Kiromic BioPharma (KRBP) Collaborates with Gemelli Teaching Hospital to Accelerate the Analysis of Allogeneic CAR-T Clinical Trial Candidate Alexis ISO-1 in Solid Cancers

October 11, 2021 8:04 AM EDT

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Kiromic BioPharma, Inc. (NASDAQ: KRBP) a pre-clinical stage biotechnology company using its proprietary DIAMOND® artificial intelligence (AI) platform to improve drug discovery and development with a therapeutic focus on immuno-oncology, announces it has engaged in a strategic collaboration with Gemelli Teaching Hospital IRCCS to accelerate the analysis of the Company’s first allogeneic CAR-T clinical trial candidate Alexis ISO-1.

Alexis ISO-1 is the Company’s first artificial intelligence-identified, Gamma Delta T Cell engineered Iso-Mesothelin candidate to address solid tumor cancers.

Gemelli Teaching Hospital IRCCS (Gemelli) is a world-class university and cancer treatment and research center based in Rome, Italy. It is led by Professor Giovani Scambia, and is recognized as a Scientific Institute for Research, Hospitalization and Healthcare (IRCCS) for the disciplines of Personalized Medicine and Innovative Biotechnology and distinguishes itself in scientific areas of prestigious university research such as oncology.

“Gemelli is the very best possible European partner for Kiromic, as it has the ability to accelerate the analysis of our immune cell therapy candidate and shares our vision for improving cancer targeting through the use of bioinformatics and artificial intelligence,” stated Maurizio Chiriva Internati, DBSc, PhDs, President, Chief Executive Officer, Chairman, and Founder of Kiromic BioPharma. “Gemelli is one of the leading immuno-oncology centers in Europe, and is led by Professor Scambia, who has more than 30 years in the immuno-oncology field, having written or contributed to more than 1,300 publications on this topic. We look forward to advancing this clinical partnership.”

Professor Scambia, PhD, MD, commented, “We are pleased to have been selected to analyze Kiromic's off-the-shelf allogeneic CAR-T candidate. Our database of cancer tissue is one of the best in Europe for the types of cancer Kiromic is trying to treat, and our comprehensive cancer center foundation is extremely strong, built on significant research and development in the field of immunotherapy and live cell therapy.”

Regulatory Guidance

The Company is anticipating being granted a Type A meeting with the FDA by the first half of 2022 to discuss the clinical hold and the clinical development path forward of its previously submitted IND. Following the Type A meeting, the Company plans to resubmit the investigational new drug (IND) application, and will continue to coordinate closely with the FDA to meet all regulatory requirements.

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