Withdrawal of the marketing authorisation application for Jenzyl (ridaforolimus)

On 27 November 2012, Merck Sharp & Dohme Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Jenzyl, for the maintenance treatment of patients with metastatic soft tissue sarcoma or bone sarcoma previously treated with chemotherapy (Press release, European Medicines Agency, NOV 27, 2012, View Source [SID1234556277]).

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Cancer Research UK and Lorus to co-develop first-of-kind drug, IL-17E, to treat solid tumours

On November 27, 2012 Cancer Research UK’s Drug Development Office; Cancer Research Technology, the charity’s commercial arm; and biopharmaceutical company, Lorus Therapeutics Inc. (Lorus) (TSX:LOR), reported they have partnered to take a new therapy with the potential to treat solid tumours, into its first clinical trial (Press release, Cancer Research Technology, NOV 27, 2012, View Source [SID1234523267]).

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The treatment, IL-17E, is a type of protein called a pro-inflammatory cytokine which, according to research done at Lorus, is thought to elicit an immune response which attacks cancer cells, and determining exactly how it does this will form part of the work being done.

It incorporates technology owned by both Lorus and Genentech. Lorus scientists were the first to discover the anticancer properties of IL-17E against a range of solid tumours.

Cancer Research UK’s Clinical Development Partnerships (CDP) is a joint initiative between Cancer Research UK’s Drug Development Office (DDO) and Cancer Research Technology, to develop promising anticancer agents that may not otherwise be developed, and take them through preclinical development and early clinical trials.

With the CDP scheme, companies retain the background rights to their programmes while enabling Cancer Research UK to take on early development work to evaluate the benefit to cancer patients. Three drugs are now in clinical trialswith others scheduled to open early 2013.

Cancer Research UK’s DDO will fund and undertake extensive preclinical work led by Professor Christian Ottensmeier at the University of Southampton, England, to further investigate the mechanism by which the protein destroys cancer cells and to further develop the drug for use in treating cancer patients.

The DDO will then fund, manage and sponsor the first Phase I clinical trial led by Professor Chris Twelves and Dr Christy Ralph at the Cancer Research UK/NIHR Leeds Experimental Cancer Medicine Centre, based at the University of Leeds, England. Lorus will manufacture and supply IL-17E for the non-clinical toxicology and Phase I clinical studies.

Professor Christian Ottensmeier, Cancer Research UK scientist at the University of Southampton, said: "This important partnership means we’ll be able to better understand how this molecule destroys cancer cells. We will investigate if it somehow supercharges the immune system to hunt down and attack cancer cells, or if it is able to trigger a ‘suicide’ signal in these cells so they self-destruct, or both, as suggested by research already done at Lorus.

"This will give us the evidence we need to take this drug further into clinical trials to investigate potential benefit to patients."

After the Phase I trial, Lorus will have the exclusive option to license the Phase I clinical trial data and resume further clinical development. If it does not exercise this option, the rights to the programme would be transferred to Cancer Research Technology to secure an alternative partner, with the aim to make the treatment available for cancer patients while Lorus would retain certain economic interests.

Dr Aiping Young, President and CEO of Lorus, said: "At Lorus our primary focus is to discover and develop novel therapies to treat some of the most important and hard-to-treat cancers. IL-17E fits all the criteria to potentially qualify as a truly unique, first-in-class cytokine-based approach to treating a range of solid tumours.

"Cancer Research UK is world renowned for its cancer research and has done similar partnership deals through its CDP initiative with some of the world’s largest pharmaceutical companies. We believe this partnership with Cancer Research UK is not only a validation of our IL-17E technology, but it also offers Lorus an innovative avenue to develop this programme, and affords us the opportunity to progress as many of our programmes as possible into the clinic.

"We are excited about collaborating with Cancer Research UK and its important network of academic and clinical collaborators in the immunotherapy field and look forward to the outcome of some key studies in the next 24 months."

Dr Victoria John, head of clinical partnerships, at Cancer Research UK’s Drug Development Office, said: "Without our unique CDP initiative, it might not have been possible to develop this promising treatment, stalling progress to provide potential new options for patients for whom existing treatments no longer work.

"We’re delighted to be working with our Canadian partner Lorus Therapeutics right from the start – collaborating closely in the preclinical research right through to manufacture and the first ever trial with patients.

"IL-17E is the third biological treatment we have brought into the CDP portfolio, building on our existing partnerships with international pharmaceutical and biotechnology companies to develop a multipeptide vaccine, a monoclonal antibody as well as five other molecularly targeted drugs.

"This latest partnership further demonstrates the breadth of molecules we can develop. And we will continue to seek future partnerships, so that by working alongside industry to combine skills and expertise we can reach our goal to license new treatments, and save more lives from cancer."

IL-17E was selected following a rigorous peer-review process conducted by Cancer Research UK’s New Agents Committee (NAC). Assessment of IL-17E by the NAC was based on several criteria, including scientific rationale, quality of the anticancer data in relevant tumour models, novelty, and clinical need. IL-17E is the eighth treatment to enter Cancer Research UK’s Clinical Development Partnerships (CDP) scheme.

