TransCode Therapeutics Awarded $2 Million NIH Grant to Support Clinical Evaluation of Lead Candidate

Rhea-AI Summary

TransCode Therapeutics (NASDAQ: RNAZ) has been awarded a $2 million Direct to Phase II Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) to support the clinical evaluation of its lead therapeutic candidate, TTX-MC138. The grant, awarded by the National Cancer Institute (NCI), will be disbursed over two years.

TransCode has recently activated three clinical trial sites for a Phase I/II clinical trial of TTX-MC138 for treating advanced solid tumors. The trial aims to assess the safety of TTX-MC138 and may provide early evidence of its clinical activity in patients with metastatic disease. TTX-MC138 is described as a first-in-class therapeutic candidate with novel relevance to metastatic disease, potentially offering a viable treatment option for many metastatic cancer patients.

Positive

• Received $2 million NIH grant for clinical development of lead candidate
• Activated three clinical trial sites for Phase I/II study of TTX-MC138
• Potential for early evidence of clinical activity in metastatic patients
• TTX-MC138 described as first-in-class therapeutic for metastatic disease

Negative

• None.

Insights

Financial Analyst

The $2 million NIH grant is a positive development for TransCode Therapeutics (NASDAQ: RNAZ), but its impact on the company's financial position should be viewed in context. While the grant provides non-dilutive funding, it's important to note that clinical trials are often costly, potentially exceeding this amount. The grant's distribution over two years suggests a measured financial boost rather than an immediate windfall.

Investors should consider that while this funding supports the Phase I/II trial of TTX-MC138, it doesn't guarantee commercial success. The market reaction might be cautiously optimistic, as government backing lends credibility to TransCode's research. However, the company's overall financial health, burn rate and additional funding needs remain critical factors to monitor.

Medical Research Analyst

The NIH grant for TTX-MC138's clinical evaluation signifies scientific merit in TransCode's approach to targeting metastatic cancer. This first-in-class therapeutic candidate's potential to address metastatic disease is particularly noteworthy, as it targets an area of high unmet medical need.

The Phase I/II trial's primary focus on safety, with a secondary look at efficacy, is standard for early-stage clinical research. Investors should be aware that while positive safety data is crucial, it's the potential early efficacy signals that could really move the needle. The novel mechanism of TTX-MC138, likely involving RNA therapeutics, represents an innovative approach in oncology, which could attract attention if successful.

Market Research Analyst

TransCode's focus on RNA therapeutics for cancer treatment aligns with a growing trend in the biotech sector. The market potential for effective metastatic cancer treatments is substantial, given the high mortality rates associated with metastatic disease. However, investors should be cautious as the RNA therapeutics field is competitive, with several larger players involved.

The NIH grant may enhance TransCode's credibility among potential partners or investors, potentially facilitating future fundraising or collaborations. The company's ability to progress TTX-MC138 through clinical stages and eventually to market will be important for long-term value creation. Keep an eye on upcoming trial results and any partnerships or licensing deals, as these could significantly impact the company's market position.

Grant awarded by the National Cancer Institute (NCI) of the NIH to support clinical development of lead therapeutic candidate, TTX-MC138

BOSTON, Sept. 05, 2024 (GLOBE NEWSWIRE) -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics, today announced that it has been awarded a $2 million Direct to Phase II Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) to support clinical evaluation of TTX-MC138, TransCode’s lead therapeutic candidate. TransCode has recently activated three clinical trial sites to conduct a Phase I/II clinical trial of TTX-MC138 for the treatment of advanced solid tumors.

The clinical trial is designed to generate critical data to support evaluation of the safety of TTX-MC138. While efficacy of TTX-MC138 is not an endpoint in this trial, the trial may nevertheless provide early evidence of TTX-MC138 clinical activity in patients with metastatic disease. Funds under the grant are expected to be received over two years.

“We are honored that the NIH recognizes and continues to support our mission to advance therapies against metastatic cancer,” said Zdravka Medarova, Ph.D., Chief Scientific Officer of TransCode. “NIH funding is awarded only after rigorous review. We believe that this award attests to the potential impact, novelty, and robustness of the TTX-MC138 clinical development program.”

TTX-MC138 is a first-in-class therapeutic candidate with novel relevance to metastatic disease. Successful clinical development of TTX-MC138 potentially represents a viable treatment option for many patients with metastatic cancer.

About TransCode Therapeutics

TransCode is a clinical-stage oncology company focused on treating metastatic disease. The company is committed to defeating cancer through the intelligent design and effective delivery of RNA therapeutics based on its proprietary TTX nanoparticle delivery platform. The company’s lead therapeutic candidate, TTX-MC138, is focused on treating metastatic tumors which overexpress microRNA-10b, a unique, well-documented biomarker of metastasis. In addition, TransCode is developing a portfolio of other first-in-class RNA therapeutic candidates designed to overcome the challenges of RNA delivery and thus unlock therapeutic access to a variety of novel genetic targets that could be relevant to treating a variety of cancers.

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 therapeutic potential of TransCode’s TTX-MC138 and the conduct and results of the planned Phase I/II clinical trial. 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 clinical trials will not be consistent with our pre-clinical studies or expectations or with previous clinical trials; risks associated with the timing and outcome of TransCode’s planned regulatory submissions; risks associated with TransCode’s conduct of clinical trials; 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 geopolitical events and pandemics, including 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, 2023, 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.
Tania Montgomery-Hammon, VP of Business Development
tania.montgomery@transcodetherapeutics.com

FAQ

What is the purpose of the $2 million NIH grant awarded to TransCode Therapeutics (RNAZ)?

The $2 million NIH grant awarded to TransCode Therapeutics (RNAZ) is to support the clinical evaluation of their lead therapeutic candidate, TTX-MC138, for the treatment of advanced solid tumors.

What type of clinical trial has TransCode Therapeutics (RNAZ) initiated for TTX-MC138?

TransCode Therapeutics (RNAZ) has initiated a Phase I/II clinical trial for TTX-MC138, activating three clinical trial sites to evaluate its safety and potential clinical activity in patients with metastatic disease.

How is TTX-MC138 described in relation to metastatic cancer treatment?

TTX-MC138 is described as a first-in-class therapeutic candidate with novel relevance to metastatic disease, potentially offering a viable treatment option for many patients with metastatic cancer.

When was the NIH grant awarded to TransCode Therapeutics (RNAZ) announced?

The NIH grant awarded to TransCode Therapeutics (RNAZ) was announced on September 5, 2024.