Kiromic BioPharma Advances Deltacel-01 to Expansion Phase After Safety Committee's Approval

Kiromic BioPharma, Inc. has announced that the Deltacel-01 Safety Monitoring Committee (SMC) has unanimously recommended proceeding with the expansion phase of the Deltacel-01 clinical trial. This trial focuses on evaluating Deltacel™ (KB-GDT-01), an allogeneic, off-the-shelf Gamma Delta T-cell (GDT) therapy, in patients suffering from stage 4 metastatic non-small cell lung cancer (NSCLC) who have not responded to standard treatments.

The SMC’s decision follows a positive review of safety data from the initial two cohorts, including results from the recent 40-day follow-up visit of the trial's sixth patient. These results indicated a positive safety and tolerability profile, with no dose-limiting toxicities (DLTs) observed.

During the expansion phase of the Deltacel-01 trial, Kiromic plans to enroll approximately nine patients. The recruitment process for new participants is set to begin later this month. This phase, referred to as Part 2, aims to further evaluate the effectiveness of the Deltacel treatment.

Pietro Bersani, Chief Executive Officer of Kiromic BioPharma, expressed his satisfaction with the unanimous SMC approval to advance to the expansion phase. He noted that with more activated clinical sites, patient enrollment is expected to gain momentum, and there is optimism about better understanding Deltacel’s impact on patient outcomes and addressing critical unmet needs in solid tumors.

The Deltacel-01 trial is an open-label Phase 1 clinical study 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). In this trial, patients with stage 4 NSCLC will receive two intravenous infusions of Deltacel™ along with four courses of low-dose, localized radiation over a 10-day period. The primary goal of the Deltacel-01 trial is to evaluate safety, while secondary objectives include assessing 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 being tested in the Deltacel-01 Phase 1 trial for treating stage 4 metastatic NSCLC. As an allogeneic product made from unmodified, donor-derived gamma delta T cells, Deltacel™ is a leading candidate in Kiromic’s GDT platform. It is designed to leverage the natural potency of GDT cells to target solid tumors, with an initial clinical focus on NSCLC, which accounts for roughly 80% to 85% of all lung cancer cases. Preclinical studies have shown that Deltacel™ has a favorable safety and efficacy profile when used in conjunction with low-dose radiation.

Kiromic BioPharma, Inc. is a clinical-stage, biotherapeutics company that uses its proprietary DIAMOND® artificial intelligence (AI) 2.0 target discovery engine to develop and commercialize cell therapies, particularly in the field of immuno-oncology. The company is working on a multi-indication allogeneic cell therapy platform that harnesses the natural potency of Gamma Delta T-cells to target solid tumors. Kiromic’s DIAMOND® AI significantly reduces the time and financial resources required to develop a live drug. The company is headquartered in Houston, Texas.