Luxa Biotechnology Awarded $4 Million CIRM Grant to Support Clinical Trial of Adult RPESC-RPE-4W Therapy for Dry Age-related Macular Degeneration
01 Mayo 2024 - 6:00AM
Business Wire
Luxa Biotechnology (LuxaBio), a joint venture between Y2
Solution Co. Ltd, Seoul, South Korea and the Neural Stem Cell
Institute (NSCI) in Rensselaer, New York, today announced receipt
of a $4 million grant from the California Institute for
Regeneration Medicine (CIRM) to support the ongoing Phase 1/2a
study (NCT04627428) of RPESC-RPE-4W transplantation for the
treatment of dry age-related macular degeneration (dry AMD). The
funding will accelerate manufacturing and clinical activities based
in California.
RPESC-RPE-4W is a cell product derived from adult retinal
pigment epithelial stem cells (RPESC) that generate retinal
pigmented epithelium (RPE) cell progeny (RPESC-RPE).
Transplantation of progenitor-stage RPESC-RPE cells obtained after
four weeks of differentiation (RPESC-RPE-4W) effectively replace
the native RPE cells lost during AMD disease progression.
"We are honored to have CIRM recognize the potential of our
unique technology utilizing precursor-stage RPE cells. Replacement
of lost RPE cells with RPESC-RPE-4W aims to restore vision loss in
patients with dry AMD and offers the potential to improve the
quality of life,” said Jeffrey Stern, PhD, MD, co-founder of the
NSCI.
Dry AMD is a common eye disorder in people over 50. It is caused
by the deterioration of the cells of the macula, as retinal cells
die off and are not renewed. The condition results in reduced
central vision and there are currently no treatments available to
reverse the damage.
“RPESC-RPE-4W therapy represents a potential breakthrough in the
treatment of dry AMD,” said Dr. Abla Creasey, PhD, Vice President
of Therapeutics Development at CIRM. “We are impressed with the
stem cell-based replacement approach developed by Luxa
Biotechnology and delighted to support their groundbreaking efforts
to restore vision and hope to patients with dry AMD.”
Dr. Stern will present an update on the RPESC-RPE-4W trial on
May 3, 2024, at the Foundation Fighting Blindness / Casey Eye
Center Symposium, taking place in Seattle, Washington.
About Luxa Biotechnology
Luxa Biotechnology (LuxaBio) is a clinical-stage biotechnology
company developing a novel adult RPE stem cell (RPESC) therapy for
dry AMD. The proprietary adult RPESC-derived RPE stem cell product
was developed at and licensed from the Neural Stem Cell Institute
(NSCI). LuxaBio is a partnership between the NSCI research
institute and Y2 Solution, a Korean company, to evaluate RPESC in a
clinical trial to test the safety and efficacy of RPE progenitor
stage progeny as a therapy for dry AMD. LuxaBio maintains a robust
research program at NSCI to develop the RPESC as an effective,
commercially viable cell product. The Phase 1/2a clinical trial of
RPESC-RPE-4W for the Treatment of Dry Age-related Macular
Degeneration includes the Cedars Sinai Biomanufacturing Center,
Emmes, the University of Michigan Kellogg Eye Center, the National
Eye Institute For more information, please contact
jeffreystern@luxabiotech.com
About NSCI
In 2005, Dr. Sally Temple and Dr. Jeffrey Stern founded the
Regenerative Research Foundation and the Neural Stem Cell Institute
(NSCI), the first independent stem cell research institute in the
country. Rooted in discovery research, the administratively lean
NSCI effectively advances laboratory discoveries to clinical
application of regenerative stem cell therapies that address
diseases of the central nervous system. NSCI is a non-profit
discovery research Institute led by Dr. Sally Temple, the
scientific director. The staff of 40 research staff is dedicated to
advancing the understanding of neural stem cell biology work in
cutting edge laboratories equipped for stem cell research. The
retinal pigment epithelial stem cell (RPESC) was discovered at NSCI
where in-depth characterization of this unique stem cell is
ongoing. In 2022, NSCI partnered with Y2 Solution to create Luxa
Biotechnology to advance the RPESC as therapy for dry age-related
macular degeneration, in collaboration with the NIH National Eye
Institute, Cedars-Sinai Biomanufacturing Center, Emmes Corporation,
and the University of Michigan Kellogg Eye Center.
About CIRM
At CIRM, we never forget that we were created by the people of
California to accelerate stem cell treatments to patients with
unmet medical needs, and act with a sense of urgency to succeed in
that mission. To meet this challenge, our team of highly trained
and experienced professionals actively partners with both academia
and industry in a hands-on, entrepreneurial environment to fast
track the development of today's most promising stem cell
technologies. With $5.5 billion in funding and more than 150 active
stem cell programs in our portfolio, CIRM is one of the world's
largest institutions dedicated to helping people by bringing the
future of cellular medicine closer to reality. For more information
go to www.cirm.ca.gov
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