Clinical-stage stem cell and regenerative medicine company Cynata Therapeutics Limited (ASX:CYP) recently released its quarterly business report for the three-month period ending March 31, 2022. The report includes various trial developments clinics around Cynata’s robust and diverse product portfolio.
Cynata is focused on developing various therapies based on its proprietary therapeutic stem cell platform technology, Cymerus™. The unique technology platform is designed to fill the gaps in existing methods of producing CSM for therapeutic use. Cymerus is being developed to enable cost-effective manufacturing of cell therapy products, including mesenchymal stem cells (MSCs), on a commercial scale from a single donor.
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Ongoing clinical trials and progress to date
Phase 3 clinical trial in osteoarthritis: The Australia-based biotech company is actively recruiting and treating patients in the Phase 3 SCUlpTOR (structure-modifying therapy for medial tibio-femoral osteoarthritis) trial during the quarter. A total of 440 patients with knee osteoarthritis are recruited for the trial.
Sponsored by the University of Sydney, the trial was designed to assess the effect of CYP-004, Cynata’s Cymerus MSC product for osteoarthritis, versus placebo on clinical outcomes and structure of the knee joint over a two-year period.
According to preclinical research, MSCs possess the ability to evoke a regenerative response in the underlying disease, which currently has a market size of approximately US$11.6 billion.
To read : Discuss the competitive advantages of Cynata’s Cymerus technology
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MEND Respiratory Distress Clinical Trial: Cynata made notable progress in enrolling and treating patients in the MEND (MEseNchymal coviD-19) trial during the quarter. The randomized controlled clinical trial is now halfway there and is expected to conclude by the end of 2022.
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The trial aims to enroll a total of 24 adult patients with respiratory failure who meet established criteria for ARDS (acute respiratory distress syndrome). In addition to ARDS, sepsis and CRS (cytokine release syndrome) have been identified as other potential therapeutic targets.
According to preclinical studies, these medical conditions can potentially be improved with Cymerus MSCs via modulation of the associated inflammatory response.
Clinical Trial in Diabetic Foot Ulcers: Cynata recently enrolled initial patients in the Diabetic Foot Ulcers (DUP) clinical trial, which began at the end of the December quarter. A total of 30 patients will be treated for 4 weeks in the trial, with evaluation expected to continue for 24 weeks.
Related article: Cynata Enrolls First Patients in Diabetic Foot Ulcers (DUP) Clinical Trial
Subjects will be randomly assigned to receive CYP-006TK or standard therapy. CYP-006TK is a new polymer coated silicone dressing seeded with Cymerus mesenchymal stem cells to facilitate topical application to the wound. This unique dressing technology has been exclusively licensed from a leading manufacturer of innovative biomedical coatings, TekCyte Limited.
A quick look at other developments
During the quarter, Cynata finalized all remaining operational details of the Strategic Partnership Agreement (SPA) with FUJIFILM and the associated Manufacturing Services Agreement (MSA) with FUJIFILM Cellular Dynamics, Inc (FCDI). The Company has already commenced activities associated with establishing the Cymerus manufacturing process at FCDI.
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Cynata further strengthened its intellectual property portfolio during the quarter, with granted patents in China and Japan. These two countries are key markets for the development of advanced technologies in regenerative medicine.
Image source: © Stuartbur | Megapixl.com
Must read: Cynata (ASX:CYP) strengthens its IP portfolio with a new patent
The biotech company also plans to launch a phase 2 clinical trial in acute graft versus host disease (aGvHD) in the United States. To conduct the trial, Cynata will seek FDA approval this year. The Company’s lead MSC product candidate, CYP-001, has already met all clinical endpoints and demonstrated breakthrough positive safety and efficacy data for the treatment of aGvHD in a trial phase 1, providing crucial validation of Cymerus’ MSCs.
Cynata received approximately A$833,000 R&D tax incentive reimbursement for fiscal year 2020/2021 during the quarter. The R&D Tax Incentive is an Australian Government initiative to support companies engaged in R&D for the benefit of Australia, reflecting the potential of Cymerus MSCs to improve the lives of patients suffering from a variety of devastating diseases.
The Company ended the quarter with a strong cash balance of A$25.28 million in cash, as of March 31, 2022.
Cynata shares are trading at A$0.380 as of 2:50 p.m. AEST.