Cellular Logistics Inc. (CL) in Madison, Wisconsin, and Allele Biotechnology Inc. (ALLELE) in San Diego, California, have entered a collaboration to develop regenerative medicine products to treat ischemic heart disease. The relationship has been recently bolstered by the Catalyze award that Cellular Logistics received from the National Institutes of Health (NIH), National Heart Lung and Blood Institute (NHLBI). The award will accelerate the developmental studies toward clinical grade manufacturing of the company’s lead product, Solus™, at ALLELE’s stem cell dedicated cGMP facility in San Diego.

Solus™, is a highly promising formulation of a regenerative medicine biomaterial designed to minimize injury and revitalize damaged heart tissue for patients suffering a heart attack. Suffering a heart attack can lead to a more serious condition, heart failure, which is a leading cause of death and hospitalization in the United States. Over six million Americans currently suffer from heart failure and this number is expected to exceed eight million by 2030.

Solus™ exhibits potent angiogenic, anti-inflammatory, and cardio-reparative properties and it has not been shown to elicit any adverse immune reactions in laboratory assays and in immunocompetent hosts. Intramyocardial injection of Solus™ was shown to restore heart function, in a dose dependent fashion, in a mouse model. This data was presented at the recent American Heart Association Scientific Sessions in November 2023.

Clinical development of Solus™ will utilize ALLELE’s GMP-grade iPSC lines embodying the company’s IP protected mRNA-based cell reprogramming technology. The IND-enabling cGMP process development and clinical manufacturing activities will take place in ALLELE’s state-of-the art GMP facility that specializes in stem cell therapy development.

“It is with great pleasure we announce our partnership with Cellular Logistics to tackle ischemic cardiac diseases, a major health problem in the world. ALLELE has built the industry leading methods for cell reprogramming and cell fate manipulation, as well as a quality system designed for the development of advanced cell therapy products. This collaboration, like in our many other partnerships with pharmaceutical and biotech companies, will benefit from ALLELE’s in-depth iPSC experience and dedicated cGMP capabilities in getting to the finish line quicker”, said Jiwu Wang, Ph.D., CEO of Allele Biotechnology.

“Translating Solus™ toward clinical-grade production is an exciting and transformative step forward. Our patients with advanced heart disease such as refractory angina and heart failure following myocardial infarction are desperate for new treatments that can save their life and improve their quality of life”, says Amish Raval M.D., Cellular Logistics Board Chair, Interventional Cardiologist and Professor of Medicine and Principal investigator.

“With its unique composition, Solus™ has the potential to be a gamechanger in cardiac care, and we are excited that ALLELE’s technologies will enable and accelerate its development”, commented Rajesh Ambasudhan, Ph.D., Chief Strategist of Allele Biotechnology.

The NHLBI Catalyze Program facilitates the transition of basic science discoveries into viable diagnostic and therapeutic candidates cleared for human testing. It also supports and funds preclinical research and development of technologies and transformative platforms such as Cellular Logistics’ iCFX platform technology.

Cellular Logistics is actively pursuing an FDA Investigational New Drug approval to permit initial human trials.

Press Contacts: Alex Vodenlich, Cellular Logistics President & CEO, Rajesh Ambasudhan, Allele Biotechnology Chief Strategist

About Cellular Logistics

Cellular Logistics, Inc. (CL) is dedicated to improving the lives of individuals suffering from cardiovascular disease. CL was founded in 2016 by a multi-disciplinary clinical and scientific team from the University of Wisconsin-Madison School of Medicine and Public Health. The company’s vision is to help create a world where a new generation of therapies can reverse the debilitating symptoms of cardiovascular diseases, dramatically reducing re-hospitalization, and enabling patients to live longer, healthier lives. Cellular Logistics holds an exclusive license from the Wisconsin Alumni Research Foundation (WARF) to the iCFX™ technology.

About Allele Biotech

Allele Biotechnology and Pharmaceuticals, Inc. (ALLELE) is a San Diego-based company that explores the mechanisms of biological processes to develop technologies and products for biomedical research and therapy development. ALLELE’s mission is to increase accessibility to superior research and clinical assets by offering cutting edge technologies in individual products and fully integrated platforms. Allele utilizes proprietary non-integrating, mRNA-based, cellular reprogramming methods to develop cell therapy using cGMP-grade human iPS cells and their derivatives. In 2018 the company commissioned world’s first commercial cGMP facility that has been custom built for clinical manufacturing of pluripotent stem cells and their derived products.

Disclaimer

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Research reported in this release was supported by the National Heart Lung and Blood Institute of the National Institutes of Health as a sub-award to contract number 75N92022A00005.