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ThermoGenesis Announces That Results of ImmuneCyte’s Licensed Neutralizing Antibody Therapeutics for COVID-19 Were Published in bioRxiv

RANCHO CORDOVA, Calif., June 8, 2020 — ThermoGenesis Holdings, Inc. (Nasdaq: THMO), a market leader in automated cell processing tools and services in the cell and gene therapy field, announced today that the Institute of Biomedical Sciences and School of Life Sciences, East China Normal University, the research partner of ThermoGenesis’ joint venture, ImmuneCyte, Inc., published the results of ImmuneCyte’s licensed, fully human neutralizing antibody therapeutics for COVID-19 in an article entitled, “Cross-neutralization antibodies against SARS-CoV-2 and RBD mutations from convalescent patient antibody libraries,” in bioRxiv on June 6, 2020.

The emergence of the COVID-19 pandemic led to an urgent need to develop therapeutic interventions. Among them, neutralizing antibodies play crucial roles for preventing viral infections and contribute to resolution of infection. In this published report, the research teams from the Institute of Biomedical Sciences and School of Life Sciences, East China Normal University and Key Laboratory for Drug Evaluation and Clinical Research at Zhejiang University School of Medicine described the process of generation of antibody libraries from 17 different COVID-19 recovered patients with high antibody titers. After 3 rounds of screening from phage display libraries, 456 positive clones were obtained with high binding affinity to the receptor binding domain of spike-1 glycoprotein (S1-RBD) of SARS-CoV-2 (the virus that causes COVID-19). The positive clones were sequenced and reconstituted into whole human IgG for a series of rigid testing. In the end, four fully human monoclonal antibodies demonstrated single digit nanomole IC50 efficacy range. Consistently, these antibodies effectively neutralized viral entry into several human cell lines. In human Vero-E6 cells, these antibodies can effectively block the entry of live SARS-CoV-2 into cells at only 12.5 nM, indicating their strong drug-like properties. Most importantly, these 4 neutralizing antibodies can also strongly bind with mutant SARS-CoV-2 strains, suggesting a broad therapeutic application to SARS-CoV-2 and its mutants in this global pandemic.

As previously announced, ThermoGenesis’ ImmuneCyte joint venture has acquired the global intellectual property rights to the above four high-affinity neutralizing antibody drug candidates against the COVID-19 virus. ImmuneCyte intends to advance these antibodies as therapeutics in human clinical trials. ThermoGenesis currently owns approximately 19% of the equity in ImmuneCyte.

“The research team at the Institute of Biomedical Sciences and School of Life Sciences, East China Normal University, led by Dr. Minyao Liu, is among the leading research groups in the field, and we are thrilled to work with them to develop cutting-edge therapeutics against COVID-19,” stated Chris Xu, Ph.D, Chairman and Chief Executive Officer of ThermoGenesis and Chairman of ImmuneCyte. “The importance of these four neutralizing antibodies, which also strongly bind with mutant COVID-19 viral strains, suggests their strong potential to become effective therapeutic agents against COVID-19 and its mutants causing the global pandemic.”

 

 

About ThermoGenesis Holdings, Inc.
ThermoGenesis Holdings, Inc. develops, commercializes and markets a range of automated technologies for CAR-T and other cell-based therapies. The Company currently markets a full suite of solutions for automated clinical biobanking, point-of-care applications, and automation for immuno-oncology, including its semi-automated, functionally-closed CAR-TXpress™ platform, which streamlines the manufacturing process for the emerging CAR-T immunotherapy market. For more information about ThermoGenesis, please visit: www.thermogenesis.com.

About ImmuneCyte, Inc.
ImmuneCyte, Inc., f/k/a. ImmuneCyte Life Sciences, Inc., is a joint venture which is 19% owned by ThermoGenesis. ImmuneCyte develops various immunological products and services and provides clients the opportunity to bank their own immune cells when the cells are “healthy and unaffected” as a future resource for cellular immunotherapies, such as CAR-T. ImmuneCyte utilizes ThermoGenesis’ proprietary CAR-TXpress™ platform, a GMP compliant close-system capable of automated separating and cryopreserving different components from blood, simultaneously. For more information about ImmuneCyte, Inc., please visit: www.immunecyte.com.

 

Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical facts, but rather reflect the current expectations of ThermoGenesis concerning future events and results. Forward-looking statements based on ThermoGenesis’ current assumptions, expectations and beliefs are generally identifiable by use of words “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential” or “continue,” or similar expressions and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. Such forward-looking statements involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and factors include, but are not limited to, market and other conditions, as well as those risk factors discussed in Item 1A of our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) as well as other documents that may be filed by ThermoGenesis from time to time with the SEC, which are available at www.sec.gov. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this press release.

Company Contact:
Wendy Samford
916-858-5191
ir@thermogenesis.com

Investor Contact:
Paula Schwartz, Rx Communications
917-322-2216
pschwartz@rxir.com

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