Advaxis and Array BioPharma separately inked clinical collaborations with Bristol-Myers Squibb (BMS) to evaluate their investigational anticancer candidates with BMS’ approved programmed cell death protein 1 (PD-1) checkpoint inhibitor Opdivo® (nivolumab) and/or with its cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)-targeting monoclonal antibody Yervoy® (ipilimumab).

The clinical collaboration between BMS and Array BioPharma will test the latter’s investigational MEK inhibitor binimetinib in combination with Opdivo, and in combination with an Opdivo plus Yervoy regimen, for the potential treatment of metastatic colorectal cancer in patients with microsatellite stable tumors. An initial Phase I/II study, projected to start later this year, aims to establish dose regimens for future trials and will investigate early evidence of antitumor activity. Array will sponsor the study, which the firms say they will support jointly. Results from the trial are expected to help direct future clinical development of combination therapy regimens with binimetinib, Opdivo, and Yervoy.

“Based on emerging data, we believe that studying combinations of targeted therapies, such as binimetinib, with immuno-oncology agents, such as Opdivo and Yervoy, could provide important scientific advances for patients fighting cancer,” said Ron Squarer, CEO Array BioPharma.

Earlier this month, Array reported a clinical trial collaboration with Merck to evaluate binimetinib in combination with the latter’s anti-PD-1 antibody Keytruda® (pembrolizumab) in metastatic colorectal cancer patients microsatellite stable tumors. 

The clinical collaboration between Advaxis and BMS aims to evaluate the latter’s ADXS-DUAL immunotherapy, which targets human papillomavirus (HPV)-associated cancers, combined with Opdivo for treating metastatic cervical cancer in women who have failed at least one prior line of systemic therapy. Advaxis will sponsor the study, which is expected to start this year.

“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 CEO 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.”

ADXS-DUAL represents the second generation of Advaxis’ bioengineered Listeria monocytogenes (Lm) immunotherapy platform for targeting HPV-associated cancers. Lead candidate axalimogene filolisbac is in Phase III development as monotherapy for patients with high-risk, locally advanced cervical cancer.

Axalimogene filolisbac is separately in clinical development in combination with AstraZeneca’s recently FDA-approved Imfinzi (durvalub) as a potential treatment for metastatic cervical cancer and HPV-associated head and neck cancer.

Advaxis licensed the Lm technology to Sellas in February as part of a potentially $385 million cancer immunotherapy collaboration to combine the Advaxis platform with Sellas’ patented Wilms tumor antigen 1 (WT1)-targeted heteroclitic peptide antigen mixture (galinpepimut-S).

 








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