Kiromic BioPharma, Inc. reported early efficacy results showing primary lung tumor stabilization and the complete disappearance of brain metastases in the second patient in the Company?s Deltacel-01 Phase 1 clinical trial. Deltacel-01 is evaluating Deltacel? (KB-GDT-01), Kiromic?s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC).

Preliminary results obtained six weeks from the beginning of treatment show Deltacel?s efficacy in controlling tumor growth, as well as favorable safety and tolerability. Stable disease status was confirmed by CT scan. An MRI scan of the patient?s brain performed before treatment began noted new onset metastatic disease, which completely resolved on repeat MRI imaging performed six weeks from the beginning of treatment.

This patient is being treated at the Beverly Hills Cancer Center (BHCC). Kiromic expects to announce initial safety, tolerability, and preliminary efficacy results from the third patient enrolled in Deltacel-01 by the end of March. 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.