Allele will provide CIRM grantees with priority access to Allele’s mRNA reprogrammed cGMP iPSC lines, mRNA technologies for reprogramming, differentiation, gene editing, and end-to-end cell therapy CDMO services.
Allele Biotechnology & Pharmaceuticals Inc. (ALLELE), a San Diego, CA, based biopharma and California Institute for Regenerative Medicine (CIRM) has signed a Memorandum of Understanding by which ALLELE will serve as an Industry Resource Partner (IRP) under CIRM’s Industry Alliance Program (IAP) supporting its regenerative medicine initiatives.
Voters approved a 2020 ballot measure, Proposition 14, to provide CIRM with $5.5 billion in state funds to advance regenerative medicine research in California. CIRM supports a wide range of stem cell and gene therapy programs from discovery stage through phase III clinical trials. CIRM’s IAP is aimed at building a collaborative network of grantees, pharma and biotech companies, and VCs to accelerate development and commercialization of regenerative medicine products.
The agreement provides a unique opportunity for the CIRM-supported cell therapy developers to access ALLELE’s elite resources and services at a discounted rate. These include ALLELE’s patented mRNA-based cell reprogramming and differentiation technologies; off-the-shelf clinical ready GMP iPSC lines and/or generation of bespoke GMP iPSC lines; prioritized access to ALLELE CDMO services at its FDA registered, state of the art and purpose built cGMP facility that offer R&D, process development, technology transfer, and clinical manufacturing of cell therapy products; benefits of IP-supported, mRNA-enabled MAD7-CRISPR genome editing platform that ALLELE pioneered. Moreover, grantees can get help from consultation with Allele’s staff who have extensive domain expertise and front-line experience in cell therapy development, particularly using stem cells, for a wide range of indications spanning across cardiology, neurology, ophthalmology, diabetes, and immuno-oncology.
CIRM grantees can choose from multiple donor eligibility-confirmed GMP-grade iPSC lines and their cognate research-grade versions, all in-house generated using ALLELE’S patent-protected footprint-free mRNA technology under tight quality control. The mRNA method offers more complete reprogramming, as experienced by ALLELE’s industry partners, resulting in iPSC lines that exhibit superior performance and ease of use, especially when transitioning into large scale processing and scale-up. This can be of great advantage to grantees in that they can perform all their discovery and early developmental studies using high-quality cognate research grade lines that are forward compatible with clinical and commercial development, thus saving considerable time and money otherwise spent on later comparability studies or protocol re-optimization for a new GMP line. Such early “commercial ready” strategies can increase the value proposition for biotech companies considering future pharma partnerships or M&A exits.
“This partnership is an excellent extension to our long-standing relationship with CIRM. In the past we have supported CIRM grantees and have hosted participants from CIRM’s stem cell training programs. We have had other productive interactions including organizing Stem Cell cGMP Manufacturing Roundtables with leaders in cell therapy production. The new CIRM partnership will boost our mission to enable our fellow scientists in cell and gene therapy field to think boldly and produce medical breakthroughs”, said Jiwu Wang Ph.D., CEO of Allele Biotechnology.
“CIRM’s Industry Resource Partner Program aims to amplify its impact by partnering with industry leaders who possess the necessary resources, expertise, and experience to accelerate regenerative medicine research projects,” says Shyam Patel, Ph.D., Senior Director of Business Development & Alliance Management at CIRM. “We are thrilled to welcome Allele to our network of partners who share our unwavering commitment to advancing transformative regenerative medicine therapies for patients.”
About Allele Biotechnology:
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. More information can be found at www.allelebiotech.com.
About the California Institute for Regenerative Medicine (CIRM):
At CIRM, we never forget that we were created by the people of California to accelerate stem cell treatments to patients with unmet medical needs, and act with a sense of urgency to succeed in that mission. To meet this challenge, our team of highly trained and experienced professionals actively partners with both academia and industry in a hands-on, entrepreneurial environment to fast track the development of today’s most promising stem cell technologies. With $5.5 billion in funding and more than 150 active stem cell programs in our portfolio, CIRM is one of the world’s largest institutions dedicated to helping people by bringing the future of cellular medicine closer to reality. For more information go to www.cirm.ca.gov
Contact:
Rajesh Ambasudhan, Ph.D.,
Chief Strategist, Allele Biotechnology.
