Cynata (ASX:CYP) focuses on clinical trials in September quarter

Highlights

• Cynata is enrolling and treating patients actively in Phase 3 SCUlpTOR osteoarthritis clinical trial and the DFU clinical trial.
• Following the clearance of IND by the FDA, Cynata is undertaking startup activities for a planned Phase 2 clinical trial in an acute graft-versus-host disease (aGvHD).
• Cynata collaborator St Vincent’s Institute of Medical Research has received a grant of ~AU$1 million to investigate Cynata’s MSCs in ischaemic heart disease in a major preclinical project.

Cynata Therapeutics Limited (ASX:CYP), a leading cell therapy player, has published its quarterly report for the three months period ended 30 September 2022. The company has advanced its clinical trial programs with patient recruitment and ongoing startup activities during the reporting period.

Cynata is developing Cymerus™, a proprietary therapeutic mesenchymal stem cell (MSC) platform technology and is the leading company worldwide in the development of induced pluripotent stem cell (iPSC)-derived cell therapies.

Below are the major activities of the company during the September quarter and its subsequent period:

Image source: © 2022 Kalkine Media®, Data source: Company update

Phase 3 osteoarthritis clinical trial

Cynata continues patient recruitment and treatment in the Phase 3 SCUlpTOR (structure-modifying treatment for medial tibiofemoral osteoarthritis) osteoarthritis trial. The trial will evaluate the efficacy of CYP-004, Cynata’s Cymerus™ intra-articular injectable mesenchymal stem cell (MSC) product for osteoarthritis.

Sponsored by the University of Sydney and funded by an Australian Government National Health and Medical Research Council project grant, the trial is expected to conclude in 2024 end.

According to preclinical research, MSCs may have the ability to produce a tissue regenerative response, leading to a potential breakthrough in the US$11.6-billion global osteoarthritis market.

Diabetic Foot Ulcer (DFU) trial

During the quarter, the company continued recruitment activities in the DFU  clinical trial. The trial is designed to assess the safety and early efficacy of the company’s topical MSC product, CYP-006TK, in patients with DFU.

Based on current recruitment estimates, the results are anticipated in the second half of 2023.

Phase 2 clinical trial of graft-versus-host disease (aGvHD)

Cynata is preparing for a planned Phase 2 clinical trial of CYP-001 in aGvHD patients. The company has received clearance for an IND application from the FDA, placing it in an excellent position to explore additional clinical targets and commercial partnership prospects.

The company is undertaking negotiations with study centres for the trial and anticipates opening the first clinical trial site in next few months, subject to timely ethics and administrative approvals. It is expecting the results in 2024.

Strategy to optimise resources

The company undertook a strategic review of its clinical pipeline during the quarter. Given the success of ongoing clinical activities, including the Phase 3 SCUlpTOR trial and the Phase 1 DFU trial, together with the proposed Phase 2 aGvHD trial, the company decided to focus its resources on these initiatives and ended the MEND respiratory distress clinical trial. Cynata adopted this strategy to optimise its portfolio in line with commercial prospects available to the company.

AU$1 million grant

Cynata collaborator, St Vincent’s Institute of Medical Research received a grant of AU$1 million from the National Health and Medical Research Council (NHMRC). The grant will fund a major preclinical research project investigating Cynata’s Cymerus™ MSCs as a potential treatment for ischaemic heart disease (IHD), a leading cause of heart failure and death worldwide.

Bolstering IP portfolio

After the quarter, Cynata saw major achievements in strengthening its intellectual property (IP) portfolio in Australia and Canada.

Image source: © 2022 Kalkine Media®, Data source: Company update

Cynata expects that both patents will be granted in the near term.

Publication

Cynata’s scientific paper describing the optimisation of Cymerus^TM MSCs for treating coronary artery disease (CAD) was published in the peer-reviewed Journal of Tissue Engineering and Regenerative Medicine. The paper validates the potential of Cymerus^TM MSCs to treat serious diseases and provides the recognition of Cynata’s ability to provide a scalable stem cell therapy solution.

Team addition

During the reporting period, the company strengthened its board by appointing Ms Janine Rolfe as an independent Non-Executive Director. Ms Rolfe has more than two decades of experience in different legal, governance and management sectors.

Financial update – Cynata ended the quarter with AU$18.3 million in cash.

Outlook

Cynata is focused on completing recruitment for its active clinical trials and piloting the commencement of its planned Phase 2 clinical trial in aGvHD. Further, the company is engaged in commercial discussions with several potential partners and adding to its robust pipeline with an extensive database of preclinical data.

At the time of drafting this article (16 Nov, 3:49 PM AEST), shares of CYP were trading at AU$0.350 with an uptick of about 7.692%.