Allele Biotech’s cGMP iPSCs Used as Packaging Factories for Dual COVID Vaccine

SAN DIEGO--(BUSINESS WIRE)-- Allele Biotechnology and Pharmaceuticals, Inc. has been using mRNA as its core technology for creating cGMP-grade iPSC (induced pluripotent stem cells) lines for regenerative medicine and oncology for over a decade. At the onset of the COVID-19 pandemic, Allele had to pause ongoing therapeutic programs developing iPSC derived pancreatic beta cells, neuroprogenitor cells, lung epithelium cells, and CAR-T/CAR-NK cells. The management and scientific teams at Allele along with academic collaborators saw a great potential in utilizing Allele’s cGMP capability and iPSC platform to help with the fight against the devastating situations in California, Washington, New York, and many parts of the US, and diverted resources accordingly.

Mimicking the early stages of human development, iPSCs can divide quickly and expand without any limit, making them ideal “production factories” for biomaterials. Allele quickly figured out an innovative way of inducing these active cells to produce significant quantities of extracellular vesicles or exosomes, which can contain both RNAs AND proteins. Working diligently even under lockdown, Allele obtained preliminary data this week showing that mRNAs encoding the SARS-CoV-2 antigen proteins could be packaged in iPSCs and delivered in extracellular vesicles, potentially together with the viral proteins these mRNAs encode—a dual mRNA and protein vaccine, all naturally packaged in cells.

Multiple vaccine mRNAs delivered this way, as opposed to mostly single mRNA in the ongoing trials, plus the multiple proteins they encode, could provide a more powerful and robust vaccine platform. The production scale and stability faced by some of the mRNA vaccines could also be solved if Allele’s method of mRNA packaging is used. For instance, some of the mRNA vaccine candidates need to be stored at -80^oC to remain stable, causing difficulties in shipping and storage. In comparison, the SARS-CoV-2 S1 mRNA packaged in Allele’s iPSC-derived vesicles appeared intact for months even when stored in a 4^oC refrigerator.

Allele is putting its strength into this novel vaccine program, while at the same time moving forward with a cell phone based rapid COVID-19 antigen diagnostic product using various llama nanoantibodies and proprietary superbright fluorescent proteins. Additionally, as recently published in a front-page article by the San Diego Business Journal, some of Allele’s nanoantibodies are being tested as blocking antibodies for a nasally delivered COVID-19 prophylactic or “passive vaccines”, and treatment.

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