Studies to Support Expected IND Application
COLUMBIA, Mo.–(BUSINESS WIRE)–Endevica Bio (formerly known as Tensive Controls Inc.), a company developing best-in-class peptide drug candidates with better safety and efficacy properties, has signed an agreement with Wuxi AppTec to begin toxicology studies for TCMCB07, its investigational therapeutic for cancer cachexia. These studies will support an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA), which will allow it to commence clinical trials.
Cachexia, a serious clinical consequence also known as “wasting syndrome,” is estimated to be prevalent in approximately 50-80% of those with advanced malignant cancer and it is estimated to be the cause of death for up to 40% of cancer patients.
TCMCB07 is a first-in-class melanocortin ¾ antagonist peptide designed to help people with cancer cachexia live longer by enabling greater tolerability of cancer treatment and improved quality of life. Discovered by Endevica Bio Founder and Chief Scientific Officer, Dr. Kenneth Gruber, the compound reduces pro-inflammatory cytokine gene expression in the brain and is designed to effectively cross the blood-brain barrier.
“TCMCB07 has many advantages – in addition to being able to cross the blood-brain barrier, it has shown to be more stable in plasma, orally active and has predictable pharmacokinetics (PK) properties,” said Russ Potterfield, Executive Chairman of Endevica Bio. “Further, due to our patented technology for the suppression of cardiovascular side effects in melanocortin-based therapeutics, we believe TCMCB07 will have a robust safety profile.”
Results from these toxicology studies are expected to be announced by December 2021. Endevica expects to file its IND by the first quarter of 2022.
About Endevica Bio
Endevica Bio was formed to create best-in-class peptide drug candidates with better safety and efficacy properties than other drugs in the same class. Endevica’s technology platform, protected by a family of patents and pending applications, allows for the modification of peptides to perform with improved half-life, oral activity, and the ability to cross the blood-brain barrier. Endevica’s initial drug candidate, TCMCB07, is designed to treat cancer cachexia, which is the cause of death for up to 40% of cancer patients. The company expects to enter clinical development by Q1 2022. More information can be found at www.endevicabio.com.
LeAnn Kuhlmann Qi
Chief Commercial Officer