Kiromic BioPharma Shares Six-Month Deltacel-01 Trial Results for First Patient

Kiromic BioPharma, Inc. (OTCQB: KRBP), known as "Kiromic," has announced encouraging six-month follow-up results from the initial patient enrolled in their Deltacel-01 Phase 1 clinical trial. This study is focused on evaluating Deltacel™ (KB-GDT-01), an allogeneic Gamma Delta T-cell (GDT) therapy, designed to treat patients with stage 4 metastatic non-small cell lung cancer (NSCLC) who have not responded to conventional treatments.

Clinical Findings

Six months after treatment, scans revealed a 13% reduction in the patient's tumor size compared to pre-treatment measurements. Additionally, no new tumor lesions were observed, indicating a six-month period of progression-free survival. Importantly, no dose-limiting toxicities were reported, affirming the safety profile of Deltacel seen in earlier follow-up visits. This patient is receiving treatment at the Beverly Hills Cancer Center (BHCC).

Expert Commentary

"We are thrilled to share that the first patient in our Deltacel-01 trial has achieved six-month progression-free survival, with no adverse side effects," said Pietro Bersani, CEO of Kiromic BioPharma. "The 13% reduction in tumor size is particularly notable. These findings support our confidence in Deltacel as a potentially effective treatment for advanced cancers. Our commitment to advancing this trial aims to bring new hope to patients with limited treatment options."

Future Plans

Kiromic expects to release long-term follow-up data for the other two subjects in the first cohort and the initial subject in the second cohort by the end of June. The fifth patient began treatment in May and is reportedly doing well, showing no signs of toxicity. This patient is slated for their first efficacy assessment in July. The sixth patient is undergoing pre-enrollment screening and is expected to start treatment in mid-June.

About Deltacel-01

The Deltacel-01 trial, formally 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), is an open-label study. Participants with stage 4 NSCLC receive two intravenous infusions of Deltacel™ alongside four courses of low-dose, targeted radiation over a ten-day period. The primary goal is to assess safety, while secondary objectives include measuring 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 GDT therapy currently in Phase 1 trials for treating stage 4 metastatic NSCLC. As an allogeneic therapy derived from unmodified donor gamma delta T cells, Deltacel™ is the frontrunner in Kiromic’s GDT platform. The therapy leverages the natural potency of GDT cells to target solid tumors, specifically NSCLC, which accounts for 80%-85% of all lung cancer cases. Preclinical studies have shown Deltacel™'s favorable safety and efficacy when combined with low-dose radiation.

About Beverly Hills Cancer Center

The Beverly Hills Cancer Center (BHCC) is a private, academic, community-based institution offering state-of-the-art cancer treatments and leading clinical trials. Known for attracting patients globally, BHCC provides access to some of the most advanced cancer treatments under development. Their multidisciplinary medical team includes medical oncologists, radiation oncologists, radiologists, hematologists, and internists, ensuring exceptional patient care. The center is also supported by a highly efficient team of clinical research professionals.

About Kiromic BioPharma

Kiromic BioPharma, Inc. is a clinical-stage biotherapeutics company specializing in immuno-oncology. Utilizing its DIAMOND® artificial intelligence (AI) 2.0 target discovery engine, Kiromic focuses on developing and commercializing allogeneic cell therapies that leverage Gamma Delta T-cells to target solid tumors. The company is headquartered in Houston, Texas.

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