8 February 2019 - - US-based biotechnology company Antidote Therapeutics, Inc. has entered into a collaboration with the National Cancer Institute to further develop its lead compound, ATI-1013, to a successful filing of an Investigational New Drug application, the company said.

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 programme 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.

This 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 programme will be progressed based on achievement of interim milestones.

Antidote Therapeutics, Inc. is a biotechnology company with a portfolio of first-in-class nicotine-blocking drugs to treat diseases caused or worsened by nicotine.

In addition to ATI-1013, the company has other product candidates that neutralize or eliminate nicotine in the blood.

Results of a preclinical, proof-of-concept study of its nicotine-degrading enzyme, NicA2, were published recently in the journal, BMC biotechnology, and validate the approach of using a nicotine-degrading enzyme to treat nicotine addiction and prevent relapse.