TIDMPRTC
PureTech Health PLC
11 December 2020
11 December 2020
PureTech Health plc
PureTech Advances Wholly Owned Candidate LYT-200 into Phase 1
Trial for Potential Treatment of Metastatic Solid Tumors
LYT-200 is a monoclonal antibody designed to block a
foundational immunosuppressive protein, galectin-9, which is
associated with poor survival rates for a number of cancers
Trial will assess safety and tolerability of escalating doses of
LYT-200 with results expected in Q4 2021
Company to discuss LYT-200, other Wholly Owned Pipeline assets,
and novel therapeutic opportunities in lymphatics, related immune
pathways and immuno-oncology during virtual R&D Day today
PureTech Health plc (LSE: PRTC, Nasdaq: PRTC) ("PureTech" or the
"Company"), a clinical-stage biotherapeutics company dedicated to
discovering, developing and commercializing highly differentiated
medicines for devastating diseases, today announced the initiation
of its Phase 1 clinical trial of LYT-200 for the potential
treatment of metastatic solid tumors that are difficult to treat
and have poor survival rates. LYT-200 is one of several novel
therapeutic opportunities within PureTech's Wholly Owned Pipeline
that will be discussed today at its virtual R&D Day.
"Each year, hundreds of thousands of people are diagnosed with
solid tumors, and many will present with metastatic disease that do
not respond to existing immunotherapy agents," said Zev Wainberg,
M.D., co-director of the UCLA GI Oncology Program, associate
professor of medicine at UCLA and the principal investigator on
PureTech's LYT-200 trial. "By targeting galectin-9, LYT-200 is
designed to block foundational immunosuppressive mechanisms that
shut down the body's natural ability to fight a number of cancers.
The unique mechanism of LYT-200 holds potential across a number of
solid tumor types and may enable LYT-200 to be used as a single
agent, as well as in combination with checkpoint inhibitors and
other anti-cancer treatments."
LYT-200 is a clinical stage, fully human, monoclonal antibody
(mAb), that is designed to target galectin-9, an immunosuppressive
protein that simultaneously activates multiple immunosuppressive
pathways in the tumor microenvironment and is prominently expressed
in multiple difficult-to-treat cancers, including breast cancer,
pancreatic and cholangiocarcinoma . It is currently being evaluated
in the first stage of an adaptive Phase 1/2 trial. The primary
objective of the Phase 1 portion of the trial is to assess the
safety and tolerability of escalating doses of LYT-200 in order to
identify a dose to carry forward into a subsequent Phase 2 trial.
The Phase 1 will also assess LYT-200's pharmacokinetic and
pharmacodynamic profiles. Following the topline results, which are
expected in the fourth quarter of 2021, PureTech intends to
initiate the Phase 2 expansion cohort portion of the trial, which
will further assess the recommended Phase 2 dose as a single agent
or in combination with chemotherapy and anti-PD-1 therapy in
multiple solid tumor types, including pancreatic cancer and
cholangiocarcinoma.
"We are pleased to have initiated the Phase 1 part of our
LYT-200 clinical trial, which is a dose-finding portion designed to
assess safety and tolerability and explore preliminary signals of
efficacy for LYT-200," said Aleksandra Filipovic, M.D. PhD, head of
oncology at PureTech. "We have generated compelling preclinical
data to date, which we believe support the potential of LYT-200 as
a new anti-cancer therapy targeting galectin-9, both as a single
agent and in combination with other anti-cancer therapies."
Dr. Zev Wainberg and Dr. Siddhartha Mukherjee, clinician and
researcher at Columbia University and Pulitzer Prize-winning author
of The Emperor of All Maladies and The Gene, will discuss their
perspectives on the field of immuno-oncology during today's virtual
R&D Day, which will be available on the Investors section of
the corporate website under Events & Presentations. To
register, please sign up here .
