Advaxis nabs SynCo Bio for manufacturing of its lead cancer immunotherapy
Under the agreement, SynCo will assist Advaxis in developing scale-up and commercial manufacturing processes for ADXS-HPV bulk drug substance and drug product.
Advaxis plans to initiate registration trials by the end of this year with ADXS-HPV for the treatment of cervical cancer, and “we would expect the product is on the world market in the second half of 2017,” Shawn Walsh, director of manufacturing at Advaxis, told BioPharma-Reporter.com
“We were looking for a partner to help with commercialization and they have a track record of scaling up,” he added. “From a fermentation standpoint, we still haven’t finalized plans, but we’re looking to use single-use” bioreactors. SynCo has facilities in Amsterdam, Netherlands.
ADXS-HPV has demonstrated improved survival and objective tumor responses in a Phase 2 trial in 110 patients with recurrent cervical cancer. Advaxis is now planning the registrational program for ADXS-HPV.
The treatment is also being evaluated in other HPV-associated cancers including a Phase 2 in advanced cervical cancer, a Phase 1/2 in head and neck cancer, and a Phase 1/2 in anal cancer. ADXS-HPV has been granted orphan drug designation for both anal and head and neck cancers.
Pierre Warffemius, CEO of SynCo Bio Partners, added, "SynCo is very pleased to enter into a long-term manufacturing collaboration and looks forward to working with Advaxis to support global licensure of ADXS-HPV.
“Our leading position for supply of live microbial biopharmaceuticals, through providing high quality manufacturing services, will bring this therapeutic vaccine safely to patients for the treatment of HPV-associated cancers."
