Regeneus Ltd (ASX:RGS) is on track to enter its first significant partnering agreement in Japan by the end of September for its stem cell product, Progenza.
Progenza is an off-the-shelf stem cell product with the first targeted treatment being for knee osteoarthritis.
The company’s executive team visited Japan to advance discussions in late May, which have had a positive effect on developing a partnership.
Interest in cell based regenerative medicine technologies in Japan has grown since regulatory changes in 2014, which allow for an accelerated pathway to approval for regenerative therapies like Progenza.
The Progenza Phase 1 STEP trial for knee osteoarthritis is fully recruited and will complete once the last patient completes 12 months post treatment follow-up.
Progenza development strategy
Regeneus is moving forward with the regulatory registration pathway in 2 jurisdictions, Japan and the U.S.
The initial goal is to progress towards manufacture for a Phase 2 trial in Japan.
This will include donor procurement, process development and technology transfer to a chosen good manufacturing practice facility.
In the U.S., further preclinical studies will build upon the efficacy seen in the rabbit osteoarthritis study.
The results from the Australian Phase 1 STEP trial will also be helpful with the FDA pathway in the U.S.
STEP trial fully recruited
The STEP trial (Safety, Tolerability and Efficacy of Progenza) is the first clinical trial of Progenza for knee osteoarthritis. Progenza is produced from mesenchymal stem cells from adipose (fat) from a healthy donor.
The trial commenced in August 2015 and completed enrolment of 20 patients in April 2016 ahead of schedule.
Participants will be monitored for 12 months. The trial is scheduled to report in H2 FY17.
This positive milestone moved the company a step closer to completing its Progenza licensing discussions for the Japanese market.
Regeneus is a clinical-stage regenerative medicine company developing cell-based therapies to treat unmet medical needs for both humans and animals.
In the first half of FY16, the company commenced first-in-human clinical trials: the STEP trial and ACTIVATE trial, for their autologous cancer vaccine.
Regeneus shares are up 70% year to date, currently trading at circa $0.16 per share.
Upcoming news is expected during the September quarter related to securing a manufacturing and commercial partner for Progenza in Japan.
The cash position at the end of March was $1.97 million and the company has announced that it has secured a $2 million R&D funding facility which will support the clinical trials and operating activities throughout the rest of 2016.
The company anticipates the receipt of an R&D tax rebate for FY16 of around $2.5 million in early Q2 FY17.