Advaxis entered into a collaboration agreement with Amgen, where Amgen has exclusive worldwide rights to develop and commercialize ADXS-NEO. Under the agreement, Advaxis is leading clinical development of ADXS-NEO through proof of concept and will retain clinical supply and manufacturing responsibilities, with Amgen funding all clinical and commercial activities. The companies plan to file an Investigational New Drug application to the US Food and Drug Administration for ADXS-NEO, and expect a Phase 1 clinical trial to begin in 2017.
Bristol-Myers Squibb Company
Advaxis and Bristol-Myers Squibb announced a clinical development collaboration to evaluate Advaxis’ ADXS-DUAL and Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor, Opdivo (nivolumab), as a potential combination treatment for women with persistent, recurrent or metastatic (squamous or non-squamous cell) carcinoma of the cervix. This combination immunotherapy regimen may offer a potential treatment option to patients with metastatic cervical cancer because they have complementary mechanisms of action, and both have independently shown potential for efficacy.
Merck & Co., Inc.
Advaxis entered into a clinical trial collaboration agreement with Merck to evaluate the combination of Advaxis’ ADXS-PSA with Merck’s PD-1 checkpoint inhibitor KEYTRUDA® (pembrolizumab). The ongoing clinical trial evaluates the safety and efficacy of ADXS-PSA as monotherapy and in combination with KEYTRUDA® in a Phase 1/2 study of patients with previously treated metastatic castration-resistant prostate cancer (mCRPC).
AstraZeneca / MedImmune
Advaxis entered into a clinical trial collaboration with MedImmune, the global biologics research and development arm of AstraZeneca, for a Phase 1/2 study to evaluate the safety and efficacy of MedImmune’s investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736), in combination with Advaxis’ axalimogene filolisbac as a treatment for patients with advanced, recurrent or refractory cervical cancer and HPV-associated head and neck cancer.