Promising Early Results: Deltacel-01 Trial Stabilizes Lung Tumor and Clears Brain Metastases in Patient Two

Kiromic BioPharma, Inc., a clinical-stage biotherapeutics firm, has announced positive initial findings from its Deltacel-01 Phase 1 clinical study. The trial is assessing the efficacy of Deltacel™ (KB-GDT-01), an allogeneic, readily available Gamma Delta T-cell (GDT) therapy for patients with stage 4 metastatic non-small cell lung cancer (NSCLC). Early data indicates that the treatment has successfully stabilized the primary lung tumor and eliminated brain metastases in the second patient enrolled in the study. The treatment's safety and tolerability were also deemed favorable, with stable disease status confirmed via CT scan. Notably, metastatic disease observed in an MRI scan before the treatment was completely resolved in a follow-up MRI conducted six weeks into the treatment. The patient is undergoing treatment at the Beverly Hills Cancer Center (BHCC).
Pietro Bersani, CEO of Kiromic BioPharma, highlighted the promising nature of the six-week outcomes, which, along with results from the first patient, reinforce the potential of Deltacel as a treatment for advanced-stage disease. The complete disappearance of brain metastases in the patient suggests the therapy's ability to cross the blood-brain barrier and contributes to the growing evidence of its benefits.
Afshin Eli Gabayan, M.D., Medical Oncologist and Principal Investigator at BHCC, echoed the optimism, emphasizing the importance of the preliminary results, particularly the absence of dose-limiting toxicities, and the commitment of the center to offering innovative care for patients with limited treatment options.
The company anticipates sharing initial safety, tolerability, and preliminary efficacy results from the third patient in the Deltacel-01 trial by the end of March. The open-label Phase 1 clinical trial involves administering two infusions of Deltacel combined with low-dose, localized radiation therapy over a 10-day period to patients with stage 4 NSCLC. The primary goal of the trial is to assess the safety of the treatment, with secondary objectives including measures of response and survival rates.
Deltacel (KB-GDT-01) is an experimental GDT therapy in the Phase 1 trial aimed at treating stage 4 metastatic NSCLC. It is an allogeneic product made up of unmodified donor-derived GDT cells and represents the leading candidate in Kiromic’s GDT platform. The therapy is designed to harness the natural potency of GDT cells against solid cancers, with an initial focus on NSCLC, which accounts for 80% to 85% of all lung cancer cases. Preclinical studies have shown a favorable safety and efficacy profile for Deltacel when used in conjunction with low-dose radiation.
The Beverly Hills Cancer Center is a private, academic, community-based facility that offers advanced cancer treatments, clinical trials, and research, attracting patients worldwide. It provides access to cutting-edge clinical trials and is staffed by a multidisciplinary team of medical professionals who deliver exceptional patient care and support services.
Kiromic BioPharma is leveraging its proprietary DIAMOND® AI 2.0 target discovery engine to develop cell therapies, focusing on immuno-oncology. The company is developing a multi-indication allogeneic cell therapy platform that targets solid tumors using the natural potency of Gamma Delta T-cells. Kiromic’s DIAMOND® AI aims to significantly reduce the time and cost associated with developing live drugs by integrating data science with target identification.

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