iTolerance, Inc. and Northway Biotech Announce Partnership Agreement for the Manufacturing of Streptavidin-FasL Fusion Protein for Innovative iTOL-100 Immunomodulatory Technology
August 22, 2023 – BioManufacturing, Drug Delivery, Drug Discovery –
Miami, FL and Vilnius, Lithuania – 1 August 2023 – iTolerance, Inc. (“iTolerance” or the “Company”), 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 Contract Development and Manufacturing Organisation (CDMO), today announced they have entered into a partnership agreement for the manufacturing of iTolerance’s Streptavidin-FasL (SA-FasL) fusion protein, a crucial component of the proprietary iTOL-100 platform technology. The SA-FasL fusion protein has shown great potential in pre-clinical studies, establishing durable, localised immune tolerance and enabling implanted tissue, organoid, or cell therapy to function as a viable replacement for damaged native cells.
Under the terms of the agreement, 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, optimising 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. 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,” commented Dr. Anthony Japour, Chief Executive Officer of iTolerance. “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 are excited to be working with Northway Biotech on this critical component of our iTOL-100 technology. Northway has unique experience working with our cell line which we believe will accelerate our ability to prepare cGMP protein to support our planned first in human clinical study,” added Dennis M. Hester, PhD, SVP of Chemistry, Manufacturing and Controls at iTolerance, Inc.
Prof. Vladas Algirdas Bumelis, Chief Executive Officer and Chairman of the Board at Northway Biotech expressed his enthusiasm, stating, “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.”
André Markmann, PhD, VP of Business Development at Northway Biotech, added, “The partnership with iTolerance has been smooth sailing from the start. We are pleased to commence this project built on mutual trust and a collaborative spirit that drives both companies to perform at the highest level and deliver exceptional results.”
