If you key in the word “stem cell” into a search engine, results will show they have the potential to treat most diseases (but don’t forget to look for clinically-proven sources!)
There also exists an ASX-listed company focusing in stem cell therapeutics, aiming to be the panacea in treating the High-Risk acute Graft versus Host Disease (HR-aGvHD) which is a condition that can occur in 50% of patients receiving hematopoietic stem cell or bone marrow transplant. Biotech company Cynata Therapeutics (ASX: CYP) has opened recruitment of its Phase 2 clinical trial of its drug CYP-001 in patients with HR-aGvHD.
CYP-001 is a stem cell therapy that is based on Cymerus, Cynata’s proprietary therapeutic stem cell technology. The Phase 2 trial aims to enrol approximately 60 patients with HR-aGvHD, who will be randomised to receive either steroids plus CYP-001, or steroids plus placebo.
This trial is being managed and funded by Cynata, and the first clinical centre to open for recruitment in this trial is Westmead Hospital in Sydney, under the leadership of the Director of Blood Transplant & Cell Therapies Program at Westmead Hospital and Professor of Haematology from The University of Sydney, Professor David Gottlieb.
Commenting on the trial recruitment, Dr Kilian Kelly, Cynata’s Chief Executive Officer & Managing Director, said: “The commencement of this randomised controlled trial – which is being conducted under a US FDA IND – is a major milestone for Cynata.”
“With very encouraging response and survival rates, and no safety concerns identified, we are optimistic that this new trial will build on the substantial body of data we have generated so far, and ultimately make a difference to the lives of patients suffering from this terrible disease.”
CYP-001 has met all clinical endpoints and demonstrated positive safety and efficacy data for the treatment of steroid-resistant acute graft-versus-host disease (GvHD) in its Phase 1 trial. Currently, preparations are in progress for a Phase 2 clinical trial targeting GvHD, operating under an approved US FDA IND.
GvHD is a rare condition that affects individuals with weakened immune systems who have had a bone marrow transplant or blood transfusion. It can lead to skin rashes, digestive issues, and liver problems. In GvHD, the donor’s immune cells attack the recipient’s body. The donor’s cells are the “graft,” and the recipient is the “host.” This occurs when certain white blood cells in the donated cells attack the patient’s own cells.
Cynata’s Cymerus overcomes the challenges of other production methods to achieve economic manufacture of cell therapy products, including mesenchymal stem cells (MSCs), which have huge therapeutic potential for numerous unmet medical needs at commercial scale without the limitation of multiple donors.
Other clinical trials of Cymerus products are currently undergoing, such as Phase 3 of osteoarthritis treatment and Phase 1 of diabetic foot ulcers (DFU) treatment. In addition, Cymerus’ utility has been demonstrated in preclinical models of critical limb ischaemia, idiopathic pulmonary fibrosis, asthma, heart attack, sepsis, acute respiratory distress syndrome (ARDS) and cytokine release syndrome.
In the quarter ended 30 June 2023, Cynata completed a leadership transition to new CEO and Managing Director Dr. Killian Kelly, as well as successfully completing a $7 million capital raising consisting of a $5 million placement, conducted at an offer price of $0.215, as well as a $2 million SPP at an offer price of $0.155, which closed oversubscribed. Proceeds raised primarily will be used to fund the Phase 2 clinical trial of aGvHD.
The Company spent $3.4m on research and development, which was significantly higher than the projected average expenditure in the forthcoming two financial years due to one-off initial payments of $1.7m to the Company’s contract research organisation to commence the Phase 2 aGvHD clinical trial. All in all, the Company ended the quarter with a cash balance of $16.2m.
Two-year follow-up data from the Phase 1 SR-aGvHD trial was selected to be presented at the prestigious International Society for Cell & Gene Therapy (ISCT) Annual Meeting.
Clara is a Business Reporter for The Sentiment.
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