On June 6, 2024 Kiromic BioPharma, Inc. (OTCQB: KRBP) ("Kiromic" or the "Company") reported favorable six-month follow-up results from the first patient enrolled in the Deltacel-01 Phase 1 clinical trial (Press release, Kiromic, JUN 6, 2024, View Source [SID1234644172]). 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.
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Scans taken six months post-treatment showed the patient’s tumor size had decreased by 13% compared with the pre-treatment size, and no new tumor lesions were detected, which translates into a six-month progression-free survival. In addition, no dose-limiting toxicities were reported, reinforcing the safety profile of Deltacel observed in previous follow-up visits. This patient is being treated at the Beverly Hills Cancer Center (BHCC).
"We are delighted to report that Patient 1 in the Deltacel-01 clinical trial has achieved six-month progress-free survival, and that they continue to do well with no side effects. This is an important clinical milestone that underscores the potential of Deltacel in treating advanced cancers," said Pietro Bersani, Chief Executive Officer of Kiromic BioPharma. "Notably, we observed a 13% decrease in tumor size. These results are encouraging and support our belief in the potential of Deltacel to provide an effective new treatment for patients with advanced cancers. We are committed to advancing this trial and bringing hope to those with limited treatment options."
Kiromic continues to expect to report long-term follow-up results for the other two subjects in the first cohort and the first subject in the second cohort by the end of June.
Additionally, the fifth patient in Deltacel-01 began treatment in May, is currently doing well without any signs of toxicity and is expected to have their first efficacy assessment in July. The sixth patient is currently undergoing pre-enrollment screening and is projected to start treatment in mid-June.
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.