On September 11, 2013 CANbridge Life Sciences, a biopharmaceutical company focused on developing Western drug candidates in China and North Asia, reported that it has entered into a partnership with Azaya Therapeutics in San Antonio, Texas, to develop and commercialize Azaya’s investigational drug, ATI-1123, for treatment of non-small cell lung cancer (NSCLC), and potentially other solid tumor cancer indications, in China and North Asia (Press release, CANbridge Life Sciences, SEP 11, 2013, View Source [SID:1234510073]). ATI-1123, a liposomal formulation of docetaxel, has completed a FDA-approved Phase I trial in 29 patients with solid tumor cancers who had failed on other therapies. Phase II trials in the United States are planned in non-small cell lung cancer (NSCLC), gastric cancer, pancreatic cancer and soft-tissue sarcoma.

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Under the terms of the agreement, CANbridge obtains exclusive rights to clinically develop and commercialize ATI-1123 in China, Taiwan and South Korea. Upon ATI-1123’s successful approval in the above territories, CANbridge plans to manufacture the product locally and to supply the region via a technology transfer arrangement. CANbridge will be responsible for financing the development and commercialization of ATI-1123 in the territories and will pay Azaya milestones and royalties at defined stages of the partnership. Financial terms of the deal were not disclosed.

"CANbridge’s mission is to translate promising Western clinical-stage product candidates, that could provide true value, to Chinese and Asian patients with serious medical conditions underserved by current treatments," said CANbridge founder and CEO, James Xue. "As the founder of Genzyme China and a former Genzyme General Manager, I’ve observed first-hand that lung cancer treatments in China are far from satisfactory. We are therefore delighted to announce Azaya Therapeutics, an emerging leader in nanotechnology drug delivery, as our first partner.

"In China, over two-thirds of the newly diagnosed lung cancer patients are not eligible for surgery," Mr. Xue went on. Their only options are chemotherapy and radiation. We are racing against time to develop and deliver a more effective treatment to Chinese and Asian lung cancer patients. We see ATI-1123 as a promising potential new treatment in this underserved Asian market."

Lung cancer is the most common solid-tumor cancer in China in both incidence and mortality. In 2012, a national conference reported that at least 700,000 Chinese patients were diagnosed with lung cancer, annually. Over the past 30 years, incidence of lung cancer increased almost five-fold, primarily caused by smoking and pollution. The mortality rate also jumped almost 500%, during the same time period, due to lack of effective treatment.

On September 10, 2013 ImmuNext reported that it has achieved the first milestone in its collaborative effort with Janssen Biotech to carry out research and development of cancer therapeutics that antagonize the VISTA signaling pathway (Press release ImmuNext, SEP 10, 2013, http://immunext.com/news.php [SID:1234500868]). ImmuNext has received the first milestone payment as scheduled.

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On September 18, 2013 Université de Montréal (UdeM) and the Institute for Research in Immunology and Cancer – Commercialization of Research (IRICoR) reported that researchers from UdeM’s Institute for Research in Immunology and Cancer (IRIC) and Bristol-Myers Squibb Company have jointly identified a small molecule drug candidate against a novel target (Press release, Université de Montréal, SEP 8, 2013, View Source [SID1234626494]). This achievement represents a major pre-clinical milestone in the research collaboration between UdeM, IRICoR and Bristol-Myers Squibb and triggers a milestone payment to UdeM.

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The UdeM and IRICoR medicinal chemistry component of this collaboration was carried out in IRIC’s medicinal chemistry core facility. This facility employs 20 industry-trained chemists who are supported by 5 biologists and other professionals who are actively working on a number of innovative drug discovery projects being funded by IRICoR.

"We are very pleased that our medicinal chemistry team achieved this very important milestone. The clinical candidate molecule that was identified in close collaboration with Bristol-Myers Squibb meets very stringent criteria," commented Dr. Anne Marinier, Director of IRIC’s Medicinal Chemistry Core Facility at UdeM. "This speaks to the talent of our team and our ability to deliver high-quality, optimized small molecules based on a seamless integration of biology and medicinal chemistry groups under a same roof’."

"This milestone in our long-standing collaboration with Bristol-Myers Squibb, and its associated payment, further validates IRICoR’s business model of working closely with leading pharmaceutical companies to identify clinical candidate molecules," explains Dr. Michel Bouvier, President and CEO of IRICoR.

On September 2, 2013 Kymab, a monoclonal antibody biopharmaceutical company, reported the appointment of Dr Christian Groendahl as Chief Executive Officer and Dr David Chiswell, currently non-executive Director of Kymab, as Chairman, to take effect from 16 September 2013 (Press release, Kymab, SEP 2, 2013, View Source [SID1234537015]).

