AgeX Therapeutics, Inc. (“AgeX”; NYSE American: AGE), a biotechnology company developing therapeutics for human aging and regeneration, and Juvenescence, a life sciences company developing therapeutics and technologies to treat diseases of aging and to increase human longevity, announce the publication of a new paper in the peer-reviewed scientific journal Regenerative Medicine. The paper is on the engineering of allogeneic cells to be hypoimmunogenic (universal), so as not to produce an immune response. The strategies reviewed in the paper include deletion of human leukocyte antigen (HLA) class Ia/II proteins, expression of HLA class Ib molecules, and manipulation of immune checkpoints.
In addition, the paper presents a previously unpublished in vivo observation on allogeneic human pluripotent stem cells (hPSCs) modified with AgeX’s proprietary immunotolerance technology, UniverCyteTM. In humanized mice (those with a functional human immune system), UniverCyte-positive hPSCs formed larger and heavier tissue compared to controls. This observation provides support for the premise that UniverCyte-expressing tissue was potentially hypoimmunogenic and might have escaped recognition by a functional human immune system and continued to grow. Further work is required to substantiate this preliminary in vivo finding.
“Hypoimmunogenic allogeneic cells are the Holy Grail in regenerative medicine, and a number of accomplished researchers have made great strides toward engineering them over the last few years,” commented Dr. Nafees Malik, Chief Operating Officer at AgeX, Head of Cell & Gene Therapy at Juvenescence (a major investor in AgeX), and lead author on the paper. “This is a huge area of focus for us at AgeX, via our UniverCyte technology platform. In support of our own research and as a service to the overall field, we decided to put together this paper, analyzing all the leading strategies to engineer universal cells and encapsulating them in one paper.”
Dr. Malik’s co-authors on the paper are Gregory Bailey, MD, Chairman of the Board of Directors of AgeX and CEO of Juvenescence; Annalisa Jenkins, MBBS, FRCP, who serves on the Board of Directors of AgeX; and Jim Mellon, Chairman of Juvenescence.
Mr. Mellon added, “AgeX’s UniverCyte technology platform will not only be important to the company in developing in-house therapies, it may also be transformative for the wider cell therapy industry via collaborations and licensing deals. It is quite conceivable that in the near future, allogeneic cell therapies may potentially need to be universal to be clinically and commercially competitive.”
AgeX is developing its UniverCyte technology platform at its new 15,700-square-feet R&D facility, in the San Francisco Bay Area, which has current good manufacturing practices (cGMP)-capable manufacturing capacity.
“Universal cells would help us and others to fulfill the original vision of cell therapy,” said Dr. Bailey. “Thus, I am pleased that my colleagues at AgeX and Juvenescence have put together this paper, as it should be of considerable benefit to researchers, possibly enabling them to accelerate their progress.” He added, “AgeX’s UniverCyte technology uses a novel, modified form of the tolerogenic molecule HLA-G, which in nature plays a key role in preventing a mother from rejecting her semi-allogeneic baby.”