(Filing, 10-Q, Champions Oncology, JAN 31, 2013, View Source [SID:1234504159])

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On January 31, 2013 Teva reported the termination of its collaboration with CureTech Ltd (Press release Teva, JAN 31, 2013, View Source;p=irol-newsArticle&ID=1779781 [SID:1234500813]).

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"We are in the process of conducting a disciplined review of our pipeline. As we looked closely at CT-011 and the most recent clinical and biochemical data, we have made the strategic decision to invest our resources elsewhere where we can have the most impact for patients," stated Dr. Michael Hayden, President and CEO of R&D and Chief R&D Officer.

CT-011 is a humanized monoclonal antibody being developed as a treatment for hematological malignancies and solid tumors. CT-011 was assessed in several phase I and II clinical studies in various cancer indications including diffuse large B-cell lymphoma (DLBCL), colon cancer, metastatic melanoma and additional investigator initiated studies.

Teva entered into agreements with CureTech in 2006. Teva intends to book a noncash net charge of $109 million as a result of the impairment of its investment in CureTech.

(Filing 10-Q , Lion Biotechnologies, JAN 25, 2013, View Source [SID:1234501579])

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On January 24, 2013 BioInvent reported the first results from the BI-505 phase I study in patients with multiple myeloma (Press release BioInvent, JAN 24, 2013, http://www.bioinvent.com/investors/press-releases/release.aspx?releaseid=736831 [SID:1234500561]). The study has reached a final stage and the preliminary analysis shows that BI-505 has an advantageous safety profile. In cohorts where extended therapy was available, 24 % of the patients had stable disease for at least two months, indicating effect of BI-505. The final conclusions of the study will be available at a later time-point. The optimal dose has been defined according to the study protocol and will be used in the next clinical trial which is approved by the health authorities.
BI-505 is a human antibody selected from the n-CoDeR-library and fully owned by BioInvent. It is directed against the ICAM-1 adhesion protein, which is highly expressed on multiple myeloma cells. BI-505 has demonstrated significant anti-tumor activity in several relevant models of multiple myeloma.
Thirty-five patients with relapsed or refractory disease after at least two previous regimens with other drugs are included in the phase I, dose escalation study. The primary objective is to determine the safety and tolerability of BI-505 in patients with advanced disease. Pharmacokinetics and pharmacodynamic variables including relevant biomarkers for tumor response are also being evaluated in order to determine the optimal dose for further clinical development. The study is being conducted at seven sites in the US and Europe.
Groups of patients are treated with increasing doses of BI-505 (0,0004 – 20 mg/kg; eleven dose levels) every second week over a four-week period, with a possibility of extended therapy every two weeks until disease progression for patients at dose level six and onwards.
The preliminary assessment demonstrates that BI-505 has a favorable safety profile with a low number of reported adverse events. Temporary infusion-related reactions were observed when the first dose was given which is commonly seen. Despite advanced disease, 7 of the 29 patients on extended therapy (at dose level six and onwards) had stable disease for at least two months. A dosing regimen of 10 mg/kg every second week resulted in complete saturation of the ICAM-1 epitopes on the patient´s bone marrow myeloma cells. The 10 mg/kg dose will thus be used in the next clinical trial which has already been approved by the health authorities.

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On January 21, 2013 Six of the world’s top translational health research centres reported that they have come together to form a new Global Alliance of Leading Drug Discovery and Development Centres (Press release, Cancer Research Technology, 21 21, 2013, View Source [SID1234523260]). The aim of this alliance is to strengthen the international academic and/or not-for-profit drug development and commercialization network to ultimately improve the rate at which academic research is translated into new medicines.

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The founding organizations are:

The Centre for Drug Research and Development (CDRD), Canada
Lead Discovery Center (LDC), Germany
The Scripps Research Institute, Scripps Florida, United States
The Centre for Drug Design and Discovery (CD3), KU Leuven R&D, Belgium
Medical Research Council Technology, United Kingdom
Cancer Research Technology, United Kingdom

All member organizations are fully-integrated translational centres capable of professionally advancing drug discovery projects along the value chain from idea to drug candidate with proof-of-concept. Together, they represent close to 400 experienced drug developers collaborating with tens of thousands of academic scientists around the globe on over 165 highly innovative therapeutic projects targeting significant unmet medical needs. For the biopharmaceutical industry, they represent a major source of innovation. Numerous alliances with many of the industry’s leading global companies have been established to develop resulting drug candidates further and ultimately make them available to patients.

Through this Alliance, member organizations will collaborate on mutually-beneficial projects, share best practices, expertise and resources, and develop common standards and performance measurements – ultimately working together to improve the conversion of global early-stage technology into much needed therapies.

Karimah Es Sabar, President and CEO of CDRD commented, "We see a multitude of translational research initiatives around the world, but until now, these have for the most part, worked in isolation of one another. This Alliance will be a powerful vehicle in bringing such organizations together, leveraging one another’s strengths, and ultimately making for a much more effective global translational research environment."

Dr Keith Blundy, Chief Executive Officer of Cancer Research Technology, said: "Cancer Research Technology has historically worked to advance drug discovery opportunities from diverse academic sources including those in the UK, Europe, USA and Australia. This alliance of leading centres fits perfectly with our aim to grow this activity, to share our knowledge and to learn from others with the ultimate goal of providing more and better drugs for cancer patients."

For additional information on the Global Alliance of Leading Drug Discovery and Development Centres, please visit: www.drugdevelopmentalliance.org