CRO inVentiv Health Clinical and biotech sponsor Advaxis have entered into a global master services agreement for the clinical development of potential immunotherapies.
inVentiv will initially help Advaxis develop clinical study protocols and serve as the CRO on the planned registration trials that will evaluate the safety and efficacy of Advaxis’ lead immunotherapy for cervical cancer, known as ADXS-HPV. In addition, inVentiv will provide feasibility and study start-up activities for the planned clinical development of candidate ADXS-cHER2 in pediatric osteosarcoma.
inVentiv spokesman Andy Malavsky told us the immediate focus is on the planned registrational trials of ADXS-HPV, as well as the work for ADXS-cHER2 in pediatric osteosarcoma.
“Regarding our experience, inVentiv is a leader in immunotherapy oncology research - to date we've conducted studies treating more than 10,000 cancer patients,” Malavsky said. “With our experience, we fully appreciate the unique requirements of this new modality with regard to assessment criteria, training of sites, safety profiles and kinetics of response - we have conducted Phase I to IV studies, including - complex Phase I dose-escalation studies using single agents and experimental combination therapies, Phase III pivotal trials, and large, global expanded-access programs.”
Under the terms of the agreement, inVentiv will provide Advaxis with full CRO services to execute clinical studies for other cancer immunotherapy product candidates, including ADXS-HPV for cervical cancer, and other HPV- associated cancers; ADXS-cHER2 for other HER2 over-expressing cancer and ADXS-PSA for prostate cancer. In addition, pending regulatory approval, Advaxis will look to use inVentiv’s commercialization capabilities in select countries if necessary.
“After an extensive global review of potential clinical research organizations, we selected the broad-scale inVentiv platform as an important differentiator for our program,” said Daniel O’Connor, President and CEO of Advaxis. “This agreement spans clinical development, as well as potential commercial support for our cancer immunotherapy product candidates. As a next-generation CRO, inVentiv is able to work across the full development life cycle of each of our immunotherapy product candidates.”
The partnership comes as inVentiv has signed a number of partnerships over the past year, ranging from one with NeuroVive to develop cardiovascular and neurological treatments, another with Oncobiologics to develop biosimilars , and one with Medikly to improve its ability to connect with investigators.
Greg Skalicky, CCO of inVentiv also called the deal a “strategic partnership” that moves beyond what’s traditionally outsourced.