Theratechnologies Inc. (“Theratechnologies” or “the Company”)
(TSX:TH) (NASDAQ:THTX), a biopharmaceutical company focused on the
development and commercialization of innovative therapies, today
provided an update on the dose escalation portion of the TH1902
Phase 1 clinical safety study. This is Theratechnologies’
first-in-human study of TH1902, its investigational lead peptide
drug conjugate (“PDC”) linked to docetaxel for the treatment of
sortilin-expressing cancers. It has received Fast Track designation
from the United States Food and Drug Administration (“FDA”).
“We are pleased to provide an update on TH1902’s
safety profile and go forward dosage. The pharmacokinetics data
observed in humans showed low levels of free docetaxel, consistent
with what was observed in the prior animal studies, leading to a
better safety profile than cytotoxics alone. We see this as a nod
to TH1902’s safety profile,” noted Dr. Christian Marsolais, Chief
Medical Officer, Theratechnologies. “In addition, we are excited to
see early efficacy signals in heavily pretreated patients in this
dose escalation study.”
“We are excited to be a part of the
TH1902 Phase I study and to have had the opportunity to be the
first in the world to enroll a patient,” said Dr. Satish Shah,
Pennsylvania Cancer Specialist and Research Institute. “Our
research institute enrolled multiple patients in the dose
escalation phase of the study (Part 1), and we are happy to report
that two of our advanced prostate cancer patients, who had
progressed on standard chemo/hormone therapies, showed signs of
efficacy. The first patient achieved a confirmed partial
response with the tumor mass reduction of 53%, and the other
patient achieved a PSA response with stabilization of disease
without any further progression. We also had an endometrial cancer
patient with lung metastases achieve a reduction in lung mass.
She achieved prolonged stabilization of disease, over a 33-week
period, without further progression, and was able to receive 11
cycles of treatment with TH1902. This is a clinically
meaningful result in late-stage disease with very limited treatment
options.”
A total of 18 heavily pre-treated patients, who
received an average of 8 prior cancer treatments, were enrolled in
the dose escalation portion of the study. Two of those patients
remain on treatment. Following the safety observations at 420 mg/m2
including grade 3 neuropathy, grade 4 neutropenia, grade 3 ocular
changes (visual acuity, keratitis and ocular surface dryness) and
grade 2 skin toxicities (rash, pruritis and inflammation), the dose
of TH1902 was decreased to 300 mg/m2 for the next dose level and
was expanded to a total of 6 patients. No Dose Limiting Toxicities
were observed during the first cycle, therefore, the dose of 300
mg/m2 was selected for continuation of the basket part of the
study. In addition, the levels of free docetaxel are low, at only
11% of those observed at docetaxel treatment dosage of 75 mg/m2.
Thus far 300 mg/m2 appears to be a well-tolerated dose level, which
continues to be evaluated in the larger basket portion of the
TH1902 study.
Signs of efficacy have been observed in three
heavily pretreated patients in the dose escalation trial, and
recorded results include:
- Confirmed partial response in one
prostate cancer patient with 53% overall reduction in target
lesions after three cycles of TH1902 at 300 mg/m2, PSA continued to
progress.
- Stabilized disease observed in a
prostate cancer patient with measurable reduction in target lesion
sizes (single digit percentages), including one PSA response. The
patient was treated with mixed cycles of TH1902 from 420 mg/m2 to
300 mg/m2.
- Stabilized disease observed in an
endometrial cancer patient with measurable reduction in target
lesion sizes (single digit percentages). Notably, she received a
total of 11 cycles. Her dose was escalated from 60 mg/m2 to
360 mg/m2.
In an effort to optimize and ensure success of
this clinical research program, the Company has enrolled six active
trial sites across the United States, including Cedars-Sinai in
California, Karmanos Cancer Institute and START Midwest in
Michigan, Pennsylvania Cancer Specialists Research Centre, Mary
Crowley Cancer Research and University of Texas MD Anderson Cancer
Center, both in Texas.
Based on the preclinical results obtained so
far, Theratechnologies is optimistic for the continued development
of a first-in-class and promising treatment for patients with
Sortilin positive solid tumors. The Company continues to advance
the development of its SORT1+ Technology™ platform by conjugating
the proprietary peptide with other effective anti-cancer agents and
by exploring other rational combinations with established
anti-cancer drugs.
As noted earlier, the unique mechanism of entry
of TH1902 in cancer cells is believed to be a key advantage to
improving the therapeutic window of docetaxel. TH1902’s targeted
delivery and rapid internationalization in cancer cells via the
Sortilin receptor enables the potential to accumulate 7.5 to 10
times more docetaxel in cancer cells as compared to the
administration of docetaxel alone. Additionally, as shown in
preclinical models, this mechanism reduces the overall exposure of
healthy tissue to docetaxel in the body.
About TH1902
TH1902 is Theratechnologies’ proprietary peptide
drug conjugate (“PDC”) linked to docetaxel, a well-established and
well-characterized cytotoxic agent. TH1902 is being developed 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 drug candidate stemming from
Theratechnologies’ SORT1+ Technology™ in oncology.
About SORT1+ Technology™
Theratechnologies has developed a peptide which
specifically targets sortilin (SORT1) receptors. SORT1 is expressed
in ovarian, endometrial, HR+ and triple negative breast, skin,
lung, prostate and thyroid, among other cancers. SORT1 plays a
significant role in protein internalization, sorting and
trafficking, making it an attractive target for drug development.
Commercially available anticancer drugs, like free docetaxel,
doxorubicin or tyrosine kinase inhibitors are conjugated to
Theratechnologies’ investigational novel peptides to specifically
target Sortilin receptors with the aim of improving the efficacy
and safety of those agents. It has received Fast Track designation
from the United States Food and Drug Administration (“FDA”).
What is a basket trial? A type
of clinical trial that tests how well a new drug or other substance
works in patients who have different types of cancer that all have
the same mutation or biomarker. In basket trials, patients all
receive the same treatment that targets the specific mutation or
biomarker found in their cancer. Basket trials may allow new drugs
to be tested and approved more quickly than traditional clinical
trials. Basket trials may also be useful for studying rare cancers
and cancers with rare genetic changes.
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 (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 a treatment for patients with Sortilin positive
solid tumors, the development of our SORT1+ Technology™ platform,
the conduct and recruitment of patients for the basket trial using
TH1902 and the opening of new clinical trial sites. 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 pre-clinical results obtained using
TH1902 will be replicated into humans, we will be able to continue
recruiting patients to conduct the basket trial using TH1902, no
dose limiting toxicities will be observed in patients comprising
the basket trial, our manufacturer of TH1902 will be able to supply
the required quantity of TH1902 in due time to advance the basket
trial, and we will see signs of efficacy of TH1902 in the conduct
of the basket trial across all patients forming part of the
trial.
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, our inability to recruit patients
for the conduct of the basket trial, the observation of adverse
safety issues, the lack of demonstration of efficacy in many or in
all of the patients forming part of the trial, issues regarding the
manufacture and supply of TH1902, and conflicts with third party
suppliers in the conduct of our basket trials.
We refer current and potential investors to the
“Risk Factors” section of our Annual Information Form dated
February 23, 2022 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 24, 2022 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.
Investor inquiries:Elif McDonaldSenior Director, Investor
Relationsir@theratech.com1-438-315-8563
Media inquiries:Julie SchneidermanSenior Director,
Communications & Corporate
Affairscommunications@theratech.com1-514-336-7800
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