On June 14, 2013 Cancer Research Technology, the commercial arm of Cancer Research UK, the University of Manchester and AstraZeneca reported two agreements to seek new cancer drugs (Press release, Cancer Research Technology, 14 14, 2013, View Source [SID1234523254]).

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In the first agreement, scientists at the Cancer Research UK Paterson Institute for Cancer Research at the University of Manchester will develop potential new drugs which target a key protein involved in DNA damage response. AstraZeneca will provide the preliminary compounds, the basic building blocks for the development of the drugs, as well as the shape and structure of the target to best determine which compounds can interact with it. AstraZeneca has first rights to the molecules discovered through the agreement and can choose to continue further development after the agreement. In return, Cancer Research Technology will receive royalty payments when the project reaches certain milestones and has the option to develop the molecules further if AstraZeneca declines to do so.*

In an additional agreement, AstraZeneca has invited Cancer Research UK scientists from the Paterson Institute to test a potential drug target against AstraZeneca’s compound collection at Alderley Park to see if any could potentially work as a new cancer drug. This is the first time that AstraZeneca has invited an external party to screen such an extensive set of compounds within its screening facility. AstraZeneca will provide the important clinical and molecular information on any promising molecules, and Cancer Research UK scientists at the Paterson Institute will then have the opportunity to develop to a defined stage. AstraZeneca will have first rights of negotiation on any promising drug targets as a result of the extensive testing at the compound collection at Alderley Park.

Susan Galbraith, head of the AstraZeneca Oncology Innovative Medicines Unit, said: "Part of AstraZeneca’s strategy in the fight against cancer is to forge partnerships with leading academic and medical institutions. We believe the UK is on the cutting-edge of cancer research and that by working together we can ultimately bring the most value to patients. Cancer Research UK and AstraZeneca have an ongoing collaboration to tap into the cancer research expertise in the UK to deliver investigator-led studies of combinations of novel agents. This highlights the growing strategic relationship between cancer scientists from UK-based biopharmaceutical companies, charities and academic institutions."

DNA repair is a key area of interest for cancer drug discovery. Cells contain DNA which holds the cell’s instructions in the form of genes. But, DNA is continuously damaged by processes within a cell as well as harmful elements such as ultraviolet radiation or tobacco smoke.

In response to damage, DNA repair mechanisms mend DNA, but occasionally make mistakes. Over time these mistakes build up, and if located within important genes involved in cell growth, cells can multiply out of control, causing cancer. Drugs that interfere with DNA repair mechanisms show great potential to treat a wide range of cancers.

Dr Donald Ogilvie at Cancer Research UK’s Paterson Institute for Cancer Research at the University of Manchester, said: "DNA damage causes cancer. By directly targeting this pathway for drug discovery we are getting to the heart of the disease and working to translate Cancer Research UK’s world-class research into cancer treatments."

Dr Phil L’Huillier, Cancer Research Technology’s director of business development, said: "We’re delighted to reach this agreement with AstraZeneca. This is an exciting opportunity to develop potentially novel compounds targeting emerging areas of cancer biology. This work demonstrates how industry and academia can work together and use their experience to develop projects that may otherwise have never progressed and deliver patient benefits sooner."

On June 6, 2013 Patrys reported that it has been granted a New Zealand patent for lead anti-cancer product PAT-LM1 (Press release Patrys, JUN 6, 2013, View Source [SID:1234500544]).
The New Zealand Patent Office has issued a certificate of grant on a key patent in the PAT-LM1 family, PCT/IB2009/007082 entitled "LM-antibodies, functional fragments, LM-1 target antigen, and methods for making and using same". It offers patent protection through to year 2029.
This is the second jurisdiction in which the PAT-LM1 patent has been granted.
The patent, which is owned by Patrys, claims the use of the antibody PAT-LM1 that binds to its target Nmt55/NONO for the treatment or prevention of metastasis.

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On June 6, 2013 Isis Pharmaceuticals reported that it has earned a $6 million payment from AstraZeneca related to continuation of the research collaboration between Isis and AstraZeneca to discover and develop novel antisense therapeutics to treat cancer (Press release Isis Pharmaceuticals, JUN 6, 2013, View Source;p=irol-newsArticle&ID=1827576&highlight= [SID:1234500201]). In addition to the research collaboration, which includes three cancer targets, Isis and AstraZeneca are developing two antisense drugs, ISIS-ARRx and ISIS-STAT3Rx, discovered by Isis and licensed to AstraZeneca for the treatment of cancer.

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On June 6, 2013 Cancer Research UK and its commercial arm, Cancer Research Technology (CRT), reported to have joined forces with Abcodia, the biomarker validation company with a focus on cancer screening, to develop new blood tests to detect a range of cancers when they are still at a very early stage (Press release, Cancer Research Technology, JUN 6, 2013, http://commercial.cancerresearchuk.org/cancer-research-uk-and-crt-collaborate-abcodia-discover-and-develop-tests-cancer-1 [SID1234523255]).

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The strategic alliance will focus on biomarkers to detect cancers before patients develop symptoms, concentrating on cancers which currently have limited screening tests available, such as non-small cell lung cancer.

