Alector, Inc. (Nasdaq: ALEC) and GlaxoSmithKline plc (LSE/NYSE:
GSK), today announced a strategic global collaboration for the
development and commercialization of two clinical-stage, potential
first-in-class monoclonal antibodies (AL001 and AL101) designed to
elevate progranulin (PGRN) levels. PGRN is a key regulator of
immune activity in the brain with genetic links to multiple
neurodegenerative disorders, making it one of the most attractive
genetically validated targets for the development of new
immuno-neurology treatments.
The collaboration brings together Alector’s
leading immuno-neurology expertise with GSK’s R&D focus on the
science of the immune system and human genetics, proven late-stage
drug development capabilities and global footprint. Enrollment is
currently underway for a pivotal Phase 3 trial for AL001 in people
at risk for or with frontotemporal dementia due to a progranulin
gene mutation (FTD-GRN). FTD-GRN is a rapidly progressing and
severe form of dementia found most frequently in people less than
65 years old at the time of diagnosis and has no approved
treatments. AL001 is also currently in a Phase 2 study in
symptomatic FTD patients with a mutation in the C9orf72 gene and is
planned to enter Phase 2 development for amyotrophic lateral
sclerosis (ALS) in the second half of 2021. AL101 is in a Phase 1a
clinical trial and is designed to treat patients suffering from
more prevalent neurodegenerative diseases, including Parkinson’s
disease and Alzheimer’s disease.
Dr Hal Barron, Chief Scientific Officer
and President R&D, GSK, said: “Our focus on human
genetics and the science of the immune system gives us unique
insights into the potential of targets such as progranulin to help
patients with a number of neurodegenerative diseases. Working with
Alector’s world class scientists will allow us to investigate the
potential of these immuno-neurology therapies to help patients with
frontotemporal dementia, a devastating disease without any
currently approved treatments, as well as explore the ability to
help patients with other neurodegenerative diseases, such as ALS,
Parkinson’s and Alzheimer’s.”
Arnon Rosenthal, Ph.D., Chief Executive
Officer, Alector, said: “This transformative collaboration
brings together Alector’s leading immuno-neurology expertise with
GSK’s commitment to immunology and human genetics, proven drug
development capabilities and global footprint, to help expand and
accelerate the development of our progranulin franchise into large
indications, while bolstering the build out of our own late-stage
development and commercial capabilities. Importantly, this
collaboration is designed to fully support AL001 and AL101’s
development and to enable Alector to continue building a fully
integrated company as we strive to address the high unmet medical
need in patients suffering from neurodegenerative diseases. We are
confident that GSK’s extensive experience launching ground-breaking
medicines at the intersection of immunology and human genetics,
will ensure that AL001 and AL101 are developed to their full
potential.”
As part of the recent Investor Update day on 23
June 2021, GSK committed to an R&D approach focused on
maximizing opportunities by leveraging an increased understanding
of the science of the immune system and human genetics. The
collaboration with Alector on AL001 and AL101, two antibodies
designed to elevate PGRN levels and potentially slow the
progression of FTD and other neurological disorders, provides GSK
access to a promising clinical program in immuno-neurology.
Terms of the CollaborationUnder
the terms of the collaboration agreement, Alector will receive $700
million in upfront payments. In addition, Alector will be eligible
to receive up to an additional $1.5 billion in clinical
development, regulatory and commercial launch-related milestone
payments.
Alector will lead the global clinical
development of AL001 and AL101 through Phase 2 proof-of-concept.
Thereafter, Alector and GSK will share development responsibilities
for all late-stage clinical studies for AL001 and AL101 and all
costs for global development will be divided between the two
companies.
The companies will be jointly responsible for
commercialization in the U.S. and will share profits and losses.
Alector will lead commercial efforts associated with AL001 in
orphan indications and GSK will lead the commercialization of AL101
in Alzheimer’s and Parkinson’s disease. Outside the U.S., GSK will
be responsible for commercialization of AL001 and AL101 and Alector
will be eligible for tiered royalties.
The collaboration agreement is conditional upon
customary conditions including review by the appropriate regulatory
agencies under the Hart-Scott-Rodino Act.
