Theratechnologies Announces Dosing of First Patient in Updated Clinical Trial of Sudocetaxel Zendusortide in Advanced Ovarian Cancer
12 Oktober 2023 - 1:30PM
Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX:
TH) (NASDAQ: THTX), a biopharmaceutical company focused on the
development and commercialization of innovative therapies, today
announced dosing of the first participant in Part 3 of its Phase 1
clinical trial of sudocetaxel zendusortide in patients with
advanced ovarian cancer. Sudocetaxel zendusortide is an
investigational, first-in-class peptide-drug conjugate (PDC) that
targets the sortilin (SORT1) receptor and expedites the
internalization and delivery of a cytotoxic payload directly into
cancer cells.
“We are excited to dose the first of six
patients in Part 3 of the Phase 1 trial of sudocetaxel zendusortide
with its modified design and dosing regimen,” said Christian
Marsolais, Ph.D., Senior Vice President and Chief Medical Officer
at Theratechnologies. “We look forward to building on the efficacy
we’ve observed so far, which is mainly long-term disease
stabilization in a number of advanced patients. This
first-patient-dosed milestone, thus extends the momentum of our
oncology clinical development program.”
"Patients with chemo-resistant ovarian cancer
are in dire need of effective treatment options,” said Ira Winer,
M.D., Ph.D., FACOG, Gynecologic Oncology and Phase I
multidisciplinary member at Karmanos Cancer Center and trial
investigator. “Based on promising preliminary data during the first
parts of the Phase 1 trial for sudocetaxel zendusortide, I hope to
see both improved tolerability and continued benefit in this
patient population as the trial moves onto this next phase.”
The announcement follows U.S. Food and Drug
Administration (FDA) acceptance on June 2, 2023 of the Company’s
amended protocol for the Phase 1 trial. The revised protocol is
designed to improve the therapeutic window of sudocetaxel
zendusortide and extend its duration of therapy. It includes weekly
administration and also narrows the patient population to focus on
individuals with high-grade serous ovarian cancer, including
high-grade peritoneal or fallopian tube cancer, or high-grade
endometrioid cancer - a population in which sudocetaxel
zendusortide has demonstrated preliminary efficacy. After
establishing the safety of the initial dose in the first six
patients, the study aims to enroll a total of 16 patients in Part
3.
Enrollment of the first patient in Part 3 of the
trial follows closely upon demonstration of antitumor activity in
Parts 1 and 2, as presented at the 2023 annual meeting of the
American Society of Clinical Oncology. Details about the study
design, participation criteria and contact information for the five
U.S. sites simultaneously enrolling patients can be found at:
https://clinicaltrials.gov/study/NCT04706962.
About Sudocetaxel Zendusortide (TH1902)
and SORT1+ Technology™
Sudocetaxel zendusortide is a first-of-its-kind
sortilin- (SORT1) targeting PDC, and the first compound to emerge
from the SORT1+ TechnologyTM platform. A new chemical entity,
sudocetaxel zendusortide employs a cleavable linker to conjugate
(attach) a proprietary peptide to docetaxel, a well-established
cytotoxic chemotherapeutic agent used to treat many cancers. The
FDA granted Fast Track designation to sudocetaxel zendusortide as a
single agent for the treatment of all sortilin-positive recurrent
advanced solid tumors that are refractory to standard therapy.
Sudocetaxel zendusortide is currently being evaluated in a Phase 1
clinical trial.
Theratechnologies has established its SORT1+
TechnologyTM platform as an engine for the development of
proprietary PDCs that target SORT1 receptor, which is expressed in
multiple tumor types. SORT1 is a “scavenger” receptor that plays a
significant role in protein internalization, sorting, and
trafficking. Expression of SORT1 is associated with aggressive
disease, poor prognosis, and decreased survival. It is estimated
that SORT1 is expressed in 40% to 90% of endometrial, ovarian,
colorectal, triple-negative breast (TNBC), and pancreatic cancers,
making this receptor an attractive target for anticancer drug
development.
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.sedarplus.ca and on EDGAR at www.sec.gov. Follow
Theratechnologies on Linkedin and Twitter.
Forward-Looking Information
This press release contains forward-looking
statements and forward-looking information (collectively, the
“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", “promising”, “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
conduct of Part 3 of the Phase 1 clinical trial using sudocetaxel
zendusortide, the enrolments of patients in such trial, the
observation of signs of efficacy from this Phase 1 clinical trial
and the development of the Company’s SORT1+ TechnologyTM platform.
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 this
information since actual results may vary from the Forward-Looking
Statements. Certain assumptions made in preparing the
Forward-Looking Statements include that: the Company will be
successful in enrolling the required number of patients to finalize
Part 3 of its Phase 1 clinical trial, signs of efficacy will be
observed in such Phase 1 clinical trial whereas no untoward side
effects will be reported, and the development of the Company’s
SORT1+ TechnologyTM platform will be successful. Forward-Looking
Statements 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: difficulties in recruiting patients to conduct the
Phase 1 clinical trial, the reporting of adverse side effects from
the use of sudocetaxel zendusortide leading to a halt on the
clinical trial and, eventually, the Company’s development of its
SORT1+ TechnologyTM platform, the lack of observation of strong
efficacy results, and competing development programs conducted by
third parties. We refer current and potential investors to the
“Risk Factors” section of our Annual Information Form dated
February 27, 2023, available on SEDAR at www.sedarplus.ca and on
EDGAR at www.sec.gov as an exhibit to our report on Form 40-F dated
February 28, 2023, under Theratechnologies’ public filings for
additional risks involved in our business. 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.
Contacts:
Media inquiries:Julie SchneidermanSenior Director,
Communications & Corporate
Affairscommunications@theratech.com1-514-336-7800
Investor inquiries:Philippe DubucSenior Vice President and Chief
Financial Officerir@theratech.com1-438-315-6608
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