iTolerance, Inc., an early-stage regenerative medicine company developing technologies to enable tissue, organoid or cell therapy without the need for life-long immunosuppression, and Northway Biotech, an end-to-end biologics CDMO, entered into a partnership agreement for the manufacture of iTolerance’s Streptavidin-FasL (SA-FasL) fusion protein, a crucial component of the iTOL-100 platform technology. The SA-FasL fusion protein has shown great potential in preclinical studies, establishing durable, localized immune tolerance, and enabling implanted tissue, organoid, or cell therapy to function as a viable replacement for damaged native cells.

Northway Biotech will leverage its expertise to develop a robust manufacturing process for the SA-FasL fusion protein. This involves producing a master cell bank (MCB), developing, and qualifying analytical methods, optimizing the formulation, development and scaling up of the production process, and manufacturing a cGMP drug substance batch for clinical studies.

“We believe this strategic partnership is not only a significant step for iTolerance, but also in developing advanced regenerative medicine technologies,” said Anthony Japour, CEO of iTolerance. “We are incredibly delighted to establish this important partnership with Northway Biotech, a pre-eminent CDMO, to manufacture the clinical supplies necessary for our first in human clinical study for our lead program, iTOL-102.”

Japour added: “We look forward to working closely with the Northway Biotech team to advance our iTOL-100 technology and progress towards providing treatment options that have the potential to cure diseases without the need for chronic immunosuppression.”

Vladas Algirdas Bumelis, CEO and Chairman of the Board at Northway Biotech said, “We are delighted to embark on this dynamic project focused on producing the SA-FasL fusion protein for iTolerance. We believe this partnership is an exciting development in the regenerative medicine field, and we are honored to play a role in advancing this important work. With a commitment to meeting contractual timelines, our primary objective is to ensure the punctual delivery of these crucial materials to our esteemed partners at iTolerance.”