AgeX and Pluristyx announce manufacturing, marketing and distribution agreement.

AgeX Therapeutics and Seattle-based Pluristyx today announced they have entered into a manufacturing, marketing and distribution agreement which will see Pluristyx undertake commercialisation activities on behalf of AgeX with its research and clinical grade ESI brand human embryonic stem cells (sometimes referred to as hESCs).

Longevity.Technology: Welcome news for AgeX – only last week we reported on the company’s challenges with a regulatory Deficiency Letter from the staff of the NYSE American due, in part, to net losses during its two most recent fiscal years. Sharing the go-to-market with a 3rd party could prove a sound move in accelerating income. 

Pluristyx is a therapy tools and services company that serves customers in the rapidly growing fields of regenerative medicine and cellular and gene therapies. The agreement builds on Pluristyx’s strategy to manufacture, market, and distribute pluripotent stem cells to industry and academic scientists who are developing new therapies. Pluripotent cells are capable of becoming any cell in the body.

AgeX’s ESI hESC lines are distinguished for being the first clinical-grade hESC lines created under current Good Manufacturing Practice (cGMP). The AgeX ESI hESC lines are listed on the National Institutes of Health (NIH) Stem Cell Registry.

“A recent FDA IND clearance for a biotech company to begin a human trial for a cell therapy candidate derived from an AgeX ESI hESC line has amplified interest from industry and academia to utilize our cells in regenerative medicine,” said Dr Nafees Malik, Chief Operating Officer of AgeX.

“It is AgeX’s goal to make its cell lines the gold standard when it comes to therapeutic products derived from pluripotent stem cells.”

The agreement appears to be an important step in AgeX’s licensing and collaboration strategy to facilitate industry and academic access to its hESC lines, its PureStem® cell derivation and manufacturing platform and its UniverCyte™ immunotolerance technology in order to generate revenue.

“Pluristyx is excited to be working with AgeX and their ESI hESC lines,” said Dr Benjamin Fryer, CEO of Pluristyx.

“As AgeX intends to make their cell lines the gold standard, our aim is to disrupt and redefine stem cell therapy manufacturing with our proprietary, high-density format … hESC lines, which will dramatically reduce both cost and time in translating revolutionary therapies from bench to bedside.”

Academic and biopharma organisations will need to obtain separate commercial licences from AgeX in order to advance their cellular product candidates generated from AgeX hESC lines into human clinical trials and commercialisation; this may prove challenging in terms of deal-making.

According to AgeX, the company retains all rights to manufacture its own in-house cellular products as well as to extend licence rights to other third parties.