Kiromic BioPharma Reports Favorable 10-Month Results for First Deltacel-01 Patient

Kiromic BioPharma, Inc. has announced encouraging safety and efficacy results from a 10-month follow-up of the first patient in its Deltacel-01 Phase 1 clinical trial. This study is examining the effectiveness of Deltacel™ (KB-GDT-01), an allogeneic, off-the-shelf Gamma Delta T-cell (GDT) therapy, on patients with stage 4 metastatic non-small cell lung cancer (NSCLC) who have not responded to conventional treatments.

The patient involved in the study showed a notable 27% reduction in tumor size compared to pre-treatment measurements, and no new disease sites were observed. The patient has experienced 10 months of progression-free survival (PFS) without adverse events. This follows earlier results showing a 20% reduction in tumor size at eight months and a 13% reduction at six months post-treatment. The patient's treatment is being conducted at the Beverly Hills Cancer Center (BHCC).

Pietro Bersani, CEO of Kiromic BioPharma, expressed optimism about these results, noting that the patient's progress helps validate Deltacel as a potentially safe and effective therapy for advanced-stage cancers. Bersani emphasized that the findings highlight the promise of their allogeneic GDT therapy in providing long-lasting clinical benefits.

Afshin Eli Gabayan, M.D., Medical Oncologist, Medical Director, and Principal Investigator of the Deltacel-01 trial at BHCC, also shared his positive outlook. He remarked on the patient's durable PFS and tumor reduction, suggesting that continued positive results could signify a major breakthrough for late-stage cancer patients with limited treatment options.

Kiromic BioPharma plans to release additional follow-up results from the fourth patient in this study in October.

The Deltacel-01 trial is an open-label Phase 1 clinical trial designed to evaluate the safety and tolerability of Gamma Delta T Cell infusions combined with low-dose radiotherapy in patients with stage 4 metastatic NSCLC. The trial involves administering two intravenous infusions of Deltacel™ along with four courses of low-dose, localized radiation over a 10-day period. The primary goal is to assess safety, while secondary objectives include measuring response rates, progression-free survival, overall survival, time to progression, time to treatment response, and disease control rates.

Deltacel™ (KB-GDT-01) is an investigational gamma delta T-cell therapy currently being tested in the Deltacel-01 Phase 1 trial for stage 4 metastatic NSCLC. This allogeneic product consists of unmodified, donor-derived gamma delta T cells and is the leading candidate in Kiromic’s GDT platform. It aims to leverage the natural potency of GDT cells to target solid tumors, with a primary focus on NSCLC, which accounts for approximately 80% to 85% of all lung cancer cases. Preclinical studies have shown that Deltacel™ exhibits favorable safety and efficacy when combined with low-dose radiation.

The Beverly Hills Cancer Center is a private, academic, community-based institution offering state-of-the-art cancer treatments and leading clinical trials. The Center attracts patients worldwide by providing access to cutting-edge cancer therapies in development. It boasts an internationally recognized multidisciplinary medical team, including medical oncologists, radiation oncologists, radiologists, hematologists, and internists, who offer exceptional patient care and support services. The Center also has a highly efficient team of clinical research professionals.

Kiromic BioPharma, Inc. is a clinical-stage biotherapeutics company focused on developing and commercializing cell therapies targeting solid tumors using its proprietary DIAMOND® artificial intelligence (AI) 2.0 target discovery engine. Based in Houston, Texas, Kiromic’s allogeneic cell therapy platform aims to harness the natural potency of Gamma Delta T-cells for immuno-oncology applications. The DIAMOND® AI platform integrates data science with target identification, significantly reducing the time and cost required to develop live drugs.

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