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Kymab is using the Kymouse transgenic human antibody platform to discover and develop fully human monoclonal antibody drugs. Under the leadership of Dr Groendahl, Dr Chiswell and Dr Allan Bradley, Chief Scientific Officer, Kymab plans to further develop its platform and advance several drug candidates to clinical development stage over the next five years.

"Christian’s track record at Novo Nordisk and Zealand Pharma in building drug portfolios and progressing new medicines through clinical development, from both within and in partnership with global pharma companies, will enable us to maximise the potential of the Kymouse platform," said Dr Chiswell, newly appointed Chairman of Kymab.

"I would like to thank Andrew Sandham, who is stepping down as Chairman and CEO. Andy has done a tremendous job establishing Kymab and leading us from inception to this important transition stage. We all wish him every success in his next venture."

Dr Groendahl has worked in the pharmaceutical industry for nearly 20 years. Previously, he served as Chief Scientific Officer of Zealand Pharma, where he was responsible for building its clinical stage R&D portfolio and forging corporate partnerships with major pharma companies and took part in its initial public offering on the NASDAQ OMX in 2010.

Before this, Christian held research, development, clinical and corporate roles over a long career with Novo Nordisk, including VP Cancer and Inflammation, Corporate VP for Global Clinical Development and Corporate Development and Alliance Management.

"Kymab has developed a world class human antibody discovery platform since its formation in 2009. Christian’s unique mix of skills and experience will be invaluable in taking the company to the next level," added Dr Allan Bradley, Founder and Chief Scientific Officer of Kymab.

"The Kymouse technology provides a world class platform for the discovery of highly selective, potent therapeutic human monoclonal antibodies for a broad range of unmet medical needs," commented Dr Groendahl. "I am delighted to be joining Kymab and look forward to working with the founder Professor Allan Bradley, the board and the excellent Kymab team in building a substantial biopharmaceutical business in Europe over the next decade."

Dr Chiswell has over 30 years’ experience in the biotechnology industry, having co-founded Cambridge Antibody Technology in 1990 and, as CEO, built and developed the business and led public offerings on the LSE and NASDAQ exchanges. Since 2002 he served as chairman of a number of biotechnology companies including Nabriva Therapeutics, Sosei, and Daniolabs. He is currently also non-executive chairman of Albireo Pharma and a director of Nabriva Therapeutics. He joined the Kymab board in 2012.

Andrew Sandham will continue to support Kymab as a consultant until the end of the year.

On September 2, 2013 WILEX reported that its subsidiary Heidelberg Pharma signed a license agreement with Roche covering the development of a novel class of antibody drug conjugates (ADCs) based on Heidelberg Pharma’s patented technology to couple α-Amanitin to antibodies (Press release Heidelberg Pharma, SEP 2, 2013, View Source [SID:1234501083]). The license agreement covers initial joint research to apply this technology to multiple Roche antibodies towards the identification of development candidates with favourable efficacy/safety profiles.
Heidelberg Pharma will receive regular payments for granting access to its technology and providing research services. Roche will subsequently have the opportunity to exercise options for licenses to develop and market selected Antibody Targeted Amanitin Conjugates (ATACs). Heidelberg Pharma will manufacture these substances and receive customary upfront payments, milestone payments and royalties for each development candidate selected by Roche.

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α-Amanitin is a bicyclic peptide naturally occurring in the green Death Cap mushroom. It potently inhibits the biosynthesis of RNA, a mechanism which is critical for the survival of cells. Accordingly, ATACs exhibit comparable activity against proliferating and resting tumour cells. This proliferation independent activity differentiates ATACs from other ADCs, which preferentially target proliferating tumour cells. As an additional advantage ATACs could offer a substantial capability to overcome the resistance mechanisms which might limit the efficacy of other antibody drug conjugates. The ATACs tested so far have shown strong anti-tumour activity in several preclinical tumour models.

Dr Jan Schmidt-Brand, Managing Director of Heidelberg Pharma GmbH and Chief Financial Officer of WILEX AG, commented: "We are delighted about the opportunity to collaborate with a company as renowned as Roche. This cooperation is an important external validation of our technology. We will use this cooperation to jointly explore and technically expand the applicability of our technology to selected antibodies."

Dr Klaus Bosslet, heading Roche Discovery Oncology in Penzberg, Germany, added: "We look forward to collaborating with Heidelberg Pharma to elect and develop the most promising ATACs. Ultimately, these ATACs may provide novel treatment options for cancer patients, whose tumours do not respond to available cancer therapeutics."