About the Progranulin-Elevating
Monoclonal Antibodies - AL001 and AL101Decreased levels of
PGRN, a key regulator of immune response, lysosomal function, and
neuronal survival in the brain, are genetically linked to many
neurodegenerative disorders. AL001 and AL101 are novel human
monoclonal antibodies that elevate levels of progranulin by
blocking the sortilin receptor responsible for progranulin
degradation. AL001 is currently in a pivotal Phase 3 clinical study
in people at risk for or with frontotemporal dementia due to a
progranulin gene mutation (FTD-GRN). AL001 is also currently in a
Phase 2 study in symptomatic FTD patients with a C9orf72 mutation,
with another Phase 2 study in patients with ALS planned to begin in
the second half of 2021. AL101, is designed to treat people
suffering from more prevalent neurodegenerative diseases and is
currently in a Phase 1a study in healthy volunteers. AL101 is
intended to be developed for treatment of Parkinson’s disease and
Alzheimer’s disease.
About Frontotemporal Dementia
(FTD)Frontotemporal dementia is a rapidly progressing and
severe form of dementia. It affects 50,000 to 60,000 people in the
United States and roughly 110,000 in the European Union, with
potentially higher prevalence in Asia and Latin America. There are
currently no FDA-approved treatment options for FTD.
There are multiple heritable forms of FTD. In
one form, FTD-GRN, people have a mutation in the progranulin gene.
This population represents 5% to 10% of all people with FTD.
Mutations in a single copy of a progranulin gene leads to a 50% or
greater decrease in the level of progranulin protein and invariably
leads to development of FTD. In another form, people with mutations
in the chromosome 9 open reading frame 72 (C9orf72) gene can
develop FTD. FTD-C9orf72 is associated with abnormal accumulation
of the protein TDP-43, which is also a hallmark in FTD-GRN. To date
researchers have identified more than 120 inherited loss of
function mutations in the progranulin gene that lead to FTD.
Alector Conference Call
InformationAlector management will host a conference call
to discuss the collaboration today at 8:30 a.m. ET. Analysts and
investors are invited to participate in the conference call by
dialling (888) 705-0365 from the U.S. and Canada or (415) 817-9241
internationally and using the conference ID 9476664. The live
webcast can be accessed on the investor page of Alector’s website
at investors.alector.com. A replay of the webcast will be available
on Alector’s website approximately two hours after the completion
of the event and will be archived for up to 30 days.
About GSK GSK is a science-led global
healthcare company. For further information please visit
www.gsk.com/about-us.
About AlectorAlector is a
clinical stage biotechnology company pioneering immuno-neurology, a
novel therapeutic approach for the treatment of neurodegenerative
diseases. The Company is developing a broad portfolio of innate
immune system programs, designed to functionally repair genetic
mutations that cause dysfunction of the brain’s immune system and
enable the rejuvenated immune cells to counteract emerging brain
pathologies. Immuno-neurology targets immune dysfunction as a root
cause of multiple pathologies that are drivers of degenerative
brain disorders. The Company’s immuno-neurology product candidates
are supported by biomarkers and target genetically defined patient
populations in frontotemporal dementia and Alzheimer’s disease.
This scientific approach is also the basis for the Company’s
immuno-oncology programs. Alector is headquartered in South San
Francisco, California. For additional information, please visit
www.alector.com.
GSK Cautionary Statement Regarding
Forward-Looking StatementsGSK cautions investors that any
forward-looking statements or projections made by GSK, including
those made in this announcement, are subject to risks and
uncertainties that may cause actual results to differ materially
from those projected. Such factors include, but are not limited to,
those described in the Company's Annual Report on Form 20-F for
2020 and any impacts of the COVID-19 pandemic.
Alector Forward-Looking
StatementsThis press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995 that are based on the current expectations and
beliefs of Alector. Such statements are subject to numerous
important factors, risks and uncertainties that may cause actual
events or results to differ materially from current expectations
and beliefs, including but not limited to the outcome, benefits and
synergies of the proposed collaboration with GSK, the anticipated
completion of the proposed transaction and risks and uncertainties
related to market conditions, Alector and its business as set forth
in Alector’s Annual Report on Form 10-K filed with the Securities
and Exchange Commission (the “SEC”) on February 25, 2021, as well
as the other documents Alector files from time to time with the
SEC. These documents contain and identify important factors that
could cause the actual results for Alector to differ materially
from those contained in Alector’s forward-looking statements. Any
forward-looking statements contained in this press release speak
only as of the date hereof, and Alector specifically disclaims any
obligation to update any forward-looking statement, except as
required by law.
Alector Contacts:Michelle CorralVP,
Communications and Investor
Relations650-808-7016michelle.corral@alector.com
1AB (media)Dan Budwick973-271-6085dan@1abmedia.com
Argot Partners (investors)Joseph RayneArgot
Partners212.600.1902joseph@argotpartners.com
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