On August 1, 2024 Kiromic BioPharma, Inc. (OTCQB: KRBP) ("Kiromic" or the "Company"), reported favorable eight-month follow-up results from the first patient enrolled in its Deltacel-01 Phase 1 clinical trial (Press release, Kiromic, AUG 1, 2024, View Source [SID1234645263]). 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.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Scans taken eight months post-treatment showed the patient’s tumor size had decreased by 20% compared with the pre-treatment size and no new tumor lesions were detected, which indicate an eight-month progression-free survival. This follows a 13% reduction detected at six months post-treatment, showing a continued favorable progression. This patient is being treated at the Beverly Hills Cancer Center (BHCC).
"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 eight-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," said Pietro Bersani, Chief Executive Officer of Kiromic BioPharma.
Kiromic expects to report additional follow-up results from the fourth and fifth patients in the study in August.
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.