On February 14, 2024 Kiromic BioPharma, Inc. (OTCQB: KRBP) ("Kiromic" or the "Company") reported continued encouraging clinical findings from the most recent follow-up visit of the first patient enrolled in Deltacel-01, the Company’s Phase 1 clinical trial evaluating Deltacel for the treatment of stage 4 metastatic non-small cell lung cancer (NSCLC) (Press release, Kiromic, FEB 14, 2024, View Source [SID1234640095]). After stable disease and preliminary progression-free survival of one and a half months were reported six weeks post-treatment, the two-month follow-up PET/CT scan revealed that the patient’s tumor size was reduced by 6.6%, and no new disease sites (metastasis) were detected. In addition, a 20% decrease in the tumor lesion’s metabolism was noted.

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This patient, who was treated at the Beverly Hills Cancer Center (BHCC), continues to do well two months following treatment.

"We are proud and excited to report these highly promising early results showing tumor reduction in a patient population that has few treatment options available. When considering that the first patient enrolled in Deltacel-01 suffered from an actively progressing disease immediately prior to therapy, this is a remarkable finding. We look forward to advancing our trial and to treating additional patients," said Pietro Bersani, Chief Executive Officer of Kiromic.

Kiromic also reports that the second patient in the Deltacel-01 clinical trial has received the second and final infusion of Deltacel. Kiromic expects to report initial tolerability and safety data from this patient in early March, and preliminary efficacy results by the end of the first quarter.

Additionally, Kiromic reports that the third patient has been enrolled and is expected to complete treatment on February 21. Both the second and third patients are being treated at BHCC. The Deltacel-01 clinical trial is expected to start enrolling patients at two additional clinical trial sites in the first half of the year.

"The preliminary data from our first patient offers promising insights into the effectiveness of Gamma Delta T-cell therapy when used alongside low-dose radiation for this condition. We are encouraged by the preliminary data on the first patient and are optimistic about the outcomes of the subsequent patients in the study. We continue to evaluate safety and efficacy outcomes as this study progresses, and are pleased to have enrolled two additional patients in the Deltacel-01 study," said Afshin Eli Gabayan, M.D., Medical Oncologist, Medical Director and Principal Investigator at Beverly Hills Cancer Center.

About Deltacel-01

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 measurements 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 stage 4 metastatic NSCLC. An allogeneic product consisting of unmodified, donor-derived gamma delta T cells, Deltacel is the leading candidate in Kiromic’s GDT platform. Deltacel is designed to exploit the natural potency of GDT cells to target solid cancers, with an initial clinical focus on NSCLC, which represents 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.