11
April 2024
PureTech
Health plc
PureTech
Receives FDA Fast Track Designation for LYT-200 in Head and
Neck Cancers
LYT-200 is being evaluated in
locally advanced/metastatic solid tumors,
including head and neck cancers, as well as
in hematological malignancies, such as acute myeloid leukemia and
high-risk myelodysplastic syndrome
Phase 1b
and Phase 1/2 clinical trials of LYT-200 ongoing
PureTech Health
plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a
clinical-stage biotherapeutics company dedicated to changing the
lives of patients with devastating diseases, today announced that
the U.S. Food and
Drug Administration ("FDA") has granted Fast Track designation for
LYT-200 in combination with anti-PD1
therapy for the treatment of recurrent/metastatic head and neck
squamous cell carcinomas ("head and neck cancers").
"In the U.S., there are
approximately 66,000 people diagnosed with head and neck cancers
each year, and the prognosis for metastatic disease is unfavorable,
with a median survival rate of about ten months," said Eric
Sherman, M.D., Memorial Sloan Kettering Cancer Center and an
investigator in PureTech's Phase 1/2 clinical trial. "There is an
important need to explore promising new mechanisms and targets such
as galectin-9 to bring therapeutic innovation to this patient
population."
LYT-200 is an antibody against galectin-9, a potent cancer driver, and is
the most advanced clinical program against this target. It is being
evaluated in two ongoing clinical trials:
1.
a Phase 1/2 adaptive design trial
in advanced/metastatic solid tumors, including
head and neck cancers. In this trial, LYT-200 is being evaluated as
a monotherapy and in combination with tislelizumab, an anti-PD-1
antibody developed by BeiGene. LYT-200 has demonstrated a favorable
safety profile in all cohorts, including the monotherapy and
combination arms with BeiGene's tislelizumab, and shown disease
control and suggestions of initial anti-tumor activity.
2.
a Phase 1b clinical trial evaluating LYT-200
as a monotherapy and in combination with
venetoclax and hypomethylating agents in hematological malignancies,
including acute myeloid leukemia (AML) and high-risk
myelodysplastic syndrome. LYT-200 has
demonstrated a favorable safety and tolerability profile as well as
early signals of potential clinical activity.
"By granting Fast Track designation
to LYT-200 for head and neck cancers, the FDA continues to
highlight areas of critical need within oncology as well as the
potential for LYT-200," said Aleksandra
Filipovic, M.D., Ph.D., Head of Oncology at
PureTech. "As galectin-9's role in
suppressing immune-mediated activity has been well-validated, it
represents an important area of clinical research, especially in
aggressive cancers with increased mortality."
Fast Track designation is a process
designed to streamline the development and accelerate the
assessment of drugs that target serious conditions with unmet
medical need. The FDA has also
granted orphan
drug designation
to
LYT-200 for the treatment of AML.
About LYT-200
LYT-200 is a fully human IgG4
monoclonal antibody targeting galectin-9 for the potential
treatment of locally advanced/metastatic solid tumors that
have poor survival rates, including head and neck cancers. It is
also in development for the treatment of hematological
malignancies, such as acute myeloid leukemia
(AML) and high-risk myelodysplastic syndrome (MDS).
Galectin-9 is a potent oncogenic driver and
immunosuppressor, and in AML it has been
described to work via engagement with cytotoxic CD8 T cells and
natural killer cells.
A wide variety of preclinical data
underscores the importance of galectin-9 as a target and suggests a
potential opportunity for biomarker development. These data
demonstrate high expression of galectin-9 across various blood
cancers and solid tumor types and show that galectin-9 levels
correlate with poor survival in several cancers.
LYT-200 has demonstrated direct
cytotoxic, anti-leukemic effects through multiple mechanisms, as
well as synergy with standard of care chemotherapy and venetoclax
in preclinical models. Consistent with its
hub-and-spoke model, PureTech intends to advance LYT-200
via its Founded Entity Gallop Oncology.
About PureTech Health
PureTech is a clinical-stage
biotherapeutics company dedicated to giving life to new classes of
medicine to change the lives of patients with devastating diseases.
The Company has created a broad and deep pipeline through its
experienced research and development team and its extensive network
of scientists, clinicians and industry leaders that is being
advanced both internally and through its Founded Entities.
PureTech's R&D engine has resulted in the development of 28
therapeutics and therapeutic candidates, including two that have
received both U.S. FDA clearance and European marketing
authorization and a third (KarXT) that has been filed for FDA
approval. A number of these programs are being advanced by PureTech
or its Founded Entities in various indications and stages of
clinical development, including registration enabling studies. All
of the underlying programs and platforms that resulted in this
pipeline of therapeutic candidates were initially identified or
discovered and then advanced by the PureTech team through key
validation points.
For more information, visit
www.puretechhealth.com or connect with us on X (formerly Twitter)
@puretechh.
Cautionary Note Regarding
Forward-Looking Statements
This press release contains
statements that are or may be forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
All statements contained in this press release that do not relate
to matters of historical fact should be considered forward-looking
statements, including without limitation those related
to the LYT-200
development program and the timing for results from ongoing
clinical trials of LYT-200, and our future
prospects, developments, and strategies. The forward-looking
statements are based on current expectations and are subject to
known and unknown risks, uncertainties and other important factors
that could cause actual results, performance and achievements to
differ materially from current expectations, including, but not
limited to, those risks, uncertainties and other important factors
described under the caption "Risk Factors" in our Annual Report on
Form 20-F for the year ended December 31, 2022 filed with
the SEC and in our other regulatory filings. 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, we
disclaim any obligation to update or revise these forward-looking
statements, whether as a result of new information, future events
or otherwise.
Contact:
PureTech
Public Relations
publicrelations@puretechhealth.com
Investor Relations
IR@puretechhealth.com
UK/EU Media
Ben Atwell, Rob Winder
+44 (0) 20 3727 1000
puretech@fticonsulting.com
US
Media
Nichole Bobbyn
+1 774 278 8273
nichole@tenbridgecommunications.com