Silicon Investor - MedImmune

[nigel bates] AstraZeneca initiates phase III immunotherapy study for MEDI4736 in patients wit...

nigel bates — 5/13/2014 4:44:58 AM

AstraZeneca initiates phase III immunotherapy study for MEDI4736 in patients with lung cancerThursday, 8 May 2014

First MedImmune oncology immunotherapy targeting the PD-L1/PD-1 pathway progresses into Phase IIIAstraZeneca today announced the start of the Phase III programme for MEDI4736, an immunotherapy in development for the treatment of non-small cell lung cancer (NSCLC) and other cancers. The goal of the PACIFIC trial, the first study in the Phase III NSCLC programme, is to evaluate progression free survival and overall survival of MEDI4736 compared to placebo in patients with locally advanced, unresectable NSCLC (Stage III) following completion of treatment with chemoradiotherapy and no evidence of tumour progression. The PACIFIC trial is the first pivotal study of an immunotherapy in this patient population.

MEDI4736 is a 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. MEDI4736 is being developed to empower the patient’s immune system and attack the cancer.

Briggs Morrison, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca said: “This is a significant milestone for AstraZeneca and MedImmune. MEDI4736 is an important molecule in our immuno-oncology portfolio and its entry into Phase III clinical trials is further evidence of our commitment to invest in distinctive science in our core therapy areas, and to rapidly progress our immuno-oncology pipeline. Lung cancer is still the leading cancer killer; there is a clear need for more treatment options to provide patients with a better chance of beating the disease. We believe MEDI4736, and immunotherapies more broadly, hold the potential to shape the future of cancer treatment."

[nigel bates] AstraZeneca announces MedImmune’s mavrilimumab and sifalimumab both met primary ...

nigel bates — 5/13/2014 4:00:21 AM

AstraZeneca announces MedImmune’s mavrilimumab and sifalimumab both met primary endpoints in Phase IIb studiesMonday, 12 May 2014

Mavrilimumab produces rapid improvement in signs and symptoms of rheumatoid arthritis, measures of disability and patient-reported outcomesSifalimumab meets primary endpoint of reduction in global disease activity score (SRI-4), and shows clinically important improvement in skin and joint symptoms, patient reported outcomes in patients with moderate/severe systemic lupus erythematosusAstraZeneca today announced that two key molecules in MedImmune’s Respiratory, Inflammation and Autoimmune (RIA) portfolio – mavrilimumab and sifalimumab – met their primary endpoints in respective Phase II studies, demonstrating further pipeline progress in core therapeutic areas.

Top-line results from the Phase IIb study of mavrilimumab, an investigational monoclonal antibody that inhibits a key pathway in the development of rheumatoid arthritis (RA), achieved its primary endpoints. In the Phase llb study of a methotrexate inadequate responder RA population (EARTH EXPLORER-1), 326 patients with moderate and severe RA were treated for six months with either mavrilimumab (low, medium or high dose) or placebo in addition to standard methotrexate background therapy. The co-primary endpoints of the American College of Rheumatology (ACR) response of ACR20 and Disease Activity Score (DAS28) were met with all mavrilimumab doses confirming the efficacy demonstrated in the previous Phase IIa study (EARTH).

The high dose was the most effective with an ACR20 response at week 24 of 73.4 percent vs 24.7 percent for placebo (p<0.001) and a reduction in mean DAS28 score at day 85 of
-1.9 vs -0.68 for placebo (p<0.001). Additionally, all secondary endpoints including ACR50, ACR70 response and DAS28 remission score achieved statistical significance for the high dose. Mavrilimumab also produced rapid improvement in the multiple symptoms of rheumatoid arthritis and significant improvements in patient reported outcomes including disability, pain and fatigue. The safety findings observed were consistent with those previously reported for the Phase IIa study. The most commonly-reported adverse events (>3 percent) included headache, nasopharyngitis (common cold), hypertension, bronchitis and worsening of RA.

“Through innovative, novel research, MedImmune has built a diverse emerging pipeline in Respiratory, Inflammation and Autoimmune disease, covering a broad set of patients. We are focused on advancing data and drug discovery to improve treatment options and clinical outcomes for patients,” said Dr. Bahija Jallal, Executive Vice President, MedImmune. “Compelling Phase II data from two of our molecules - mavrilimumab for rheumatoid arthritis and sifalimumab for systemic lupus - further confirm our commitment to bringing new medicines to patients as quickly as possible.”