About LYT-200
LYT-200 is a monoclonal antibody targeting a foundational
immunosuppressive protein, galectin-9, for the potential treatment
of solid tumors, including pancreatic ductal adenocarcinoma,
colorectal cancer and cholangiocarcinoma, that are difficult to
treat and have poor survival rates. PureTech has presented
preclinical data demonstrating high expression of galectin-9 across
breast cancer, pancreatic and cholangiocarcinoma samples and found
that the highest levels of galectin-9 correlated with shorter time
to disease relapse and poor survival. These data suggest that
galectin-9 could be significant both as a therapeutic target for a
range of cancers and as a cancer biomarker. Preclinical animal and
patient-derived organoid tumor models also showed the potential
efficacy of LYT-200 and the importance of galectin-9 as a target.
LYT-200 is currently being evaluated in a Phase 1/2 adaptive design
trial, and results from the Phase 1 portion are expected in the
fourth quarter of 2021.
About PureTech's Virtual R&D Day
The virtual R&D Day will showcase PureTech's scientific
leadership in lymphatics and related immune pathways and detail
PureTech's Wholly Owned Pipeline. Product candidates within this
pipeline include LYT-100, a clinical-stage, anti-fibrotic and
anti-inflammatory small molecule being advanced for the potential
treatment of interstitial lung diseases and lymphedema, LYT-200, a
clinical-stage monoclonal antibody targeting foundational
immunosuppressive mechanisms for the potential treatment of solid
tumors, and LYT-300, an oral form of allopregnanolone that is being
advanced into IND-enabling studies for a range of neurological
conditions. Additionally, the R&D Day will detail PureTech's
discovery platforms, including the Glyph(TM) technology platform,
which is designed to target therapeutics to the lymphatic system
and potentially enabling oral administration of natural bioactive
molecules such as neurosteroids and cannabinoids, and the
Orasome(TM) technology platform, which is designed to enable the
oral administration of biotherapeutics, such as antisense
oligonucleotides, short interfering RNA, mRNA, modular expression
systems for therapeutic proteins, peptides and nanoparticles.
About PureTech Health
PureTech is a clinical-stage biotherapeutics company dedicated
to discovering, developing and commercializing highly
differentiated medicines for devastating diseases, including
intractable cancers, lymphatic and gastrointestinal diseases,
central nervous system disorders and inflammatory and immunological
diseases, among others. The Company has created a broad and deep
pipeline through the expertise of its experienced research and
development team and its extensive network of scientists,
clinicians and industry leaders. This pipeline, which is being
advanced both internally and through PureTech's Founded Entities,
is comprised of 24 products and product candidates, including two
that have received U.S. Food and Drug Administration (FDA)
clearance and European marketing authorization. All of the
underlying programs and platforms that resulted in this pipeline of
product candidates were initially identified or discovered and then
advanced by the PureTech team through key validation points based
on the Company's unique insights into the biology of the brain,
immune and gut, or BIG, systems and the interface between those
systems, referred to as the BIG Axis.
For more information, visit www.puretechhealth.com or connect
with us on Twitter @puretechh.
Cautionary Note Regarding Forward-Looking Statements
This press release contains statements that are or may be
forward-looking statements, including statements that relate to our
product candidates and approach towards addressing major diseases,
future prospects, developments, and strategies. The forward-looking
statements are based on current expectations and are subject to
known and unknown risks and uncertainties that could cause actual
results, performance and achievements to differ materially from
current expectations, including, but not limited to, our
expectations regarding the potential therapeutic benefits of
LYT-200 in patients with solid tumors, the expected timing of
results from our Phase 1 trial of LYT-120 and those risks and
uncertainties described in the risk factors included in the
regulatory filings for PureTech Health plc. These forward-looking
statements are based on assumptions regarding the present and
future business strategies of the company and the environment in
which it will operate in the future. Each forward-looking statement
speaks only as at the date of this press release. Except as
required by law and regulatory requirements, neither the company
nor any other party intends to update or revise these
forward-looking statements, whether as a result of new information,
future events or otherwise.
Contact:
Investors EU media U.S. media
Allison Mead Talbot Ben Atwell, Rob Winder Adam Silverstein
+1 617 651 3156 +44 (0) 20 3727 1000 +1 917 697 9313
amt@puretechhealth.com ben.atwell@FTIconsulting.com adam@tenbridgecommunications.com
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