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  • Cynata Therapeutics (CYP) has released its December 2019 quarterly report, primarily outlining positive operations
  • Highlights for the biotech company include planning multiple Phase 2 clinical trials and receiving a notice of allowance from the Canadian Intellectual Property Office
  • Moving forward with the Phase 2 trials places Cynata one step closer to commercialising its products
  • However, in what was a positive quarter, the company announced its discussions with Sumitomo have stopped as an agreement could not be reached
  • Cynata is currently down 3.18 per cent with shares trading for $1.07 apiece

Cynata Therapeutics (CYP) has released its December 2019 quarterly report, primarily outlining positive operational progress.

Highlights for the company include planning for three Phase 2 clinical trials, a broad preclinical pipeline, and receiving a notice of allowance from the Canadian Intellectual Property Office (CIPO).

Trial Updates

In November 2019, Cynata lodged an application with the U.K. Medicines Healthcare Products Regulatory Agency (MHRA) for a proposed Phase 2 clinical trial of Cynata’s Cymerus mesenchymal stem cell (MSC) product, CYP-002. The trial is for the treatment of critical limb ischaemia (narrowing of arteries in the limbs).

Following the quarter, the MHRA completed its review and granted approval for Cynata to proceed with the trial.

The company expects to conduct trials at multiple centres in the U.K. and Australia with detailed planning towards beginning the trial now underway.

This is a significant opportunity, with the global critical limb ischaemia treatment market forecast to reach US$5.4 billion (AUD$8 billion) by 2025.

Following the signing of a Research Support Agreement with the University of Sydney, significant progress was also made for the Phase 2 clinical trial for Cynata’s Cymerus MSCs as a treatment in osteoarthritis.

The 448 patient trial is expected to begin in the near-term and will be led by Professor David Hunter at the University of Sydney.

This will be one of the largest MSC trials to ever be conducted, showcasing Cynata’s MSC manufacturing capability.

Following the exercise of its licence option in treating GvHD (Graft versus host disease), Cynata’s licensee for CYP-001, FUJIFILM, is progressing with further development of the product.

Cynata is continuing to work alongside FUJIFILM on trial planning and start-up activities with the first GvHD Phase 2 trial expected to begin this year.

Broad Preclinical Pipeline

During the quarter, Cynata received an innovation connections grant of $50,000 to advance the development of therapies for CAD (coronary heart disease).

The grant was received from the Australian Government’s Department of Industry Innovation and Science to support continued research at UNSW Sydney under the leadership of Associate Professor Kristopher Killian.

In December 2019, the company also received positive efficacy data from preclinical studies for the treatment of sepsis.

Data showed the MSC treatment was successful in increasing blood oxygen levels, and lung stretching ability, and decreasing inflammation.

Studies were performed under Cynata’s development partnership with the Riyal College of Surgeons in Ireland, under the leadership of Professor Gerard Curley.

In what was a busy quarter for the company, Cynata received a notice of allowance from CIPO for a patent application covering its Cymerus MSC technology.

The company anticipates the patent will be granted before April 11 2020, and will expire on March 16 2031.

The patent will expand the already strong protection of the Cymerus platform and its unique ability to produce MSCs at scale.

MSCs are adult stem cells found in a wide range of human tissues including fat tissue, bone marrow and placenta.

They are multi-potent which means they can produce more than one type of cell, for example, they can differentiate into fat, cartilage and bone cells.

They have been shown to ease regeneration and effects on the immune system without relying on engraftment (when transplanted cells start to grow and make healthy cells).

In what has been a quarter of achievements there has also been some downfalls.

In July 2019 Cynata received an indicative, non-binding and conditional proposal from Sumitomo regarding the possible purchase of all shares in Cynata at $2 per share.

However, after engaging in discussions, Cynata was unable to reach agreement on terms meeting its requirements and withdrew from the discussions in October 2019.

The progression into multiple Phase 2 clinical trails presents an exciting opportunity for Cynata to provide treatment to patients with serious and debilitating diseases and progress the company towards commercialisation.

“Cynata continues to expand the utility of its Cymerus MSCs as a treatment for a broad range of indications,” Chairman Dr Paul Wotton commented.

“Further positive efficacy data was generated during the quarter, including in a preclinical model of sepsis, which makes us optimistic that our product can provide a new treatment option for patients in need,” he added.

He went on to say how the company is looking forward to begin the Phase 2 studies and commercialising the MSC platform.

Cynata is currently down 3.18 per cent with shares trading for $1.07 apiece at 3:42 pm AEDT.

CYP by the numbers
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