Kiromic BioPharma Announces First Patient Dosed in Phase 1 Study Evaluating Deltacel for the Treatment of Non-Small Cell Lung Cancer

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 Deltacel for 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."