TransCode Therapeutics To Present Phase 0 Data at 2023 San Antonio Breast Cancer Symposium
05 Dezembro 2023 - 11:00AM
TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology
company committed to more effectively treating cancer using RNA
therapeutics, will present data from a Phase 0 clinical trial with
its lead candidate, TTX-MC138, at this year’s San Antonio Breast
Cancer Symposium scheduled to take place December 5-9 in San
Antonio, TX.
The abstract, “Development of TTX-MC138, a
First-In-Class miRNA-10b-Targeted Therapeutic Against Metastatic
Cancers of Diverse Primary Disease Origins” will be presented as a
poster. The poster will describe the clinical development of
TTX-MC138, a therapeutic miR-10b inhibitor, delivered to metastatic
tumor cells that has elicited complete responses and life-long
disease remissions in preclinical models of adenocarcinoma. The
poster details the IND-enabling work in support of the Phase 0
trial with Cu64-labeled TTX-MC138 as well as initial results from
the trial. The trial involves injection of a microdose of
Cu64-labeled TTX-MC138 into stage IV breast cancer patients,
followed by positron emission tomography-magnetic resonance imaging
(PET-MRI). The trial seeks to determine the pharmacokinetics of
TTX-MC138 and its uptake in metastatic lesions. Studies that will
be presented in support of the Phase 0 trial include
dosimetry/pharmacokinetic (PK) and tissue distribution, as well as
metabolite analysis in non-human primates. In addition, initial
clinical data on drug candidate PK and accumulation in clinical
metastases, as well as drug candidate stability, will be
discussed.
TransCode believes that the impact of this work
is three-fold. First, TransCode believes these data show that
TTX-MC138 has the potential to accumulate in human metastases as
occurred in preclinical animal studies. TransCode believes this
supports further clinical development of the therapeutic candidate
because it shows that delivery of the therapeutic candidate to
metastases is feasible. Second, the Phase 0 trial has the potential
to reveal the pharmacokinetic behavior of TTX-MC138 which could
inform dosing during therapy. Third, if TTX-MC138 reaches
late-stage clinical trials, the radiolabeled therapeutic candidate
could be used to select patients for treatment in the trial based
on which patients’ metastases accumulate the drug candidate.
TransCode believes that these results also have the potential to
support further clinical trials using TTX-MC138 to treat metastatic
cancer and, by addressing the issue of drug delivery, enable
clinical development of a wide array of TTX-based therapeutic
candidates.
About TransCode
Therapeutics
TransCode is an RNA oncology company created on
the belief that cancer can be more effectively treated using RNA
therapeutics. Using its proprietary iron oxide nanoparticle
delivery platform, the company has created a portfolio of drug
candidates designed to target a variety of tumor types with the
objective of significantly improving patient outcomes. The
company’s lead therapeutic candidate, TTX-MC138, is focused on
treating metastatic cancer, which is believed to cause
approximately 90% of all cancer deaths totaling over nine million
per year worldwide. Another of the company’s drug candidates,
TTX-siPDL1, focuses on treating tumors by targeting a protein
called Programmed death-ligand 1 (PD-L1). TransCode also has three
cancer-agnostic programs: TTX-RIGA, an RNA–based agonist of the
retinoic acid-inducible gene I designed to drive an immune response
in the tumor microenvironment; TTX-CRISPR, a CRISPR/Cas9–based
therapy platform for the repair or elimination of cancer-causing
genes inside tumor cells; and TTX-mRNA, an mRNA-based platform for
the development of cancer vaccines designed to activate cytotoxic
immune responses against tumor cells.
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 preliminary data from a Phase 0 clinical trial with
TransCode’s lead candidate, TTX-MC138, statements concerning
expected clinical results of TransCode’s therapeutic candidates,
statements concerning the results of RNA research, statements
concerning the potential for treating cancer with RNA therapeutics,
statements concerning the timing and outcome of expected regulatory
filings and clinical trials, including the first-in-human study of
TTX-MC138 currently underway and whether this study will
demonstrate proof-of-mechanism, and statements concerning
TransCode’s portfolio of drug candidates and TTX technology
platform generally. Of note, a Phase 0 clinical trial is an
exploratory study, conducted under an exploratory Investigational
New Drug application. Exploratory IND studies usually involve very
limited human exposure to a therapeutic candidate to evaluate
mechanism of action in order to inform potential clinical
evaluation in future clinical studies, but otherwise have no
therapeutic intent. 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 our planned clinical trials will not be consistent
with our pre-clinical studies or expectations; risks associated
with the timing and outcome of TransCode’s planned regulatory
submissions; risks associated with TransCode’s planned clinical
trials for its product candidates; 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 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, 2022, 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 the release; TransCode undertakes no duty to update this
information unless required by law.
For more information, please
contact:
TransCode Therapeutics, Inc.Alan Freidman, VP Investor
Relationsalan.freidman@transcodetherapeutics.com
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