Advaxis and Bristol-Myers Squibb have announced a clinical development collaboration to evaluate ADXS-DUAL, an investigational immunotherapy targeting HPV-associated cancers, and Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor, Opdivo (nivolumab), as a potential combination treatment option for women with metastatic cervical cancer.
Bristol sadi in its press release that the study, expected to start by the end of this year, will evaluate this combination regimen in women with persistent, recurrent or metastatic (squamous or non-squamous cell) carcinoma of the cervix who have failed at least one prior line of systemic chemotherapy. According to agreement, each party will bear their own internal costs and provide its immunotherapy agents. Advaxis will sponsor the study and pay third-party costs, the company said.
Advaxis developed ADXS-DUAL by building on the learnings from the clinical development of axalimogene filolisbac and has incorporated additional HPV target antigens into its Listeria monocytogenes (Lm) bacterial vector.
“The additional HPV antigens have the potential to provide coverage against numerous HPV types in cervical cancer and other HPV-associated cancers,” said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis. “By studying the combination of Opdivo and ADXS-DUAL, we hope to bring a new option to metastatic cervical cancer patients with persistent, recurrent or metastatic disease. We are looking forward to working with Bristol-Myers Squibb to explore the potential of this combination.”
Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world in July 2014, and currently has regulatory approval in 57 countries including the United States, Japan and in the European Union.
“Combining immunotherapy agents is at the core of Bristol-Myers Squibb’s strategy, as it brings the opportunity to improve anti-tumor efficacy,” said Fouad Namouni, M.D. head of Oncology Development at Bristol-Myers Squibb. “We are excited to work with Advaxis to explore the potential of Opdivo and ADXS-DUAL to provide a potential new option for metastatic cervical cancer patients where there is a high unmet need.”