- Genentech Will Pay Lineage $50 Million Upfront
- Eligible to Receive a Total of $670 Million in Upfront and
Milestone Payments
- Conference Call to Discuss Collaboration Planned for 8 a.m.
ET
Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX),
today announced that Lineage and its subsidiary, Cell Cure
Neurosciences Ltd., have entered into an exclusive worldwide
collaboration and license agreement with Roche and Genentech, a
member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), for the
development and commercialization of a retinal pigment epithelium
(RPE) cell therapy for the treatment of ocular disorders, including
advanced dry age-related macular degeneration (dry AMD) with
geographic atrophy (GA).
Genentech will assume responsibility for further clinical
development and commercialization of Lineage’s OpRegen program,
which currently is being evaluated in a Phase 1/2a open-label, dose
escalation clinical safety and efficacy study in patients with
advanced dry AMD with GA. Under the terms of the collaboration
agreement, Lineage will complete activities related to the ongoing
clinical study, for which enrollment is complete, and perform
certain manufacturing activities. Genentech will pay Lineage a $50
million upfront payment and Lineage is eligible to receive up to
$620 million in additional development, approval and sales
milestone payments, in addition to tiered double- digit
royalties.
“Genentech is a clear global leader in ophthalmology and has
demonstrated a longstanding commitment to patients, innovative
research and successful product development,” said Brian M. Culley,
Lineage’s CEO. “Their desire to combine our cell therapy technology
with their ophthalmology expertise and capabilities will help
advance the OpRegen program more rapidly and we believe
successfully to patients with serious ocular disorders, such as dry
age-related macular degeneration. Lineage’s objective is to pioneer
a new branch of regenerative medicine, based on transplanting whole
cells into the body to restore activity lost to aging, injury or
disease. We believe the results we have demonstrated to date with
OpRegen represent a paradigm change many did not believe possible
with cell therapy, by restoring retinal tissue and potentially
halting or reversing the expansion of geographic atrophy. I am
incredibly proud of what the Lineage team has accomplished with the
OpRegen program and look forward to joining forces with the
Genentech team as they work to take this program to the next level
and potentially to patients in need of treatment.”
Mr. Culley continued, “Looking ahead, Lineage will remain
focused on advancing our spinal cord injury and oncology programs
as well as announcing new disease settings where we plan to deploy
our technology, either on our own or through strategic alliances.
All of us at Lineage are immensely proud to have the opportunity
and responsibility to advance a new and exciting branch of
medicine, and our aim is to make a profound impact on the patients
who serve as our inspiration.”
“Genentech has a longstanding commitment to discovering and
developing novel drugs for the treatment of serious eye disorders
such as with advanced dry AMD with GA, which is one of our focus
areas within ophthalmology,” said James Sabry, M.D., Ph.D., global
head of Pharma Partnering, Roche. “We are excited to partner with
Lineage Cell Therapeutics to advance potential new therapies in an
area of high unmet medical need.”
Conference Call Information
Lineage will host a live conference call and webcast today
beginning at 8 a.m. ET to discuss the collaboration with the Roche
Group and Genentech. Interested parties may access the conference
call by dialing (866) 888-8633 from the U.S. and Canada and (636)
812-6629 from elsewhere outside the U.S. and Canada and should
request the “Lineage Cell Therapeutics Call”. A live webcast of the
conference call will be available online in the Investors section
of Lineage’s website. A replay of the webcast will be available on
Lineage’s website for 30 days and a telephone replay will be
available through December 27, 2021, by dialing (855) 859-2056 from
the U.S. and Canada and (404) 537-3406 from elsewhere outside the
U.S. and Canada and entering conference ID number 5174206.
About OpRegen
OpRegen has been developed in part through contributions and
financial grants made by Hadasit Medical Research Services and
Development Ltd. (“Hadasit”) and the Israeli Innovation Authority
(the “IIA”). Lineage is obligated to pay a portion of upfront,
milestone and royalty payments it receives to Hadasit and the IIA.
OpRegen is currently being evaluated in 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 enrolled 24 patients into
4 cohorts. The first 3 cohorts enrolled only legally blind patients
with a best corrected visual acuity (BCVA) of 20/200 or worse. The
fourth cohort enrolled 12 better vision patients (BCVA from 20/65
to 20/250 with smaller mean areas of GA). Cohort 4 also included
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 was 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. OpRegen has been well tolerated to date
and there have been no new, unexpected ocular or systemic adverse
events or serious adverse events related to OpRegen or study
procedures that have not been previously reported.
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) VAC2, an allogeneic dendritic cell therapy produced from
Lineage’s VAC technology platform for immuno-oncology and
infectious disease, currently in Phase 1 clinical development for
the treatment of non-small cell lung cancer. For more information,
please visit www.lineagecell.com or follow the Company on Twitter
@LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements
of historical facts, contained in this press release, are
forward-looking statements. Forward-looking statements, in some
cases, can be identified by terms such as “believe,” “aim,” “may,”
“will,” “estimate,” “continue,” “anticipate,” “design,” “intend,”
“expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,”
“should,” “would,” “contemplate,” “project,” “target,” “tend to,”
or the negative version of these words and similar expressions.
Such statements include, but are not limited to, statements
relating to the collaboration and license agreement with Roche and
Genentech and activities expected to occur under the collaboration
and license agreement, the upfront, milestone and royalty
consideration payable to Lineage, the potential benefits of
treatment with OpRegen, and Lineage’s plans to advance its spinal
cord injury and oncology programs and announce new disease settings
where it plans to deploy its technology. Forward-looking statements
involve known and unknown risks, uncertainties and other factors
that may cause Lineage’s actual results, performance or
achievements to be materially different from future results,
performance or achievements expressed or implied by the
forward-looking statements in this press release, including the
risk that competing alternative therapies may adversely impact the
commercial potential of OpRegen, which could materially adversely
affect the milestone and royalty payments payable to Lineage under
the collaboration and license agreement, the risk that Roche and
Genentech may not be successful in completing further clinical
trials for OpRegen and/or obtaining regulatory approval for OpRegen
in any particular jurisdiction, and risks and uncertainties
inherent in Lineage’s business and other risks in Lineage’s filings
with the Securities and Exchange Commission (SEC). Lineage’s
forward-looking statements are based upon its current expectations
and involve assumptions that may never materialize or may prove to
be incorrect. All forward-looking statements are expressly
qualified in their entirety by these cautionary statements. Further
information regarding these and other risks is included under the
heading “Risk Factors” in Lineage’s periodic reports with the SEC,
including Lineage’s most recent Annual Report on Form 10-K and
Quarterly Report on Form 10-Q filed with the SEC and its other
reports, which are available from the SEC’s website. You are
cautioned not to place undue reliance on forward-looking
statements, which speak only as of the date on which they were
made. Lineage undertakes no obligation to update such statements to
reflect events that occur or circumstances that exist after the
date on which they were made, except as required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20211220005028/en/
Lineage Cell Therapeutics, Inc. IR Ioana C. Hone
(ir@lineagecell.com) (442) 287-8963
Solebury Trout IR Mike Biega (Mbiega@soleburytrout.com)
(617) 221-9660
Russo Partners – Media Relations Nic Johnson or David
Schull Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com (212) 845-4242
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