TIDMGSK
RNS Number : 0449E
GlaxoSmithKline PLC
02 July 2021
Issued: 2 July 2021, London UK
GSK and Alector announce global collaboration in
immuno-neurology for two clinical stage first-in-class monoclonal
antibodies for neurodegenerative diseases
-- GSK and Alector to co-develop progranulin-elevating
monoclonal antibodies, AL001 and AL101, for a range of
neurodegenerative diseases, including frontotemporal dementia,
amyotrophic lateral sclerosis, Parkinson's disease and Alzheimer's
disease
-- Companies will co-commercialise and share profits in the US;
GSK will retain exclusive commercialisation rights outside the
US
-- Alector will receive $700 million in upfront payments, up to
$1.5 billion in potential milestone payments, profit sharing and
royalties
GlaxoSmithKline plc (LSE/NYSE: GSK) and Alector (Nasdaq: ALEC),
today announced a strategic global collaboration for the
development and commercialisation 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. Enrolment 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 maximising
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
programme in immuno-neurology.
Terms of the Collaboration
Under 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 commercialisation
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 commercialisation of AL101 in Alzheimer's and
Parkinson's disease. Outside the U.S., GSK will be responsible for
commercialisation 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 AL101
Decreased 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 Information
Alector 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/en-gb/about-us .
About Alector
Alector 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 enquiries:
Media enquiries: Simon Steel +44 (0) 20 8047 (London)
5502
Tim Foley +44 (0) 20 8047 (London)
5502
Kristen Neese +1 804 217 8147 (Philadelphia)
Kathleen Quinn +1 202 603 5003 (Washington
DC)
Analyst/Investor James Dodwell +44 (0) 20 8047 (London)
enquiries: 2406
Sonya Ghobrial +44 (0) 7392 (Consumer)
784784
Mick Readey +44 (0) 7990 (London)
339653
Jeff McLaughlin +1 215 751 7002 (Philadelphia)
Frannie DeFranco +1 215 751 4855 (Philadelphia)
Alector Contacts
Michelle Corral
VP, Communications and Investor Relations
650-808-7016
michelle.corral@alector.com
1AB (media)
Dan Budwick
973-271-6085
dan@1abmedia.com
Argot Partners (investors)
Joseph Rayne
Argot Partners
212.600.1902
joseph@argotpartners.com
GSK Cautionary Statement Regarding Forward-Looking
Statements
GSK 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 Statements
This 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.
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END
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