TransCode Therapeutics and Quantum Leap Initiate Phase 2a Trial for Colorectal Cancer Treatment
TransCode Therapeutics, Inc. and Quantum Leap Healthcare Collaborative are embarking on a pivotal Phase 2a dose-expansion trial focusing on their innovative therapeutic candidate TTX-MC138. This collaboration arises after encouraging results from a previous Phase 1 trial conducted by TransCode, which set the foundation for subsequent research into this promising treatment.
The Phase 2a trial aims to evaluate the effectiveness of TTX-MC138 in patients with colorectal cancer who have undergone standard curative treatments. Specifically, it will enroll up to 45 participants who have exhibited a pathological complete response but remain ctDNA positive, suggesting the presence of minimal residual disease. This setting is crucial as patients in this category face a high risk of cancer recurrence, and existing treatment options have proven inadequate.
Dr. Paula Pohlmann from MD Anderson Cancer Center will spearhead the clinical investigation, which is set to commence in the first half of 2026. The clinical trial will examine both the biological and clinical efficacy of TTX-MC138, targeting a critical unmet need in cancer treatment – the detection and management of micrometastatic disease before it becomes apparent.
Daniel Vlock, MD, a Consulting Clinician for TransCode, remarked on the promising safety profile and durable anti-tumor effects observed in the earlier Phase 1a trial, paving the way for this next phase of clinical testing. Vlock expressed hope that the trial’s findings could lead to earlier intervention in patients at risk of developing metastatic disease, thereby offering new therapeutic avenues.
Laura Esserman, M.D., co-founder of Quantum Leap, emphasized the trial's unique positioning to explore TTX-MC138's capabilities in eliminating minimal residual disease— a challenge currently unmet in oncology care. She underscored the potential for effective precision therapies that not only target cancerous cells but do so with fewer side effects compared to conventional treatments.
TTX-MC138 represents a first-in-class therapy designed to inhibit microRNA-10b, which is believed to play a significant role in the progression of metastatic cancers. The initial Phase 1a trial successfully met its primary safety endpoint and established a recommended dose for further study, signaling a step forward in oncology treatments.
With the combined expertise of TransCode Therapeutics and Quantum Leap, the PRE-I-SPY clinical trial platform is set to innovate and enhance treatment options for patients battling colorectal cancer, with aspirations to eventually expand into other cancer types. Through this collaboration, both organizations aim to advance the development of less toxic, more effective treatments that could improve long-term survival rates for patients facing challenging diagnoses.
As the trial progresses, the scientific community and cancer advocates alike eagerly await the results, anticipating that TTX-MC138 could mark a significant leap forward in combating cancer recurrence effectively and safely. The partnership represents a beacon of hope for patients and families affected by colorectal and other cancers, showcasing the potential of combining clinical research with targeted therapy development.
In conclusion, the collaboration between TransCode Therapeutics and Quantum Leap Healthcare Collaborative highlights the vital intersection of research and clinical application in the fight against cancer. As advancements in understanding disease mechanisms continue, innovative trials like the one for TTX-MC138 may pave the way for more successful cancer treatments in the near future.
The Phase 2a trial aims to evaluate the effectiveness of TTX-MC138 in patients with colorectal cancer who have undergone standard curative treatments. Specifically, it will enroll up to 45 participants who have exhibited a pathological complete response but remain ctDNA positive, suggesting the presence of minimal residual disease. This setting is crucial as patients in this category face a high risk of cancer recurrence, and existing treatment options have proven inadequate.
Dr. Paula Pohlmann from MD Anderson Cancer Center will spearhead the clinical investigation, which is set to commence in the first half of 2026. The clinical trial will examine both the biological and clinical efficacy of TTX-MC138, targeting a critical unmet need in cancer treatment – the detection and management of micrometastatic disease before it becomes apparent.
Daniel Vlock, MD, a Consulting Clinician for TransCode, remarked on the promising safety profile and durable anti-tumor effects observed in the earlier Phase 1a trial, paving the way for this next phase of clinical testing. Vlock expressed hope that the trial’s findings could lead to earlier intervention in patients at risk of developing metastatic disease, thereby offering new therapeutic avenues.
Laura Esserman, M.D., co-founder of Quantum Leap, emphasized the trial's unique positioning to explore TTX-MC138's capabilities in eliminating minimal residual disease— a challenge currently unmet in oncology care. She underscored the potential for effective precision therapies that not only target cancerous cells but do so with fewer side effects compared to conventional treatments.
TTX-MC138 represents a first-in-class therapy designed to inhibit microRNA-10b, which is believed to play a significant role in the progression of metastatic cancers. The initial Phase 1a trial successfully met its primary safety endpoint and established a recommended dose for further study, signaling a step forward in oncology treatments.
With the combined expertise of TransCode Therapeutics and Quantum Leap, the PRE-I-SPY clinical trial platform is set to innovate and enhance treatment options for patients battling colorectal cancer, with aspirations to eventually expand into other cancer types. Through this collaboration, both organizations aim to advance the development of less toxic, more effective treatments that could improve long-term survival rates for patients facing challenging diagnoses.
As the trial progresses, the scientific community and cancer advocates alike eagerly await the results, anticipating that TTX-MC138 could mark a significant leap forward in combating cancer recurrence effectively and safely. The partnership represents a beacon of hope for patients and families affected by colorectal and other cancers, showcasing the potential of combining clinical research with targeted therapy development.
In conclusion, the collaboration between TransCode Therapeutics and Quantum Leap Healthcare Collaborative highlights the vital intersection of research and clinical application in the fight against cancer. As advancements in understanding disease mechanisms continue, innovative trials like the one for TTX-MC138 may pave the way for more successful cancer treatments in the near future.
Topics Health）
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