Under the deal, SynCo will manufacture Advaxis’ novel drug candidate, ADXS-HPV as well as assist them in developing scale-up and commercial manufacturing processes for ADXS-HPV bulk drug substance and drug product.
The company also intends to begin registrational trials in 2014 with ADXS-HPV for the treatment of cervical cancer.
Advaxis chief executive officer Daniel O’Connor said SynCo’s ability to manufacture both drug substance and drug product for ADXS-HPV will offer the company increased flexibility as it expands its manufacturing process in preparation for commercial-scale production.
"To have the support of a world class manufacturer, such as SynCo, is pivotal to our ability to make ADXS-HPV available to patients on a global scale, upon approval," O’Connor said.
In a Phase II trial, ADXS-HPV has showed improved survival and objective tumor responses in 110 patients with recurrent cervical cancer.
Currently, the company is now planning the registrational program for ADXS-HPV, which is also being assessed in other HPV-associated cancers including a Phase II in advanced cervical cancer, a Phase I/II in head and neck cancer, and a Phase I/II in anal cancer.
The company said that ADXS-HPV has received orphan drug designation for both anal and head and neck cancers.