On September 26, 2014 AstraZeneca reproted that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on a Type-II variation update* to the European label for IRESSA (gefitinib) (Press release AstraZeneca, SEP 26, 2014, View Source;iressa-receives-chmp-positive-opinion-to-include-blood-based-diagnostic-testing-in-european-label [SID:1234501058]). The label update will help doctors to identify lung cancer patients – based on the specific genetic drivers of their tumour – who could benefit from treatment with IRESSA but are unable to provide a suitable tumour sample.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

IRESSA is an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) indicated for the first line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of the EGFR tyrosine kinase. Therefore, only patients whose tumours are EGFR mutation positive are eligible to receive treatment. Tumour samples gained through biopsy are the primary method for determining a patient’s EGFR mutation status, without which patients are not eligible for treatment with an EGFR TKI such as IRESSA, which is the standard of care in Europe. However, up to 25 percent of patients with locally advanced or metastatic NSCLC do not have an available or evaluable tumour sample for this method of testing.

Following today’s CHMP opinion, IRESSA will be the first EGFR TKI in Europe to have a label allowing the use of circulating tumour DNA (ctDNA) obtained from a blood sample, to be used for the assessment of EGFR mutation status in those patients where a tumour sample is not an option. The update will take effect immediately and will be applicable in all 28 European Union member countries.

Briggs Morrison, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca said: "At AstraZeneca, we are committed to developing targeted medicines that improve health outcomes for patients. Understanding the nature of an individual’s tumour and therefore which medicine is most likely to benefit them is vital if we are to transform the way cancer patients are treated. If doctors are unable to assess the mutation status of a tumour, then patients’ access to potentially life-changing medicines such as IRESSA becomes restricted. Today’s decision by the CHMP to endorse a label update for IRESSA is a significant step forward."

AstraZeneca has pioneered the use of innovative blood-based diagnostic testing for solid tumours and recently announced a partnership with Qiagen to develop a ctDNA test as a companion diagnostic for IRESSA.

On September 25, 2014 CANCER RESEARCH UK, with its commercial arm Cancer Research Technology (CRT), reported that they have entered into an innovative collaboration with AstraZeneca and MedImmune, its global biologics research and development arm, to establish a joint laboratory in Cambridge, UK (Press release, Cancer Research Technology, SEP 25, 2014, View Source [SID1234523222]). The new laboratory, representing a first of its kind partnership for both organisations, will focus on the discovery and development of novel biologic cancer treatments over an initial five-year period.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As part of the collaboration, scientists from both organisations will work side-by-side on multiple oncology projects at the new CRUK-MEDI Alliance Laboratory. Cancer Research UK will provide set-up and operational funding for the laboratory and will contribute a portfolio of novel drug targets together with a team of scientists. MedImmune will oversee the laboratory activities and provide access to its human antibody phage display libraries and established antibody-engineering technologies. The joint team will share knowledge and expertise to discover and develop antibodies to treat cancer.

Bahija Jallal, executive vice president at MedImmune, said: "Oncology is a core therapeutic area for AstraZeneca and we are pleased to enter this strategic antibody discovery and development collaboration with Cancer Research UK, one of the leading charitable cancer research institutions in the world. Our collaboration represents an innovative public-private business model for biologic drug development as we will share knowledge and expertise in a dedicated laboratory to discover potentially ground-breaking medicines for cancer patients."

Jane Osbourn, vice president of R&D and Cambridge site leader at MedImmune, said: "The creation of the CRUK-MEDI Alliance laboratory underscores our strong commitment to building a broad science base across the UK and deepening our research roots here in Cambridge. Through this transformative collaboration, Cancer Research UK will have access to MedImmune’s capabilities and technology to help them develop pre-clinical candidates, while MedImmune will benefit from access to Cancer Research UK’s principal investigators and scientists."

Biological therapies are a major priority in Cancer Research UK’s new research strategy, which includes a commitment to increase investment in this area over the next few years. Collaborations that unite leading researchers together with latest technology platforms are a fundamental part of this strategy, helping turn new discoveries into treatments that can benefit patients as quickly as possible.

Keith Blundy, chief executive officer of Cancer Research Technology, said: "MedImmune is one of Cancer Research UK’s important strategic partners as we seek to advance biologic treatments for cancer. This unique partnership will bring together cutting-edge research with the most advanced antibody technologies industry can offer under one roof, to deliver significant output over a number of years.

"Cancer Research UK-funded scientists from across the UK will have the opportunity to access this unique lab and expertise. It’s the first of what we hope will be many such pioneering collaborations that will help to accelerate the translation of our research into potential new drugs."

On September 24, 2014 Instinctif Partners (formerly College Hill) reported they sponsored and hosted a breakfast briefing with Cancer Research Technology (CRT), entitled "Innovative approaches to better diagnose and treat cancer patients: analysis of blood borne tumour cells and DNA" on 23 September 2014 (Press release, Cancer Research Technology, SEP 24, 2014, View Source [SID1234523516]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

There is a pressing need to improve methods used to assess cancer diagnosis and treatment especially in light of the recent demonstration that tumours are heterogeneous genetically. Multiple direct biopsies, either from different sites or over time (or both), are difficult to achieve for many reasons. The discoveries that in the blood of cancer patients both circulating tumour cells (CTCs) and cell-free tumour DNA (cfDNA) can be detected offers new ‘non-invasive’ methods to determine the true genetic make-up of a cancer, its likelihood of spreading and its response to therapy during a course of treatment. Overall, both CTCs and cfDNA show the potential for improving drug development including in immunotherapy, an area which is demonstrating how cancer research is improving patient outcomes.

