PureTech Health PLC FDA Grants PRTC's LYT-200 Orphan Drug Designation
November 11 2021 - 7:00AM
RNS Non-Regulatory
TIDMPRTC
PureTech Health PLC
11 November 2021
11 November 2021
PureTech Health plc
PureTech Receives Orphan Drug Designation for Wholly Owned
Candidate LYT-200 for the Treatment of Pancreatic Cancer
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 the U.S.
Food and Drug Administration (FDA) has granted orphan drug
designation for its wholly owned clinical therapeutic candidate,
LYT-200, for the treatment of pancreatic cancer.
LYT-200 is a fully human IgG4 monoclonal antibody (mAb)
targeting a foundational immunosuppressive protein, galectin-9, for
the potential treatment of solid tumors, including pancreatic
ductal adenocarcinoma (PDAC), colorectal cancer (CRC) and
cholangiocarcinoma (CCA), that are difficult to treat and have poor
survival rates. LYT-200 is currently being evaluated in the first
stage of an adaptive Phase 1/2 trial, with topline results from the
Phase 1 portion expected in the first half of 2022 to allow for
continued dose escalation as a maximum tolerated dose has not yet
been reached.
"The FDA's decision to grant orphan drug designation for LYT-200
reflects its potential as a novel anti-cancer therapy designed to
block multiple immunosuppressive pathways in the tumor
microenvironment," said Julie Krop, M.D., Chief Medical Officer at
PureTech. "Too many pancreatic cancer patients do not respond to
existing immunotherapy agents and other standard of care regimens.
We are looking forward to advancing LYT-200 through the clinic in
hopes of meeting this substantial need."
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 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. Results from the Phase 1 dose escalation
portion of the 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 the potential incentives for the Company as a
result of LYT-200 receiving an 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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