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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