Theratechnologies Inc. (Theratechnologies) (TSX: TH) (NASDAQ:
THTX), a biopharmaceutical company focused on the development and
commercialization of innovative therapies, today announced that new
in vivo preclinical data were presented at the 2021 Annual Meeting
of the American Association for Cancer Research (AACR). These data
demonstrated sustained tumor regression, better anti-tumor activity
and tolerability with TH1902 compared to docetaxel alone in all
cancer types studied, namely melanoma, pancreatic, ovarian,
endometrial, colorectal and triple-negative breast cancers. The
anti-tumor effect of TH1902 persisted longer post-treatment than
with docetaxel alone. TH1902 is the Company’s lead investigational
peptide-drug conjugate (PDC) derived from its SORT1+ Technology™.
“The FDA fast-track designation for TH1902 was
supported by the data presented today. This designation is a
significant recognition of our SORT1+ Technology™ as very few
investigational therapies receive fast track designation based on
preclinical data. It strongly endorses TH1902 as a potentially new
and innovative treatment for all patients with sortilin positive
(SORT1+) solid tumors that are refractory to standard therapy. The
Phase 1 clinical trial is now underway and we look forward to
advancing TH1902 through further stages of its development,” said
Dr. Christian Marsolais, Senior Vice President and Chief Medical
Officer, Theratechnologies.
AACR Poster #1313 – TH1902, a docetaxel
peptide-drug conjugate, shows pre-clinical efficacy in several
SORT1+ cancersHighlights of the poster include new data on
TH1902 in melanoma, where the sortilin receptor is expressed in
over 90% of cases. TH1902 was associated with superior anti-tumor
effect and sustained post-treatment effect compared to docetaxel
alone.
Other highlights of this poster include better
and sustained anti-tumor effect in pancreatic tumors, where
sortilin is expressed in 30% to 50% of cases and in triple-negative
breast cancer, where sortilin is expressed in almost 60% of cases.
Treatment effect was also observed with TH1902 in colorectal
cancer, which is encouraging as docetaxel is not recognized as
standard of care due to lack of response in this cancer. The
positive effect of TH1902 on tumor regression was also observed in
these cancer types at an equimolar quarter dose compared to
docetaxel alone.
Only registered attendees can access the
poster. AACR Poster #1439 – Increasing potency
of anticancer drugs through SORT1+ Technology™: A new targeted
approach for treatment of ovarian and endometrial
cancers
New data presented in this poster demonstrated
sustained inhibition of ovarian and endometrial cancers with TH1902
at equimolar doses of docetaxel alone. Specifically, TH1902 showed
improved anti-tumor activity in endometrial cancer at an equimolar
quarter doses compared to docetaxel alone.
Sortilin is expressed in over 90% of ovarian and
endometrial cancers, making it an excellent target for drug
development. Ovarian and endometrial cancers have poor prognosis
and survival outcomes.
Sortilin expression increases as a function of
tumor grade (I to IV) and is associated with poor prognosis and
decreased survival in different cancers.
Only registered attendees can access the
poster.
Absence of neutropenia with
TH1902Neutropenia was absent after six consecutive
treatments with TH1902 at an equivalent dose of the maximum
tolerated dose (MTD) of docetaxel, whereas a single treatment of
docetaxel strongly reduced neutrophil counts.
Neutropenia increases susceptibility to develop
infections. Several cancer treatments are known to cause
neutropenia and require on and off treatment cycles to avoid the
potentially severe consequences of infections associated with the
onset of neutropenia.
Phase 1 clinical trial of TH1902The Phase 1
dose-escalating study is evaluating 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.
The detailed Phase 1 study protocol is available
at ClinicalTrials.gov under the identifier number: NCT04706962.
About TH1902TH1902 combines
Theratechnologies’ proprietary peptide to docetaxel. This PDC is
the lead candidate derived 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).
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 for all patients with sortilin positive
(SORT1+) solid tumors that are refractory to standard therapy, and
the determination of the MTD.
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 will 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,
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
Theratechnologies (NASDAQ:THTX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Theratechnologies (NASDAQ:THTX)
Historical Stock Chart
From Apr 2023 to Apr 2024