TransCode Therapeutics Announces First Subject Dosed with Radiolabeled TTX-MC138 in First-In-Human Clinical Trial
23 Agosto 2023 - 9:00AM
TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology
company committed to more effectively treating cancer using RNA
therapeutics, today announced the dosing of the first subject in
its First-in-Human Phase 0 clinical trial. The Phase 0 trial is an
open-label, single-center, microdose study intended to demonstrate
delivery of the radio-labeled version of TransCode’s lead
therapeutic candidate, TTX-MC138, to radiographically-confirmed
metastases in subjects with advanced solid tumors.
The subject received a single subtherapeutic
dose of radiolabeled TTX-MC138 and appeared to tolerate the dosing
well. Analysis and monitoring of data from this subject is ongoing
including results of positron emission tomography-magnetic
resonance imaging (PET-MRI), to determine uptake of TTX-MC138 to
the subject’s metastatic lesions. Enrollment of additional subjects
is also currently underway.
TTX-MC138 is designed to inhibit the
pro-metastatic RNA, microRNA-10b, described as the master regulator
of metastasis in a number of advanced solid tumors. TransCode
believes that TTX-MC138 could be used as a treatment for many of
these cancers.
“We are pleased to have commenced our First-in-Human (FIH)
clinical trial,” said TransCode’s Chief Executive Officer and
co-founder, Michael Dudley. “The capability to deliver nucleic-acid
based therapeutics to cancer represents a major turning point in
the field of RNA because it opens up the possibility of developing
an entire new class of drugs against most previously undruggable
genetic targets. Overcoming this challenge could constitute an
unprecedented step in unlocking therapeutic access to a range of
cancers and beyond. Demonstrating successful delivery to cancer
using TransCode’s proprietary TTX delivery platform could also
enable progress towards more personalized cancer therapy guided by
genetic profiling."
The Company believes that TTX-MC138 has the potential to
dramatically improve clinical outcomes in a range of cancers,
including breast, pancreatic, ovarian and colon cancer,
glioblastomas and others. In a preclinical murine model of
triple-negative breast cancer (TNBC), treatment with TTX-MC138
eliminated pre-existing local metastases in 100% of treated animals
representative of stage II/III metastatic cancer. In a more
aggressive murine model representative of stage IV metastatic
cancer, treatment with TTX-MC138 resulted in elimination of distant
metastases in 65% of animals treated. In a murine model of
pancreatic adenocarcinoma, administration of TTX-MC138 as
monotherapy resulted in complete responses, manifested as
regression without recurrence, in 40% of treated animals. In
addition to murine models of cancer, TTX-MC138 was successfully
delivered and demonstrated preliminary efficacy in spontaneous
feline mammary carcinoma.
TransCode’s Chief Technology Officer and co-founder, Dr. Zdravka
Medarova, said, “TTX-MC138 is a first-in-class therapeutic
candidate against cancer, not only because of its molecular
mechanism of action as an inhibitor of a noncoding RNA, but also
because of its novel relevance to metastatic disease. There is
currently a lack of drugs in cancer therapy that specifically
exploit features unique to drivers of metastatic disease. If
successful, TTX-MC138 could help demonstrate the potential for
treatments specific to metastatic progression offering new hope for
advanced cancer subjects who often have limited options for
long-term disease remission.”
A Phase 0 clinical trial is an exploratory study conducted under
an Investigational New Drug application. Up to 12 subjects may be
enrolled in this clinical trial, each of which is intended to
receive a single microdose of radiolabeled TTX-MC138 followed by
PET-MRI. The trial is intended to quantify the amount of TTX-MC138
delivered to metastatic lesions and the pharmacokinetics of the
therapeutic candidate in cancer subjects, but not to have a
therapeutic effect. The trial could yield critical data regarding
therapeutic dosing, timing, and potential safety that could inform
later clinical trials, including a Phase 1 trial planned to
commence in 2024.
About TransCode Therapeutics
TransCode is an RNA oncology company created on
the belief that cancer can be more effectively treated using RNA
therapeutics. The Company has created a platform 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, believed to cause approximately 90% of all cancer deaths
totaling over nine million per year worldwide. The Company believes
that TTX-MC138 has the potential to produce regression without
recurrence in a range of cancers, including breast, pancreatic,
ovarian and colon cancer, glioblastomas and others. One of the
Company’s other drug candidates, TTX-siPDL1, is an siRNA-based
modulator of programmed death-ligand 1. 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 timing and
outcome of TransCode’s FIH clinical trial, statements concerning
the timing and outcome of expected regulatory filings and other
clinical trials, statements concerning whether this study will
demonstrate proof-of-mechanism, statements concerning expected
clinical results of TransCode’s therapeutic candidates generally,
statements concerning the results of RNA research, statements
concerning the potential for treating cancer with RNA therapeutics,
and statements concerning TransCode’s development programs and TTX
technology platform generally. Of note, a Phase 0 clinical trial is
an exploratory study, conducted under an exploratory
Investigational New Drug (eIND) 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: 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; the risk that the results of our planned clinical
trials will not be consistent with our pre-clinical studies or
expectations; the risk that the timing or outcome of the Phase 0
clinical trial will not meet TransCode’s expectations; the risk
associated with drug discovery and development; 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; the risk of competition from other companies developing
products for similar uses; risks associated with TransCode’s
dependence on third parties; and risks associated with the COVID-19
coronavirus and other unexpected events. 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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