Temozolomide sales reach $1 billion

On February 6, 2009 Cancer Research UK reported that sales of Temozolomide*, an anti-cancer drug developed by its scientists, have reached $1 billion (Press release, Cancer Research Technology, FEB 6, 2009, View Source [SID1234523359]). The charity receives a percentage royalty on these sales, which it uses to invest in new research to beat cancer.

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Temozolomide – a chemotherapy drug for patients with the most common form of brain tumour – was discovered 30 years ago in a Cancer Research UK laboratory led by Professor Malcolm Stevens, then at Aston University in Birmingham.

The charity also undertook the first clinical trials of the drug which proved its activity against glioblastoma multiforme – the most aggressive type of brain tumour accounting for over 50 per cent of all primary cases of the disease.

Based on these phase I and phase II trials – which were managed by Cancer Research UK’s Drug Development Office – the charity’s commercial and development arm Cancer Research Technology (CRT) licensed the drug to Schering-Plough which now markets the drug. The company undertook the pivotal phase III studies which found that temozolomide, when given in combination with radiotherapy, results in a significant increase in survival with minimal side effects.

Dr Keith Blundy, chief executive of CRT, said: "We’re delighted that Temozolomide has achieved sales of over $1 billion. We’re extremely proud of our involvement in the licensing of Temozolomide as it has proved to be an effective treatment for people with brain tumours who otherwise have very limited treatment options.

"The royalties we receive from the sales of Temozolomide go straight back into the pot to fund further research to aid the development of even more drugs to help in our fight against the disease."

The standard of care for glioblastoma multiforme – also known as glioma – includes chemotherapy during and after radiotherapy. The use of temozolomide both during radiotherapy and for six months post radiotherapy is now the gold standard treatment for most cases of the disease. Temozolomide works by killing cancer cells and sensitising them to the effects of radiation.

Harpal Kumar, chief executive of Cancer Research UK, said: "This milestone highlights the significant impact our research is having on cancer drug development. It is testament to the ingenuity of the scientists who developed the original compound as well as the unique capabilities of our drug development and technology transfer teams."

Cancer Research UK scientists have contributed to the discovery or early clinical development of 5-10 per cent of all major cancer treatments currently in clinical use around the world and has taken over 100 new drugs into patients for the first time.

Harpal Kumar continued: "This is just the latest example in a long list of successful treatments that have come out of Cancer Research UK funded research. Our scientists helped to discover and develop two of the most widely used cancer drugs in the world – carboplatin and cisplatin – which are used to treat ovarian, lung and testicular cancer.

"We also have a very exciting pipeline of almost 50 new drugs currently in clinical trials which could provide further significant weapons in the fight against cancer. Of these, several are in phase III development, including three potential new drugs for lung cancer, a disease in which we have sadly made little progress over the past few decades.

"Today’s news is a fantastic example of how the public’s investment, through their generous donations, in Cancer Research UK pays off."

Cymap deal puts new generation technology in focus

On November 28, 2008 Cancer Research Technology Limited (CRT), the oncology-focused development and commercialisation company, and the technology development specialists The Technology Partnership plc (TTP) reported they have agreed to join forces to progress new lens-free imaging equipment called CyMap (Press release, Cancer Research Technology, NOV 28, 2008, View Source [SID1234523361]).

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CyMap is able to detect a range of particle types in a solution and holds the potential to be used in highly cost-effective medical diagnostics systems* in hospitals, doctors surgeries and research laboratories to detect, quantify and analyse medical samples such as blood or bacteria.

This technology is based on the principle that when illuminated using a simple light source, ‘items’ such as cells or pathogens in a sample create light diffraction** and interference patterns that can be recorded by a charge-coupled device (CCD) – a type of digital camera – and then analysed using computer algorithms. This will enable scientists to count the number of ‘items’ in a sample, and also to monitor changes over time, such as location, movement and division of cells. This information will be useful in helping scientists understand cell division and cell movement, which are important in some normal processes such as wound healing, and in some diseases including cancer.

In the diagnostics field, CyMap may also be developed to monitor bacterial contamination, the presence of other pathogens, or to count red and white blood cells. One of the other advantages of CyMap technology is that it can be easily miniaturised and integrated with microfluidic systems – and it may also have other wider research applications as well.

