Antidote Therapeutics has entered into a collaboration with the National Cancer Institute (NCI) to further develop its lead compound, ATI-1013, to a successful filing of an Investigational New Drug (IND) application. The scope of the collaboration includes manufacturing process development, IND-enabling pharmacology and toxicology studies, and production of ATI-1013 for use in clinical trials. All program results and materials will be provided to ATI for further development.
ATI-1013 is a human, monoclonal antibody that sequesters nicotine in the blood. Studies in rodents show that following an injection of nicotine, ATI-1013 reduces nicotine levels in the brain by more than 90% which, in turn, reduces nicotine’s addictive effects. The clinical aim is to help smokers at elevated risk of developing smoking-induced lung cancer to stop or substantially reduce smoking.
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The collaboration will be managed through NCI’s Division of Cancer Prevention PREVENT Cancer Preclinical Drug Development Program, a peer reviewed program which supports the best ideas in preclinical cancer prevention agent development. In partnership with ATI, PREVENT will fund and manage contract resources for the manufacturing, pre-IND development, and filing of an IND for ATI-1013. The program will be progressed based on achievement of interim milestones.
“This is an exciting and significant development for Antidote Therapeutics and we’re delighted to have the opportunity to work closely with the NCI’s Division of Cancer Prevention” said Matthew W. Kalnik, Ph.D., President and Chief Executive Officer of ATI. “This partnership provides a path forward to an IND for our first-in-class human anti-nicotine antibody, and subsequent clinical testing aimed at reducing the occurrence of smoking-induced lung cancer.”
Smoking is the leading cause of lung and smoking-related cancers, as well as contributing significantly to cardiovascular and pulmonary disease, and 16 million Americans suffer from smoking-related illness. Annually in the U.S., 480,000 people prematurely die from smoking -- more than AIDS, alcohol, car accidents, illegal drugs (including opioid overdose), murders, and suicides combined.