Date: 2014-07-22
Type of information: Clinical research agreement
Compound: MEDI4736 (durvalumab) and ADXS-HPV (axalimogene filolisbac)
Company: MedImmune (USA), the global biologics arm of AstraZeneca (UK), Advaxis (USA - NJ)
Therapeutic area: Cancer - Oncology - Infectious diseases
Type agreement: clinical research
Action mechanism: monoclonal antibody/immune checkpoint inhibitor/immunotherapy product. Both MEDI4736 and ADXS-HPV are cancer immunotherapies. MEDI4736 is designed to counter the tumour’s immune-evading tactics by blocking a signal that helps tumours avoid detection, while ADXS-HPV enhances the ability of immune cells to combat the tumour. Preclinical evidence suggests that the combination of ADXS-HPV with a checkpoint inhibitor, such as MEDI4736, can enhance overall anti-tumour response. MEDI4736 is an investigational human monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumours avoid detection by the immune system. MEDI4736 blocks these signals, countering the tumour’s immune-evading tactics. ADXS-HPV is currently under investigation in three HPV-associated cancers: invasive cervical cancer, head and neck cancer and anal cancer. In cervical cancer, a recently completed Phase 2 study of ADXS-HPV demonstrated improved survival and a manageable safety profile alone or in combination with chemotherapy, which warrants further development of the molecule. Clinical trials in head and neck cancer and in anal cancer are ongoing. Advaxis has received Orphan Drug Designation from the FDA for ADXS-HPV for HPV-associated Stage II-IV cervical cancer, head and neck cancer, and for anal cancer.
Disease: advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer, HPV-associated head and neck cancer.
Details: * On July 22, 2014, AstraZeneca announced that MedImmune, its global biologics research and development arm, has entered into a clinical trial collaboration with Advaxis, a US-based biotechnology company developing cancer immunotherapies. The Phase I/II immunotherapy study will evaluate the safety and efficacy of MedImmune’s investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with Advaxis’ lead cancer immunotherapy vaccine, ADXS-HPV, as a treatment for patients with advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer.
Under the terms of the agreement, MedImmune and Advaxis will evaluate the combination as a treatment for HPV-associated cervical cancer and squamous cell carcinoma of the head and neck. The Phase I part of the trial is expected to establish a recommended dose regimen of MEDI4736 with ADXS-HPV, and the Phase II portion will assess the safety and efficacy of the combination. The study will be funded and conducted by Advaxis. Results from the study will be used to determine whether further clinical development of this combination is warranted.
AstraZeneca and MedImmune have recently initiated other immuno-oncology combination trials, including a collaboration with biopharmaceutical company Incyte to study MEDI4736 with Incyte’s oral indoleamine dioxygenase-1 (IDO1) inhibitor, INCB24360.
Financial terms: Under the terms of the deal, MedImmune has a non-exclusive relationship with respect to HPV-driven tumour types. MedImmune has first right of negotiation for future development of combinations involving MEDI4736 and ADXS-HPV.
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