Kiromic BioPharma Achieves 20% Tumor Reduction in 8 Months for First Deltacel-01 Patient

Kiromic BioPharma, Inc. (OTCQB: KRBP) has announced encouraging results from its ongoing Deltacel-01 Phase 1 clinical trial. The study is assessing the effectiveness of Deltacel™ (KB-GDT-01), the company’s allogeneic, off-the-shelf Gamma Delta T-cell (GDT) therapy. The trial specifically targets patients with stage 4 metastatic non-small cell lung cancer (NSCLC) who have not responded to conventional treatments.

Recent scans conducted eight months after treatment revealed that the tumor size of the first patient enrolled in the trial had reduced by 20% compared to its pre-treatment size. Moreover, no new tumor lesions were detected, indicating an eight-month period of progression-free survival. These results build upon a 13% reduction observed at the six-month mark, showing continued positive progression. The patient is being treated at the Beverly Hills Cancer Center (BHCC).

Pietro Bersani, Chief Executive Officer of Kiromic BioPharma, expressed enthusiasm about the ongoing results. “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,” he stated.

Kiromic plans to provide further follow-up results for the fourth and fifth patients involved in the study by August.

The Deltacel-01 trial, officially 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), involves patients with stage 4 NSCLC receiving two intravenous infusions of Deltacel™ along with four rounds of low-dose localized radiation over a 10-day period. The primary aim of the trial is to evaluate the safety of the treatment while secondary objectives include measuring 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 therapy currently being tested in the Deltacel-01 Phase 1 trial for stage 4 metastatic NSCLC. This allogeneic product is composed of unmodified, donor-derived gamma delta T cells and is the flagship candidate in Kiromic’s GDT platform. Deltacel™ is designed to harness the natural effectiveness of GDT cells in targeting solid tumors, initially focusing on NSCLC, which accounts for about 80% to 85% of all lung cancer cases. Previous preclinical studies have shown Deltacel™ to have a favorable safety and efficacy profile when combined with low-dose radiation.

Kiromic BioPharma, Inc. is a clinical-stage biotherapeutics company that uses its proprietary DIAMOND® artificial intelligence (AI) 2.0 target discovery engine to develop and commercialize cell therapies. The company’s focus is primarily on immuno-oncology. Kiromic is working on a multi-indication allogeneic cell therapy platform that leverages the natural potency of Gamma Delta T-cells to combat solid tumors. The company’s DIAMOND® AI aims to significantly reduce the time and cost required to develop live drugs. Kiromic BioPharma maintains its offices in Houston, Texas.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!