TransCode Therapeutics Receives National Institutes of Health (NIH) Notice of Award

Rhea-AI Summary

TransCode Therapeutics (Nasdaq: RNAZ) has secured a $2.3 million funding from a Fast-Track SBIR grant to continue clinical development of TTX-MC138, its lead candidate for treating advanced solid tumors.

The second tranche of this funding was activated following the achievement of a program milestone in Q1 2022, which contributed $1.1 million to the company. The CEO has confirmed plans to submit an eIND for a first-in-human study this year, aiming to validate the novel delivery platform targeting microRNA-10b, implicated in metastatic disease.

Positive

• Awarded $2.3 million from SBIR grant to support clinical development.
• Achieved first milestone in Q1 2022, activating $1.1 million payment.
• Plans to submit eIND for first-in-human study of TTX-MC138 this year.

Negative

• None.

Funding is part of a 2021 Fast-Track Small Business Innovation Research (SBIR) grant to Support Clinical Development of First-in-Class Therapy for Advanced Solid Tumors

First SBIR program milestone achieved in Q1 2022

BOSTON, June 01, 2022 (GLOBE NEWSWIRE) -- TransCode Therapeutics, Inc. (Nasdaq: RNAZ), the RNA oncology company committed to defeating cancer using RNA therapeutics, today announced that it was awarded the second tranche of funding from a Fast-Track Small Business Innovation Research (SBIR) grant from the National Cancer Institute of the NIH (Award Number R44CA257093). The SBIR award, totaling $2.3 million, supports the continued clinical evaluation of TTX-MC138, TransCode’s lead therapeutic candidate for the treatment of advanced solid tumors. The Company achieved the first milestone related to the SBIR grant during the first quarter of 2022 -triggering a payment of $1.1 million as the second tranche of the award.

“We are honored to have the support of the NIH as we progress our lead candidate to our planned first-in-human study this year,” commented Michael Dudley, President and Chief Executive Officer of TransCode. “This is an important trial designed to evaluate and demonstrate proof-of-mechanism for our novel delivery platform, potentially enabling us to pursue a diverse pipeline of TTX-based therapeutics across a range of indications. We remain on track to submit an eIND for this study in 2022.”

TransCode’s proprietary TTX platform leverages an iron oxide nanoparticle as a novel, image-guided system designed to safely and efficiently deliver oligonucleotides to genetic targets. TTX-MC138 targets microRNA-10b, believed to drive metastatic disease. TTX-MC138 has been validated preclinically in multiple indications and has been shown to induce durable regression of metastatic disease in murine models of disseminated breast cancer.

About TransCode Therapeutics

TransCode is an RNA oncology company created on the belief that cancer can be defeated using 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 is believed to cause approximately 90% of all cancer deaths totaling over nine million 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. Two of the Company’s other drug candidates, TTX-siPDL1 and TTX-siLIN28B, focus on treating tumors by targeting PD-L1 and LIN28B, respectively. TransCode also has three cancer-agnostic programs—TTX-RIGA, an RNA–based agonist of the retinoic acid-inducible gene I, or RIG-I, approach 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 Statement

This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements concerning the SBIR award, 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 filing of an eIND for the planned first-in-human study of TTX-MC138, statements concerning the timing and outcome of this study, including whether this study will demonstrate proof-of-mechanism, statements concerning patent applications, and statements concerning TransCode’s development programs and TTX technology platform generally. 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 Annual Report on Form 10-K for the year ended December 31, 2021, 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 Relations
alan.freidman@transcodetherapeutics.com

Dave Gentry, CEO
RedChip Companies
Office: 1.800.RED.CHIP (733.2447)
Cell: 407.491.4498
RNAZ@redchip.com  

FAQ

What is the significance of TransCode's SBIR grant for RNAZ?

The SBIR grant of $2.3 million is crucial for supporting the clinical evaluation of TTX-MC138, TransCode's lead candidate for advanced solid tumors.

When did TransCode achieve the first milestone in the SBIR program?

TransCode achieved the first milestone in Q1 2022, triggering a payment of $1.1 million.

What are the future plans for TTX-MC138?

TransCode plans to submit an eIND for a first-in-human study of TTX-MC138 in 2022.

What type of cancer does TTX-MC138 target?

TTX-MC138 targets microRNA-10b, which is associated with metastatic disease.