Cynata Therapeutics Limited (ASX: CYP) is a biotechnology company based out in Victoria, Australia. The company is engaged in developing Cymerus technology, a therapeutic stem cell, in collaboration with the University of Wisconsin-Madison (UWM), a renowned leader in stem cell research. The company is also engaged in medicine development with a specialization in cell therapeutics.
Cymerus technology is based upon stem cells known as mesenchymoangioblasts (MCAs), a precursor of mesenchymal stem cells (MSCs), with a proven utility in asthma, limb ischemia, diabetic wounds, heart attack, and cytokine release syndrome treatment.
Today, the company announced the completion of clinical study report (CSR), describing full details of the results from the Phase 1 clinical trial of CYP-001 for the treatment of steroid-resistant acute graft versus host disease (GvHD) with a positive treatment.
GvHD is a complication that usually occurs when the donor’s immune cells attack the recipient of the bone marrow transplant with corticosteroid therapy being the only approved treatment. It is typically effective in about 50% of patients only.
The Phase 1 trial represented the first-time clinical trial of using an induced pluripotent stem cell (iPSC)-derived therapy with the following key highlights:
- Overall Response rate by Day 100 was 87%
- Complete Response rate by Day 100 was 53% with GvHD signs and symptoms completely resolved in 8 patients
- 87% overall survival at Day 100
- None of the serious adverse events or any safety concerns were identified during the test
The trial was conducted over fifteen participants out of which, the first eight participants were enrolled in Cohort A and the remaining seven participants were enrolled in Cohort B. Cohort A participants received two infusions of CYP-001, with a one week’s gap, with a dose of 1 million cells/kg and a cap of a dose of 100 million cells whereas Cohort B participants again received two infusions of CYP-001, with a gap of one week, but the dosage was changed to 2 million cells/kg, the cap was set to a maximum dose of 200 million cells.
The objective of the trial was to test the safety and tolerability of CYP-001 and assess the efficacy of two infusions of CYP-001 with steroid-resistant GvHD.
According to Dr. Adrian Bloor, the UK Chief Investigator for the trial, no safety concerns were identified, with the encouraging overall Response and complete response rates.
The company plans to advance its Cymerus MSCs into Phase 2 trials for GvHD and critical limb ischemia and further, receiving Fujifilm’s decision on exercising the license option.
On 13 December 2018, CYP announced that the Australian National Health and Medical Research Council (NHMRC) approved a grant to fund a 448-patient Phase 2 clinical trial in osteoarthritis, a chronical joint disease that causes pain and disability, expected to commence in 2H 2019.
On 19 November 2018, the company received a $1,308,551.78 Research and Development tax incentive refund for 2017/2018 financial year which augmented CYP’s cash position and extended its operating runway. The refund was a part of the Australian Government program that aims at refunding 43.5% of expense on R&D.
During the year, the CYP stock has gone up by 68%, but over the past one month, the share price is down by 7.4%, currently trading at $1.04. Post the clinical study results, the price is up by 4% today.
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