Endevica Bio Begins Phase 2 Trial Dosing for Stage 4 Metastatic Colorectal Cancer

Endevica Bio, a privately-held biotechnology firm based in NORTHBROOK, Illinois, has reached a significant milestone in its efforts to develop innovative treatments for cancer patients. On April 17, 2025, the company announced that it had administered the first dose of its investigational drug, TCMCB07 (B07), to a patient participating in a Phase 2 clinical trial. This trial aims to prevent weight loss in patients with cancer undergoing chemotherapy, a condition that can lead to cachexia—a severe wasting syndrome associated with chronic illnesses, including cancer.

The Phase 2 trial is being conducted in collaboration with WuXi Clinical and will span 20 different sites, enrolling a total of 100 patients diagnosed with stage 4 metastatic colorectal cancer. As these patients commence their chemotherapy treatment, they will receive doses of B07 during the initial chemotherapy cycles. The primary goal of the trial is to prevent weight loss, a critical factor as cachexia can significantly worsen a patient's health and quality of life.

Endevica Bio's CEO and Executive Chair, Russell Potterfield, emphasized the importance of this milestone, stating that each step in the trial process brings the company closer to providing a viable treatment solution for cachexia. He reiterated the company's commitment to enhancing the lives of those affected by this debilitating condition. Dr. Daniel Marks, the Chief Medical and Scientific Officer at Endevica Bio, expressed enthusiasm regarding the initiation of the trial. He highlighted the urgent need for an effective treatment for cancer cachexia, given the absence of any FDA-approved therapies in this area. Dr. Marks further indicated the company’s eagerness to see the trial results, which could potentially transform treatment options for cancer patients worldwide.

The journey to this Phase 2 trial was paved by successful completion of a Phase 1 clinical trial in 2024, where preliminary results demonstrated the drug’s safety and efficacy. Additionally, the Journal of Clinical Investigation published findings in November showing that B07 improved appetite and preserved both lean and fat mass in rodent models of cancer and related chemotherapy. These results underscore B07’s potential to mitigate chemotherapy-induced anorexia and weight loss, offering hope to millions of cancer patients globally.

TCMCB07 is a melanocortin-3/4 antagonist peptide currently under clinical development for treating cachexia. The peptide is engineered to be a pioneering drug, capable of crossing the blood-brain barrier to engage previously unreachable target receptors. By doing so, it modulates the body's behavioral and metabolic responses to chronic illnesses. Pre-clinical trials on animals have shown promising outcomes, such as significant retention of lean muscle mass and reversal of cachexia across various chronic disease models.

Endevica Bio is dedicated to creating groundbreaking peptide drug candidates. Their technology platform, supported by a robust portfolio of patents and patent applications, enables the modification of peptides to influence crucial drug targets located beyond the blood-brain barrier. This innovative approach holds the potential to revolutionize treatment strategies for chronic conditions like cachexia, providing hope and improved outcomes for patients suffering from these challenging diseases.