9 January
2025
PureTech Health plc
PureTech Receives FDA Fast
Track Designation for LYT-200 in Acute Myeloid Leukemia
(AML)
Single agent and combination
data from Phase 1b AML/MDS trial presented at ASH 2024 showed
potential of LYT-200 to serve broad range of patients
across various lines of treatment
LYT-200 is currently being
evaluated in two Phase 1/2 trials for the potential treatment of
AML/MDS and head and neck cancers
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 to LYT-200, a first-in-class
anti-galectin-9 monoclonal antibody, for the treatment of acute
myeloid leukemia ("AML"). 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.
"Fast
Track designation from the FDA reinforces our belief in the
potential for LYT-200 to address the urgent needs of AML
patients," said Luba Greenwood, J.D.,
Entrepreneur-in-Residence at PureTech who is leading the Gallop
Oncology work. "This milestone builds on the FDA's
recognition of LYT-200's promise, including Orphan Drug designation
for AML and a second Fast Track designation for head and neck
cancers, both of which were granted last year. By targeting
galectin-9, a key driver of cancer proliferation and immune
suppression, LYT-200 represents a novel and promising approach for
patients in need, and we look forward to the continued development
of this program."
LYT-200
exerts its therapeutic effects in AML by killing cancer cells
directly via apoptosis and DNA damage as well as reactivating
central anti-cancer effectors of the immune system. LYT-200 is the
most advanced clinical program against galectin-9 and is being
evaluated in two ongoing clinical trials, including:
1. Phase 1/2
clinical trial evaluating LYT-200 as a
monotherapy and in
combination with venetoclax and hypomethylating
agents in hematological malignancies,
including AML and high-risk myelodysplastic syndrome
(MDS). In this trial,
LYT-200
has demonstrated a favorable safety and
tolerability profile as well as early signals of clinical activity
as single agent and in combination.
2. Phase 1/2
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. To date, 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.
The FDA has also
granted orphan drug designation to
LYT-200 for the treatment of AML as well as a
separate
Fast Track designation for the
treatment of recurrent/metastatic head and
neck squamous cell carcinomas ("head and
neck cancers"), in combination with
anti-PD1 therapy. PureTech
previously announced that it intends to advance LYT-200 via its
Founded Entity, Gallop Oncology.
About LYT-200
LYT-200
is a fully human IgG4 monoclonal antibody targeting a foundational
oncogenic and immunosuppressive protein, galectin-9, for the
potential treatment of hematological malignancies and locally
advanced metastatic solid tumors, including head and neck cancers,
with otherwise poor survival rates. A wide variety of preclinical
data support the potential clinical efficacy of LYT-200 and the
importance of galectin-9 as a target and suggest a potential
opportunity for biomarker development. PureTech has
presented data demonstrating high expression of galectin-9 across
various solid tumor types and blood cancers and has found that, in
several cancers, galectin-9 levels correlate with shorter time to
disease relapse and poor survival. Preclinical work also
demonstrates single mechanistic and anti-tumor efficacy of LYT-200
in multiple animal and patient-derived tumor cell models. For
example, LYT-200 outperforms anti-PD-1 in solid tumor models models
as a single agent. LYT-200 also synergizes with anti-PD-1 in
activating CD4 and CD8 T cells in in vivo cancer
models. LYT-200 is currently being evaluated in two ongoing
Phase 1/2 adaptive design trials for the potential treatment of
AML/MDS and head and neck cancers.
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 29 therapeutics and therapeutic candidates,
including three that have been approved by the U.S. Food and Drug
Administration. 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 development plans for LYT-200,
potential benefits to patients, 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, 2023, 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
Justin Chen
jchen@tenbridgecommunications.com
