Theratechnologies Inc. (Theratechnologies) (TSX: TH) (NASDAQ:
THTX), a biopharmaceutical company focused on the development and
commercialization of innovative therapies, is pleased to announce
that the United States Food and Drug Administration (FDA) has
granted fast track designation to TH1902 as a single agent for the
treatment of patients with sortilin positive recurrent advanced
solid tumors that are refractory to standard therapy.
“Receiving fast track designation for TH1902 at
this early stage of development is a significant recognition for
our SORT1+ Technology™ and further supports the future development
of TH1902. The designation, which applies to all solid tumours
expressing sortilin, also highlights the broad applicability and
immense medical need for innovative, targeted, and potentially more
effective and better-tolerated therapies for cancer,” said Dr.
Christian Marsolais, Senior Vice President and Chief Medical
Officer, Theratechnologies.
Phase 1 clinical trial of
TH1902Theratechnologies announced on January 7, 2021 that
it had received a “Study May Proceed” letter from the FDA for the
Phase 1 clinical trial of TH1902.
The proposed Phase 1 trial design includes a
dose escalation study to evaluate the safety, pharmacokinetics,
maximum tolerated dose (MTD) and preliminary anti-tumor activity of
TH1902 administered once every three weeks in patients with
advanced solid tumors refractory to available anti-cancer
therapies. Once the MTD is determined, it is planned that a total
of 40 additional patients will be enrolled to evaluate the
potential anti-tumor activity of TH1902 in patients with
endometrial, ovarian, colorectal, pancreatic and triple negative
breast cancers where it has been estimated that the sortilin
receptor is expressed in 40 to 90% of cases. The Phase 1 trial is
expected to be initiated in the second quarter of calendar year
2021 and is designed to identify a recommended dose for Phase 2
development.
Funda Meric-Bernstam, M.D., Chair of the
Department of Investigational Cancer Therapeutics at The University
of Texas MD Anderson Cancer Center is the Lead Principal
Investigator of the Phase 1 trial for TH1902. The detailed study
protocol is available at ClinicalTrials.gov under the identifier
number: NCT04706962.
About Fast Track DesignationThe
FDA’s fast track designation is designed to facilitate the
development and expedite the review of drugs to treat serious
conditions and fill an unmet medical need. The purpose of fast
track designation is to bring important new drugs to patients
earlier.
A drug that receives fast track designation is
eligible for some or all of the following:
-
More frequent meetings with FDA to discuss the drug's development
plan and ensure collection of appropriate data needed to support
drug approval
-
More frequent written communication from FDA about such things as
the design of the proposed clinical trials and use of
biomarkers
-
Eligibility for Accelerated Approval and Priority Review, if
relevant criteria are met
-
Rolling Review, which means that a drug company can submit
completed sections of its Biologic License Application (BLA) or New
Drug Application (NDA) for review by FDA, rather than waiting until
every section of the NDA is completed before the entire application
can be reviewed. BLA or NDA review usually does not begin until the
drug company has submitted the entire application to the FDA
About TH1902TH1902 combines
Theratechnologies’ proprietary peptide to docetaxel. This
peptide-drug conjugate (PDC) is the lead candidate stemming from
Theratechnologies’ SORT1+ Technology™ in oncology.
The Canadian Cancer Society and the Government
of Quebec, through the Consortium Québécois sur la découverte du
médicament (CQDM), will contribute a total of 1.4 million dollars
towards some of the research currently being conducted for the
development of Theratechnologies’ targeted oncology platform.
About SORT1+ Technology™
Theratechnologies has developed a peptide which specifically
targets sortilin (SORT1) receptors. SORT1 is expressed in ovarian,
triple negative breast, skin, lung, colorectal and pancreatic
cancers, among others. SORT1 plays a significant role in protein
internalization, sorting and trafficking, making it an attractive
target for drug development.
Commercially available anticancer drugs, like
docetaxel, doxorubicin or tyrosine kinase inhibitors are conjugated
to Theratechnologies’ investigational novel peptide to specifically
target sortilin receptors. This could potentially improve the
efficacy and safety of those agents.
About Theratechnologies
Theratechnologies (TSX: TH) (NASDAQ: THTX) is a biopharmaceutical
company focused on the development and commercialization of
innovative therapies addressing unmet medical needs. Further
information about Theratechnologies is available on the Company's
website at www.theratech.com, on SEDAR at www.sedar.com and on
EDGAR at www.sec.gov.
Forward-Looking Information
This press release contains forward-looking statements and
forward-looking information, or, collectively, forward-looking
statements, within the meaning of applicable securities laws, that
are based on our management’s beliefs and assumptions and on
information currently available to our management. You can identify
forward-looking statements by terms such as "may", "will",
"should", "could", “would”, "outlook", "believe", "plan",
"envisage", "anticipate", "expect" and "estimate", or the negatives
of these terms, or variations of them. The forward-looking
statements contained in this press release include, but are not
limited to, statements regarding the development of TH1902 for the
potential treatment of various types of cancer, the timelines to
initiate the Phase 1 trial, the determination of the MTD and the
enrollment of patients in such Phase 1 trial.
Forward-looking statements are based upon a
number of assumptions and include, but are not limited to, the
following: pre-clinical in vivo results will be replicated in
humans during the Phase 1 trial, we will be able to determine the
MTD, the timelines to initiate the Phase 1 trial is accurate, we
will be able to enroll patients for the Phase 1 trial, treatment
with TH1902 will be efficacious and safe in various types of cancer
and no serious adverse side effects will be discovered from the
administration of TH1902 to patients.
Forward-looking statements are subject to a
variety of risks and uncertainties, many of which are beyond our
control that could cause our actual results to differ materially
from those that are disclosed in or implied by the forward-looking
statements contained in this press release. These risks and
uncertainties include, among others, the risk that the Covid-19
pandemic materially adversely affect the conduct of our Phase 1
trial, we are unable to determine the MTD, results obtained from
the administration of TH1902 do not allow the pursuit of additional
clinical trials, patients die and such death is related to the
administration of TH1902 resulting in the abandonment of our Phase
1 trial, discovery of serious adverse side effects also leading to
the abandonment of the Phase 1 trial, difficulty in recruiting
patients leading to delays in initiating or completing the Phase 1
trial and non-performance by our third-party contract suppliers of
their covenants, obligations or undertakings under the terms of our
agreements with them.
We refer potential investors to the "Risk
Factors" section of our annual information form dated February 24,
2020 available on SEDAR at www.sedar.com and on EDGAR at
www.sec.gov as an exhibit to our report on Form 40-F dated February
25, 2020 under Theratechnologies’ public filings for additional
risks regarding the conduct of our business and Theratechnologies.
The reader is cautioned to consider these and other risks and
uncertainties carefully and not to put undue reliance on
forward-looking statements. Forward-looking statements reflect
current expectations regarding future events and speak only as of
the date of this press release and represent our expectations as of
that date.
We undertake no obligation to update or revise
the information contained in this press release, whether as a
result of new information, future events or circumstances or
otherwise, except as may be required by applicable law.
For media inquiries:Denis BoucherVice President, Communications
and Corporate Affairs514-336-7800communications@theratech.com
For investor inquiries:Leah GibsonSenior Director, Investor
Relations617-356-1009lgibson@theratech.com
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