MedImmune also announced top-line results from the Phase II study of sifalimumab (MEDI-545), a novel monoclonal antibody being investigated as a treatment for patients with moderate/severe systemic lupus erythematosus (SLE or lupus). The study met its primary endpoint of percentage of subjects that responded by the SLE Responder Index (SRI-4) at Day 365. Clinically important improvements in organ-specific outcome measures (joint, skin) and patient reported outcomes were also observed.

In the study, three doses of sifalimumab were evaluated against placebo when added to stable standard of care therapy in patients with moderately to severely active lupus despite standard of care therapy. In addition to efficacy in the primary endpoint, there is a broad-based body of clinical evidence supporting the efficacy of sifalimumab. The study achieved two secondary endpoints at specific doses - improvement in skin (rashes) as measured by CLASI (Cutaneous Lupus Erythematosus Disease Area and Severity Index) and improvement in fatigue. Sifalimumab demonstrated an overall acceptable safety profile, with a numerical increase in the incidence of Herpes Zoster reactivations.

“Patients with lupus have severely limited options for control of their symptoms, as only one new treatment has been approved in more than 50 years,” said Dr. Bing Yao, Senior Vice President and Head of MedImmune’s Respiratory, Inflammation and Autoimmunity Innovative Medicines Unit. “There is clearly a sense of urgency to deliver new treatments for patients suffering from this debilitating, chronic disease, and we are hopeful that
we will be able to offer a new option.”

The company anticipates presenting additional study results for both molecules at a future medical conference later this year. The Phase II programme in lupus with anifrolumab (MEDI-546), which targets the type 1 interferon receptor, is also ongoing.

NOTES TO EDITORSAbout Rheumatoid Arthritis (RA)Rheumatoid arthritis is a painful, systemic, chronic inflammatory autoimmune disease which causes damage to the joints and vital organs. The disease affects approximately one in 100 people worldwide. If not adequately treated, RA is a major cause of disability leading to diminished work capacity and is associated with reduced life expectancy.

The American College of Rheumatology (ACR) response represents a percentage improvement in symptoms. To achieve an ACR20 score, a person with RA must have at least 20 percent fewer tender joints and at least 20 percent fewer swollen joints. In addition the patient must also have a 20 percent improvement in at least three of the following five areas: 1) the patients overall (global) assessment of their RA 2) the patient assessment of their pain 3) the patients assessment of their physical functioning 4) the physician’s global assessment of their patients RA, and 5) the results of a C-reactive protein and erythrocyte sedimentation rate blood test as key indicators of inflammation.
The Disease Activity Score (DAS) represents an assessment of disease symptoms. The DAS score consists of a numerical assessment of a set of 28 joints for swelling and tenderness, plus the patients overall (global) assessment of their RA and the results of a C-reactive protein and erythrocyte sedimentation rate blood test as key indicators of inflammation.

About LupusLupus is an autoimmune disease in which the immune system produces antibodies that, instead of targeting viruses or other foreign invaders, attacks healthy tissue in the body, including skin, joints, the brain, and blood vessels. Lupus can cause a range of symptoms, including pain, rashes, fatigue, swelling in joints, and fevers, and is associated with a higher risk of death from causes such as infection and cardiovascular disease.

The SLE Responder Index-4 represents a clinically significant improvement in lupus disease activity. To achieve SRI-4 response, a person with lupus must have at least a 4 point improvement on the SLE Disease Activity – 2K (SLEDAI-2K) score, a validated measure of disease activity and have no worsening on the Physician Global Assessment of disease activity and the BILAG (British Isles Lupus Assessment Group) disease activity index.

About MavrilimumabMavrilimumab (formerly CAM-3001) is a first in class human monoclonal antibody that targets the alpha receptor for the cytokine granulocyte-macrophage colony-stimulating factor (GM-CSF). Through the targeted blockade of the receptor on the macrophage, a key cell in the pathogenesis of rheumatoid arthritis, mavrilimumab could add a significant new treatment option for RA patients.

About SifalimumabSifalimumab (formerly MEDI-545) is an investigational human monoclonal antibody that targets IFN-a, a type of inflammatory cytokine in the body known to play a role in the development of SLE. Previous studies have shown that high levels of type I IFN-a are correlated with more severe disease activity in SLE patients, and early studies of sifalimumab have demonstrated that this agent blocks signaling of all interferon alpha subtypes.

