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Under a manufacturing agreement, Northway Biotech will develop a manufacturing process for iTolerance’s fusion protein in development for regenerative therapy.
On Aug. 1, 2023, US-based iTolerance, an early-stage regenerative medicine company, and Lithuania-based Northway Biotech, a contract development and manufacturing organization, announced that they have entered into an agreement for the manufacturing of Streptavidin-FasL (SA-FasL) fusion protein, an important component of iTolerance’s proprietary iTOL-100 platform technology.
According to a company press release, the SA-FasL fusion protein has demonstrated promising potential in pre-clinical studies; it was shown to establish durable, localized immune tolerance, which would thus enable implanted tissue or organoid, or a cell therapy, to function as a viable replacement for damaged native cells.
Under the agreement, Northway Biotech will use its expertise to develop a robust manufacturing process for SA-FasL. Process development work will involve the production of a master cell bank, the development and qualification of appropriate analytical methods, the optimization of formulation, and the development and scaling up of the production process. Northway Biotech will also be responsible for manufacturing a current good manufacturing practice-produced batch of drug substance for clinical studies.
“We believe this strategic partnership is not only a significant step for iTolerance, but also in developing advanced regenerative medicine technologies. We are incredibly delighted to establish this important partnership with Northway Biotech … to manufacture the clinical supplies necessary for our first in human clinical study for our lead program, iTOL-102,” said Anthony Japour, CEO of iTolerance, in the press release. “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.”
“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,” said Vladas Algirdas Bumelis, CEO and chairman of the board at Northway Biotech, in the release.