TransCode Therapeutics and Quantum Leap Collaborate on Phase 2a Trial for Colorectal Cancer Treatment

TransCode Therapeutics, Inc. (NASDAQ: RNAZ) and Quantum Leap Healthcare Collaborative have announced a collaboration to evaluate TransCode's lead therapeutic candidate TTX-MC138 in the PRE-I-SPY Phase 2a clinical trial platform. The study plans to enroll up to 45 colorectal cancer patients who are ctDNA positive following standard curative-intent therapy, beginning in the first half of 2026 and led by Dr. Paula Pohlmann of MD Anderson Cancer Center.

The trial will assess the biological and clinical activity of TTX-MC138 in the minimal residual disease setting, where recurrence risk is high and therapeutic options are limited. This collaboration reflects growing interest in precision treatments targeting micrometastatic disease, which represents a significant challenge in oncology. TTX-MC138 is focused on treating metastatic tumors that overexpress microRNA-10b, a unique, well-documented biomarker of metastasis that has been identified as a key driver in cancer progression.

The PRE-I-SPY trial platform represents an innovative approach to clinical research, designed to accelerate the development of promising cancer therapies. By targeting patients with minimal residual disease—those who have completed standard treatment but remain at high risk for recurrence—this study addresses a critical unmet need in cancer care. Current treatment options for this patient population are limited, and new approaches are urgently needed to prevent disease recurrence and improve long-term outcomes.

TransCode Therapeutics is a clinical stage company pioneering immunoncology and RNA therapeutic treatments for high risk and advanced cancers. The company maintains a newsroom where investors can access the latest updates at https://ibn.fm/RNAZ. In addition to TTX-MC138, TransCode has developed a portfolio of other first-in-class therapeutic candidates designed to mobilize the immune system to recognize and destroy cancer cells, representing a comprehensive approach to cancer treatment.

The collaboration between TransCode and Quantum Leap Healthcare Collaborative brings together expertise in RNA therapeutics and clinical trial design, potentially accelerating the development pathway for TTX-MC138. The study's focus on colorectal cancer is particularly significant given the disease's prevalence and the limited options available for patients with minimal residual disease. Colorectal cancer remains one of the most common cancers worldwide, and preventing recurrence after initial treatment represents a major challenge in oncology practice.

This trial represents an important step forward in the development of precision oncology treatments that target specific molecular pathways involved in cancer metastasis. By focusing on microRNA-10b overexpression, TTX-MC138 aims to address a fundamental mechanism of cancer spread that has been implicated in multiple cancer types. The successful development of such targeted therapies could transform the treatment landscape for patients at high risk of recurrence, offering new hope for improved survival and quality of life.