Initial Tolerability and Safety Data from First Patient Expected by Year-End, with Preliminary Efficacy Results by End of January 2024

HOUSTON, TX, USA I December 14, 2023 I Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”), a clinical-stage, fully-integrated biotherapeutics company using its proprietary DIAMOND® artificial intelligence and data mining platform to develop cell therapies with a focus on immuno-oncology, announces that the first patient has initiated treatment at the Beverly Hills Cancer Center (BHCC) in the Company’s Deltacel-01 clinical trial. This Phase 1 study is evaluating Deltacelfor the treatment of stage 4 metastatic non-small cell lung cancer (NSCLC).

Initial tolerability and safety data from this first patient is expected to be available by year-end. Additionally, Kiromic expects to report preliminary efficacy results from the first patient by the end of January 2024.

The Company expects that the Deltacel-01 clinical trial will start enrolling patients at two additional clinical sites in early 2024.

“We are extremely proud to initiate this first-in-human trial of Deltacel when we stated we would,” said Pietro Bersani, Chief Executive Officer of Kiromic. “Non-small cell lung cancer represents a significant unmet medical need, and a leading cause of death in the U.S. We look forward to enrolling additional patients to advance the clinical development of Deltacel for the treatment of solid tumors, starting with NSCLC.”

“Beverly Hills Cancer Center is pleased to announce the dosing of the first patient in our Deltacel-01 study,” said Dr. Afshin Eli Gabayan, Medical Oncologist, Medical Director, and Principal Investigator at Beverly Hills Cancer Center. “We are excited about the potential of this novel Gamma Delta T-cell therapy combined with low dose radiation for our patients with lung cancer who have few treatment options left. We look forward to evaluating long term safety and efficacy outcomes as the study progresses.”

Dr. Arash Gabayan, Radiation Oncologist at Beverly Hills Cancer Center and the sub-investigator who administered the low dose radiation treatments, commented: “The first course of combination of Deltacel and low dose radiation was successfully delivered to this first patient. Our clinical research team will continue monitoring this patient closely as we seek to understand how this innovative and exciting dual approach may impact the immune response against the cancer cells. We are hopeful that this investigational treatment approach can make a meaningful difference for lung cancer patients.”

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 study is to evaluate safety, while secondary ones 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 non–small cell lung cancer. An allogeneic product consisting of unmodified, donor-derived gamma delta T cells, Deltacel is Kiromic BioPharma’s leading candidate in its GDT platform. Deltacel is designed to exploit the natural potency of GDT cells to target solid cancers, with an initial focus on NSCLC, the most prevalent type of lung cancer and representing about 80% to 85% of lung cancer cases. Data from two preclinical studies demonstrated Deltacel’s favorable safety and efficacy profile when it was combined with low-dose radiation.

About Kiromic BioPharma

Kiromic BioPharma, Inc. is a clinical-stage, fully integrated biotherapeutics company using its proprietary DIAMOND® artificial intelligence (AI) 2.0 target discovery engine to develop and commercialize cell therapies focusing on immuno-oncology. Kiromic is developing a multi-indication allogeneic cell therapy platform that exploits the natural potency of Gamma Delta T-cells to target solid tumors. Kiromic’s DIAMOND® AI is where data science meets target identification to dramatically compress the years and hundreds of millions of dollars required to develop a live drug. The Company maintains offices in Houston, Texas. To learn more, visit and connect with us on Twitter and LinkedIn.

About Beverly Hills Cancer Center

As a private, academic, community-based cancer center, Beverly Hills Cancer Center not only provides the latest state-of-the-art cancer treatments all under one roof, but also provides leading clinical trials and research, attracting patients globally. By providing access to groundbreaking clinical trials, the Beverly Hills Cancer Center offers patients the opportunity to participate in the most advanced cancer treatments currently in development in the world. Beverly Hills Cancer Center is composed of an internationally recognized multidisciplinary medical team consisting of Medical Oncologists, Radiation Oncologists, Radiologists, Hematologists, and Internists who provide exceptional patient care and support services including a robust and highly efficient team of clinical research professionals. More information is available on:

SOURCE: Kiromic BioPharma