[nigel bates] AstraZeneca to invest £330 Million in new strategic R&D centre and global headqu...

nigel bates — 3/18/2013 9:43:35 AM

AstraZeneca to invest £330 Million in new strategic R&D centre and global headquarters in CambridgeMonday, 18 March 2013

AstraZeneca today announced its intention to establish a new global R&D centre and corporate headquarters in Cambridge in the UK by 2016. The planned investment of around £330 million ($500 million) to establish a purpose-built site reinforces AstraZeneca’s long-term commitment to the UK and underscores the country’s global importance as a location for biopharmaceutical research and development.

The move is part of the company’s proposals, announced today, to create strategic global R&D centres in the UK, US and Sweden to improve pipeline productivity and to establish AstraZeneca as a global leader in biopharmaceutical innovation. Under the proposed plans, AstraZeneca’s small molecule and biologics research and development activities will be concentrated in three strategic centres by 2016: Cambridge, UK; Gaithersburg, Maryland, US; and Mölndal near Gothenburg, Sweden.

Focusing the company’s UK-based R&D activities at a new centre in Cambridge builds on AstraZeneca’s world-leading protein engineering capabilities already based in the city through MedImmune, the company’s biologics arm. Cambridge offers easy access to scientific talent and excellent collaboration opportunities through renowned academic research institutions, pre-eminent hospitals and leading-edge biotech companies. The city also has strong links with important research institutions in London. By 2016, the new site is expected to house a highly-skilled workforce of approximately 2,000.

Pascal Soriot, Chief Executive Officer, AstraZeneca said: “Our proposed investment is a clear signal of AstraZeneca’s long-term commitment to the UK and highlights the important role Cambridge plays internationally in bioscience research. The Government’s Life Sciences Strategy and the meaningful policies they have put in place in recent years to encourage investment help make Britain an attractive location for biopharmaceutical research and development.

“Cambridge, which boasts strong links with London-based research institutions, is a world-renowned bioscience hotspot that rivals the likes of San Francisco and Boston. In a world where partnerships and collaborations drive medical progress, becoming an integral part of the Cambridge ecosystem offers compelling advantages for AstraZeneca, giving us easier access to leading-edge academic and industry networks, scientific talent and valuable partnering opportunities.

“I believe that the investment we are announcing today greatly increases the chances that the next generation of innovative medicines will be invented and manufactured in Britain.”

The consolidation of R&D and some other corporate and global functions at a new facility in Cambridge will impact other UK sites over the next three years.

Alderley Park, Cheshire: Under the proposals, research and development work will no longer be carried out at the Alderley Park site which today houses around 2,900 employees. Approximately 1,600 roles will relocate from Alderley Park over the next three years, with a significant majority going to the new centre in Cambridge and the remainder to the company’s nearby Macclesfield facility or sites overseas. At least 700 non-R&D roles are expected to remain at the site. AstraZeneca is committed to exploring all options to ensure that Alderley Park has a successful future.

London: AstraZeneca’s global headquarters in Paddington, west London, has around 350 employees in commercial, global and corporate functions. It is expected that the majority of these roles will move to the new facility in Cambridge, which will become the company’s new global headquarters, or to other sites. The Paddington offices are expected to close by 2016.

The proposed changes announced today are estimated to result in an overall headcount reduction of about 700 in the UK from Alderley Park and other sites over the 2013-2016 period. Approximately 300 further roles may be relocated outside the UK. Today, AstraZeneca employs around 6,700 people in the UK.

While the proposals would see a move of research and development employees from Alderley Park to Cambridge over the next three years, AstraZeneca will continue to have a strong presence in the North West with some 3,000 employees at Alderley Park, its Macclesfield manufacturing site and the MedImmune vaccine manufacturing facility in Speke. The company also has extensive and close scientific collaborations with academic institutions such as Manchester University which will continue to play an important role in discovery work.

Pascal Soriot said: “I recognise that our plans will have a significant impact on many of our people at our sites in Cheshire and London and the surrounding communities. We are fully committed to treating all our employees with respect and fairness as we navigate this period of change.

“AstraZeneca remains strongly committed to the North West of England. We are keen to work with central and local government, as well as the business community in the region, to ensure that all practical solutions for the future of Alderley Park are considered in order to support the local economy over the long term.”