Kiromic BioPharma Announces Strategic Collaboration with Gemelli Teaching Hospital to Accelerate the Analysis of Allogeneic CAR-T Clinical Trial Candidate Alexis ISO-1 in Solid Cancers

Alexis ISO-1 is Company’s First Artificial Intelligence-identified, Gamma Delta T Cell Engineered Iso-Mesothelin Candidate to Address Solid Tumor Cancers

Company Also Provides Guidance on Regulatory Pathway

HOUSTON–(BUSINESS WIRE)–$KRBP #KRBP–Kiromic BioPharma, Inc. (NASDAQ: KRBP) (“Kiromic” or the “Company”), 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.

About Gemelli Teaching Hospital IRCCS

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. More information can be found on their website.

About Kiromic BioPharma

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 robust 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. For more information, please visit the company’s website at www.kiromic.com.

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. We make such forward-looking statements pursuant to the safe harbor provisions of the U.S. Private Securities Litigation Reform Act, Section 21E of the Securities Exchange Act of 1934, as amended, and other federal securities laws. All statements other than statements of historical facts are forward-looking statements. These statements relate to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements include, but are not limited to, statements about: our collaboration with Gemelli, including statements about expected benefits or progress of such collaboration, when we will be granted a Type A meeting with the FDA and our plans following any such meeting.

In some cases, you can identify forward-looking statements by terms such as “may,” “in coming years,” “could,” “by,” “if,” “will,” “should,” “would,” “expect,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “project” or “continue” or the negative of these terms or other comparable terminology. These statements are only predictions. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties and other factors, which are, in some cases, beyond our control and which could materially affect results. Factors that may cause actual results to differ materially from current expectations include, among other things, those risks described in our filings with the Securities and Exchange Commission (SEC), including those discussed in our annual report on Form 10-K for the year ended December 31, 2020, in our quarterly reports on Form 10-Q for any subsequent quarterly periods, and elsewhere in this press release. If one or more of these risks or uncertainties occur, or if our underlying assumptions prove to be incorrect, actual events or results may vary significantly from those implied or projected by the forward-looking statements. No forward-looking statement is a guarantee of future performance. The forward-looking statements made in this report relate only to events or information as of the date on which the statements are made in this report. Except as expressly required by the federal securities laws, there is no undertaking to publicly update or revise any forward-looking statements, whether as a result of new information, future events, changed circumstances or any other reason.

Contacts

Linda Phelan Dyson, MPH

Global Head, Investor Relations

Kiromic

[email protected]
973-986-5973