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BOSTON - TransCode Therapeutics, Inc. (NASDAQ: RNAZ), an RNA oncology company with a current market capitalization of $12.21 million, has announced the initiation of dosing the first patient in Cohort 4 of its Phase I clinical trial with TTX-MC138, a therapeutic candidate aimed at metastatic cancer treatment. According to InvestingPro data, the company’s stock has experienced significant volatility, trading near its 52-week low after a 97% decline over the past year. This marks a progression in the multi-center, open-label study designed to evaluate the safety and tolerability of escalating doses of TTX-MC138 in patients with various metastatic solid tumors.
The treatment of the first patient in Cohort 4 follows the successful dosing of ten patients across the first three cohorts without any significant safety issues or dose-limiting toxicities. The current dose administered is approximately fifty percent higher than that of the previous cohort. Seven of these patients continue to receive treatment, indicating an absence of safety events or disease progression. While the company maintains a favorable cash-to-debt ratio, InvestingPro analysis indicates the company is quickly burning through its cash reserves, with a negative free cash flow of $15.87 million in the last twelve months.
The trial’s primary objective during this dose-escalation phase is to assess the safety and tolerability of TTX-MC138. The subsequent dose-expansion phase will further evaluate its safety, tolerability, and potential anti-tumor activity. While not a primary endpoint, the trial may also provide early indications of the clinical activity of TTX-MC138.
TTX-MC138, which targets microRNA-10b—a key player in metastatic disease—has shown promise in preclinical studies and a Phase 0 clinical trial. The latter demonstrated the drug candidate’s delivery to metastatic lesions and pharmacodynamic activity, even at microdoses.
Sue Duggan, Senior Vice President of Operations at TransCode, expressed optimism about the commencement of Cohort 4, emphasizing its role in informing the dose expansion stage and potentially providing initial evidence of clinical activity. The Safety Review Committee has also approved the enrollment of additional patients in Cohort 3 to strengthen the safety profile of TTX-MC138.
The company is dedicated to defeating cancer by developing RNA therapeutics based on its proprietary TTX nanoparticle platform. TransCode’s portfolio includes several first-in-class RNA therapeutic candidates designed to address the challenges of RNA delivery.
This news is based on a press release statement from TransCode Therapeutics, Inc. Further details on the trial are available on the clinicaltrials.gov website under the identifier NCT06260774. Investors should note that TransCode is scheduled to report its next earnings on March 31, 2025. InvestingPro subscribers have access to 15 additional exclusive insights about TransCode, including detailed financial health metrics and Fair Value analysis that suggests the stock may be currently undervalued.
In other recent news, TransCode Therapeutics has made notable advancements in its Phase 1 clinical trial for TTX-MC138, a therapeutic candidate aimed at treating metastatic cancers. The company has successfully dosed three patients in Cohort 3, with the Safety Review Committee approving this progression after evaluating safety and pharmacokinetic data from the first two cohorts. Importantly, no significant safety issues or dose-limiting toxicities have been reported among the nine patients involved in the trial. Preliminary data suggest that TTX-MC138’s pharmacokinetic and pharmacodynamic profile is consistent with earlier preclinical and Phase 0 trial outcomes. Notably, Cohort 1 confirmed the drug’s pharmacodynamic activity, achieving a 66% inhibition of miR-10b at 24 hours post-infusion in patients with high baseline expression. The ongoing trial is designed to assess the safety, tolerability, and potential anti-tumor activity of TTX-MC138 across various metastatic solid cancers. This development is part of TransCode’s broader focus on RNA therapeutics for metastatic disease, leveraging its proprietary TTX nanoparticle platform. Further details on the trial are available under the NCT Identifier: NCT06260774.
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