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,
SolusTM, at ALLELE’s stem cell dedicated cGMP facility in San Diego.
SolusTM, 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.
SolusTM 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 SolusTM 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 SolusTM 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
“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 SolusTM 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, SolusTM 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.