Prothena Announces Bristol Myers Squibb Opt-in of Anti-Tau PRX005 as the First Program from Global Neuroscience Research and ...
2021年6月24日 - 9:30PM
Prothena Announces Bristol Myers Squibb Opt-in of Anti-Tau PRX005
as the First Program from Global Neuroscience Research and
Development Collaboration
Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical
company with a robust pipeline of novel investigational
therapeutics built on protein dysregulation expertise, today
announced that Bristol Myers Squibb exercised its option under the
global neuroscience research and development collaboration to enter
into an exclusive U.S. license for PRX005 and will pay Prothena $80
million. PRX005 is designed to be a best-in-class anti-tau antibody
by specifically targeting an area within the microtubule binding
region (MTBR) for the potential treatment of Alzheimer’s disease
(AD). Phase 1 study with PRX005 has initiated.
“Our continued collaboration with Bristol Myers
Squibb on PRX005 allows us to further leverage our combined
expertise to accelerate the development of therapies with the
potential to transform the lives of those affected by
neurodegeneration,” said Gene Kinney, PhD, President and Chief
Executive Officer of Prothena. “Mounting scientific evidence
suggests the MTBR of tau is most closely associated with the
pathogenic spread of tau. The presence of MTBR fragments in
cerebrospinal fluid have also been shown to correlate with dementia
stages in Alzheimer’s disease to a higher degree than fragments of
other tau regions. These recent biological understandings support
the further development of PRX005, which uniquely targets a key
region within the MTBR of the tau protein. In our studies, we have
found that targeting specific regions within the MTBR reduce
pathogenic tau uptake into neurons, an attribute that was not
achievable with antibodies targeting other regions of tau.”
“We are pleased that our collaboration with
Prothena has successfully identified and developed PRX005, a novel,
differentiated anti-tau antibody that we believe has the potential
to provide a meaningful disease modifying treatment option for the
millions of patients that suffer from Alzheimer’s disease,” said
Richard Hargreaves, Senior Vice President and Head of Bristol Myers
Squibb’s Neuroscience Thematic Research Center. “We look forward to
our continued partnership with Prothena.”
Tau is a microtubule associated protein, which
aggregates and hyper-phospohrylates in the brains of individuals
with AD to form pathological neurofibrillary tangles. Tau tangles,
along with amyloid beta plaques represent the pathological
hallmarks of AD. The presence of tau pathology strongly correlates
with neurodegeneration and cognitive impairment in AD and its
pattern of progression throughout the brain suggests that tau
pathology spreads through anatomically connected pathways via
cell-to-cell transmission, a hypothesis supported by multiple
preclinical studies. This propagation of pathology is thought to be
mediated by tau “seeds” containing the MTBR of tau. PRX005 has
demonstrated superior ability to bind, intercept and block cellular
internalization of pathogenic tau, and mitigate downstream
neurotoxicity compared to other anti-tau antibodies in multiple
preclinical studies.
About the Global Neuroscience Research
and Development Collaboration
This global neuroscience research and
development collaboration is focused on three proteins implicated
in the pathogenesis of several neurodegenerative diseases,
including tau, TDP-43 and an undisclosed target. PRX005 is designed
to be a best-in-class anti-tau, MTBR-specific antibody for the
potential treatment of Alzheimer’s disease and is the first program
to advance to the clinic from this collaboration, where the Phase 1
study has initiated. With this payment, Prothena will have received
a total of $230 million pursuant to the collaboration, and is
eligible to receive up to an additional $160 million for U.S.
rights, up to $165 million for global rights, and up to $1.7
billion for regulatory and commercial milestone payments for a
total of up to $2.2 billion plus potential tiered commercial sales
royalties across multiple programs.
About PRX005
for Alzheimer’s Disease
PRX005 is designed to be a best-in-class
anti-tau antibody that specifically targets a key region within the
microtubule binding region (MTBR), which has been shown in
preclinical studies to be involved in the pathological spread of
tau. Neurofibrillary tangles composed of misfolded tau proteins,
along with amyloid beta plaques, are pathological hallmarks of
Alzheimer’s disease (AD). Cell-to-cell transmission of pathogenic
extracellular tau and the accumulation of pathogenic tau also
correlate with the progression of symptomatology and clinical
decline in patients with AD. Recent publications suggest that
during the course of AD progression, tau appears to spread
throughout the brain via synaptically-connected pathways; this
propagation of pathology is thought to be mediated by tau “seeds”
containing the MTBR of tau. Additionally, it has been recently
reported that the presence of MTBR fragments in cerebrospinal fluid
correlate with dementia stages in AD to a higher degree than
fragments of other tau regions. In preclinical research, antibodies
targeting this region of tau were superior in blocking tau uptake
and neurotoxicity, which has been associated with efficacy in AD
animal models. In these preclinical models, PRX005 demonstrated
significant inhibition of cell-to-cell transmission and neuronal
internalization in vitro and in vivo and slowed pathological
progression in a tau transgenic mouse model.
About Alzheimer’s Disease
Alzheimer’s disease is a type of dementia that
can cause increasingly serious symptoms, including confusion,
disorientation, mood and behavioral changes, difficulty speaking,
swallowing, and walking. Approximately 6.2 million Americans age 65
and older are currently estimated to be living with Alzheimer’s
disease, making it the most common neurodegenerative disorder. It
is also the sixth leading cause of death among adults in the United
States. There is an urgent need for therapies that slow the
progression and ultimately prevent Alzheimer’s disease to address
this global healthcare crisis. Prothena’s Alzheimer’s disease
portfolio spans next generation antibody immunotherapy, small
molecule and vaccine approaches, geared toward building upon first
generation treatments to advance the treatment paradigm.
About Prothena
Prothena Corporation plc is a late-stage
clinical company with a robust pipeline of novel investigational
therapeutics built on protein dysregulation expertise with the
potential to change the course of devastating rare peripheral
amyloid and neurodegenerative diseases. Fueled by its deep
scientific expertise built over decades of research, Prothena is
advancing a pipeline of therapeutic candidates for a number of
indications and novel targets for which its ability to integrate
scientific insights around neurological dysfunction and the biology
of misfolded proteins can be leveraged. Prothena’s pipeline
includes both wholly-owned and partnered programs being developed
for the potential treatment of diseases including AL amyloidosis,
ATTR amyloidosis, Alzheimer’s disease, Parkinson’s disease and a
number of other neurodegenerative diseases. For more information,
please visit the Company’s website at www.prothena.com and follow
the Company on Twitter @ProthenaCorp.
Forward-looking Statements
This press release contains forward-looking
statements. These statements relate to, among other things, the
treatment potential, design, and proposed mechanism of action of
PRX005; and amounts we might receive under our collaboration with
BMS. These statements are based on estimates, projections, and
assumptions that may prove not to be accurate, and actual results
could differ materially from those anticipated due to known and
unknown risks, uncertainties, and other factors, including but not
limited to those described in the “Risk Factors” section of our
Prospectus Supplement filed pursuant to Rule 424(b)5 with the
Securities and Exchange Commission (SEC) on March 24, 2021, as well
as discussions of potential risks, uncertainties, and other
important factors in our subsequent filings with the SEC. We
undertake no obligation to update publicly any forward-looking
statements contained in this press release as a result of new
information, future events or changes in our expectations.
Contact:
Jennifer Zibuda, Director, Investor Relations
& Communications650-837-8535, jennifer.zibuda@prothena.com
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