AgeX Therapeutics, ImStem Biotechnology sign non-binding letter of intent regarding investigational

AgeX Therapeutics, a biotechnology company developing therapeutics for human aging and regeneration, and ImStem Biotechnology, Inc., a biopharmaceutical company developing human embryonic stem cell-derived mesenchymal stem cells (hES-MSC), announced their signing of a non-binding letter of intent for ImStem to obtain from AgeX a non-exclusive license to use AgeX’s embryonic stem cell line ESI 053 to derive ImStem’s investigational MSC product IMS001 for development in COVID-19 as well as acute respiratory distress syndrome (ARDS) due to other causes.

AgeX and ImStem are co-operating to finalize financial terms and other provisions of a license agreement.

ImStem has previously used AgeX ESI 053 to derive the ImStem IMS001 product which is being investigated for multiple sclerosis under an IND. Earlier this year, the U.S. Food and Drug Administration (FDA) cleared IMS001 to begin a Phase 1 clinical study in patients with multiple sclerosis, after a clinical hold on its Investigational New Drug (IND) application was removed.

This is believed to be the first MSC product derived from human embryonic stem cells to be accepted for a clinical trial by the FDA. AgeX and ImStem already have a commercial license in place, which grants ImStem rights to use AgeX’s ESI 053 to derive IMS001 as a product candidate for development in autoimmune disease, including multiple sclerosis.

To date, in patients with pneumonia and ARDS due to COVID-19, preliminary literature suggests MSCs, such as ImStem’s hES-MSC candidate IMS001, may warrant further development consideration. An early clinical study conducted in China by an unrelated group with a different MSC product, “Transplantation of ACE2- Mesenchymal Stem Cells Improves the Outcome of Patients with COVID-19 Pneumonia,” and published in Aging and Disease (2020, Vol. 11, No. 2, pp. 216-228) showed that an intravenous infusion of a different MSC product appeared safe and improved functional outcomes in seven treated patients with COVID-19 pneumonia. MSCs are well recognized to be immunomodulatory in nature, possessing immunosuppressive and anti-inflammatory properties.

Even before their application to COVID-19, MSCs were being investigated as a potential therapeutic option in ARDS, and emerging data in preclinical models has been encouraging. ARDS remains an area of considerable unmet medical need, affecting around 200,000 patients annually in the U.S., accounting for 10% of all intensive care unit patients, and having a mortality of approximately 40%. At the present time, no specific direct therapies exist for ARDS and only supportive treatment is available.

“We feel privileged to be part of a global effort to combat COVID-19. This is a unique opportunity for AgeX to leverage its resources to help with the public health challenge at hand. Decades of pioneering work with human embryonic stem cells means this technology is now at a point where it may play a role in the development of a cell-based approach to combating COVID-19. We are very excited by the prospect of expanding our relationship with ImStem to include COVID-19 and ARDS,” said Dr. Nafees Malik, Chief Operating Officer of AgeX.

“We welcome the opportunity to continue to collaborate with AgeX and explore future development of our IMS001 product in COVID-19 and ARDS from other causes,” commented Richard Kim, M.D., Chief Medical Officer of ImStem Biotechnology.