On February 7, 2010 Cancer Research UK’s commercialisation and development arm, Cancer Research Technology (CRT), reported it has teamed up with biopharmaceutical business, AstraZeneca in a major, multi-project alliance, in which around 30 scientists will be focused on creating a stream of new anti-cancer drugs, it is announced today (Sunday) (Press release, Cancer Research Technology, FEB 7, 2010, View Source [SID1234523340]).

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The three-year alliance will work on a portfolio of projects carefully selected by CRT from Cancer Research UK’s portfolio of biological research in the emerging field of cancer metabolism.

Cancer metabolism research seeks to explain why cancer cells use energy differently to normal cells in order to survive and grow, particularly under the conditions of nutrient and hypoxic stress faced by rapidly growing tumours. New drugs that control a cell’s metabolism could attack an "Achilles heel" of the tumour whilst sparing normal tissues.

The alliance team will work at CRT’s Discovery Laboratories in London and Cambridge, and AstraZeneca’s cancer research centre near Manchester. They will seek to develop small molecules which attempt to target the changes to a cell’s metabolism – attempting to deprive cancer cells of the nutrients they need to grow and survive.

AstraZeneca will take the most promising projects forward into pre-clinical and clinical drug development – through an innovative model for sharing the risks and potential rewards in creating new anti-cancer treatments. CRT will receive milestone payments and royalties on the projects that AstraZeneca take into clinical development.

Dr Keith Blundy, chief executive of CRT said: "We’re thrilled to be entering this alliance with AstraZeneca which has extensive capability in the late drug discovery and development stages and a long history in oncology. It’s a major milestone in the development of CRT’s Discovery Laboratories which have been created to advance early stage cancer discoveries to a point where they are attractive to commercial collaborators."

"Increasing evidence shows that cancer metabolism is an exciting area of research. It’s now clear that cells produce and use oxygen and energy very differently to normal cells, which presents us with an opportunity to find new ways to control these processes. We’re confident that the scale and breadth of this project – which should see us progressing around five projects at any one time – will yield many exciting results in the years to come."

Dr Les Hughes, Global Vice President of Cancer Research at AstraZeneca, said: This deal with CRT will enable us to speed up research in this exciting area by pairing AstraZeneca’s drug discovery and development capabilities with CRT’s expertise in indentifying and progressing new targets selected from Cancer Research UK’s basic research portfolio. We look forward to this collaboration adding a new dimension to our hunt for new and innovative cancer treatments."

Harpal Kumar, Cancer Research UK’s chief executive, said: "This important and innovative deal between CRT and AstraZeneca is great news for Cancer Research UK, and for cancer patients. The next generation of cancer treatments will be targeted to specific biological mechanisms that are fundamentally different between cancer and normal cells. Cancer metabolism is one such area and this alliance recognises the global excellence of Cancer Research UK’s expertise in uncovering these important mechanisms. It’s going to vastly improve and expand our knowledge, enabling a team of talented scientists to come together to find new drugs.

"Investing in partnership with pharmaceutical companies in the discovery and development of new cancer drugs will help us to accelerate progress towards our goal of finding new treatments for cancer patients. We hope this alliance will result in a number of new weapons in our fight to beat cancer."

On February 2, 2010 TopoTarget and Spectrum Pharmaceuticals reported an agreement to co-develop and commercialise belinostat, TopoTarget’s lead anticancer drug for cancer in North America and India (Press release TopoTarget, FEB 2, 2010, View Source;messageId=459613 [SID:1234500428]). Belinostat, an HDAC inhibitor, is in registrational clinical trial in Peripheral T-Cell Lymphoma (PTCL) as monotherapy and in a randomized phase 2 clinical trial for cancer of unknown primary site (CUP) in combination with carboplatinum and paclitaxel (BelCaP). Belinostat is currently being investigated in 20 clinical trials in aematological and solid cancers in monotherapy as well as in combination therapies.
Under the terms of the agreement, TopoTarget will receive an upfront payment of USD 30 million in cash. The total potential value of up-front and milestones (for both development and sales) of the agreement, in the event of full commercial success could exceed USD 350. In addition, TopoTarget will receive a double digit royalty on sales of belinostat as well as one million Spectrum shares. Spectrum commits to fund 100% of the costs for the ongoing PTCL study; TopoTarget will fund 100% of the ongoing CUP study. Spectrum and TopoTarget will split the development costs in a 70 to 30 ratio for future development of belinostat.
Under the agreement it is now expected that the BELIEF trial will be finalised and NDA filed with the FDA in 2011 the previous timeline announced by TopoTarget was December 2010. The CUP trial will be fully recruited in 2010 – the previous timeline announced by TopoTarget was H1 2010. In addition other randomised clinical trials in indications such as in lungcancer (NSCLC) are expected to be initiated.
Taking into account the 70:30 cost sharing arrangement under the collaboration, the sign on fee and existing cash resources excluding any other partnerships TopoTarget will, as a result of entering into the Agreement with Spectrum, have sufficient cash resources for at least two to three years. The agreement also includes diligence provisions on development and commercialisation as well as an option to co-promote under certain conditions.

