On January 5, 2024 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, reported favorable safety and tolerability from the first patient 23 days after Deltacel infusion in the Phase 1 clinical trial for treatment of stage 4 metastatic non-small cell lung cancer (NSCLC) at Beverly Hills Cancer Center, located in Beverly Hills, California, USA (Press release, Kiromic, JAN 5, 2024, View Source [SID1234639013]). Specifically, laboratory test results and observations by clinical staff identified no adverse events and confirmed that Deltacel is being well tolerated with initial safety profile. Continued monitoring of safety and tolerability will provide more insights as the trial enrolls additional patients.

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Kiromic expects to report preliminary efficacy results from this patient by the end of January 2024. Two more patients are expected to be enrolled between January and February 2024.

"Our first-in-human clinical trial of Deltacel is proceeding very well and on plan," said Pietro Bersani, Chief Executive Officer of Kiromic. "With no adverse events observed during the first 23 days post-treatment, we have strong indication that Deltacel is well tolerated. We look forward to discussing updates with members of the investment community during our meetings next week in San Francisco, concurrent with the 42nd Annual J.P. Morgan Healthcare Conference."

Investment professionals interested in meeting with Mr. Bersani, Chief Financial Officer Brian Hungerford and Chief Scientific Officer Dr. Leonardo Mirandola at LHA’s offsite event being held January 8-10 should contact Tirth Patel at [email protected].

"We are very pleased to see favorable initial safety and tolerability data from the first patient treated in our Deltacel-01 study," said Dr. Afshin Eli Gabayan, Medical Oncologist, Medical Director, and Principal Investigator at Beverly Hills Cancer Center. "Seeing no adverse events reported 23 days after Deltacel infusion provides early validation that this novel cell therapy is well tolerated when combined with low dose radiation for lung cancer patients. We look forward to further evaluating optimal dose level, efficacy, and long-term safety outcomes as additional patients are enrolled and treated. If this promising initial data is replicated in more patients, Deltacel could become a new alternative treatment option for NSCLC patients."

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 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 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 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.