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 first patient received a dose of TH1902, its lead
peptide-drug conjugate (PDC) for the treatment of sortilin positive
(SORT1+) solid tumors.
“This is yet another major achievement for our
oncology program. Given the important medical need for novel,
targeted cancer treatments, the rapid progression of our promising,
unique and innovative approach to fight cancer is a great source of
hope for patients,” said Paul Lévesque, President and CEO,
Theratechnologies.
“Despite the progress made in recent years in
the field of oncology, many patients are unfortunately not
responding to current treatments or do not tolerate them well.
Targeting the sortilin receptor is an exciting and promising new
approach for the potential treatment of cancer. Dosing the first
patient with TH1902 brings us closer to a potential much needed new
option in oncology,” said Dr. Satish Shah, Medical Director,
Gettysburg Cancer Center, Gettysburg, Pennsylvania and Dr. Tina
Khair, Research Director, Gettysburg Cancer Center.
About TH1902TH1902 combines
Theratechnologies’ proprietary peptide to docetaxel. The U.S. Food
and Drug Administration (FDA) recently granted fast track
designation to TH1902 as a single agent for the treatment of all
advanced solid tumors expressing sortilin that are refractory to
standard therapy. TH1902 is the Company’s lead PDC 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 at the
molecular oncology laboratory of Dr. Borhane Annabi at the
Université du Québec in Montréal (UQAM).
Phase 1 clinical trial of
TH1902The Phase 1 clinical trial includes a
dose-escalating part 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.
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 Phase 1 study protocol is available
at ClinicalTrials.gov under the identifier number: NCT04706962.
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.
It is estimated that the sortilin receptor is
expressed in 40 to 90% of cases depending on cancer type.
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 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, 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 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,
2021 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, 2021 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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