New RNA Drug Trial Aims to Stop Colorectal Cancer Recurrence

BOSTON, MA – February 05, 2026 – In a significant move to combat cancer recurrence, TransCode Therapeutics and Quantum Leap Healthcare Collaborative have announced the submission of a key regulatory filing to the U.S. Food and Drug Administration (FDA). The filing paves the way for a Phase 2a clinical trial of TTX-MC138, a novel RNA-based therapeutic designed to hunt down and neutralize the hidden cancer cells that can lead to relapse in colorectal cancer patients.

The trial represents a major milestone for both organizations. For TransCode, it is a pivotal step in the clinical development of its lead drug candidate. For Quantum Leap, it marks the first expansion of its innovative PRE-I-SPY clinical trial platform into colorectal cancer, a disease that remains a leading cause of cancer-related deaths worldwide.

Targeting the Invisible Enemy: Minimal Residual Disease

For many colorectal cancer patients, the successful removal of a tumor through surgery and chemotherapy is not the end of their journey, but the beginning of a tense period of watchful waiting. Despite therapies intended to be curative, between 30% and 50% of patients experience a recurrence, often because of microscopic clusters of cancer cells that remain in the body.

This phenomenon, known as minimal residual disease (MRD), represents an invisible enemy. These cells are too few to be detected by conventional imaging like CT scans but can eventually grow into new, often metastatic, tumors. In recent years, a powerful new tool has emerged to detect this threat: highly sensitive blood tests that can identify circulating tumor DNA (ctDNA). The presence of ctDNA after treatment is a strong predictor of relapse and signifies an urgent, unmet medical need.

TransCode's upcoming trial directly addresses this challenge. It will enroll up to 45 colorectal cancer patients who have completed their primary treatment but still test positive for ctDNA. The goal is to see if TTX-MC138 can eliminate these residual cancer cells, effectively stopping a recurrence before it starts. This strategy of early intervention in a high-risk, ctDNA-positive population could represent a paradigm shift in post-treatment cancer care.

A Novel Weapon in the RNA Arsenal

At the heart of the trial is TTX-MC138, a first-in-class therapeutic that targets a specific molecule called microRNA-10b (miR-10b). This microRNA is a well-documented driver of metastasis, acting like a master switch that allows cancer cells to spread and thrive. By inhibiting miR-10b, TTX-MC138 aims to shut down this metastatic process and induce cancer cell death.

The drug's potential has been supported by promising earlier-stage clinical data. A Phase 0 study confirmed that the drug, delivered via an iron oxide nanoparticle platform, could successfully reach metastatic tumors throughout the body. More importantly, a subsequent Phase 1a dose-escalation study involving 16 patients with advanced solid tumors met its primary safety endpoint, showing no dose-limiting toxicities.

Beyond its strong safety profile, the Phase 1a trial also provided encouraging signs of clinical activity. Data showed that 44% of participants experienced stable disease for four months or longer, with some patients remaining on the study for over seven months without their cancer progressing. Pharmacodynamic analysis further confirmed the drug was hitting its target, achieving up to 66% inhibition of miR-10b in the blood. These results provide a solid scientific foundation for advancing TTX-MC138 into the new Phase 2a trial.

Accelerating Discovery Through Collaboration

The partnership with Quantum Leap Healthcare Collaborative is a critical component of the strategy. Quantum Leap is renowned for its I-SPY platform trials, which have revolutionized breast cancer research by creating a more efficient and collaborative model for testing new drugs. The PRE-I-SPY program extends this model to earlier-phase studies, aiming to rapidly assess the safety and preliminary efficacy of new agents and accelerate their path to larger, later-stage trials.

By incorporating TTX-MC138 into this established platform, TransCode gains access to a network of top-tier clinical sites, many of which are members of the National Cancer Center Network, and a streamlined operational structure designed to complete analysis within 12 to 18 months. This collaborative approach significantly shortens the timelines of traditional drug development.

"This IND submission marks a pivotal step in TransCode's clinical development program, positioning TTX-MC138 where its mechanism of action has the potential to deliver meaningful benefit to patients," said Sue Duggan, TransCode's Senior VP of Operations. "We are pleased to partner with Quantum Leap's PRE-I-SPY program to evaluate TTX-MC138 and to support the expansion of this platform into new indications such as colorectal cancer."

The trial, which is planned to begin in the first half of 2026, will be led by Principal Investigator Dr. Paula Pohlmann of the prestigious MD Anderson Cancer Center, further underscoring the study's clinical significance.

A New Hope in a High-Stakes Field

The quest to conquer MRD in colorectal cancer is an active and competitive area of oncology research. Other companies are exploring different approaches, including immunotherapies and personalized cancer vaccines, to prevent recurrence in ctDNA-positive patients. TransCode's RNA-based approach offers a distinct and promising alternative within this dynamic landscape.

As a clinical-stage biotechnology company, TransCode operates in a high-risk, high-reward environment. Its financial reports reflect significant investment in research and development, a common characteristic of companies pioneering new medical frontiers. The success of the upcoming trial will be a crucial catalyst for the company's future and for its lead therapeutic.

The trial's focus on a well-defined patient population, its foundation in promising early data, and its execution within a world-class collaborative platform position it as a study of major interest. For the thousands of colorectal cancer survivors living with the uncertainty of potential relapse, the prospect of a therapy that can actively clear the residual disease detected by a simple blood test offers a profound new sense of hope.