Kiromic BioPharma, Inc. announced continued encouraging clinical findings from the most recent follow-up visit of the first patient enrolled in Deltacel-01, the Company's Phase 1 clinical trial evaluating Deltacel tm for the treatment of stage 4 metastatic non-small cell lung cancer (NSCLC). After stable disease and preliminary progression-free survival of one and a half months were reported six weeks post-treatment, the two-month follow-up PET/CT scan revealed that the patient's tumor size was reduced by 6.6%, and no new disease sites (metastasis) were detected. In addition, a 20% decrease in the tumor lesion's metabolism was noted.

When considering that the first patient enrolled in DELacel-01 suffered from an actively progressing disease immediately prior to therapy, this is a remarkable finding. Kiromic also reports that the second patient in the Deltacel-01 clinical trial has received the second and final infusion of Deltacel. Kiromic expects to report initial tolerability and safety data from this patient in early March, and preliminary efficacy results by the end of the first quarter.

Additionally, Kiromic reports that the third patient has been enrolled and is expected to complete treatment on February 21. Both the second and third patients are being treated at BHCC. The Deltacel-01clinical trial is expected to start enrolling patients at two additional clinical trial sites in the first half of the year.

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 study 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. 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.