Professor Borivoj Vojnovic, one of the inventors of the technology at the Gray Institute for Radiation Oncology and Biology, University of Oxford, (GIROB) said: "This new generation of imaging technology will hopefully be much smaller, cheaper and easier to use than the existing alternatives which are usually only available to scientists and pathologists in larger well equipped bioscience laboratories. We envisage CyMap working well as a hand-held device which should make the equipment accessible and affordable for more people working in cancer and other health related disciplines across the world."

The technology was developed by members of the Optical Biochips Consortium, at GIROB, Cardiff University and Bangor University. This Consortium was backed by funding*** from Research Councils UK, which includes the Biotechnology and Biological Science Research Council and the Engineering Physical Sciences Research Council.

The intellectual property arising from this laboratory-based research has been assigned to CRT which has filed a patent to protect the academic work. Under the terms of the agreement announced today, CRT has awarded TTP an exclusive option to license and develop the CyMap technology. TTP will seek other commercial partners to develop and bring to market a range of applications based on CyMap, either by direct licensing arrangements or through co-development partnerships. CRT and TTP will share the revenues arising from any future development and sales of the technology.

Paul Galluzzo, consulant at TTP, said: "We specialise in commercialising technology that holds the potential to make a real difference in sectors such as clinical and consumer diagnostics, drug discovery, consumer products, digital printing, and communications. We frequently work in partnership with the scientists who made the discovery to bring exciting concepts to the marketplace. CyMap is genuinely innovative and we believe it has great commercial potential, for example to enable new diagnostic platforms, and to introduce imaging capability to products where imaging is currently too expensive. The next stage will be to develop the technology for a range of specific product areas."

Dr Phil L’Huillier, CRT’s director of business management said: "We believe this technology is very exciting and it’s great to be able to see it progressed in today’s deal. We hope CyMap will help understand and predict what is happening to patients at a basic biological level. This could, one day, have an impact on treatments and how they are delivered. CyMap technology has the potential to be cheaper, more compact and simpler to use which will hopefully prevent doctors from having to send as many samples to laboratories for analysis and enable quicker and easier monitoring of the samples. Only time will tell if this early stage promise pays off but we will watch its progress eagerly."

Oncalis AG Licenses PI3K Inhibitors From ChemDiv Inc.

On October 6, 2008 Oncalis AG (Oncalis), a privately-owned Swiss biotechnology company, and ChemDiv Inc. (ChemDiv), a privately-owned, California-based discovery services company reported that they entered into an exclusive agreement for a license to Oncalis a family of PI3K inhibitors (Press release, Oncalis, OCT 6, 2008, View Source [SID1234521054]). ONC-201, the first development candidate from this family, is a potent and selective orally-bioavailable member of a new class of drugs targeting PI3-kinase. ONC-201 has demonstrated highly promising anti-cancer efficacy in pre-clinical cancer models.

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Under the terms of the agreement, Oncalis receives a family of compounds targeting different forms of PI3-kinase (PI3-K). PI3-K is an enzyme known to be important in cancer disease progression and potentially in the regulation of certain immune and inflammation-related diseases. The potential of PI3-K inhibitors has been recently confirmed by advancing development programs from top-tier pharmaceutical companies with this class of compounds. Under the terms of the agreement ChemDiv will perform R&D activities for Oncalis’ lead compounds. Financial terms of the agreement were not disclosed.

Commenting on the license, Dr. Didier Coquoz, CEO, and Dr. Alcide Barberis, CSO/COO, said that "the in-licensing of the PI3-kinase program represents a major evolution for Oncalis, a company dedicated to the development of oral inhibitors of kinases for the treatment of cancer. This program expands Oncalis’ internal portfolio and we are extremely excited to successfully move ahead with the development of the PI3-kinase inhibitor ONC- 201 in addition to the triple RAF/EGFR/EPHB4 inhibitor ONC-101. We aim to enter clinical trials within the next two years with very promising new anticancer drugs in an extremely promising segment of oncology treatment".

"ChemDiv successfully provided research services to Oncalis over the past two years. We are excited about this new collaboration with our established partner. I am pleased that Oncalis shares our enthusiasm for the therapeutic potential of PI3-kinase inhibitors and ONC-201 in particular for multiple cancer indications," said Dr. Nikolay Savchuk, President and CEO of ChemDiv. "Oncalis has a significant development and business expertise in oncology which we believe will help accelerate the development of these novel small molecules designed to inhibit the important cancer and inflammation related PI3K-Akt pathway."

