On July 1, 2021 Exacis Biotherapeutics, Inc., a development-stage immuno-oncology company working to harness the immune system to cure cancer, reported two significant advances in its manufacturing capabilities. Exacis’ is partnering with parent Factor Bioscience to produce its iPSC-derived CAR-T and NK cells within a GMP cleanroom facility built by Factor, and Exacis has hired Bryan Jones PhD as its Head of Technical Operations.
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Exacis’ parent company, Factor Bioscience, recently completed construction of a 5,000 square foot GMP cleanroom facility at its Cambridge, Massachusetts headquarters. The facility includes two ISO Class 7 cleanrooms and is designed to enable production of advanced mRNA, gene-editing, and cell therapy products to support all phases of clinical development. Exacis will use this new facility to produce its allogeneic mRNA engineered cell-therapy product candidates for non-clinical and clinical testing.
Exacis’ next generation approach avoids the use of DNA and viruses and instead uses proprietary, innovative mRNA-based technology. This technology is used for generating iPSCs and for performing gene editing to create potent, targeted, allogeneic (off-the-shelf) cell therapy products, termed ExaCAR-T and ExaCAR-NK cells. The company anticipates that the Factor GMP cleanroom facility will have sufficient capacity to support its programs through late-stage clinical development.
Matthew Angel, PhD, CEO of Factor Bioscience, Exacis’ parent company, added, "We invested in constructing our GMP cleanroom facility to give our partners more control over the manufacturing aspects of their cell-therapy programs. We look forward to supporting Exacis as it advances its engineered NK-cell and T-cell programs through clinical development."
Bryan Jones, PhD, Head of Technical Operations
Dr. Jones joins the company with 30 years of drug development experience in a variety of roles including at the C-suite level which allows him to contribute across many dimensions. Most recently, he was Chief Operating Officer at Sollis Therapeutics. Immediately prior, he was Vice President of Operations at Sorrento Therapeutics, a leading therapeutic antibody company and one of the early adopters of cell therapy. Dr. Jones will oversee the buildout of the Manufacturing and Quality Operations working alongside Factor Bioscience in the new facility. "The high cost and long lead times required for cell therapy manufacturing are major issues that have hindered the progress of developing new treatments," said Dr. Jones. "The Exacis technology brings several significant advances that will allow for greater adoption of these highly targeted medicines."
Exacis CEO Gregory Fiore MD commented, "We are excited to announce these major steps forward in our ability to maintain control of our own cell supply and its quality. Adding Bryan as head of Technical Operations and securing a dedicated GMP manufacturing capacity within the Factor facility allows us to produce our unique and high quality cells on our own timeline as we progress toward the clinic."