Kiromic BioPharma, Inc. reported favorable early efficacy results from the first patient enrolled in the Phase 1 Deltacel-01 clinical trial with Deltacel for treating stage 4 metastatic non-small cell lung cancer (NSCLC). Favorable preliminary evidence demonstrates Deltacel?s efficacy in controlling the growth of NSCLC. Deltacel continues to be well-tolerated, further confirming the early safety assessment reported on January 5th.

The first patient was enrolled at the Beverly Hills Cancer Center (BHCC) and was confirmed to suffer from an actively progressing disease three days prior to beginning treatment. The CT scan performed six weeks later confirmed stabilization of the disease, indicating a preliminary progression-free survival of one and one-half months. Kiromic plans to provide updates as more data becomes available from follow-up monitoring activities and as additional subjects are enrolled in the study.

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 (KB-GDT-01) is an investigational gamma delta T-cell (GDT) therapy currently in the Deltacel-01 Phase 1 trial for the treatment of stage 4 metastatic NSCLC. An allogeneic product consisting of unmodified, donor-derived gamma delta T cells, Deltacel is the leading candidate in Kiromic?s GDT platform. 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.