Smoking due to nicotine addiction is the leading preventable cause of
ATI-1013 is a novel human antibody that tightly binds and blocks
nicotine, the main addictive component of tobacco products
The goal of the collaboration with NCI is to successfully file an IND
GAITHERSBURG, Md.–(BUSINESS WIRE)–lt;a href=”https://twitter.com/hashtag/NCI?src=hash” target=”_blank”gt;#NCIlt;/agt;–Antidote Therapeutics, Inc. (ATI) announced today it 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.
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” says 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.1
For additional information on the NCI PREVENT Program, please visit: http://prevention.cancer.gov/programs-resources/programs/prevent
About Antidote Therapeutics, Inc.
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 Biotechnology2, and
validate the approach of using a nicotine-degrading enzyme to treat
nicotine addiction and prevent relapse. For further information, please
Prior research on ATI-1013 was funded by a grant from the National
Institute of Health, National Institute on Drug Abuse (R01DA038877).
Antidote Therapeutics is currently seeking partnerships and funding for
combating nicotine addiction and creating improved methods of smoking
cessation. Interested parties may contact the company for further
1 USHHS. The Health Consequences of Smoking—50
Years of Progress, A Report of the Surgeon General (2014). www.surgeongeneral.gov/library/reports.