Benzinga | Nov 30, 2021 04:48PM EST

AgeX Therapeutics' Licensee ImStem Biotechnology Announces First U.S. Multiple Sclerosis Patient Dosed With IMS001

AgeX Therapeutics, Inc. (("AgeX", NYSE:AGE), a biotechnology company focused on developing therapeutics for human aging and regeneration, announced today that ImStem Biotechnology, Inc. ("ImStem"), a biopharmaceutical company developing human embryonic stem cell (ESC)-derived mesenchymal stem cells, has dosed the first U.S. multiple sclerosis (MS) patient with ImStem's lead investigational drug candidate IMS001 at the Shepherd Center in Atlanta, GA. IMS001 was derived by ImStem from AgeX's pluripotent stem cell line designated ESI-053, under a non-exclusive sublicense from AgeX.

AgeX will be entitled to receive revenues in the form of royalties on the sale of IMS001 if successfully developed by ImStem and approved for marketing by the FDA or foreign regulatory authorities, as well as a share of certain other revenues that ImStem may receive in connection with the development or commercialization of IMS001, in multiple sclerosis.

IMS001 is derived from AgeX pluripotent stem cells induced to differentiate into mesenchymal stem cells (MSCs), and is an investigational, allogeneic cell product to be administered intravenously to patients suffering from MS. IMS001 is believed to be the first MSC product derived from an ESC line to be accepted for a human trial by the FDA (NCT04956744). ImStem plans to continue enrollment in a dose-escalating, open-label study to evaluate the safety, tolerability, and exploratory efficacy of a single dose of intravenous IMS001 in patients with relapsing-remitting, secondary, or primary progressive MS for whom other treatments have failed.

"After decades of ground-breaking work with human embryonic stem cells in the biopharma industry, it is fantastic to see cellular therapies derived from them now being explored in clinical trials," said Dr. Nafees Malik, Chief Operating Officer of AgeX. "The ESI stem cell lines are distinguished as the first clinical-grade human pluripotent stem cell lines created under Good Manufacturing Practices, and we wish to expand access to them for the derivation of cell therapies, by working with academic and industry partners, like ImStem. Also, ESI cells are among only a small number of pluripotent stem cell lines from which a derived cell therapy product candidate has gained FDA IND clearance for human studies."