Theratechnologies Inc. (Theratechnologies) (TSX: TH) (NASDAQ:
THTX), a biopharmaceutical company focused on the development and
commercialization of innovative therapies, today announced new
preclinical in vivo findings on the anti-metastatic effect and
tolerability of its novel investigational proprietary peptide-drug
conjugate (PDC), TH1902.
These results demonstrate that TH1902 has better
anti-metastatic activity when compared to docetaxel alone when
administered at an equimolar concentration in a lung metastasis
cancer model expressing the sortilin (SORT1) receptor.
Metastasis is a form of cancer that has spread from its original
site to a distant site or organ where it grows or metastasizes. It
is well-known that the survival rate for metastatic cancer is low.
The Company intends to present these findings at an upcoming
scientific meeting.
“These new results are very encouraging for the
development of TH1902 in SORT1+ cancers. It is known that
SORT1-receptor expression increases as cancers progress and these
new data confirm that by targeting the SORT1 receptor TH1902 could
potentially be effective in the treatment of
metastasis. Most importantly, these preclinical
findings, if confirmed in humans, are promising signs that we may
finally be able to inhibit hard-to-treat cancers with a more
effective and better-tolerated treatment,” said Dr. Christian
Marsolais, Senior Vice President and Chief Medical Officer of
Theratechnologies.
The Company will host a webcast today at 11:00
a.m. ET to discuss its SORT1+ Technology and TH1902, which will
include additional details on these preclinical findings. To access
the live webcast please click here. An archived
webcast will also be available on the Company’s website under the
‘Past Events’ section.
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 dollars
towards some of the research currently being conducted for the
development of Theratechnologies’ targeted oncology platform.
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 effects and tolerability of
TH1902, the development of TH1902,, and the use of TH1902 for the
potential treatment of various cancer types.
Forward-looking statements are based upon a
number of assumptions and include, but are not limited to, the
following: results observed in pre-clinical in vivo research and
development work will be replicated in humans, no adverse side
effects will be discovered from the administration of TH1902 into
humans,the Company will be able to enroll patients for the ongoing
Phase 1 trial using TH1902 and the Covid-19 pandemic will not
adversely affect the development of TH1902 and other peptides that
may be derived from the Company’ s SORT1+ TechnologyTM .
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 results (whether
safety or efficacy, or both) obtained through the administration of
our SORT1-targeting PDCs in humans will not be similar to those
obtained in animals, , the risks that we are unable to enroll
patients to complete the ongoing Phase 1 trial using TH1902 or that
serious adverse effects resulting from the administration of TH1902
are discovered leading to a suspension or cancellation of any
development work using TH1902, and the risk that new cancer
treatments are discovered or introduced which may prove safer
and/or more effective than our SORT1+ Technology™ for the cancer
types in which we aim to demonstrate efficacy and safety.
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
Relations617-356-1009ir@theratech.com
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