13 October 2021 - - US-based pre-clinical stage biotechnology company Kiromic BioPharma, Inc. (NASDAQ: KRBP) 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, the company said.

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.

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 application, and will continue to coordinate closely with the FDA to meet all regulatory requirements.

Founded in 1964 and dedicated to the memory and vision of Father Agostino Gemelli, Gemelli Teaching Hospital IRCCS is one of the most important and internationally acclaimed care providers in Italy.

Gemelli Teaching Hospital IRCCS has been ensuring excellence in both diagnostics and therapy for fifty years: as an academic medical center operating in all areas of health and clinical assistance, it is at the heart of the Italian healthcare system.

Gemelli Teaching Hospital IRCCS continues to evolve and innovate on the wings of its heritage and its ability to grasp change and look towards to the future: its operational model aims to integrate the care processes and all the hospital's activities, which are currently managed by 8 departments.

Kiromic BioPharma, Inc. is an artificial intelligence-driven, end-to-end CAR-T and gene therapy company, developing the first multi-indication allogeneic CAR-T cell therapy, that exploits the natural potency of Gamma Delta T-cells to target solid cancers.

Kiromic BioPharma, Inc is focused on discovering, developing, and commercializing novel immuno-oncology applications through its product pipeline. The pipeline development is leveraged through the company's proprietary target discovery engine called "DIAMOND."

Kiromic's DIAMOND is where big data science meets target identification in an effort to dramatically compress the man-years and billions of drug development dollars required to develop a live drug. The company maintains offices in Houston, Texas.