Date: 2014-05-14
Type of information: Clinical research agreement
Compound: MEDI4736 and INCB24360
Company: MedImmune (USA - global biologics arm of AstraZeneca (UK) - Incyte Corporation (USA- DE)
Therapeutic area: Cancer - Oncology
Type agreement: clinical research
Action mechanism: monoclonal antibody/immune checkpoint inhibitor/IDO1 inhibitor. Both MEDI4736 and INCB24360 are immunotherapies, which use the body's own immune system to help fight cancer. MEDI4736 is an anti-PD-L1 immune checkpoint inhibitor. It blocks the signals that help tumours avoid detection by the immune system, countering the tumour’s immune-evading tactics. INCB24360 is an oral indoleamine dioxygenase-1 (IDO1) inhibitor. It enhances the ability of immune cells to combat the tumour. Preclinical evidence suggests that the combination of these two agents may lead to an enhanced anti-tumour immune response.
Disease: multiple solid tumours including metastatic melanoma, non-small cell lung cancer, squamous cell carcinoma of the head and neck and pancreatic cancer
Details: * On May 14, 2014, AstraZeneca announced that MedImmune, its global biologics research and development arm, has entered into a clinical study collaboration with biopharmaceutical company Incyte Corporation. The Phase I/II oncology study will evaluate the efficacy and safety of MedImmune’s investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with Incyte’s oral indoleamine dioxygenase-1 (IDO1) inhibitor, INCB24360. Under the terms of the agreement, MedImmune and Incyte will collaborate on a non-exclusive basis on the study, to evaluate the combination in multiple solid tumours including metastatic melanoma, non-small cell lung cancer, squamous cell carcinoma of the head and neck and pancreatic cancer. The Phase I part of the trial is expected to establish a recommended dose regimen of both MEDI4736 and INCB24360 and the Phase II part of the study will assess the safety and efficacy of the combination. Results from the study will be used to determine whether further clinical development of this combination is warranted. The study will be co-funded equally by Incyte and MedImmune and conducted by Incyte. AstraZeneca and MedImmune have recently initiated other immuno-oncology combination trials, including MEDI4736 with IRESSA and MEDI4736 with tremelimumab. Other combination trials are planned to start imminently, demonstrating the strength and rapid progression of the company’s immuno-oncology portfolio. AstraZeneca has just initiated a phase III trial with MEDI4736 in patients with locally advanced, unresectable NSCLC (Stage III) following completion of treatment with chemoradiotherapy. INCB24360 is currently in Phase I/II development for metastatic melanoma in combination with ipilimumab (NCT01604889) and as monotherapy for ovarian cancer (NCT01685255). Incyte has also established a clinical agreement to combine INCB24360 with a novel anti-PD-1 immunotherapy checkpoint inhibitor.
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