TransCode Therapeutics and Quantum Leap Submit IND Amendment for Phase 2a Trial of TTX-MC138

TransCode Therapeutics and Quantum Leap Collaboration

TransCode Therapeutics, Inc. (NASDAQ: RNAZ), a pioneering name in the realm of immuno-oncology and RNA therapies, has recently taken a significant step forward. In partnership with Quantum Leap Healthcare Collaborative, the company announced the submission of an Investigational New Drug (IND) application amendment to the U.S. Food and Drug Administration (FDA). This amendment is intended for a planned Phase 2a clinical trial featuring their key therapeutic candidate, TTX-MC138.

This ambitious study will be part of the PRE-I-SPY program, known for fostering innovative clinical trials in oncology. In an exciting first for this program, TTX-MC138 aims to specifically target colorectal cancer. This decision marks a noteworthy expansion of the PRE-I-SPY platform, which had previously not ventured into this area, highlighting the critical need for new treatment options for patients struggling with this type of cancer.

The upcoming Phase 2a trial is particularly crucial as it plans to enroll up to 45 patients diagnosed with colorectal cancer. These participants will have already completed standard treatments intended for curing cancer but will exhibit positive markers for circulating tumor DNA (ctDNA). Recent research underscores the importance of ctDNA as a prognostic marker for cancer recurrence, potentially indicating minimal residual disease (MRD). Detecting MRD early is essential, as it could significantly improve patient outcomes with timely interventions.

The Phase 2a trial is set to commence in the first half of 2026, with Dr. Paula Pohlmann from MD Anderson Cancer Center leading the charge. The primary objective of this trial is to evaluate both the biological and clinical efficacy of TTX-MC138 in addressing MRD. The focus here is clear: to explore how the therapeutic intervention can optimize long-term patient outcomes in colorectal cancer.

Sue Duggan, the Senior Vice President of Operations at TransCode, expressed optimism regarding this IND submission. She noted, "This marks a pivotal step in TransCode's clinical development program, positioning TTX-MC138 where its mechanism of action can potentially provide significant benefits to patients." Duggan also emphasized the value of collaborating with the Quantum Leap's PRE-I-SPY program to better assess TTX-MC138 and extend this innovative platform into new indications like colorectal cancer.

The clinical trial is set to be executed at numerous clinical sites affiliated with the PRE-I-SPY Platform Network, with many of these being part of the National Cancer Center Network. Furthermore, the program seeks to collaborate with the Colorectal Cancer Alliance, a prominent advocate for patients battling this disease. For those interested in further details about the PRE-I-SPY program and the forthcoming Phase 2a trial, additional information is available on clinicaltrials.gov (NCT05868226).

About TransCode Therapeutics

TransCode Therapeutics is at the forefront of developing next-generation treatments for high-risk and advanced cancers through their innovative approaches to immuno-oncology and RNA therapies. Their leading candidate, TTX-MC138, specifically targets metastatic tumors that overexpress microRNA-10b, a well-documented biomarker associated with metastasis. The company is committed to advancing its portfolio of first-in-class therapeutic options designed to harness the immune system’s power to identify and eradicate cancerous cells. For more details, visit TransCode Therapeutics.

Forward-Looking Statements

This announcement contains forward-looking statements within the context of the Private Securities Litigation Reform Act of 1995. These statements cover various aspects of TransCode’s upcoming collaborations and trials, including expected timing, conduct, and results. The company acknowledges several risks associated with drug discovery, development processes, and potential financial challenges that could impact future outcomes. As always, any new information will be updated as required by law.