an experimental gamma delta T-cell therapy currently under investigation 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 the leading candidate in Kiromic’s GDT platform. Deltacel™ is engineered to harness the natural potency of GDT cells to target solid tumors, with an initial clinical focus on NSCLC, which accounts for about 80% to 85% of all lung cancer cases. Preclinical studies have shown Deltacel™ to have a favorable safety and efficacy profile when combined with low-dose radiation.

Kiromic BioPharma, Inc. is a clinical-stage biotherapeutics company that leverages its proprietary DIAMOND® artificial intelligence (AI) 2.0 target discovery engine to develop and commercialize cell therapies, primarily focusing on immuno-oncology. The company is developing a multi-indication allogeneic cell therapy platform that uses the inherent 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 cost required to develop live drugs. The company is headquartered in Houston, Texas.