Cancer Research UK and AstraZeneca sign deal to trial first-of-kind cancer drug

On September 13, 2010 Cancer Research UK and Cancer Research Technology – the charity’s development and commercialisation arm – reported to have reached an agreement with AstraZeneca to take compound AZD-3965 – a first-of-its-kind experimental drug to potentially treat a range of cancers- into clinical trial (Press release, Cancer Research Technology, SEP 13, 2010, View Source [SID1234523331]).

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AZD-3965 targets the monocarboxylate transporter 1 (MCT1)* which is essential in cell metabolism. Blocking this transporter limits cancer cells’ ability to generate energy, and decreases their ability to survive. The drug is ready to be taken into early phase clinical trials.

It is the sixth treatment to enter Cancer Research UK’s Clinical Development Partnerships (CDP) scheme**.

CDP is a joint initiative between Cancer Research UK’s Drug Development Office and Cancer Research Technology, to progress promising anti-cancer agents which pharmaceutical companies do not have the resources to progress through early phase clinical trials.

The deal with AstraZeneca will enable the charity’s Drug Development Office to carry out early clinical trials of the compound to see if it can benefit cancer patients.

Dr Ian Walker, licensing manager for clinical partnerships at Cancer Research Technology, said: "It is fantastic to see a drug from our CDP programme progressing toward a clinical trial to be tested as a potential new treatment for cancer patients.

"This clinical trial simply would not have been possible without the CDP initiative and it demonstrates how Cancer Research UK and Cancer Research Technology can work with industry to develop anti-cancer drugs that would otherwise remain on companies’ shelves. We will continue to work to set in place future similar agreements with industry with the aim of licensing more drugs to provide new treatments for patients."

Les Hughes, global vice president of cancer research at AstraZeneca, said: "AstraZeneca is committed to the discovery and development of new, targeted anti-cancer therapies to improve the lives of cancer patients but if we are going to be successful in delivering new treatments for cancer patients, it will be important for charities, academics and industry to work collaboratively.

"Working with CRT will enable a compound with a very exciting mechanism to be evaluated in patients using Cancer Research UK’s extensive clinical network. We look forward to this collaboration adding a new dimension to AstraZeneca’s pipeline which contains a number of promising candidates already in development."

Cancer Research UK will fund the Phase I/IIa clinical trial of up to 60 patients to start in 2011. The trial will be managed by its Drug Development Office. The lead clinical trial centre will be Newcastle’s Cancer Research UK Experimental Cancer Medicine Centre Network,*** led by Professor Ruth Plummer.

Under the terms of the agreement, AstraZeneca can decide if they wish to develop the drug further based on the clinical trial data results at the end of the Phase I/IIa trial. If it chooses not to, the rights will be given to Cancer Research Technology to secure an alternative partner and ensure the drug has every possible chance of reaching patients. In either case, the charity will receive a share of any future revenues generated by the drug.

Professor Ruth Plummer, study lead at the Newcastle Experimental Cancer Medicine Centre, said: "It is incredibly exciting to have the opportunity to run a trial of a completely new type of potential drug to treat patients across a range of different cancers.

"We hope to recruit the first patient soon – and it is thanks to the generosity and time of these patients that it is possible to develop new treatments to potentially treat thousands of patients in the future."

Dr Nigel Blackburn, director of drug development at Cancer Research UK’s Drug Development Office, said: "One of Cancer Research UK’s key aims is to boost the number of new treatments for cancer patients.

"Our strong links with industry have enabled us to make great progress by launching this clinical trial of a promising compound that without this partnership may have remained on a shelf gathering dust."

CRT & Bayer Schering investigate new therapeutic approach in gynaecological & oncological diseases

On August 25, 2010 Cancer Research Technology Ltd. reported it has signed an agreement with Bayer Schering Pharma AG, Germany to evaluate new leptin antagonist peptides as potential experimental treatments initially in the area of gynaecological diseases, including cancer (Press release, Cancer Research Technology, AUG 25, 2010, View Source [SID1234523333]).

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Under the terms of the agreement, Bayer Schering Pharma will evaluate the ability of the peptides to switch off the activity of a protein called leptin in a first evaluation phase. After the evaluation period both parties have the option to enter into a license agreement for the technology, the major terms of which have been agreed.

Leptin triggers the growth of different types of cells including endometrial cells and has been linked to angiogenesis – new blood vessel growth. It is hoped that blocking leptin’s action will offer a potential new treatment for a range of cancers and gynaecological diseases.

The leptin antagonists were first developed at the Boston Biomedical Research Institute (BBRI) in the USA by Drs. Paul Leavis and Ruben Gonzalez who have shown that the peptides are effective in blocking the effects of leptin in several diseases.

Cancer Research Technology – through its US subsidiary, CRT Inc – had agreed with BBRI to market and commercialise the technology and also provided support to BBRI for further development of the inhibitors and this agreement represents the successful outcome of these activities.

Larry Steranka, Managing Director of CRT Inc, said: "We’re delighted to have worked alongside BBRI to partner its technology with the right commercial partner to take forward the development of potential new treatments. "We’re looking forward to using our expertise and access to the international community to connect other US institutions with industrial partners and assist in the commercialisation of their technologies."

