ADXS-cHER2 is being developed to target the Her2 receptor, which is overexpressed in certain solid-tumor cancers, including bone cancer (osteosarcoma), breast cancer, esophageal and gastric cancer.
The company is planning to start a Phase I trial with ADXS-cHER2 in pediatric osteosarcoma, for which it received orphan drug designation, and is pursuing early development clinical collaborations for breast, esophageal and gastric cancers.
First patent covers composition for ADXS-cHER2, as well as methods of composition use for preventing or eliciting an immune response against, or treating, tumors that express Her2/neu in humans.
The patent also covers ADXS-cHER2 use within the tumor, specifically: increasing the ratio of CD8 T cells to regulatory T cells (Tregs) and decreasing the frequency of Tregs and myeloid-derived suppressor cells (MDSCs).
In addition, the patent covers ADXS-cHER2 use for preventing an escape mutation in the treatment of Her2/neu over-expressing tumors in a subject.
The company said that the second patent covers methods of ADXS-cHER2 use for preventing, eliciting an immune response against, or treating Her-2/neu-expressing tumors, such as osteosarcoma, in non-human animals, particularly pet dogs.
Advaxis president and CEO Daniel O’Connor said the two patents cover the ways in which the company’s ADXS-cHER2 immunotherapy product candidate increases anti-cancer immune response in the tumor microenvironment in both humans and animals.
"Allowance of these patents further expands an already robust IP portfolio for our ADXS-cHER2 asset as we move forward with the clinical trial program," O’Connor said.