Symbiotix Biotherapies Announces Process Development & Manufacturing Agreement with Paragon Bioservices
BOSTON, MA, January 3, 2018 — Symbiotix Biotherapies, Inc. (“Symbiotix”), a pioneering venture-backed microbiome company developing novel molecular therapeutics based on the human microbiome, today announced that it has entered into a process development and manufacturing agreement with Paragon Bioservices, Inc., a global leader in the manufacturing of complex biopharmaceuticals.
According to the agreement, Paragon will continue its work on Symbiotix’s lead program to complete the optimization of the downstream production process for SYMB-104 in preparation for production of clinical material at scale. The process development work will utilize Symbiotix’s proprietary engineered production strain of B. fragilis, a strain engineered to overexpress a specific immunomodulatory polysaccharide without production of other capsular polysaccharides typically produced by this organism. SYMB-104 is a Reglemer™ based on a specific capsular polysaccharide produced by B. fragilis that is capable of modulating regulatory T cell activity, and is protected by issued composition-of-matter patents. Terms of the manufacturing agreement were not disclosed.
“Paragon Bioservices has a proven track record in biopharmaceutical process development and is known for transitioning from the research bench to manufacturing of finished drug product for clinical use,” said Nader Yaghoubi, M.D., Ph.D., President and Chief Executive Officer of Symbiotix. “As we position Symbiotix for commencing human clinical trials, this agreement enables us to operationally leverage Paragon’s expertise while we seek to advance SYMB-104 for treatment of immune-mediated diseases.”
“We are pleased that Symbiotix Biotherapies has chosen Paragon Bioservices as their process development and manufacturing partner and believe that it is testament to the value that our scientific expertise brings to a program,” said Peter Buzy, Chief Executive Officer of Paragon. “We look forward to having our best-in-class development and manufacturing teams continue to work closely with the Symbiotix team to advance their first-in-class programs from development into the clinic.”
About Symbiotix Biotherapies, Inc.
Symbiotix Biotherapies, Inc. is a pioneering venture-backed microbiome company founded on the basis of over two decades of research at Brigham & Women’s Hospital/Harvard Medical School, California Institute of Technology and Dartmouth College. Symbiotix is developing a novel class of Treg-modulating therapeutics based on molecules derived from the human microbiome. As one of the earliest companies in the microbiome sector, our most advanced clinical candidate has been described in over 100 scientific publications, represents the most well studied microbiome-derived molecule to date, and is now protected by issued composition-of-matter patents. Symbiotix is dedicated to delivering first-in-class oral agents that improve the lives of patients with inflammatory bowel disease (IBD), multiple sclerosis (MS) and other serious immune-mediated diseases. For more information, please visit www.symbiotix-bio.com.
About Paragon Bioservices, Inc.
Paragon Bioservices is an industry-leading, private-equity backed contract development and manufacturing organization (CDMO) with over two hundred employees whose focus is the development and manufacturing of cutting-edge biopharmaceuticals. Paragon’s aim is to build strong client partnerships with the world’s best biotech and pharma companies, focusing on transformative technologies, including gene therapies (AAV), next-generation vaccines, oncology immunotherapies (oncolytic viruses and CAR-T cell therapies), therapeutic protein, and other complex biologics.
Source: Symbiotix Biotherapies, Inc.