AgeX Therapeutics’ Licensee ImStem Biotechnology Announces First U.S. Multiple Sclerosis Patient Dosed with IMS001

Rhea-AI Summary

AgeX Therapeutics, Inc. (NYSE American: AGE) announced that ImStem Biotechnology has successfully dosed the first U.S. patient with the investigational drug candidate IMS001, derived from AgeX's pluripotent stem cell line ESI-053. This marks a significant milestone in advancing cellular therapies for multiple sclerosis (MS). AgeX stands to gain royalties from IMS001's potential future sales and revenues upon successful FDA approval. This investigational product aims to treat patients suffering from MS, showcasing AgeX's commitment to innovative therapeutic development.

Positive

• AgeX is entitled to royalties from IMS001 sales, providing potential revenue stream.
• IMS001 is believed to be the first MSC product from an ESC line accepted for human trials, marking a significant industry milestone.
• The trial's focus on MS addresses a high unmet medical need, enhancing AgeX's strategic positioning.

Negative

• There is no guarantee IMS001 will prove safe or effective in clinical trials.
• FDA or foreign regulatory approval for IMS001 is uncertain, potentially hindering revenue generation for AgeX.

• ImStem’s MSC Product Candidate IMS001 is Derived from AgeX’s Pluripotent Stem Cell Line ESI-053

ALAMEDA, Calif.--(BUSINESS WIRE)-- AgeX Therapeutics, Inc. (“AgeX”; NYSE American: 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.”

About AgeX Therapeutics
AgeX Therapeutics, Inc. (NYSE American: AGE) is focused on developing and commercializing innovative therapeutics to treat human diseases to increase healthspan and combat the effects of aging. AgeX’s PureStem^® and UniverCyte™ manufacturing and immunotolerance technologies are designed to work together to generate highly defined, universal, allogeneic, off-the-shelf pluripotent stem cell-derived young cells of any type for application in a variety of diseases with a high unmet medical need. AgeX has two preclinical cell therapy programs: AGEX-VASC1 (vascular progenitor cells) for tissue ischemia and AGEX-BAT1 (brown fat cells) for Type II diabetes. AgeX’s revolutionary longevity platform induced Tissue Regeneration (iTR™) aims to unlock cellular immortality and regenerative capacity to reverse age-related changes within tissues. HyStem^® is AgeX’s delivery technology to stably engraft PureStem or other cell therapies in the body. AgeX is seeking opportunities to establish licensing and collaboration arrangements around its broad IP estate and proprietary technology platforms and therapy product candidates.

For more information, please visit www.agexinc.com or connect with the company on Twitter, LinkedIn, Facebook, and YouTube.

About ImStem Biotechnology
ImStem Biotechnology, Inc. is aspiring to revolutionize how serious diseases with significant unmet needs are treated with a new generation of regenerative and cellular therapies. Pioneering research led to the proprietary state-of-the-art pluripotent stem cell technology, enabling off-the-shelf, allogeneic stem cell-derived products to be manufactured at scale, differentiating itself from the typical challenges imposed by autologous adult cell therapy products. The company's mission is to advance the science and understanding of human pluripotent stem cell based regenerative cellular therapies through novel and creative development pathways and to fulfill unmet medical needs in serious diseases. Its development strategy focuses on neurologic, autoimmune, degenerative, and rare orphan diseases. ImStem Biotechnology Inc. is a privately held company headquartered in Farmington, CT. For more information, visit www.imstem.com.

About IMS001
IMS001 is an investigational, allogeneic, MSC product derived from human embryonic stem cell line. IMS001 has demonstrated preclinical immunomodulatory and blood-brain-barrier (BBB) repair activities, which may lead to potential therapeutic benefits in a wide array of neurological, autoimmune, and rare orphan diseases with high unmet medical needs. These mechanistic properties may lead to therapeutic benefits in diseases such as MS, potentially reducing relapses, disability progression, and inducing disease arrest. Clinical trial IMS001-01 in MS patients is listed on clinicaltrials.gov (NCT04956744).

About ES Cell International
ESI – ES Cell International Pte Ltd (“ESI”). Established in 2000, ESI, a wholly owned subsidiary of Lineage Cell Therapeutics, Inc., developed ESI hESC lines in compliance with the principles of current Good Manufacturing Practices and has made them available to various biopharmaceutical companies, universities and other research institutions, including AgeX. These ESI cell lines are extensively characterized and most of the lines have documented and publicly available genomic sequences.

Forward-Looking Statements for AgeX
Certain statements contained in this release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not historical fact including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” should also be considered forward-looking statements. Forward-looking statements involve risks and uncertainties. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of AgeX Therapeutics, Inc. and its subsidiaries, particularly those mentioned in the cautionary statements found in more detail in the “Risk Factors” section of AgeX’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commissions (copies of which may be obtained at www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. In addition, with respect to AgeX’s sublicense agreement with ImStem there is no assurance that (i) IMS001 will prove to be safe and efficacious in clinical trials or receive FDA or foreign regulatory approval, (ii) IMS001 will be successfully commercialized, or (iii) AgeX will derive revenue or other financial benefits from the sublicense agreement with ImStem. AgeX specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211130005454/en/

Dr. Nafees Malik

Chief Operating Officer

AgeX Therapeutics, Inc.

nmalik@agexinc.com

Source: AgeX Therapeutics, Inc.

FAQ

What is the significance of AgeX's partnership with ImStem regarding IMS001?

AgeX's partnership with ImStem allows them to receive royalties on IMS001's sales if it is approved for marketing, providing a potential revenue opportunity.

What is IMS001 and how does it relate to AgeX?

IMS001 is an investigational drug candidate for multiple sclerosis, derived from AgeX's pluripotent stem cell line, indicating AgeX's technological contributions to innovative therapies.

When was the first patient dosed with IMS001?

The first U.S. patient was dosed with IMS001 at the Shepherd Center in Atlanta, GA.

What are the potential benefits of IMS001?

IMS001 may provide therapeutic benefits for MS patients, potentially reducing relapses and disability progression.

What are the risks associated with IMS001's clinical trials?

There are risks that IMS001 may not be safe or effective, and it may not receive necessary regulatory approvals.