Prothena Announces Bristol Myers Squibb Opt-in for Worldwide Rights of PRX005, a Novel Anti-MTBR-Tau Antibody
10 Julho 2023 - 5:10PM
Business Wire
- Prothena to receive $55 million from Bristol Myers Squibb for
exclusive worldwide license to PRX005, building on exclusive U.S.
license which was optioned in June 2021
- Bristol Myers Squibb will be responsible for development,
manufacturing, and commercialization going forward
Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical
biotechnology company with a robust pipeline of 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
obtain the exclusive worldwide commercial rights for PRX005 and
will pay Prothena $55 million. PRX005, which is designed to be a
best-in-class anti-tau antibody, specifically targets an area
within the microtubule binding region (MTBR) of tau for the
potential treatment of Alzheimer’s disease.
“Earlier this year, as part of our collaboration with Bristol
Myers Squibb, we announced topline data from the single ascending
dose portion of the Phase 1 clinical trial showing that PRX005
across three dose cohorts was safe and well tolerated with expected
pharmacokinetic properties, meeting the primary objectives of the
study. We are proud of our pioneering role in targeting this key
region within the MTBR of tau and excited that Bristol Myers Squibb
have exercised their option for worldwide rights to PRX005,” said
Gene Kinney, PhD, President and Chief Executive Officer, Prothena.
“At Prothena, we will continue advancing our broad portfolio of
product candidates for Alzheimer’s disease, including PRX012, our
next-generation antibody targeting amyloid beta, a well-validated
disease pathway, and PRX123 an amyloid beta/tau dual-targeting
vaccine with the potential to prevent Alzheimer’s disease. We
believe that our portfolio is well-positioned to revolutionize the
care of patients suffering from this devastating disease.”
“PRX005, identified and developed by Prothena through our
partnership, has the potential to provide a meaningful
disease-modifying treatment option for the millions of people that
suffer from Alzheimer’s disease,” said Richard Hargreaves, Senior
Vice President and Head of Bristol Myers Squibb’s Neuroscience
Thematic Research Center. “PRX005 becomes a key component of our
commitment to the Alzheimer’s disease community and our
neuroscience portfolio, and we look forward to continuing its
development.”
The multiple ascending dose (MAD) portion of the Phase 1
clinical trial for PRX005 is ongoing. All program updates,
including results from ongoing and any future PRX005 clinical
studies, will be reported by Bristol Myers Squibb going
forward.
About the Global Neuroscience R&D 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. Prothena is eligible to receive up
to an additional $160 million for U.S. rights, up to $110 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,
which also includes amounts received to date.
About Tau
Tau is a microtubule associated protein, which
hyper-phosphorylates and aggregates in the brains of individuals
with Alzheimer’s disease to form pathological neurofibrillary
tangles. Tau tangles and amyloid beta plaques represent the
pathological hallmarks of Alzheimer’s disease. The presence of tau
pathology strongly correlates with neurodegeneration and cognitive
impairment in Alzheimer’s disease 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 MTBR-tau
“seeds”. 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 PRX005
PRX005 is designed to be a best-in-class anti-tau antibody that
specifically binds with high affinity the R1, R2, and R3 repeats
within the MTBR of tau and targets both 3R and 4R tau isoforms.
MTBR tau 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. 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 Alzheimer’s
disease. Recent publications suggest that during the course of
Alzheimer’s disease 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 and tau tangles in Alzheimer’s disease 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 Alzheimer’s disease animal models. In these
preclinical models, PRX005 demonstrated significant reduction of
intraneuronal tau pathology and protection against behavioral
deficit in a tau transgenic mouse model and complete blockade of
neuronal tau internalization in vitro.
About Alzheimer’s Disease
Alzheimer’s disease is a fatal disease and the most common form
of dementia causing increasingly serious symptoms, including
confusion, disorientation, mood and behavioral changes, and
difficulty speaking, swallowing, and walking. Approximately 50
million people worldwide are estimated to be living with
Alzheimer’s disease or other dementias. Alzheimer’s disease is the
most common neurodegenerative disorder. 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, all
geared toward building upon first generation treatments to advance
the treatment paradigm.
About Prothena
Prothena Corporation plc is a late-stage clinical biotechnology
company with expertise in protein dysregulation and a pipeline of
investigational therapeutics with the potential to change the
course of devastating neurodegenerative and rare peripheral amyloid
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, proposed mechanism of action, and potential administration
of PRX005; attributes of epitopes and PRX005 we have identified;
the timing for advancement of our PRX005 program, including the
ongoing multiple ascending dose (MAD) portion of the Phase 1 study;
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” sections of our
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission (SEC) on May 4, 2023, and 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.
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Media and Investor Contact:
Media Michael Bachner, Senior Director, Corporate Communications
609-664-7308, michael.bachner@prothena.com
Investors IR@prothena.com
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