AstraZeneca plc and Medimmune Announces Immuno-Oncology Collaboration with Innate Pharma SA
May 4 15
AstraZeneca plc and MedImmune, have entered into a collaboration with Innate Pharma SA to develop Innate's anti-NKG2A antibody, IPH2201, including in combination with MEDI4736, an anti-PD-L1 immune checkpoint inhibitor developed by MedImmune. Currently in Phase II development, IPH2201 is a potential first-in-class humanised IgG4 antibody. NKG2A is a checkpoint receptor that inhibits the anticancer functions of Natural Killer (NK) and cytotoxic T-cells. The initial development plan includes: Phase II combination clinical trials with MEDI4736 in solid tumours; multiple Phase II trials planned by Innate to study IPH2201 both as monotherapy and in combination with currently approved treatments across a range of cancers; and the development of associated biomarkers. The combination of IPH2201 with MEDI4736 adds to the broad programme of immuno-oncology combination trials that AstraZeneca and MedImmune have planned and underway. The studies aim to address multiple immune pathways, harnessing AstraZeneca's own extensive pipeline and working in partnership to explore the significant potential of immunotherapies in transforming the way cancer patients are treated. Under the terms of the agreements, AstraZeneca will make an initial payment to Innate of $250 million, which includes the consideration for exclusive global rights to co-develop and commercialise IPH2201 in combination with MEDI4736, as well as access to IPH2201 in monotherapy and other combinations in certain treatment areas. AstraZeneca will pay a further $100 million prior to initiation of Phase III development, as well as additional regulatory and sales-related milestones. AstraZeneca will book all sales and will pay Innate double-digit royalties on net sales. The arrangement includes the right for Innate to co-promote in Europe for a 50% profit share in the territory.
AstraZeneca Presents Positive Phase III Results Ceftazidime-Avibactam
Apr 27 15
AstraZeneca presented positive Phase III data demonstrating the efficacy and safety of ceftazidime-avibactam (CAZ-AVI), an investigational antibiotic being developed to treat serious Gram-negative bacterial infections including complicated intra-abdominal infections. New Phase III data was also presented for ZINFORO (ceftaroline fosamil), an antibiotic approved for the treatment of adult patients with complicated skin and soft tissue infections (cSSTI) or community-acquired pneumonia (CAP). AstraZeneca held a symposium at the congress, which highlighted the need for new treatment strategies to address antibiotic resistant infections, which remains a rapidly accelerating global concern. Epidemiological data was presented at the symposium which demonstrated the high clinical burden associated with Gram-positive and Gram-negative infections, including those caused by multidrug-resistant (MDR) pathogens. Full Phase III results for the global RECLAIM-1 and RECLAIM-2 studies were presented at ECCMID. Both studies evaluated the safety and efficacy of CAZ-AVI, administered intravenously (IV) as a two hour infusion (2000 mg /500 mg) every eight hours plus metronidazole 500 mg IV as a one hour infusion every eight hours, compared to meropenem, administered intravenously as a 30 minute infusion (1 g) every eight hours, in hospitalised adult patients with presumed or definite diagnosis of complicated intra-abdominal infections. Data from the RECLAIM-1 and RECLAIM-2 studies were analysed as a single-pooled dataset with the agreement of the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Results showed CAZ-AVI met the objective of statistical non-inferiority compared to meropenem. The number of patients randomised to CAZ-AVI plus metronidazole was 532, with 534 randomised to meropenem. The primary endpoint was a clinical cure rate 28 to 35 days after randomisation (the Test of Cure visit). Findings also showed CAZ-AVI treated cIAI patients infected with ceftazidime-resistant bacteria as effectively as meropenem. The adverse event rate for CAZ-AVI in combination with metronidazole was similar to meropenem (45.9% vs 42.9% with serious adverse event rates of 7.9% and 7.6% respectively). The most commonly reported adverse events for CAZ-AVI in combination with metronidazole were diarrhoea, nausea, vomiting and fever, which were not unexpected based on the known safety profiles of ceftazidime and metronidazole. Full Phase III results from the global REPRISE study were also presented at ECCMID. This study evaluated the safety and efficacy of CAZ-AVI, administered intravenously as a two hour infusion (2000 mg /500 mg) in patients with complicated intra-abdominal or complicated urinary tract ceftazidime-resistant gram-negative infection. Patients with complicated intra-abdominal infection also received metronidazole. CAZ-AVI was compared to best available therapy. Results showed that efficacy for CAZ-AVI and Best Available Treatment was similar as reflected by the primary endpoint of clinical response at Test of Cure (TOC) visit. CAZ-AVI showed that in patients with complicated urinary tract infection (cUTI), microbiological cure rates at TOC (and beyond) were substantially higher in patients treated with CAZ-AVI. The Phase III COVERS trial evaluated the safety and efficacy of ceftaroline fosamil for cSSTI patients with evidence of systemic inflammatory response or underlying comorbidities, administered via a 600 mg IV infusion over 120 minutes every eight hours, rather than the currently approved 600 mg every 12 hours dosing regimen. The study included patients from Asia, Europe, North and South America who were randomised 2:1 to receive ceftaroline fosamil 600 mg every eight hours, or to vancomycin 15 mg/kg every 12 hours plus aztreonam 1 g every eight hours for five to 14 days. Results demonstrated that ceftaroline fosamil was effective and well-tolerated for these patients at the adjusted dose, demonstrating non-inferiority versus vancomycin plus aztreonam. Ceftaroline fosamil was well tolerated with 45.6% and 45.5% patients treated with ceftaroline fosamil and vancomycin plus aztreonam respectively, experiencing =1 adverse event. The qualitative safety profile of ceftaroline fosamil 600 mg every eight hours was similar to previous trials with the 12 hour dosing, with no new safety signals identified.
AstraZeneca PLC Approves Adoption of New Articles of Association
Apr 24 15
AstraZeneca PLC at its Annual General Meeting on April 24, 2015, approved adoption of new articles of association of the company.