Cancer Research UK and Astex Therapeutics join forces to develop new anti-cancer treatment

On September 29, 2008 Cancer Research UK, Cancer Research Technology (CRT) – the charity’s development and commercialisation arm – and Astex Therapeutics Limited reported that they have agreed to take into development a potential new anti-cancer treatment (Press release, Cancer Research Technology, SEP 29, 2008, View Source [SID1234523360]).

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AT13148 – a protein kinase B inhibitor* – is the second drug to enter the charity’s Clinical Development Partnerships (CDP) programme. This deal follows the first CDP agreement with AstraZeneca** in May 2008.

The CDP initiative was set up in 2006 to advance promising anti-cancer agents into the clinic – offering companies with compounds an alternative model to traditional out licensing by allowing them to retain rights to the compound throughout the development process.

Under the terms of this new agreement, Cancer Research UK’s specialised Drug Development Office will carry out further development work on the agent. Some of this work will be undertaken by The Institute of Cancer Research and if successful it will be taken into phase I clinical trials at the Royal Marsden Hospital.

Dr Victoria John, head of clinical partnerships at Cancer Research UK, said: "We’re very excited to be entering this deal with Astex Therapeutics. This agent has been identified as a promising development candidate, which has the potential to impact on a wide range of cancers. Entering into this partnership is an excellent example of how the charity can work with industry to help bring much needed new treatments to cancer patients."

This work will be funded primarily by Cancer Research UK with the charity receiving a share of any revenues including a royalty on sales. The molecule was originally discovered by scientists on the PKB drug discovery programme, a collaboration between Astex Therapeutics, CRT and The Institute of Cancer Research, which ran from 2003 through to 2006.

Harren Jhoti, Astex Therapeutics’ chief executive officer said: "This agreement with Cancer Research UK builds on the previous PKB drug discovery collaboration with The Institute of Cancer Research and CRT, which began in 2003 and first identified this agent.

"Astex Therapeutics is committed to the discovery of small molecule drugs and we already have a number of our candidate agents in development with pharmaceutical companies across the world. Given the productivity of our drug discovery approach, the challenge for Astex has been to find innovative ways to continue to fund the development of all of our compounds and the CDP programme clearly addresses that constraint. Our history of working with Cancer Research UK on AT13148 means they are uniquely placed to partner with us on the development of this potentially exciting new treatment and we await the outcome of their work with interest."

Dr Keith Blundy, chief executive of Cancer Research Technology, said: "We’re very pleased to be entering our second CDP agreement this year and this deal presents us with an opportunity to take forward an exciting new development candidate. Pharmaceutical and biotechnology companies have to prioritise which agents they take into clinical development and this agreement highlights the benefits of collaborating in research efforts to advance the development of new cancer treatments."

CRT licenses colorectal cancer risk technology

On July 31, 2008 Cancer Research Technology Limited (CRT), the oncology-focused development and commercialisation company, reported it has agreed a non-exclusive licence with ArcticDx Inc. for the development of a Colo Risk test to help health professionals determine an individual’s predisposition to developing colorectal cancer (Press release, Cancer Research Technology, JUL 31, 2008, View Source [SID1234523362]).

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The agreement allows for some results from Cancer Research UK funded genome-wide association studies* to be integrated into the risk assessment technology. It is hoped this Colo Risk technology – which is currently in development – will prove effective in assessing people who may be at higher risk of developing bowel cancer so they can receive tailor-made screening and lifestyle advice.

The technology will be based on recent genome-wide association studies which were the first to identify a number of common ‘genetic variants’ that increase bowel cancer risk. These are known as single-nucleotide polymorphisms (SNPs). SNPs appear more frequently in the DNA of people who have developed bowel cancer than of those free from, or at low risk, of developing the disease.

Greg Hines, chief executive officer of ArcticDx Inc. said: "With eight years expertise in the field of in vitro diagnostics development, we’re well placed to take forward these findings and combine them with work we have already done to process information on other risk factors such as age and body mass index which we know also contribute to increased risk of developing the disease. This saliva-based test will be commercially available by the end of this year."

As part of this licensing deal, CRT will receive an upfront payment as well as royalties on any sales.

Dr Phil L’Huillier, CRT’s director of business management, said: "We are committed to ensuring that the most promising findings in the field of cancer research are developed into technology that can be used to fight cancer. This licence agreement with ArcticDx Inc. incorporates important genetic findings into potentially workable technology which could help identify and manage people at higher risk of bowel cancer – it’s an exciting development."