New Hope for NSCLC Patients, Kiromic's Deltacel Therapy Delivers Positive Interim Results

Kiromic BioPharma's investigational allogeneic gamma delta T-cell (GDT) therapy, KB-GDT-01 (Deltacel), currently under evaluation in the phase 1/2 Deltacel-01 clinical trial (NCT06069570) for non-small cell lung cancer (NSCLC), has demonstrated promising progression-free survival (PFS) results in an interim analysis.

Among the five patients in long-term follow-up who have been assessed, the average PFS was 4.8 months, with a range of 2 to 8 months. Importantly, Kiromic reported that no dose-limiting toxicities were observed in patients who completed a full course of Deltacel. However, one patient experienced an adverse event linked to an existing comorbidity, unrelated to Deltacel, and consequently withdrew from the trial before completing the treatment. This patient was excluded from the PFS evaluation. To date, all treated patients have been part of Part 1 of the Deltacel-01 trial, which focuses on dose escalation. The sixth and final patient in Part 1 began treatment on August 6, 2024. Part 1 consists of two cohorts, each with three patients.

Kiromic expects to share initial safety data from the sixth patient in September, with initial efficacy data anticipated in October. In July 2024, the company announced plans to proceed to Part 2 of the Deltacel-01 trial, following a positive assessment from the Safety Monitoring Committee. Part 2, which will involve dose expansion, is scheduled to start in September.

Pietro Bersani, CPA, the chief executive officer of Kiromic, said, “We are pleased to have completed enrollment in Part 1 of our clinical trial. The favorable results of our GDT therapy, particularly with respect to PFS, in the first 2 cohorts that comprise Part 1 underscore the potential of Deltacel to treat solid tumors, and we look forward to launching Part 2 of this study.”

Deltacel is a nonengineered therapy designed to harness the natural properties of gamma delta T cells (GDTs) to target solid tumors, eliminating the need for viral vectors in its production. In the Deltacel-01 clinical trial, patients receive two separate intravenous infusions of Deltacel, combined with four sessions of low-dose, localized radiation over a 10-day period. This trial is currently being conducted at several locations, including Beverly Hills Cancer Center, Virginia Oncology Associates in Norfolk, VA, and the University of Pittsburgh School of Medicine. It is open to patients with stage 4 metastatic non-small cell lung cancer (NSCLC) who have not responded to standard treatments.

The latest update on progression-free survival (PFS) adds to a series of encouraging data releases about the therapy from the company. Earlier this month, Kiromic revealed that the first patient treated in the Deltacel-01 trial experienced a 20% reduction in tumor size on scans eight months after treatment, compared to pretreatment measurements. Notably, no new lesions were detected, and the patient had previously shown a 13% reduction in tumor size from baseline at the six-month assessment.

Bersani also added, “We are pleased to announce continued excellent clinical results from our Deltacel-01 trial, with the first patient enrolled demonstrating not only stable disease and continuing to do well, but also a 20% reduction in tumor size at the 8-month post-treatment evaluation. This result is a promising indication of the potential for our novel GDT therapy. We remain dedicated to advancing innovative cancer treatments and are encouraged by the progress we are making toward providing new options for patients,”