Detecting cancer earlier will give doctors the best chance to treat cancer effectively, before the disease develops and spreads when it becomes more difficult to treat. Identifying patients at an early stage will also provide the scientific and pharmaceutical communities with the ability to select patients for the development of a new generation of anti-cancer medicines.

The partnership combines Cancer Research UK’s extensive clinical oncology and scientific network with Abcodia’s expertise in the longitudinal profiling of biomarkers, as well as its exclusive access to one of the world’s largest prospective collections of serum samples available for biomarker research. This collection is derived from the UK Collaborative trial for Ovarian Cancer Screening* (UKCTOCS) created at UCL and contains more than five million serum samples. The trial is part funded by Cancer Research UK.

The samples in the collection have been taken from healthy people annually and in many cases, up to 10 years prior to a cancer diagnosis. The collaboration will use these samples to select biomarkers which provide a clear indication of change in the early pre-diagnosis stages of disease.

Cancer Research UK, CRT and Abcodia will seek partnerships in the UK and internationally, with academic and commercial organisations which have leading-edge biomarker technology, to discover, validate and further develop the markers.

Dr Julie Barnes, Abcodia’s CEO, said: "We are delighted to be able to work with Cancer Research UK and CRT in this new global venture. The early diagnosis of cancer has never been more important and with the collective expertise that this alliance can bring, we aim to make a real difference in the field of early cancer detection and screening."

The alliance is particularly interested in seeking markers that may be expressed in serum; for example, proteins, microRNAs – regulators of gene expression, exosomes ­– cell-derived vesicles, autoantibodies – antibodies targeting an individual’s own proteins, and DNA methylation – a molecular switch to turn DNA on and off. Both genetic and acquired risk factors will also be investigated.

Abcodia and CRT will jointly commercialise any biomarkers discovered during the collaboration and share revenues resulting from potential licensing deals with additional third parties.

Dr Harpal Kumar, Cancer Research UK’s chief executive, said: "Earlier detection of cancer remains a huge challenge but also a tremendous opportunity. We know that for most types of cancer, the earlier we detect them, the greater the chance of being able to treat them effectively and successfully. Furthermore, treating earlier stage disease is usually associated with fewer side effects from treatment for our patients. The scope and scale of this alliance, aimed at developing new tests for a range of cancers at their earliest stage, before symptoms develop, is very exciting. The combination of expertise formed by this partnership provides a great opportunity to accelerate this vital biomarker research, which we hope will help save thousands of lives from cancer."

Professor Ian Jacobs, vice president at the University of Manchester, director of UKCTOCS and an Abcodia founder, said: "I’m delighted that the biobank developed through UKCTOCS will be used for such an important collaborative venture which has potential to yield important discoveries and to benefit patients through early detection across a range of cancers."

Dr Keith Blundy, Cancer Research Technology’s chief executive, said: "This important alliance combines Cancer Research UK’s clinical expertise, with the commercialisation expertise of both Abcodia and CRT. Together with additional technology partners, we hope to be able to identify early detection biomarkers that will enable patients to be treated as soon as possible, ultimately saving lives."

Does the novel progesterone receptor (PR) modulator BAY 1002670, based on its preclinical pharmacological profile, offer a potential novel treatment option for uterine fibroids?
The newly synthesized BAY1002670 has proved to be a very potent, highly selective PR modulator in all in vitro and in vivo pharmacodynamics assays performed: it exhibits marked efficacy in an innovative humanized fibroid disease model, suggesting BAY 1002670 to be a very promising treatment option for uterine fibroids.
PR inhibiting ligands have shown clinical utility in a range of potential indications and applications. Despite the emergence of the first PR antagonist >30 years ago, no agent of this compound class has been authorized in any indication for long-term application. Among other reasons, suboptimal selectivity and safety profiles of previous candidates have led to discontinuation and modification of development programmes.
The preclinical studies include relevant in vitro and in vivo assays to clarify the properties of the PR modulator BAY 1002670 as well as a fibroid xenograft study to show directly the efficacy of BAY 1002670 on the human target tissue.
BAY 1002670 was tested for binding and transactivational activity towards different human steroid receptors. Activity of the compound in the corresponding in vivo models (rat, rabbit) was assessed. Furthermore, BAY 1002670 was tested in a disease model for uterine fibroids utilizing primary human tumour tissues as xenograft in immunodeficient mice treated with estradiol (E2) and progesterone (P).
BAY1002670 in subnanomolar concentrations exhibits a highly selective binding profile and antagonistic activity for the PR. These properties are also reflected in its action in two progesterone-dependent animal models that assess the termination of pregnancy and endometrial transformation. Favourable selectivity towards other nuclear hormone receptors was demonstrated. No in vivo activity was found at the glucocorticoid, estrogenic and mineralocorticoid receptors with only weak anti-androgenic activity. In a human fibroid xenograft model BAY 1002670 showed a marked dose-dependent reduction of fibroid tumour weight gain of 95% at a dose of 3 mg/kg/day (P < 0.005).
Selectivity and potency of BAY 1002670 have only been determined in vitro and in animal models so far.
The PR modulator BAY 1002670 might offer a treatment option not only for uterine fibroids but also for other gynaecological indications.
The studies took place at Bayer Pharma AG. All authors are employees of Bayer Pharma AG. No external funding declared.

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