Theratechnologies, Inc. (Theratechnologies, or Company) (TSX: TH)
(NASDAQ: THTX), a biopharmaceutical company focused on the
development and commercialization of innovative therapies,
announced today the publication of data from its preclinical
research of TH1902 for the treatment of sortilin-positive triple
negative breast cancer (TNBC) in the peer-reviewed journal Cancer
Science, confirming the in vivo efficacy and safety of TH1902
against TNBC through a SORT1 receptor-mediated mechanism.
The article is titled
“TH1902, a new docetaxel-peptide conjugate for the
treatment of sortilin-positive triple-negative breast
cancer.”
“This publication in a
highly-respected cancer journal represents the first peer-reviewed
scientific paper for our lead investigational PDC TH1902 and
further validates the novel approach of our SORT1+ Technology™ for
the treatment of sortilin-expressing cancers. Our team of
scientific researchers are pleased to add to the growing body of
scientific evidence of sortilin expression as a potential
targetable biomarker for various hard-to-treat cancers, and we have
great hope that TH1902 represents a promising avenue in the
treatment of personalized cancer therapy,” said Dr. Christian
Marsolais, Senior Vice President and Chief Medical Officer at
Theratechnologies.
Cancer Science is a
well-recognized peer-reviewed journal and the official journal of
the Japanese Cancer Association (JCA). The article can be accessed
online here.
About SORT1+
Technology™Theratechnologies is currently developing a
platform of new proprietary peptides for cancer drug development
targeting SORT1 receptors called SORT1+ TechnologyTM. SORT1 is a
receptor that plays a significant role in protein internalization,
sorting and trafficking. It is highly expressed in cancer cells
compared to healthy tissue making it an attractive target for
cancer drug development. Expression has been demonstrated in, but
not limited to, ovarian, triple-negative breast, endometrial, skin,
lung, colorectal and pancreatic cancers. Expression of SORT1 is
associated with aggressive disease, poor prognosis and decreased
survival. It is estimated that the SORT1 receptor is expressed in
40% to 90% of cases of endometrial, ovarian, colorectal,
triple-negative breast and pancreatic cancers.
The Company’s
innovative peptide-drug conjugates (PDCs) generated through its
SORT1+ TechnologyTM demonstrate distinct pharmacodynamic and
pharmacokinetic properties that differentiate them from traditional
chemotherapy. In contrast to traditional chemotherapy,
Theratechnologies’ proprietary PDCs are designed to enable
selective delivery of certain anticancer drugs within the tumor
microenvironment, and more importantly, directly inside SORT1
cancer cells. Commercially available anticancer drugs, like
docetaxel, doxorubicin or tyrosine kinase inhibitors are conjugated
to Theratechnologies’ PDC to specifically target SORT1 receptors.
This could potentially improve the efficacy and safety of those
agents.
In preclinical data,
the Company’s SORT1+ TechnologyTM has shown to improve anti-tumor
activity and reduce neutropenia and systemic toxicity compared to
traditional chemotherapy. Additionally, in preclinical models,
SORT1+ TechnologyTM has shown to bypass the multidrug resistance
protein 1 (MDR1; also known as P-glycoprotein) and inhibit the
formation of vasculogenic mimicry - two key resistance mechanisms
of chemotherapy treatment.
About
TH1902TH1902 combines Theratechnologies’ proprietary
peptide to the cytotoxic drug docetaxel. TH1902 is currently
Theratechnologies’ lead investigational PDC candidate for the
treatment of cancer derived from its SORT1+ Technology™. The FDA
granted fast track designation to TH1902 as a single agent for the
treatment of all sortilin-positive recurrent advanced solid tumors
that are refractory to standard therapy. TH1902 is currently being
evaluated in a Phase 1 clinical trial for the treatment of cancers
where the sortilin receptor is expressed.
The Company is also
evaluating TH1904 in preclinical research, a second PDC derived
from its SORT1+ TechnologyTM TH1904 is conjugated to the cytotoxic
drug doxorubicin.
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.
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 InformationThis 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 use of TH1902 for the potential treatment of of
sortilin-positive TNBC and other sortilin-expressed cancer types,
and the conduct of our clinical trial with TH1902.
Although the Forward-Looking Statements
contained in this press release are based upon what the Company
believes are reasonable assumptions in light of the information
currently available, investors are cautioned against placing undue
reliance on these statements since actual results may vary from the
Forward-Looking Statements. Certain assumptions made in preparing
the Forward-Looking Statements include that: the current COVID-19
pandemic will have limited adverse effect on the Company’s
operations and its business plan; the Company will succeed in
pursuing the conduct of its Phase 1 clinical trial using TH1902;
research and development activities using peptides derived from its
SORT1+ TechnologyTM will yield positive results allowing for the
development of new drugs for the treatment of cancer; and the
Company’s business plan will not be substantially modified.
Forward-Looking Statements assumptions are
subject to a number of risks and uncertainties, many of which are
beyond Theratechnologies’ control that could cause actual results
to differ materially from those that are disclosed in or implied by
such Forward-Looking Statements. These risks and uncertainties
include, but are not limited to, those related to or arising from:
the adverse impact of the ongoing COVID-19 pandemic on (a) the
Company’s sales efforts and sales initiatives, (b) the capacity of
the Company’s suppliers to meet their obligations vis-à-vis the
Company, (c) the Company’s research and development activities, (d)
the health of the Company’s employees and its capacity to rely on
its resources, as well as (e) global trade; the Company’s ability
to successfully conduct its Phase 1 clinical trial using TH1902 in
various types of cancer; the Company’s capacity to acquire or
in-license new products and/or compounds; and the Company’s
estimates regarding its capital requirements.
We refer current and
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 related to
the Company. 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
Affairscommunications@theratech.com514-336-7800
For investor inquiries:Leah GibsonSenior
Director, Investor Relationsir@theratech.com617-356-1009
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