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news.US-based biotechnology firm developing cancer immunotherapies Advaxis and inVentiv Health Clinical, a clinical research organization (CRO), have entered into a master services agreement for the clinical development of certain immunotherapy product candidates in Advaxis's proprietary pipeline.
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The global agreement will initially focus on Advaxis’s lead immunotherapy for cervical cancer, ADXS-HPV.
As part of the deal, inVentiv will provide Advaxis with full CRO services to execute clinical studies for the current Advaxis cancer immunotherapy product candidates including ADXS-HPV for cervical cancer, and other HPV- associated cancer; ADXS-cHER2 for pediatric osteosarcoma and other HER2 over-expressing cancer and ADXS-PSA for prostate cancer.
Additionally, pending regulatory approval, Advaxis can leverage inVentiv’s significant commercialization capabilities in select countries, should it seek to do so.
The deal will see both the firms work together to develop clinical study protocols and inVentiv will serve as the CRO on the planned registrational trials that will evaluate the safety and efficacy of ADXS-HPV in women with recurrent cervical cancer.
inVentiv will also provide feasibility and study start-up activities for the planned clinical development of ADXS-cHER2 in pediatric osteosarcoma.
inVentiv Health Clinical chief commercial officer Greg Skalicky said the company is happy to be collaborating with Advaxis in advancing Advaxis’s platform of cancer immunotherapies.
"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," Skalicky said.
Advaxis president and CEO Daniel O’Connor said after an extensive global review of potential clinical research organizations, the company has selected the broad-scale inVentiv platform as an important differentiator for its program.
"This agreement spans clinical development, as well as potential commercial support for our cancer immunotherapy product candidates," O’Connor said.
"As a next-generation CRO, inVentiv is able to work across the full development life cycle of each of our immunotherapy product candidates."