(Presentation, EntreChem, NOV 26, 2012, View Source [SID:1234503759])

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Startup Glactone Pharma develops prostate cancer drug

Glactone Pharma is a new project company within PULS, Sweden´s largest private incubator in life science. Glactone Pharma develops a new drug against castration-resistant prostate cancer, a stage of the disease when the tumor is unresponsive to therapy with anti-hormonal drugs (Press release, Glactone Pharma, NOV 22, 2012, View Source [SID1234522052]). This corresponds to approximately 40% of all prostate cancer patients and they lack effective treatment today.

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Prostate cancer is the most common cancer in the western world and hundreds of thousands of men are affected each year. Castrate resistant prostate cancer is a more serious stage of the disease when anti-hormonal treatment no longer is effective. A multidisciplinary group consisting of researchers from Lund University, Skåne University Hospital and Cordoba University has studied the natural substance galiellalactone over many years. This substance has proven effective in inhibiting the growth of tumors.

– Our research has shown that this substance can inhibit a signal making castration-resistant prostate cancer cells divide in an uncontrolled way. The same signaling mechanism is also active in other types of cancer. The research, that from the beginning was curiosity-driven, is a great example of how Swedish academic research through PULS can be developed, commercialized and made useful for patients and doctors, says Olov Sterner, professor of organic chemistry at Lund University.

– With Glactone Pharma, PULS starts yet another project company developing a treatment against a disease with a huge unmet medical need. Glactone Pharma is a long-term project with great potential and with the goal to develop a treatment for severely ill cancer patients, says Pontus Ottosson, CEO of PULS.

Lewis and Clark Discover New Growth Route with CIT GAP Funds

On November 19, 2012 (HERNDON, Va.) – The Center for Innovative Technology (CIT) reported a $100,000 investment in Charlottesville, Va.-based Lewis and Clark Pharmaceuticals, Inc. (Lewis and Clark) (Press release, Lewis & Clark Pharmaceuticals, NOV 19, 2012, View Source [SID1234520532]). Nearly 200 years after Charlottesville native Meriwether Lewis, and his partner, William Clark, set out to discover the western territory of the United States, Dr. Robert Thompson and his team of scientists at Lewis and Clark Pharmaceuticals are discovering ways in which adenosine-based compounds can be used to solve difficult clinical challenges.

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CIT President and CEO Pete Jobse said, “Large pharmaceutical companies face over $100 billion in lost revenue through patent expirations by 2015. These companies need to fill the pipeline sooner, and Lewis and Clark is well positioned to be a leader in the development of novel adenosine-based pharmaceutical compounds for autoimmune and other diseases.”
While pharmaceutical companies regularly work with university researchers to find new discoveries, academics often lack expertise in moving compounds though pre-clinical testing and into clinical trials. Lewis and Clark solves the problem by focusing on developing new compounds from discovery through initial clinical trials and beyond.
The company will initially focus its efforts on two large markets: stress imaging, which represents a $1 billion annual market and autoimmune diseases such as rheumatoid arthritis, currently a $20 billion market. Lewis and Clark believes that its compounds are more selective, more potent and exhibit lower toxicity than comparable compounds.
Robert Thompson, Ph.D., Lewis and Clark Founder and CEO, an organic chemist with over 30 years of experience in designing and developing drug compounds, said, “We are filling a huge market need and CIT’s investment will help move us down the path to growth and commercialization.”
Tom Weithman, CIT Vice President and GAP Funds Managing Director, said, “It is truly inspirational to see the innovation taking place within biotech companies like Lewis and Clark, and it is an honor to help this experienced management team bring much needed therapies to market.”
Since its 2005 launch, CIT GAP Funds has placed over 75 investments across the Commonwealth, deploying greater than $7 million of public funds and attracting over $80 million more in private funding. For a list of portfolio companies, please visit the GAP Funds website.
About the Center for Innovative Technology, www.cit.org
CIT is a nonprofit corporation that accelerates the next generation of technology and technology companies. CIT creates new technology companies through capital formation, market development and revenue generation services. To facilitate national innovation leadership and accelerate the rate of technology adoption, CIT creates partnerships between innovative technology start-up companies and advanced technology consumers. CIT’s CAGE Code is 1UP71.
About the CIT GAP Funds, www.citgapfunds.org
CIT GAP Funds makes seed-stage equity investments in Virginia-based technology, clean tech and life science companies with a high potential for achieving rapid growth and generating significant economic return for entrepreneurs, co-investors and the Commonwealth of Virginia. CIT GAP Funds investments are overseen by the CIT GAP Funds Investment Advisory Board (IAB). This independent, third-party panel consists of leading regional entrepreneurs, angel and strategic investors, and venture capital firms such as: New Enterprise Associates, Grotech Ventures, Valhalla Partners, Harbert Venture Partners, HIG Ventures, Edison Ventures, In-Q-Tel, Intersouth Partners, SJF Ventures, Carilion Clinic, Johnson & Johnson, General Electric and Alpha Natural Resources.