Cynata Expands MEND clinical trial in COVID-19 and Respiratory Failure

MELBOURNE, Australia, March 29, 2021 (GLOBE NEWSWIRE) — Cynata Therapeutics Limited (ASX: CYP), a clinical-stage biotechnology company specialising in cell therapeutics, is pleased to announce that it has received ethics committee approval to expand recruitment criteria in its active MEND (MEseNchymal coviD-19) clinical trial.

Key highlights

• Ethics committee approval received to expand the recruitment criteria of Cynata’s MEND clinical trial in patients in intensive care with respiratory failure, to include other causes beyond COVID-19 (such as influenza)
• The MEND trial will investigate early efficacy of Cymerus MSCs in patients with respiratory failure, who meet the well-established criteria for Acute Respiratory Distress Syndrome (ARDS)

• The trial expansion increases the pool of eligible patients, and is therefore expected to significantly accelerate recruitment
• Respiratory failure/distress (including ARDS) is a severe and life-threatening illness, representing a major unmet medical need

The MEND clinical trial was initially designed to investigate early efficacy of Cynata’s proprietary Cymerus™ mesenchymal stem cells (MSCs) in adults admitted to intensive care with COVID-19. The approved expansion will enable recruitment of patients with respiratory failure arising from other causes, with COVID-19 no longer a requirement. In view of the current state of control of the COVID-19 pandemic in Australia, this expansion of recruitment criteria is expected to substantially increase the pool of potential subjects for the trial.

The MEND trial is an open-label, randomised controlled clinical trial to investigate early efficacy of Cymerus MSCs in patients with respiratory failure. Cynata is seeking to enrol 24 adult patients admitted to intensive care with respiratory distress (or compromised lung function) at selected hospitals in Australia.

A corporate presentation on the MEND clinical trial and respiratory distress is attached to this announcement.

Dr. Kilian Kelly, Cynata’s Chief Operating Officer, said:
“The expansion of this clinical trial represents execution of our strategy to ensure that, despite the dynamics of the COVID-19 pandemic, we will substantially increase the catchment of patients to accelerate the completion of the MEND trial. We have developed a solid pre-clinical data set in relevant disease models of the severe respiratory distress and associated complications suffered by many patients affected by respiratory viruses such as SARS-CoV-2 (the virus that causes COVID-19) and influenza. This expansion will increase the number of patients eligible for recruitment into this trial, which is designed to investigate the potential benefits of our MSCs in treating these severely ill patients.”

Authorised for release by Dr Ross Macdonald, Managing Director & CEO

About Cynata Therapeutics (ASX: CYP)
Cynata Therapeutics Limited (ASX: CYP) is an Australian clinical-stage stem cell and regenerative medicine company focused on the development of therapies based on Cymerus™, a proprietary therapeutic stem cell platform technology. Cymerus™ overcomes the challenges of other production methods by using induced pluripotent stem cells (iPSCs) and a precursor cell known as mesenchymoangioblast (MCA) to achieve economic manufacture of cell therapy products, including mesenchymal stem cells (MSCs), at commercial scale without the limitation of multiple donors.

Cynata’s lead product candidate CYP-001 met all clinical endpoints and demonstrated positive safety and efficacy data for the treatment of steroid-resistant acute graft-versus-host disease (GvHD) in a Phase 1 trial. Clinical trials of Cymerus MSC products in osteoarthritis (Phase 3) and in respiratory distress (Phase 2) are currently ongoing. Planning is also underway for further clinical trials of Cymerus MSC products in GvHD (through licensee Fujifilm), critical limb ischemia, idiopathic pulmonary fibrosis, renal transplantation, and diabetic foot ulcers. In addition, Cynata has demonstrated utility of its Cymerus MSC technology in preclinical models of numerous diseases, including the clinical targets mentioned above, as well as asthma, heart attack, sepsis, acute respiratory distress syndrome (ARDS) and cytokine release syndrome.