The breakfast briefing was chaired by CRT Chief Scientific Officer Dr Clive Stanway, and included discussions on these innovative developments by leading Cancer Research UK-funded scientists Professor Carlos Caldas, Dr Nitzan Rosenfeld, and Professor Caroline Dive. The event attended by key journalists from the industry provided an excellent opportunity for media exposure to this rapidly evolving field.

Dr Clive Stanway, CRT Chief Scientific Officer explained: "This event really helped us demonstrate the potential of analysing circulating tumour cells (CTCs) and cell-free tumour DNA (cfDNA), two new technologies for cancer patient treatment and drug discovery. The Instinctif Partners team was instrumental in helping us getting this message across, the planning and execution of the event went very smoothly and it has been great to work with the team."

Commenting on Instinctif Partner’s sponsorship of the event, Dr Christelle Kerouedan, Associate Partner, added: "Using our extensive experience and resources in media event planning and execution, Instinctif has helped Cancer Research Technology to highlight this rapidly evolving field of cancer research to key journalists. We are delighted to have worked with the CRT team on the organisation of this successful event".

On September 23, 2014 Inivata, a clinical cancer genomics company focused on harnessing the potential of circulating tumour DNA (ctDNA) analysis to improve cancer testing and treatment, reported it has raised £4m in a funding round led by Imperial Innovations and including Cambridge Innovation Capital and Johnson & Johnson Development Corporation (Press release, Cancer Research Technology, SEP 23, 2014, View Source [SID1234523223]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Inivata is focused on developing clinical applications of ctDNA through collaborations with clinical oncologists at prominent academic institutions, leading community treatment centres and innovative biopharmaceutical companies.

Novel applications of ctDNA are enabled by Inivata’s technology platform which includes its proprietary, enhanced TAm-Seq technology. TAm-Seq, which is licensed to Inivata from Cancer Research Technology and the University of Cambridge, allows the detection and analysis of genomic material from a cancer patient’s cell-free ctDNA collected through routinely accessible blood samples. This non-invasive approach – a liquid biopsy – offers a revolution in how cancer is detected, monitored and treated. Inivata’s founders are recognised leaders in the clinical genomics and ctDNA fields having developed pioneering ctDNA and novel treatment approaches in Cancer Research UK-funded laboratories at the University of Cambridge.

Inivata works with industry and academics to develop new clinical applications for ctDNA analysis which will bring real benefits to physicians, patients, pharmaceutical companies and payers. Inivata’s goal is to provide physicians with the information they need to provide the best outcomes for patients and effective design for clinical trials.

Michael Stocum, CEO of Inivata, said: "There is major focus on ctDNA analysis which promises the ability to improve monitoring and treatment of cancer based on information from routine blood samples. We are taking a collaborative approach to the development of clinical applications for ctDNA analysis which have the potential to transform how the disease is understood and treated.

"Nitzan Rosenfeld and his team are leaders in the field. I am excited to be working with our scientific founders, and with this significant fund raising secured we are now focused on working with pharmaceutical, clinical and academic partners to identify applications and rapidly realise the potential of the enhanced TAm-Seq approach."

Rob Woodman of Imperial Innovations said: "The oncology molecular testing and treatment market is large and growing. Inivata is well-placed to capitalise on this market growth by bringing real benefits to physicians, patients, pharmaceutical companies and payers."

Robert Tansley of Cambridge Innovation Capital said: "The research by Dr Rosenfeld’s team is ground breaking and offers new options in cancer monitoring to better manage treatment response prediction. This investment will secure the development of this technology in Cambridge and facilitate its translation into the clinic for the benefit of patients."

Keith Blundy, Chief Executive Officer of Cancer Research Technology and Inivata board member, said: "We’re delighted to be involved in taking this promising technology developed by Cancer Research UK scientists to the next level. Developing technologies that allow clinicians to monitor how tumours respond to treatment non-invasively and in real-time forms a crucial part of Cancer Research UK’s commitment to deliver the promise of precision cancer medicine to patients."

On September 22, 2014 Circle Pharma, Inc., a newly created, early-stage biotechnology company, reported that it has received seed funding from Pfizer Inc. and QB3’s seed-stage venture fund, Mission Bay Capital, LLC, and has initiated two collaborations with Pfizer to develop cell permeable macrocyclic peptide therapeutics (Press release, Circle Pharma, SEP 22, 2014, View Source [SID1234638553]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are very pleased to have launched Circle with the backing of Pfizer and Mission Bay Capital, and to have initiated two exciting collaborative projects with Pfizer," said David J. Earp, J.D., Ph.D., Circle’s President and CEO. "In addition to these collaborations, Circle will be undertaking development work against our own therapeutic targets. We are open to additional collaborations with partners who share our excitement in the potential of permeable macrocyclic peptides, which, we believe, could be applicable to a large number of important therapeutic targets."

Circle’s technology is based in part on research sponsored by Pfizer through an agreement with QB3.

About Macrocyclic Peptides
Macrocyclic peptides have the potential to provide access to therapeutic targets that are considered undruggable with conventional small molecule or biologic modalities. In particular, there is great interest in developing macrocycles to modulate protein-protein interactions, which play a role in almost all disease conditions, including cancer, fibrosis, inflammation and infection. However, the development of macrocyclic therapeutics has been limited to this point by the need for a greater understanding of how to design macrocycles with appropriate pharmacokinetics, cell permeability and oral bioavailability. Indeed, today, most clinical programs testing macrocyclic peptides are aimed at extracellular protein targets because of the challenge of identifying cell permeable macrocycles. The ability to design potent macrocycles with inherent permeability is expected to give access to a large number of important therapeutic targets that have been out of reach to this point.