InterveXion’s anti-METH therapies work by preventing the abused drug from rapidly reaching the brain in large quantities. These therapies involve antibodies that can “absorb” METH in the blood to block their rewarding effects and simultaneously reduces their detrimental health effects. In addition to reducing the acute effects of overdose, these antibodies may also be used in the chronic setting to help abusers overcome their dependency.
Anti-METH monoclonal antibody
Chimeric anti-METH monoclonal antibody mAb7F9 (ch-mAb7F9) is the most developed product in our pipeline. We have a Master Cell Bank of a CHO cell line that produces about 2 g/L of culture medium. A 200L GMP batch was manufactured to produce the antibody for our Phase 1 human studies. InterveXion submitted the IND for this product in March 2012 and the Phase 1a safety study was completed in 2013. More details on the clinical trial may be found on clinicaltrials.gov and in the Stevens et al. paper published November 2014.
The next steps in the ch-mAb7F9 development program include further nonclinical toxicology testing, then a Phase 1b clinical study in METH-using volunteers. This study will provide additional safety information and early efficacy data to support the use of ch-mAb7F9 in long-term METH treatment programs.
Additionally, a METH active vaccine product is in early stages of development. The lead candidate and adjuvant have been selected. InterveXion is currently preparing for GMP manufacturing and IND-enabling toxicology testing.