Charles Emerson Jr, Director of the BBRI, said: "CRT is an excellent partner to work with and has made a real impact in helping commercialise this project. We look forward to seeing the project progress with our industrial partner and to working with CRT again in the future".

Simcere Pharmaceutical Group Announces SFDA Approval to Manufacture and Market Palonosetron in China

On August 12, 2010 Simcere Pharmaceutical Group ("Simcere" or the "Company") (NYSE:SCR – News), a leading pharmaceutical company specializing in the development, manufacturing, and marketing of branded generic and proprietary pharmaceuticals in China, reported that its subsidiary company Simcere Dongyuan Pharmaceutical Co., Ltd. has recently received SFDA new drug certification and registration approval to manufacture and market Palonosetron material and injections in China (Press release, Jiangsu Simcere Pharmaceutical Company, AUG 12, 2010, View Source [SID1234591865]).

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Palonosetron is a second generation 5-HT3 antagonist used for the prevention and control of acute chemotherapy-induced nausea and vomiting (CINV). According to industry analysis, 5-HT3 antagonists account for 90 percent of the CINV market in China.

CRT and ValiRx sign licensing deal to develop Prostate Cancer treatment

On August 12, 2010 Cancer Research Technology reported it has signed a deal to provide biotech company ValiRx plc with the global rights to develop a promising compound to treat hormone-resistant prostate cancer (Press release, Cancer Research Technology, AUG 12, 2010, View Source [SID1234523334]).

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The compound, now called VAL 201, has been shown in pre-clinical tests in mice to stop growth of tumours which have been unresponsive to hormone treatments. VAL 201 blocks genes which can cause prostate cancer to develop. The compound has been shown to be effective in treating mice with breast and prostate cancer and is now rapidly progressing towards the first clinical trials in patients.

Under the terms of the deal, ValiRx has exclusive rights to use the compound to treat, prevent and diagnose cancer and other diseases. Cancer Research Technology will receive milestone payments throughout the development and commercialisation of the compound and royalty payments for potential licensed treatments.

Currently, prostate cancer is the most common cancer amongst men with 36,000 men being diagnosed and around 10,150 deaths each year in the UK. Of all men with advanced stage prostate cancer, hormone therapy will work for between eight and nine out of every 10. But many men will become resistant to the treatment at some stage. This does not appear to be related to the length of time a man is receiving treatment.

Dr Phil L’Huillier, Cancer Research Technology’s director of business management, said:
"This partnership demonstrates CRT’s ability to maximise its broad network, having identified and licensed this project from Naples, and then in turn partnered it for further preclinical and clinical development with ValiRx.

"We will follow further trials to test its suitability as a new treatment to potentially increase survival from this disease with great interest."

Under the terms of the licence with Cancer Research Technology, ValiRx will be responsible for performing the pre-clinical regulatory development of VAL 201 to prepare the compound for early clinical trials in patients. ValiRx will manage the commercialisation of potential treatments after clinical trials.

Satu Vainikka, CEO of ValiRx, said: "This is a significant and exciting opportunity for ValiRx and we look forward to continue working with CRT and in taking VAL 201 forward in its next stage of development as a potentially exciting treatment against prostate cancer."

Antibody Licence Agreement with Scancell Holdings Plc

On August 9, 2010 Cancer Research Technology Ltd (‘CRT’) – Cancer Research UK’s commercialisation and development arm, and Scancell Holdings Plc, (AIM:SCLP), the developer of therapeutic cancer vaccines – reported that they have signed an agreement under which Scancell has been granted a licence to use a human antibody known as 105AD7 (Press release, Cancer Research Technology, AUG 9, 2010, View Source [SID1234523335]).

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105AD7 is a human monoclonal antibody that mimics the complement regulatory protein, CD55. The antibody was discovered and originally developed at the University of Nottingham with support from Cancer Research UK and has previously been evaluated in clinical trials for osteosarcoma. The agreement will give Scancell a worldwide licence to use 105AD7 for the development of new ImmunoBody vaccines for any immunotherapy indication.

The licence will be restricted to the use of the antibody as a framework for future ImmunoBody vaccines. Scancell’s current ImmunoBody vaccines, such as SCIB1, its vaccine currently in Phase I clinical trials for the treatment of melanoma, use a deimmunised* antibody as the framework. 105AD7 will allow Scancell to use a fully human framework for the development of future ImmunoBody vaccines.

Under the terms of the agreement, Scancell will make an upfront payment to CRT in addition to development milestone payments, and royalty payments on future sales. Scancell will exclusively fund the development work, and have sub-licensing rights on agreed terms.

Professor Lindy Durrant, Chief Executive Officer of Scancell, commented:
"I am pleased that we have secured this important agreement with Cancer Research Technology. By utilising antibody 105AD7, Scancell will be able to further enhance the clinical utility and safety of Scancell’s ImmunoBody platform both in cancer and other immunotherapy indications."

Dr Phil L’Huillier, Cancer Research Technology’s director of business management, said:
"Through this deal with Scancell we are able to take forward this antibody arising from research from our worldclass scientists into commercial development to potentially make new vaccines to treat a range of diseases."