TIDMPRTC
PureTech Health PLC
12 November 2021
12 November 2021
PureTech Health plc
PureTech Presents Clinical Trial Design Supporting Wholly Owned
Immuno-Oncology Candidate LYT-200 at the Society for Immunotherapy
of Cancer (SITC) 36(th) Annual Meeting
LYT-200 is being advanced in a range of difficult-to-treat solid
tumors including pancreatic cancer, colorectal cancer and
cholangiocarcinoma
Phase 1 portion of its adaptive Phase 1/2 trial with LYT-200 in
solid tumors continues to progress, with a maximum tolerated dose
not yet reached
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 that a poster
presentation describing the adaptive Phase 1/2 trial of LYT-200 for
the potential treatment of difficult-to-treat solid tumors will be
given at the Society for Immunotherapy of Cancer (SITC) 36(th)
annual meeting.
The scientific poster to be presented at SITC details the
Company's adaptive Phase 1/2 clinical trial of LYT-200, an
investigational monoclonal antibody targeting galectin-9, which is
an immunosuppressive protein prominently expressed in multiple
difficult-to-treat cancers, including, but not limited to,
pancreatic cancer, cholangiocarcinoma, and breast cancer. The
clinical study includes a dose finding/dose escalation phase (part
1) and an expansion cohort phase (part 2) in patients with relapsed
and refractory metastatic solid tumors. The trial will assess the
safety, tolerability, pharmacokinetics, pharmacodynamics,
immunogenicity and preliminary anti-tumor activity of LYT-200 both
as a single agent and in combination with either BeiGene's
tislelizumab or chemotherapy. Topline results from the Phase 1
portion of the study are now expected in the first half of 2022 to
allow for continued dose escalation as a maximum tolerated dose has
not yet been reached.
"PureTech's preclinical data package elegantly supports the
significance of galectin-9 as a therapeutic target, showing it is a
multifaceted immunosuppressor in cancer biology and potential
biomarker of prognosis," said Zev Wainberg, M.D., Professor of
Medicine at UCLA and Co-director of the UCLA GI Oncology Program
and the lead primary investigator of the study.
"High galectin-9 levels in patients have been associated with a
worse prognosis, and our anti-galectin-9 research candidates
outperformed approved immunotherapies in multiple preclinical
models of difficult-to-treat cancers, giving us confidence as we
moved into the clinical phase to establish key safety and
therapeutic parameters and initial insights into efficacy," said
Aleksandra Filipovic, M.D., Ph.D., Head of Oncology at
PureTech.
Part 1 is a dose-finding study being conducted using a
reassessment method to evaluate safety and establish the
recommended Phase 2 dose. Two to six patients per treatment cohort
are assigned to receive sequentially higher intravenous infusions
of LYT-200 every two weeks on day one and day 15 of each 28-day
cycle, starting at a dose of 0.2 mg/kg, with escalating dose
cohorts up to 16 mg/kg. Part 1 will be completed when six
consecutive patients have received the optimal biologic dose and/or
the maximal tolerated dose. The study is currently evaluating
patients enrolled in the fourth cohort of part 1 at an active dose
measuring 6.3 mg/kg. The Phase 2 portion of the study is currently
planned to enroll patients with a range of solid tumor types,
including pancreatic cancer and other GI solid tumor types.
The U.S. Food and Drug Administration (FDA) recently granted
orphan drug designation for LYT-200 for the treatment of pancreatic
cancer. The FDA grants orphan drug designation to novel drug and
biologic products for the treatment, diagnosis or prevention of
conditions affecting fewer than 200,000 persons in the U.S. Orphan
drug designation qualifies PureTech for incentives under the Orphan
Drug Act, including tax credits for some clinical trials and
eligibility for seven years of market exclusivity in the U.S. if
the drug is approved.
About LYT-200
LYT-200 is a fully human IgG4 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 of the dose escalation trial are expected in the first half
of 2022.
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 25 therapeutics and therapeutic
candidates, including two that have received both U.S. FDA
clearance and European marketing authorization, as of the date of
PureTech's most recently filed Half Year Report and corresponding
Form 6-K. 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 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 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 statements
that relate to our expectations regarding the potential therapeutic
benefits of LYT-200 in patients with solid tumors, the design of
the Company's adaptive design Phase 1/2 trial for LYT-200, the
progression and expected timing of results from our Phase 1/2 trial
of LYT-200, and any incentives that the Company may receive as a
result of LYT-200 receiving orphan drug designation. 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, 2020
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:
Investors EU media
Allison Mead Talbot Ben Atwell, Rob Winder
+1 617 651 3156 +44 (0) 20 3727 1000
amt@puretechhealth.com ben.atwell@FTIconsulting.com
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