First Patient with Colon Cancer Dosed in a Phase 2 Study of TCMCB07

The first patient with metastatic colorectal cancer has received TCMCB07 in a phase 2 trial to prevent weight loss in those undergoing chemotherapy: © stock.adobe.com.

The first patient with metastatic colorectal cancer (mCRC) has been dosed with TCMCB07 in a phase 2 trial aiming to prevent weight loss in patients with cancer undergoing chemotherapy, according to a news release from Endevica Bio.

"This marks an important milestone in our commitment in developing a potentially life changing treatment for cachexia," Russell Potterfield, CEO and executive chair of Endevica, said in the news release. "Each trial brings us closer to offering a viable solution for this debilitating disease, and we remain dedicated to making a lasting impact on the lives of those affected."

The trial, conducted in partnership with WuXi Clinical, will enroll 100 patients with stage 4 metastatic colorectal cancer across 20 patient sites.

Patients will receive TCMCB07 at the start of chemotherapy and during the initial rounds of treatment. The primary goal is to prevent weight loss, which can lead to cachexia; this is a life-threatening condition, also referred to as wasting syndrome, which presents in the form of weight and muscle loss and is linked to chronic diseases such as cancer, according to the release.

"We are incredibly excited to have our first patient dosed with B07 in individuals diagnosed with metastatic colorectal cancer who are undergoing chemotherapy," Dr. Daniel Marks, Chief Medical and Scientific Officer of Endevica Bio, said in the news release. "Since there is no [Food and Drug Administration (FDA)] approved therapeutic for cancer cachexia, this trial is a crucial step to provide a therapy for an area of huge unmet clinical need, and we look forward to the results."

More Information on the Study of TCMCB07

In 2024, Endevica Bio completed a phase 1 trial with early results supporting the safety and effectiveness of TCMCB07. A November study published in the Journal of Clinical Investigation showed the drug improved appetite and preserved lean and fat mass in rodent models who had cancer and were receiving chemotherapy.

Additional findings showed peripheral administration of TCMCB07 stabilized weight, preserved heart mass and slightly protected lean mass after repeated chemotherapy cycles. Combining the drug with a growth differentiation factor 15 antibody enhanced treatment effectiveness. No notable side effects or added chemotherapy-related toxicities were observed. Researchers said TCMCB07 may help reduce chemotherapy-related anorexia and weight loss in patients worldwide.

More About TCMCB07, Cachexia and mCRC

TCMCB07, a melanocortin-3/4 antagonist peptide, is in clinical development for cachexia. The first-in-class drug is designed to cross the blood-brain barrier and target previously inaccessible receptors to influence behavioral and metabolic responses to chronic illness. In preclinical animal studies, TCMCB07 significantly preserved lean muscle mass and reversed cachexia across various chronic disease models.

Cachexia is a condition marked by unintentional weight loss of more than 10%, including muscle and fat, according to the National Cancer Institute. It may also involve diarrhea, weakness or fever lasting at least 30 days. The condition signals malnutrition and is caused by changes in how the body uses nutrients, often linked to inflammation and increased metabolism. It is difficult to reverse and typically occurs near the end of life.

Colorectal cancer begins in the colon, the longest part of the large intestine, or the rectum, the final section before the anus. Metastasis occurs when cancer cells spread from where they first formed to another part of the body.

Reference:

“Melanocortin-4 receptor antagonist TCMCB07 alleviates chemotherapy-induced anorexia and weight loss in rats,” by Dr. Xinxia Zhu, et at., Journal of Clinical Investigation.

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