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On January 7, 2010 Astrazeneca reported a Protein Kinase B inhibitor to be taken into clinical development, following a successful collaboration with the biotechnology company Astex Therapeutics (Press release, Cancer Research Technology, JAN 7, 2010, View Source [SID1234523341]). The PKB programme, from which the clinical candidate was selected, stemmed from collaborative research originally carried out by The Institute of Cancer Research, CRT and Astex. Click here to find out more about the deal.

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On January 4, 2010 CANCER RESEARCH UK and Cancer Research Technology (CRT), the charity’s development and commercialisation arm, reported to undertake a phase I clinical trial of an investigational monoclonal antibody * drug from Merck KGaA, Darmstadt, Germany, called DI-B4 (Press release, Cancer Research Technology, JAN 4, 2010, View Source [SID1234523342]).

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DI-B4 is the fourth anti-cancer drug to enter Cancer Research UK’s Clinical Development Partnerships (CDP) programme** – an initiative which allows companies to retain the rights to a treatment whilst enabling the charity to take on its early development work. DI-B4 is the first monoclonal antibody to join the scheme.

DI-B4 binds to the CD19 protein, found on B-cells, and is thought to recruit cells from the immune system to attack the tumour. It is hoped that it may one day help patients with leukaemia and lymphoma who do not respond to existing therapies. Currently, the standard treatment for B-cell lymphoma targets the CD20 protein.

DI-B4 will be one of the first drugs to be manufactured at Cancer Research UK’s new state-of-the-art, £20 million Biotherapeutic Development Unit***. After pre-clinical work on it has been completed, it will be taken into a phase I trial in around 20-40 patients with advanced B-cell lymphoma – a cancer of the white blood cell.

The trial will be managed by Cancer Research UK’s Drug Development Office and will take place at up to five**** hospitals across the UK.

Under the terms of the partnership, Cancer Research UK will fund the study through early clinical development. Merck KGaA will then have an option to take forward and commercialise the drug in exchange for future payments to the charity. If Merck KGaA elects not to progress the programme, the rights to the molecule will be given to CRT to secure an alternative development partner.

Dr Nigel Blackburn, director of Cancer Research UK’s Drug Development Office, said: "We’re very excited to be entering this venture with Merck KGaA. Equipped with the knowledge they have gained from creating the antibody, we will use our brand new manufacturing facility to develop it into a potential new treatment for cancer patients."

Dr Keith Blundy, chief executive of CRT said: "In an increasingly competitive market place, pharmaceutical and biotechnology companies have to focus strategically on certain areas of research and hold back on others. This deal demonstrates how we can work together to progress cancer drugs."

Dr Andrew Davies, Cancer Research UK senior lecturer in medical oncology at University of Southampton, who will run the phase I trial at Southampton General Hospital, added: "Existing treatments which target cancerous cells and draw in the body’s immune system can be extremely helpful. But we still need to search for alternative approaches for patients with B-cell cancers which have not responded to existing treatments. We hope that DI-B4 will have the same effects in patients as it has shown in the lab."

On December 23, 2009 Cancer Research Technology (CRT) – Cancer Research UK’s commercialisation and development arm – reported it has granted Aura Biosciences Inc. worldwide licence to use its cancer-targeting peptides in delivering cancer treatments directly to the tumour (Press release, Cancer Research Technology, DEC 23, 2009, View Source [SID1234523343]).

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These peptides bind to a protein on the surface of the cell called integrin αγβ6, a protein complex that is found at high levels on many tumour cells but is absent in most normal tissues. By seeking out this protein and binding to it, the peptides are able to deliver cancer treatments directly to the site with increased precision and reduced side effects. One of the cancers this could have particular benefit in targeting is pancreatic cancer as these tumours express high levels of integrin αγβ6. Pancreatic cancer is currently very difficult to treat with only around 2 to 3 per cent of patients surviving the disease for five years or more. Recent pre-clinical studies have also shown that these peptides may improve imaging in pancreatic cancer by binding to the αγβ6 *.

This deal strengthens Aura’s investment in the technology and builds on an evaluation agreement between Aura and CRT announced earlier this year**. The peptides were originally developed at Queen Mary, University of London with support from Cancer Research UK and DebRA – who work on behalf of people in the UK with the genetic skin blistering condition Epidermolysis Bullosa (EB).

Under the terms of the agreement, Aura Biosciences will make an upfront payment to CRT as well as providing clinical development milestones and royalties on future sales. Aura will exclusively fund the development work, and have sub-licensing rights on agreed terms.

Dr Elisabet de los Pinos, chief executive of Aura Biosciences said: "This partnership with CRT enables us to make use of their peptide technology as way to deliver our innovative NanosmartTM treatment particles – which are hollow particles made of nano-sized protein shells – to the tumour with increased accuracy. We are delighted with the progress we have already made in developing the technology and are looking forward to progressing it into potential new treatments for cancer."

Dr Phil L’Huillier, CRT’s director of business management said: "These peptides – combined with Aura’s award winning nanotechnology – have the potential to seek out and destroy cancer cells, leaving the surrounding areas unharmed. We believe this technology could have particular strengths in delivering treatments for cancers that have limited treatment options such as pancreatic and head and neck cancer. Crucially this targeted treatment could also reduce the side effects that are commonly associated with standard therapies. We look forward to the results of the programme with great interest."