CRO inVentiv Partners With Advaxis On Immunotherapy Candidates Trials
By Cyndi Root
Advaxis announced via press release that it has partnered with inVentiv Health Clinical, a clinical research organization (CRO). The two companies have agreed to develop Advaxis' immunotherapy candidates, calling the collaboration a global, master service agreement. Initial focus is on the immunotherapy agent ADXS-HPV for cervical cancer.
Greg Skalicky, Chief Commercial Officer of inVentiv Health Clinical said, "By combining the fully-integrated research and development capabilities of Advaxis with inVentiv's broad clinical development and commercial expertise, we are moving well beyond traditional outsourced services and into the realm of a true strategic partnership." Daniel O'Connor, President and CEO of Advaxis, said, "This agreement spans clinical development, as well as potential commercial support for our cancer immunotherapy product candidates.”
Advaxis and inVentiv Agreement
inVentiv has agreed to provide Advaxis with a complete range of CRO services in support of registrational studies and clinical trials. Advaxis will utilize the partnership in feasibility studies, start-up activities, and clinical trial execution. Additionally, if drugs are approved, inVentiv is positioned to help Advaxis commercialize the medicines in several countries.
Advaxis Immunotherapy Product Candidates
The two companies are collaborating on Advaxis’ immunotherapy product candidates. These include ADXS-HPV for cervical cancer, ADXS-cHER2 for pediatric osteosarcoma, and ADXS-PSA for prostate cancer. Advaxis uses bioengineered live attenuated bacteria, which suppress the Tregs and MSDCs in the cancer microenvironment that contribute to tumor growth.
Advaxis' lead candidate, ADXS-HPV, is the target of initial focus as it shows promise in human papillomavirus (HPV)-associated cancers. ADXS-HPV is an immunotherapy that targets and eliminates dysplastic and malignant cells. The agent gains access to antigen-presenting cells, initiates an immune response of cytotoxic Tcells, which attack the tumors. Additionally, the agent inhibits the tumor-protecting Tregs and MDSCs without causing auto-immunity.The FDA designated ADXS-HPV as an Orphan Drug and it is currently in trials for cervical cancer, head and neck cancer, and anal cancer. Advaxis is initiating a new study in cervical cancer in 2014 and has secured licensing partners in India and Asia for commercialization.
Another compound that inVentiv will assist Advaxis with is ADXS-cHER2, which targets the HER2 receptor. This receptor is overexpressed in pediatric bone cancer (osteosarcoma), breast cancer, and gastric cancer. Interim findings from a canine test model found clinical benefits in bone cancer.