TransCode Therapeutics Announces Publication in Cancer Nanotechnology of Preclinical Data Supporting Therapeutic Potential of TTX-MC138 in Metastatic Breast Cancer
September 23 2021 - 07:30AM
Business Wire
– Imaging study confirms the biodistribution of
TTX-MC138 in models of metastatic cancer, supporting TransCode’s
TTX platform for delivery of RNA targeted therapy to metastatic
solid tumors –
-- eIND submission for TTX-MC138 anticipated in
1Q 2022 to support Phase 0 study in metastatic solid tumors,
designed to establish proof of concept for TTX delivery platform
--
TransCode Therapeutics, Inc. (Nasdaq: RNAZ), an emerging RNA
oncology company created on the belief that cancer can be defeated
through the intelligent design and effective delivery of RNA
therapeutics, today announced that preclinical research supporting
its lead candidate, TTX-MC138, was published in Cancer
Nanotechnology. The article, entitled “Radiolabeling and PET-MRI
microdosing of the experimental cancer therapeutic, MN-anti-miR10b,
demonstrates delivery to metastic lesions in a murine model of
metastatic breast cancer,” resulted from research conducted at the
Athinoula A. Martinos Center for Biomedical Imaging in the
Department of Radiology at Massachusetts General Hospital and
Harvard Medical School.
This preclinical study developed a radio-labeled derivative of
TTX-MC138 (referenced as MN-anti-miR10b) tagged with Cu-64,
enabling highly sensitive and specific quantitative determination
of its pharmacokinetics and biodistribution, as well as observation
of delivery to metastases via noninvasive positron emission
tomography-magnetic resonance imaging (PET-MRI). The key results of
the study demonstrated that TTX-MC138, when injected intravenously,
accumulated in metastatic lesions. These results suggest that
TransCode’s TTX platform delivers its therapeutic candidate as
intended and the company believes supports clinical evaluation of
TTX-MC138. In addition, the investigation describes the development
of a microdosing PET-MRI approach that could potentially be used
for measurement of TTX-MC138 biodistribution in cancer patients and
its delivery to clinical metastases. The capacity to carry out
microdosing PET studies in patients under an exploratory
investigational new drug application protocol would represent an
important step on the path to clinical translation because it could
facilitate and expedite approval from the U.S. Food and Drug
Administration (FDA) for initial human studies.
“Our TTX technology builds upon prior experience with similar
iron oxide nanoparticles that have long been used in humans for
imaging, potentially enabling clinical studies that may de-risk
future clinical trials by demonstrating successful drug delivery
and assist in patient selection for future treatment,” said Michael
Dudley, CEO of TransCode Therapeutics. “For TransCode, we believe
this study further confirms the pharmacokinetic profile of
TTX-MC138, supporting the viability of our platform for delivery of
RNA-based therapy to metastatic solid tumors. Our preclinical data
further suggest the therapeutic potential of TTX-MC138, and we look
forward to our Phase 0 study which has the potential to establish
clinical proof-of-concept for this therapy.”
TransCode expects to file an exploratory investigational new
drug (eIND) application for TTX-MC138 in the first quarter of 2022
to support a Phase 0 study in patients with metastatic cancer.
Under an eIND, FDA approval may be obtained more quickly and at
lower cost than with a traditional IND for therapeutic agents.
About TransCode Therapeutics
TransCode is an emerging RNA oncology company created on the
belief that cancer can be defeated through the intelligent design
and effective delivery of 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, which causes approximately
90% of all cancer deaths representing over nine million deaths 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. The Company’s other drug candidates,
TTX-siPDL1, TTX-siLIN28b, TTX-RIGA, TTX-CRISPR and TTX-mRNA, focus
on treating tumors using RNA technology made possible through its
proprietary delivery platform. The Company is also developing
diagnostic products related to its planned therapeutics
business.
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 results
and implications of the preclinical study described above and the a
potential microdosing PET-MRI approach in future clinical trials as
well as the therapeutic potential of TTX-MC138 more generally, and
the timing and outcome of expected regulatory filings, including
the filing of an eIND for the planned first-in-human study of
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 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;
the risk 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 Quarterly Report on Form 10-Q for the period ended
June 30, 2021, as well as discussions of potential risks,
uncertainties and other important factors in TransCode’s subsequent
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210923005306/en/
Investor Contact: Josh Rappaport Stern Investor Relations
josh.rappaport@sternir.com
Company Contact: Tom Fitzgerald, CFO
tom.fitzgerald@transcodetherapeutics.com
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