FDA grants Advaxis pre-IND meeting for ADXS-HER2 cancer immunotherapy

Oct 12 2011

Advaxis, Inc., (OTCBB:ADXS) a leader in developing the next generation of immunotherapies for cancer and infectious diseases, has been granted a pre-Investigational New Drug ("IND") meeting with the U.S. Food and Drug Administration ("FDA") on November 22^nd, 2011 to discuss the initial clinical development plan for ADXS-HER2, a construct for the treatment of HER2 expressing cancers.

ADXS-HER2 is manufactured by Vibalogics, located in Cuxhaven, Germany.

A pre-IND meeting is conducted to develop mutual understanding and agreement between the FDA and the Company regarding the content needed to assess manufacturing, toxicology, pre-clinical and rationale to support a first in humans clinical trial. Once an IND is submitted, the FDA has 30 days to comment before the Company can begin Phase 1 trials. The Company plans to file the IND application early in 2012 to initiate a Phase 1/2 safety study in humans.

"ADXS- HER2 immunotherapy is the third Lm-LLO agent Advaxis is advancing to the clinic," commented Dr. John Rothman, Executive VP of Advaxis. "It uses a proprietary chimeric form of the HER2 antigen (cHER2) that gives it the potential to overcome "escape mutations" in cancer, and has shown encouraging results in mouse models for HER2 positive breast cancer and preliminary data in brain cancer. Advaxis constructs are designed to redirect the powerful immune response we all have to Listeria to selected tumor associated antigens such as those over expressing HER2."