BOSTON - TransCode Therapeutics, Inc. (NASDAQ: RNAZ), a clinical-stage oncology company, announced today that the U.S. Food and Drug Administration (FDA) has authorized the commencement of a Phase 1/2 clinical trial for its leading drug candidate, TTX-MC138. This trial aims to assess the safety and preliminary anti-tumor activity of the drug in patients with advanced solid tumors.
The FDA's clearance follows the agency's review of TransCode's Investigational New Drug (IND) application, marking a significant milestone for the company. Sue Duggan, Senior Vice President, Operations at TransCode, expressed the company's enthusiasm about moving TTX-MC138 into clinical testing, highlighting the potential of the drug to impact patient outcomes across a range of cancers.
The forthcoming trial will be multicenter, open-label, and will include both dose-escalation and dose-expansion phases. Initially, the trial will focus on establishing the safety and tolerability of TTX-MC138 across various escalating doses in patients with metastatic solid cancers. Subsequent stages of the trial will evaluate the drug's anti-tumor activity in more detail, based on the results obtained from the initial phase.
TransCode believes that TTX-MC138 could significantly influence patient outcomes for several types of cancer, including but not limited to breast, pancreatic, ovarian, and colon cancers, as well as glioblastomas. Preclinical studies have shown promising results, with TTX-MC138 leading to a statistically significant reduction in metastatic burden and an increase in survival rates in animal models when compared to control treatments.
The company's approach to treating metastatic disease involves the intelligent design and delivery of RNA therapeutics using its proprietary TTX nanoparticle platform. TTX-MC138 specifically targets metastatic tumors that overexpress microRNA-10b, a biomarker associated with metastasis.
This press release contains forward-looking statements regarding the therapeutic potential of TTX-MC138 and the expected timeline and outcomes of the clinical trial. However, it is important to note that drug development is subject to significant risks and uncertainties, and the trial results may differ from preclinical studies or expectations.
TransCode's future plans include regulatory submissions and the continued development of a portfolio of RNA therapeutic candidates aimed at addressing a variety of cancers. The information in this article is based on a press release statement from TransCode Therapeutics.
InvestingPro Insights
As TransCode Therapeutics, Inc. (NASDAQ: RNAZ) makes strides with its leading drug candidate, TTX-MC138, and begins its Phase 1/2 clinical trial, it's important for investors to consider the financial health and market performance of the company. According to InvestingPro data, RNAZ currently has a market capitalization of $3.61 million USD. The company's price/book ratio as of the last twelve months ending in Q4 2023 stands at 2.19, which can offer insights into how the market values the company's net assets. Additionally, the stock has experienced significant price volatility, with a 1-month price total return of -5.21% and a 6-month price total return of -96.21%.
Two key InvestingPro Tips for RNAZ include the fact that the company holds more cash than debt on its balance sheet, which can be a positive sign for financial stability. However, the company is quickly burning through cash. This cash burn, combined with the fact that analysts do not anticipate the company will be profitable this year, may raise concerns about the sustainability of its operations amid the costly process of drug development and clinical trials.
Investors looking to delve deeper into TransCode's financials and market performance can find additional insights on InvestingPro. There are a total of 14 InvestingPro Tips available for RNAZ, which can offer a more comprehensive understanding of the company's financial health and stock performance. For those interested in accessing these insights, remember to use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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