Patents and production announced for MSC product

Stem cell company Cynata Therapeutics (ASX:CYP) has had a busy week, announcing a successful patent for its Cymerus mesenchymal stem cell (MSC)  technology, a patent application describing certain novel aspects of the technology and the manufacture of its clinical trial product.

On Monday, the Japanese Patent and Trademark Office issued a decision to grant a patent covering certain aspects of the Cymerus MSC manufacturing technology. The exclusive patent covers a proprietary method for deriving MSCs from pluripotent stem cells and will provide commercial rights in Japan through to 16 March 2031. 

On Thursday, the company announced that it had filed a further patent application describing certain novel aspects of the Cymerus technology. The patent application is owned by Cynata and, should it mature to a granted patent, will provide additional commercial exclusivity in key markets around the world. The company claims the new discovery will add further value to the Cymerus technology that clears a path towards low-cost, cutting-edge MSC therapy.

Cynata’s US-based contract manufacturer, Waisman Biomanufacturing, has meanwhile commenced the manufacture of Cymerus MSC product CYP-001 for use in a clinical trial in graft-versus-host disease (GvHD), expected to commence within the next few months. Manufacture was initiated following a lengthy series of good manufacturing practice (GMP) manufacturing qualification runs, which determined that product of consistent, high quality could be derived using the Cymerus process.

“The production of the clinical trial batch of CYP-001 is a very important step for Cynata,” said Dr Kilian Kelly, Cynata’s vice president of product development. “It follows the major achievement last year of transferring the original laboratory process to Waisman and upscaling it in a GMP environment. The product derived from the qualification runs has provided abundant material for the preclinical program that has been underway for around 12 months; now we will complete that phase with the manufacture of our clinical trial batch.”

The news comes one month after the company announced positive interim data from a proof-of-concept study of CYP-001, with the product demonstrating prolonged patient survival.

Cynata Therapeutics (ASX:CYP) shares were trading 2.78% higher at $0.37 as of around 2.30 pm on Thursday.