On August 9, 2024 Kiromic BioPharma, Inc. (OTCQB: KRBP) ("Kiromic" or the "Company") reported interim results near the completion of Part 1 of its Deltacel-01 Phase 1 clinical trial. This trial is evaluating Deltacel (KB-GDT-01), the Company’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC) who have failed to respond to standard therapies (Press release, Kiromic, AUG 9, 2024, View Source [SID1234645676]).
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Based on data from the five patients evaluated for Progression-Free Survival (PFS) in the long-term follow-up, Kiromic has registered a PFS ranging from 2 to 8 months, with an average of 4.8 months.
No dose limiting toxicities (DLTs) have been reported by the clinical site for patients that have completed the full course of therapy. One patient was withdrawn from the study before completing the full course of therapy due to an adverse event related to a pre-existing co-morbidity and unrelated to Deltacel. Consequently, this subject could not be evaluated for PFS.
Additionally, the sixth and last patient in Part 1 of the Deltacel-01 study started treatment on August 6th.
"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 two 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," said Pietro Bersani, Chief Executive Officer of Kiromic BioPharma.
Kiromic expects to obtain early safety and tolerability outcomes from the last enrolled patient in September and efficacy results in early October. Kiromic is on track to initiate Part 2 of Deltacel-01 in September.
About Deltacel-01
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.
About Deltacel
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 all lung cancer cases. Data from two preclinical studies demonstrated Deltacel’s favorable safety and efficacy profile when it was combined with low-dose radiation.