Regeneus’ clinical focus is on osteoarthritis (OA) and other musculoskeletal disorders, oncology and dermatology.
The company’s product pipeline is underpinned by proprietary stem cell and immunotherapy technologies comprising:
· mesenchymal stem cells (MSCs) from human donor adipose tissue for OA and other musculoskeletal disorders (Progenza for humans andCryoShot for animals)
· bioactive secretions from MSCs from human donor adipose tissue for inflammatory skin conditions (Sygenus for humans only)
· cancer immunotherapy that uses the patient’s tumour cells and a bacterial adjuvant for immune recognition (RGSH4K for humans andKvax for animals)
MSCs respond to the local disease environment and secrete a diverse variety of bioactive factors including cytokines, growth factors and exosomes that are responsible for reducing inflammation, promoting tissue repair and reducing scarring.
The company has over 70 patent and patent applications across 14 patent families supporting its technologies and products.
A successful Phase I trial for Progenza was completed in 2017, meeting primary endpoints of safety and tolerability. Secondary endpoints showed a significant, rapid and sustained reduction in knee pain and significant improvement in cartilage volume compared to placebo, with positive signs of disease modification.
Recruitment for the cancer vaccine Phase I trial (ACTIVATE) has now closed and a report on the trial results is anticipated in H2 FY18.
The company is carrying out further development of Sygenus to target specific pain and dermatological topical applications.
Regeneus has partnered with Asahi Glass (AGC), a leading Japanese manufacturer of biopharmaceuticals, in an exclusive manufacturing licence for Progenza in Japan. As a part of the collaboration, Regeneus and AGC have formed a joint venture, Regeneus Japan, to license the clinical development and marketing rights for all clinical indications in Japan.