TransCode Therapeutics Announces First Patients Treated in Phase 1 Clinical Trial with First-in-Class Lead Therapeutic Candidate
17 September 2024 - 1:00PM
TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology
company committed to more effectively treating cancer using RNA
therapeutics, today announced dosing of the first two patients in
its Phase 1 clinical trial with its lead candidate, TTX-MC138.
Several additional patients have been screened for enrollment in
the trial, a multicenter, open-label, dose-escalation and
dose-expansion study of TTX-MC138.
“We are thrilled to announce the first two
patients were administered TTX-MC138 in our Phase 1 clinical trial.
This is a significant milestone for the TTX-MC138 clinical
development program with our novel approach to treating metastatic
cancers,” commented Sue Duggan, Senior Vice President of
Operations, at TransCode. Duggan added, “TTX-MC138 is a
first-in-class therapeutic candidate that showed evidence of
delivery to metastatic lesions in our Phase 0 clinical trial.”
TransCode believes that TTX-MC138 is the first
therapeutic candidate in clinical development designed to
specifically target a molecule responsible for metastatic
disease across multiple indications and irrespective of the
site of metastasis. It has the potential to positively affect
patient outcomes in a range of cancers, including breast,
pancreatic, ovarian, colon, lung and others. Successful clinical
development of TTX-MC138 could represent a breakthrough approach to
effectively treating patients with metastatic cancer.
About the TrialThe Phase 1
clinical trial is a multicenter, open-label, dose-escalation and
dose-expansion study, designed to generate critical data to support
evaluation of the safety and tolerability of TTX-MC138 in patients
with a variety of metastatic solid cancers. While not an endpoint,
the trial may provide early evidence of clinical activity of
TTX-MC138. The trial comprises an initial dose-escalation phase
followed by a dose-expansion phase. The primary objective of the
dose-escalation phase is to evaluate the safety and tolerability of
escalating dose levels of TTX-MC138. In the dose-expansion phase,
the safety, tolerability and anti-tumor activity of TTX-MC138 will
be further evaluated in certain tumor types selected based on
preliminary results from the dose-escalation phase.
Further information is available at
www.clinicaltrials.gov NCT Identifier: (NCT06260774).
About TransCode
TherapeuticsTransCode is a clinical-stage oncology company
focused on treating metastatic disease. The company is committed to
defeating cancer through the intelligent design and effective
delivery of RNA therapeutics based on its proprietary TTX
nanoparticle platform. The company’s lead therapeutic candidate,
TTX-MC138, is focused on treating metastatic tumors which
overexpress microRNA-10b, a unique, well-documented biomarker of
metastasis. In addition, TransCode is developing a portfolio of
other first-in-class RNA therapeutic candidates designed to
overcome the challenges of RNA delivery and thus unlock therapeutic
access to a variety of novel genetic targets that could be relevant
to treating a variety of cancers.
Forward-Looking StatementsThis
release contains “forward-looking statements” within the meaning of
the Private Securities Litigation Reform Act of 1995, including,
without limitation, statements concerning the therapeutic potential
of TransCode’s TTX-MC138 and the timing, conduct and results of the
planned Phase 1 clinical trial. Any forward-looking statements in
this press release are based on management’s current expectations
of future events and are subject to a number of risks and
uncertainties that could cause actual results to differ materially
and adversely from those set forth in or implied by such
forward-looking statements. These risks and uncertainties include,
but are not limited to: the risk associated with drug discovery and
development; the risk that the results of clinical trials will not
be consistent with TransCode’s pre-clinical studies or expectations
or with results from previous clinical trials; risks associated
with the conduct of clinical trials; risks associated with the
timing and outcome of TransCode’s planned regulatory submissions;
risks associated with obtaining, maintaining and protecting
intellectual property; risks associated with TransCode’s ability to
enforce its patents against infringers and defend its patent
portfolio against challenges from third parties; risks of
competition from other companies developing products for similar
uses; risks associated with TransCode’s financial condition and its
need to obtain additional funding to support its business
activities, including TransCode’s ability to continue as a going
concern; risks associated with TransCode’s dependence on third
parties; and risks associated with geopolitical events and
pandemics, including the COVID-19 coronavirus. For a discussion of
these and other risks and uncertainties, and other important
factors, any of which could cause TransCode’s actual results to
differ from those contained in or implied by the forward-looking
statements, see the section entitled “Risk Factors” in TransCode’s
Annual Report on Form 10-K for the year ended December 31, 2023, as
well as discussions of potential risks, uncertainties and other
important factors in any subsequent TransCode filings with the
Securities and Exchange Commission. All information in this press
release is as of the date of this release; TransCode undertakes no
duty to update this information unless required by law.
For more information, please
contact:TransCode Therapeutics, Inc.Tania
Montgomery-Hammon, VP of Business
Developmenttania.montgomery@transcodetherapeutics.com
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