On February 18, 2025 Kiromic BioPharma, Inc. (OTCQB: KRBP) ("Kiromic" or the "Company") reported continued favorable efficacy results from the 10-month follow-up visit for the fourth patient enrolled in its Deltacel-01 Phase 1 clinical trial and provides an enrollment update (Press release, Kiromic, FEB 18, 2025, View Source [SID1234650336]). 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 or locally-advanced non-small cell lung cancer (NSCLC) who have failed to respond to standard therapies.
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The fourth patient in Deltacel-01 demonstrated a partial response (defined as a 30% or greater decrease in the size of the tumor) at the eight-month follow-up visit and continued without any evidence of disease progression as of the 10-month follow-up visit, thereby extending progression-free survival (PFS) to 10 months.
"We are very pleased that as of January 2025 Patient 4 had no evidence of disease progression since the partial response registered in November 2024, with a PFS of 10 months reinforcing our view that Deltacel may offer a transformative treatment option for people with advanced solid tumors," said Pietro Bersani, Chief Executive Officer of Kiromic BioPharma. "Our team remains committed to advancing the Deltacel-01 clinical program, and we look forward to building upon these encouraging results as we expand the trial to additional participants."
Additionally, Kiromic reports that two subjects are undergoing screening and are scheduled to start treatment at Texas Oncology in Tyler, Texas, in late February and early March, respectively.
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 advanced NSCLC receive three intravenous infusions of Deltacel with six courses of low-dose, localized radiation over a 31-day period. The primary objective of Deltacel-01 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.