TransCode Therapeutics Announces Safety Review Committee Approval of Second Cohort Opening in Phase 1 TTX-MC138 Clinical Trial Following Favorable Review of Cohort 1 Safety Data
23 Oktober 2024 - 1:00PM
TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology
company committed to more effectively treating cancer using RNA
therapeutics, today announced that the Safety Review Committee
(SRC) monitoring its Phase 1 clinical trial has unanimously
approved opening of the second cohort of patients based on its
favorable review of Cohort 1 safety data. The therapeutic candidate
being evaluated, TTX-MC138, is TransCode’s lead candidate designed
to inhibit microRNA-10b, a microRNA critical to the emergence and
progression of metastatic cancer. All patients in the first cohort
remain on study for continued treatment. No significant
safety or dose limiting toxicities have been reported. The dose
administered to the second cohort will be approximately double the
dose administered to the first cohort.
“An SRC is a group of clinicians and experts
that oversee the safety of subjects during the conduct of the
trial. The SRC makes decisions on whether and how the study should
proceed, including dose escalation and de-escalation decisions per
the study design. The recommendations of the SRC are used to decide
whether a clinical trial should be continued as designed, changed,
or terminated,” commented Sue Duggan, TransCode’s Senior Vice
President of Operations. Duggan added, “No dose-limiting toxicities
were reported in the first cohort of patients treated with
TTX-MC138. Eligible subjects may now be scheduled in Cohort 2 for
treatment with the next dose level of TTX-MC138.”
About TTX-MC138
TTX-MC138 is a first-in-class therapeutic
candidate that targets microRNA-10b, a micro-RNA widely believed to
be a driver of metastatic disease. TransCode’s 2023 Phase 0
clinical trial produced evidence of delivery of a radiolabeled
version of TTX-MC138 to metastatic lesions and pharmacodynamic
activity, even at a microdose of the drug candidate, suggesting a
broad therapeutic window for TTX-MC138.
About the Trial
TransCode’s 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
Therapeutics
TransCode 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
Statements
This release contains “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995, including, without limitation, statements
concerning the timing, conduct and results of the Phase 1 clinical
trial, statements about microRNAs and their involvement in cancer,
and statements concerning the therapeutic potential of TransCode’s
TTX-MC138. 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 risks
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 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 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
dependence on third parties; and risks associated with geopolitical
events and pandemics, including the COVID-19 coronavirus and
military actions. 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
Development tania.montgomery@transcodetherapeutics.com
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