Lineage Cell Therapeutics Announces Extension of OpRegen® Development Grant From Israel Innovation Authority
July 06 2020 - 8:00AM
Business Wire
Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX),
a clinical-stage biotechnology company developing novel cell
therapies for unmet medical needs, today announced that as a result
of continued clinical progress, the Israel Innovation Authority
(IIA) has extended its previously awarded development grant in
support of OpRegen®, the Company’s retinal pigment epithelium (RPE)
cell transplant therapy in development for the treatment of dry
age-related macular degeneration (AMD). The research &
development grant of up to 9 million Israeli New Shekels
(approximately $2.5 million) was awarded in 2019 by the IIA and has
been extended for use through June 2021 based on promising clinical
data from the ongoing Phase 1/2a clinical study of OpRegen. The IIA
has provided annual grants totaling approximately $16 million for
the development of the OpRegen program so far.
“We are pleased that the IIA has elected to extend its financial
support based on the positive momentum and clinical achievements we
have demonstrated with our OpRegen program to date,” stated Brian
M. Culley, Lineage CEO. “We continue to generate promising data
supporting the use of our RPE cells in dry AMD with GA. Notably,
after moving into patients with less advanced disease, we announced
the first known finding of retinal tissue regeneration alongside
reductions in the growth of geographic atrophy, and improvements in
visual acuity and reading speeds in some patients. We recently
resumed patient enrollment in our OpRegen study, and our immediate
efforts are focused on treating and monitoring the final three
patients in Cohort 4 and utilizing these data to direct our
clinical, regulatory, and partnership discussions for the program.
The partnerships we have built with notable institutions like the
IIA, the California Institute for Regenerative Medicine, and Cancer
Research UK, provide not only capital, but also external validation
of our programs, and we are working to strengthen and expand these
alliances as we move forward. Concurrently, we are actively looking
to identify new partnerships to help support the development of all
of our programs.”
About Dry AMD
Dry age-related macular degeneration (AMD) is a leading cause of
adult blindness in the developed world. There are two forms of AMD:
wet AMD and dry AMD. Dry AMD is the more common of the two types,
accounting for approximately 85-90% of cases. Wet AMD is the less
common of the two types, accounting for approximately 10-15% of
cases. Global sales of the two leading wet AMD therapies were in
excess of $10 billion in 2019. Nearly all cases of wet AMD begin as
dry AMD. Dry AMD typically affects both eyes. There are currently
no U.S. Food and Drug Administration (FDA) or European Medicines
Agency (EMA) approved treatment options available for patients with
dry AMD.
About The Israel Innovation Authority
The Israel Innovation Authority, an independent publicly funded
agency, was created to provide a variety of practical tools and
funding platforms aimed at effectively addressing the dynamic and
changing needs of the local and international innovation
ecosystems. This includes early-stage entrepreneurs, mature
companies developing new products or manufacturing processes,
academic groups seeking to transfer their ideas to the market,
global corporations interested in collaborating with Israeli
technology, Israeli companies seeking new markets abroad and
traditional factories and plants seeking to incorporate innovative
and advanced manufacturing into their businesses. More information
is available at:
https://innovationisrael.org.il/en/contentpage/israel-innovation-authority.
About OpRegen
OpRegen is currently being evaluated a Phase 1/2a open-label,
dose escalation safety and efficacy study of a single injection of
human retinal pigment epithelium cells derived from an established
pluripotent cell line and transplanted subretinally in patients
with advanced dry AMD with GA. The study will enroll patients into
4 cohorts, with 18 of 21 expected patients enrolled to date. The
first 3 cohorts enrolled only legally blind patients with best
corrected visual acuity (BCVA) of 20/200 or worse. The fourth
cohort, which is currently enrolling, will include patients with
vision as high as 20/64. Cohort 4 also includes patients treated
with a new “thaw-and-inject” formulation of OpRegen, which can be
shipped directly to sites and used immediately upon thawing,
removing the complications and logistics of having to use a dose
preparation facility. The primary objective of the study is to
evaluate the safety and tolerability of OpRegen as assessed by the
incidence and frequency of treatment emergent adverse events.
Secondary objectives are to evaluate the preliminary efficacy of
OpRegen treatment by assessing the changes in ophthalmological
parameters measured by various methods of primary clinical
relevance. Additionally, for the patients in Cohort 4 that receive
subretinal delivery of OpRegen utilizing the Orbit Subretinal
Delivery System (Orbit SDS), objectives will include the evaluation
of the safety of delivery of OpRegen using the Orbit SDS.
Recently, Lineage reported the first known finding of retinal
tissue regeneration in a patient receiving OpRegen for the
treatment of atrophic dry AMD. This unprecedented finding supports
the view that dry AMD is not an irreversible, degenerative
condition and that some portion of diseased retinal tissue may be
recoverable in atrophic end-stage disease patients. These findings
were initially observed by an independent external advisor using
multiple imaging technologies and were subsequently confirmed by
the reading center and additional experts in the field of retinal
imaging. The Company also has observed evidence of benefit in other
patients, including increases in Best Corrected Visual Acuity
(BCVA), reduction in the growth of GA, and increases in reading
speed.
OpRegen is a registered trademark of Cell Cure Neurosciences
Ltd., a majority-owned subsidiary of Lineage Cell Therapeutics,
Inc.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology
company developing novel cell therapies for unmet medical needs.
Lineage’s programs are based on its robust proprietary cell-based
therapy platform and associated in-house development and
manufacturing capabilities. With this platform Lineage develops and
manufactures specialized, terminally differentiated human cells
from its pluripotent and progenitor cell starting materials. These
differentiated cells are developed to either replace or support
cells that are dysfunctional or absent due to degenerative disease
or traumatic injury or administered as a means of helping the body
mount an effective immune response to cancer. Lineage’s clinical
programs are in markets with billion dollar opportunities and
include three allogeneic (“off-the-shelf”) product candidates: (i)
OpRegen®, a retinal pigment epithelium transplant therapy in Phase
1/2a development for the treatment of dry age-related macular
degeneration, a leading cause of blindness in the developed world;
(ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a
development for the treatment of acute spinal cord injuries; and
(iii) VAC, an allogeneic dendritic cell therapy platform for
immuno-oncology and infectious disease, currently in clinical
development for the treatment of non-small cell lung cancer and in
preclinical development for additional cancers and as a vaccine
against infectious diseases, including SARS-CoV-2, the virus which
causes COVID-19. For more information, please visit
www.lineagecell.com or follow the Company on Twitter
@LineageCell.
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version on businesswire.com: https://www.businesswire.com/news/home/20200706005069/en/
Lineage Cell Therapeutics, Inc. IR Ioana C. Hone
(ir@lineagecell.com) (442)
287-8963
Solebury Trout IR Gitanjali Jain Ogawa
(Gogawa@troutgroup.com) (646) 378-2949
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