Study will investigate potential activity of a
novel immunotherapeutic (LYT-200) with checkpoint inhibition as a
new treatment modality
Topline Phase 1 results with single-agent
LYT-200 expected in the fourth quarter of 2021
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the
“Company”), a clinical-stage biotherapeutics company dedicated to
discovering, developing and commercializing highly differentiated
medicines for devastating diseases, today announced a clinical
trial and supply agreement with an affiliate of BeiGene, Ltd.
(Nasdaq: BGNE; HKEX: 06160) to evaluate BeiGene’s tislelizumab, an
anti-PD-1 immune checkpoint inhibitor, in combination with
PureTech’s LYT-200, an investigational monoclonal antibody
targeting galectin-9, for the potential treatment of
difficult-to-treat solid tumor indications that are associated with
poor survival rates.
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PureTech announced a clinical trial and
supply agreement with BeiGene to evaluate BeiGene’s tislelizumab,
an anti-PD-1 immune checkpoint inhibitor, in combination with
PureTech’s LYT-200, an investigational monoclonal antibody
targeting galectin-9, for the potential treatment of
difficult-to-treat solid tumor indications that are associated with
poor survival rates. (Photo: Business Wire)
Galectin-9 is a pivotal immune modulator widely expressed in
multiple difficult-to-treat tumor types and involved in the
regulation of tumor promoting inflammatory and immunosuppressive
pathways. Inhibition of galectin-9 with targeted antibodies leads
to upregulation of immunostimulatory cytokines and anti-tumor
activity in preclinical cancer models. LYT-200 is currently being
evaluated as a single agent in the first phase of an adaptive Phase
1/2 clinical trial, which, based upon the trial protocol, will be
followed by the portion of the trial intended to investigate
LYT-200 in combination with tislelizumab. PureTech expects to
report topline Phase 1 results in the fourth quarter of 2021. In
addition, PureTech plans to investigate LYT-200 as a single agent
and in combination with other anti-cancer treatments, including
chemotherapy and other immunotherapies.
Tislelizumab is potentially differentiated from the currently
approved programmed cell death protein 1 (PD-1) antibodies in an
engineered fragment crystallizable region (Fc region), which in
preclinical studies has been shown to minimize potentially negative
interactions with other immune cells. Tislelizumab has been
approved in China for four solid tumor indications and regulatory
decisions are pending for two additional indications. In January
2021, BeiGene and Novartis entered into a collaboration and license
agreement granting Novartis rights to develop, manufacture and
commercialize tislelizumab in North America, Europe and Japan.
“After a decade of optimizing use of immuno-oncology therapies,
such as the checkpoint inhibitors that have certainly provided a
paradigm shift in treating malignant diseases, we in the industry
are eager to advance novel breakthrough agents and combinations to
serve a wider range of cancer patients. Patients need new options
as the first wave of immunotherapies work only in a small
percentage of them. Well thought-out combination immunotherapy
regimens may be that way forward,” said Aleksandra Filipovic, M.D.,
Ph.D., Head of Oncology at PureTech. “We believe LYT-200 has the
potential to engage the immune system against what are currently
intractable cancers, both as a single agent and in combination with
checkpoint inhibitors. We look forward to evaluating whether
LYT-200 in combination with BeiGene’s tislelizumab can improve
outcomes for patients with metastatic solid tumors.”
Under the terms of the agreement, PureTech will maintain control
of the LYT-200 program, including global R&D and commercial
rights. BeiGene has agreed to supply tislelizumab for use in
combination with LYT-200.
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 cancer 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 solid tumors 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 Tislelizumab Tislelizumab (BGB-A317) is a humanized
IgG4 anti-PD-1 monoclonal antibody specifically designed to
minimize binding to FcγR on macrophages. In pre-clinical studies,
binding to FcγR on macrophages has been shown to compromise the
anti-tumor activity of PD-1 antibodies through activation of
antibody-dependent macrophage-mediated killing of T effector cells.
Tislelizumab is the first drug from BeiGene’s immuno-oncology
biologics program and is being developed internationally as a
monotherapy and in combination with other therapies for the
treatment of a broad array of both solid tumor and hematologic
cancers.
The China National Medical Products Administration (NMPA) has
granted tislelizumab in five indications, including full approval
for first-line treatment of patients with advanced squamous
non-small cell lung cancer (NSCLC) in combination with chemotherapy
and for first-line treatment of patients with advanced non-squamous
NSCLC in combination with chemotherapy; and conditional approval
for the treatment of patients with classical Hodgkin’s lymphoma
(cHL) who received at least two prior therapies, for the treatment
of patients with locally advanced or metastatic urothelial
carcinoma (UC) with PD-L1 high expression whose disease progressed
during or following platinum-containing chemotherapy or within 12
months of neoadjuvant or adjuvant treatment with
platinum-containing chemotherapy, and for the treatment of patients
with hepatocellular carcinoma (HCC) who have received at least one
systemic therapy. Full approval for these indications is contingent
upon results from ongoing randomized, controlled confirmatory
clinical trials.
In addition, two supplemental Biologics License Applications for
tislelizumab have been accepted by the Center for Drug Evaluation
(CDE) of the NMPA and are under review for second- or third-line
treatment of patients with locally advanced or metastatic NSCLC who
progressed on prior platinum-based chemotherapy and for patients
with previously treated, locally advanced unresectable or
metastatic microsatellite instability-high (MSI-H) or mismatch
repair-deficient (dMMR) solid tumors.
BeiGene has initiated or completed 17 potentially
registration-enabling clinical trials in China and globally,
including 13 Phase 3 trials and four pivotal Phase 2 trials.
In January 2021, BeiGene and Novartis entered into a
collaboration and license agreement granting Novartis rights to
develop, manufacture, and commercialize tislelizumab in North
America, Europe and Japan.
Tislelizumab is not approved for use outside of China.
About PureTech Health PureTech is a clinical-stage
biotherapeutics company dedicated to discovering, developing and
commercializing highly differentiated medicines for devastating
diseases, including inflammatory, fibrotic and immunological
conditions, intractable cancers, lymphatic and gastrointestinal
diseases and neurological and neuropsychological disorders, 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 26 products and
product candidates, including two that have received 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 the
company's 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 our therapeutic candidates, 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-200 and the initiation of the Phase 2 trial, and the potential
benefits of LYT-200 in combination with BeiGene’s anti-PD-1 therapy
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210707005110/en/
Investors Allison Mead Talbot +1 617 651 3156
amt@puretechhealth.com
U.S. media Stephanie Simon +1 617 581 9333
stephanie@tenbridgecommunications.com
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