On February 16, 2010 CANCER RESEARCH UK and Cancer Research Technology – the charity’s development and commercialisation arm – reported to have reached a collaboration agreement with immatics biotechnologies to trial their new treatment vaccine, IMA950, for glioblastoma multiforme (GMB), one of the most common forms of brain cancer* (Press release, Cancer Research Technology, FEB 16, 2010, View Source [SID1234523339]).

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IMA950 is the fifth treatment to enter Cancer Research UK’s Clinical Development Partnerships (CDP) scheme and the second one to be completed this year**. The CDP programme allows companies to retain the rights to their treatment while enabling the charity to take on its early development work to assess if there is a potential benefit to cancer patients. This is the first treatment vaccine to enter the CDP programme.

IMA950 contains 11 peptides linked to glioblastoma multiforme, an aggressive form of glioma. These peptides encourage the T cells in the immune system to recognise cancer cells and destroy them. In a phase I clinical trial that will open in the next year, up to 45 patients who have been newly diagnosed with this form of glioma will receive a number of doses of the vaccine, alongside routine surgery, radiotherapy and chemotherapy treatments.

The trial, will take place at four hospitals*** across the UK through Cancer Research UK’s Experimental Cancer Medicine Centre network and it will be managed by the charity’s Drug Development Office (DDO).

Under the terms of the partnership, Cancer Research UK will fund the trial. immatics Biotechnologies will then have an option to further develop and commercialise the drug in exchange for future payments to the charity. If they elect not to, the rights will be given to CRT to secure an alternative partner.

Dr Ian Walker, licensing manager at CRT, said: "We’re delighted to have formed this agreement with immatics Biotechnologies. Following rigorous peer-review of the scientific data, Cancer Research UK’s scientific committee decided that the potential of the vaccine should be investigated further and we are very pleased that the company sought the expertise of the charity to develop a potential new treatment."

Paul Higham, CEO of immatics said: "Cancer Research UK is a world-renowned cancer research organisation and we are delighted that through this collaboration we will be able to efficiently move our third therapeutic cancer vaccine into the clinic, highlighting the wide applicability and productivity of our technology platform."

Professor Roy Rampling, who will lead the study at Beatson West of Scotland Cancer Centre at the University of Glasgow, said: "The clinical trial will aim to find out if this vaccine targets and stimulates the patient’s immune system to fight the cancer.

Although we’re still planning the trial and are not ready to recruit patients yet, it’s exciting to be working on a possible new way to treat glioma."

Dr Victoria John, head of clinical partnerships at Cancer Research UK’s Drug Development Office, said: "We’re very pleased to be taking on the next stage of this vaccine’s development. This form of glioma is very difficult to treat successfully and we hope this trial will help to establish if the vaccine might offer another viable treatment option for people with this type of cancer."

On February 11, 2010 3SBio Inc. (Nasdaq: SSRX) ("3SBio" or "the Company"), a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, and Ascentage Pharma Group Corporation, Ltd. ("Ascentage Pharma") reported that they have formed a strategic alliance to research, develop and commercialize best-in-class targeted cancer therapeutics focusing on programmed cell death, or apoptosis (Press release, 3SBio, FEB 11, 2010, 3SBio and Ascentage Pharma Form Strategic Alliance to Research, Develop and Commercialize Cancer Therapeutics [SID:1234513482]). The alliance will leverage Ascentage Pharma’s expertise in structure-based small molecule design, lead optimization and preclinical development with 3SBio’s proven drug development and commercialization capabilities in China.

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Under the terms of the agreement, 3SBio will make a US$3 million equity investment in Ascentage Pharma. The investment will be used to fund Ascentage Pharma’s R&D programs. 3SBio will have the exclusive right to develop and commercialize cancer therapeutics in China that are discovered through Ascentage Pharma programs, while Ascentage Pharma will retain the rights to the rest of the world and receive future milestone and royalty payments from any sales by 3SBio in China.

"The collaboration with Ascentage Pharma represents a key strategic initiative for 3SBio to develop our pipeline in the area of cancer therapeutics," said Dr. Jing Lou, CEO of 3SBio. "This investment allows 3SBio to gain access to the best external science and small molecule drug discovery platform in China."

"Apoptosis targeted small molecule has the potential to play a key role in the next generation of highly effective targeted cancer drugs," said Dr. Dajun Yang, CEO of Ascentage Pharma. "We believe that this ‘win-win’ collaboration will generate innovative medicines that benefits patients worldwide."

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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