Cytora Therapeutics Ltd., Made Scientific Inc. and Zeo ScientifiX Inc. announced Jan. 7 a strategic partnership to advance and commercialize Cytora’s novel allogeneic, off-the-shelf, human oral mucosal stem cell therapy in the United States.
Cytora Therapeutics is a Tel Aviv-based clinical-stage biotechnology company developing allogeneic, stem cell therapies. Made Scientific is a Princeton-based cell therapy contract development and manufacturing organization; and Fort Lauderdale, Fla.-based Zeo ScientifiX is a clinical-stage biopharmaceutical company specializing in research, clinical trials, manufacturing and the commercialization, and market access of biologics.
The partnership objectives will be the commercialization of the Cytora novel therapeutic through available avenues that have opened up under Florida’s recently passed stem cell law, which permits the use of non-FDA-approved stem cells therapies that are compliant with the new regulations for the treatment of wound care, pain and orthopedic conditions and the parallel commencement of U.S. FDA Phase 2b clinical trials for the therapeutic toward the goal of obtaining an approved FDA license.
Under this collaboration, Cytora will provide the right to make Cytora’s product, while continuing clinical and regulatory development. Made Scientific will serve as the exclusive U.S. manufacturing partner, GMP (good manufacturing practices) manufacture, and quality control release testing of starting tissue-derived cell banks and final drug product from its Princeton facility. Zeo will serve as the exclusive U.S. commercial partner, providing market access, distribution infrastructure, and clinical site management.
The partnership will initially pursue commercialization under Florida’s Senate Bill 1768, a stem cell therapy access law, which provides a pathway for commercialization of adult allogeneic stem cell therapies for patients that suffer from wound care, pain, and orthopedic conditions. Diabetic foot ulcers (DFUs) will serve as the lead indication, providing a potentially meaningful treatment option for an estimated 125,000 new patients annually in Florida alone.
The collaboration plans to expand into additional wound, orthopedic and pain management indications — therapeutic categories that collectively represent over 3.6 million annual cases in the state. The partnership will also support a U.S. FDA IND pathway for a Phase 2b clinical trial and future international regulatory submissions.
Cytora’s technology is based on proprietary allogeneic human oral mucosal stem cells (hOMSCs), a unique cell population with demonstrated regenerative potential supported by hOMSC200 Phase 1/2a clinical data. Unlike other stem cell sources, oral mucosal stem cells can be collected through minimally invasive procedures and exhibit favorable characteristics for tissue regeneration and wound healing.
“We are excited to partner with Cytora and Zeo on this transformative collaboration that brings together complementary expertise across technology, manufacturing, and commercialization,” said Syed T. Husain, chairman and CEO of Made Scientific.
“This partnership exemplifies Made’s commitment to supporting innovative cell therapies from development through commercial supply. Our integrated GMP manufacturing capabilities — including full compliance with U.S. FDA and EU GMP Annex 1 requirements — position us to deliver Cytora’s innovative therapy that can make a meaningful difference for patients suffering from chronic wounds.”
