Regeneus Enters Partnership With Cryosite For New Stem Cell Products
By C. Rajan, contributing writer
Australian regenerative medicine company, Regeneus, has just entered a new collaboration with Cryosite, an Australian biotech company, for the development and manufacture of new stem cell products for human applications. This agreement will help to fast-track the production of Regeneus' novel stem cell therapy for osteoarthritis, Progenza, to make it available for preclinical and clinical trials for market entry into Japan.
Under the terms of the agreement, Regeneus will be providing the technology, know-how, and research facilities to assist Cryosite with the expansion of cord tissue-derived mesenchymal stem cells (MSCs), while Cryosite will provide production facilities for Progenza. The product will be manufactured within Cryosite’s good manufacturing practice (GMP) clean room facilities by Regeneus staff. The companies plan to jointly explore new product development and manufacturing opportunities, as well.
This deal extends Regeneus' relationship with Cryosite, which currently provides stem cell handling and storage services for Regeneus’ other stem cell product, HiQCell.
Regeneus CEO Professor Graham Vesey said, “Our relationship with Cryosite is developing into a strong partnership and we anticipate that it will continue to grow over time. Cryosite’s capabilities in the manufacturing and storage of GMP cell-based products in a TGA licensed facility complements Regeneus’ product development and early stage commercialization capabilities. We foresee a future where our two companies use these capabilities together to develop and supply a range of regenerative medicine products”.
Progenza is an off-the-shelf allogenic stem cell product for human osteoarthritis, which is manufactured using a small amount of human fat. The stem cells from the fat are expanded or multiplied by tissue culture, dispensed into vials, and frozen. Fat extracted from a single donor can be expanded into several hundred thousand doses of the product.
Regeneus recently raised $3 million through a fully subscribed private placement to commercialize its regenerative therapies. With this new agreement with Cryosite, it is preparing for the full-fledged commercialization of its stem cell products.
This agreement follows closely on the heels of another piece of good news for Regeneus' line of stem cell treatments. Regeneus just announced the positive results from its 386-patient clinical research study that is tracking the safety and efficacy of its innovative cell therapy, HiQCell, in the treatment of osteoarthritis. Patients in this study showed considerable reduction in pain and significant improvements in knee function and sleep quality. HiQCell was been found to be safe and well tolerated, and the patients in the trial will continue to be followed and assessed for joint pain symptoms for up to five years.
Regeneus also entered another agreement last month for its new personalized therapeutic human cancer vaccine with Northern Sydney Local Health District (NSLHD), which grants Regeneus the exclusive worldwide rights to develop and commercialize the vaccine. According to the terms of the agreement, Regeneus will be responsible for the clinical and commercial development of the cancer vaccine for human applications and will pay royalties to NSLHD on the commercial use of the product.