On December 23, 2013 Cancer Research UK and Cancer Research Technology – the charity’s development and commercialisation arm – reported an agreement with AstraZeneca to take AZD2098, an experimental drug originally designed for asthma, into a clinical trial to treat kidney cancer (Press release, Cancer Research Technology, 23 23, 2013, View Source [SID1234523245]).

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This is the third agreement the parties have made under the Clinical Development Partnerships (CDP) scheme. CDP is a joint initiative between Cancer Research UK’s Drug Development Office (DDO) and Cancer Research Technology (CRT), to develop promising anti-cancer agents which pharmaceutical companies have not selected for further development and CRT is better placed to progress through early phase clinical trials. It is the ninth* treatment to enter Cancer Research UK’s CDP scheme, with 6 having progressed into the clinic.

This deal with AstraZeneca will enable the charity’s Drug Development Office to complete preclinical development and carry out early clinical trials of the compound to see if it can benefit kidney cancer patients. Cancer Research UK’s DDO is also funding the early phase trial of AZD2098 in which up to 40 patients will take part commencing in 2015.

AZD2098 targets a molecule found on immune cells called CCR4, which is important for directing these cells to where they need to go. It is thought that in kidney cancer, immune cells move to the tumour because of this molecule. Once the immune cells arrive, the tumour often forces them to become inactive, or worse, help the cancer develop.

By blocking this function, AZD2098 may change the immune cell environment around the cancer, encouraging those cells to attack the tumour. CCR4 has also been found to be expressed on the surface of cancer cells, which may provide an additional way for this blocker to impair tumour growth. The work establishing the potential anti-tumour effect of AZD2098 was carried out by Professor Frances Balkwill at Queen Mary University of London’s Barts Cancer Institute and was supported by Cancer Research UK.

Professor Tom Powles, trial lead and Cancer Research UK clinician at Queen Mary University of London, said: "I’m excited that we will be able to repurpose this drug for the treatment of kidney cancer. The fact that we can now search for new treatments for cancer among drugs that were already in development for other diseases demonstrates how much more we understand the basic nature behind what drives cancer.

"AZD2098 potentially allows us to target the support network which helps keep cancer cells alive, and it may be particularly potent in kidney cancer. As cancer treatments become more and more refined and our ability to attack the disease from new angles increases, we hope to bring forward the day when we can cure this disease."

Susan Galbraith, Head of the Oncology Innovative Medicines Unit at AstraZeneca, commented, "We are pleased to see AZD2098 being taken forward by Cancer Research UK to assess a novel hypothesis identified in translational studies led by Professor Frances Balkwill in collaboration with scientists at AstraZeneca."

Around 9,600 people in the UK are diagnosed with kidney cancer each year and the incidence rates in Britain have more than doubled since the 1970s.

Dr Nigel Blackburn, Cancer Research UK’s director of drug development at the DDO, said: "We’re delighted to reach this agreement for such a promising new drug which can potentially wake up the immune system to help fight our cancer battles for us.

"This is the ninth drug from our CDP programme – without the scheme it simply might not have been possible to provide this drug to patients. We’ll continue to build on these successes to accelerate the development of further treatments though new trials of drugs which otherwise may not have reached patients for many years.

On December 18, 2013 Domain Therapeutics, a France-based biopharmaceutical company that specializes in the research and development of new drug candidates that target G-protein coupled receptors (GPCRs), reported the signing of a licensing and partnership agreement on GPCRbiosensor technology with Université de Montréal (UdeM) and its commercialization unit, with the Institute for Research in Immunology and Cancer – Commercialization of Research (IRICoR), as well as with McGill University (Press release, Domain Therapeutics, DEC 18, 2013, View Source [SID1234626506]).

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The GPCR biosensor technology was developed with the support of a grant from the Quebec Consortium for Drug Discovery (CQDM), whose mission is to fund breakthrough technologies with the financial support of major pharma companies. This project was overseen by a team of researchers from UdeM’s Institute for Research in Immunology and Cancer (IRIC) led by Dr. Michel Bouvier. Dr. Bouvier is internationally renowned for his work on GPCRs.

The agreement gives Domain Therapeutics co-exclusive access, with AstraZeneca, Merck and Pfizer having access via their participation in the CQDM, to biosensor technology developed by Dr. Bouvier’s team. This new approach, which makes it possible to discriminate the functional activation of intracellular signalling pathways associated with GPCRs, is considered a prime technology for accelerating the discovery and development of biased ligands for this class of receptors.

In addition, Domain Therapeutics will offer a unique service in profiling drug candidates for the pharma and biotech industries. Domain Therapeutics also leverages a screening platform called DTect-All, designed to discover innovative drugs that target GPCRs. By combining the two technologies, Domain Therapeutics can discover and optimize more effective non-toxic therapeutic candidates for its internal programs and for collaborative programs with industry partners.

The biosensor technology already covers more than twenty signaling pathways and, under the terms of the agreement, a partnership will also be set up for the joint development of additional biosensors. IRIC researchers and their colleagues from UdeM, McGill University and Université de Sherbrooke will contribute their research expertise in molecular pharmacology.

"This technology, which is unique in the world, strengthens our capacity to discover the drugs of tomorrow, more effective and also safer," says Pascal Neuville, Chief Executive Officer of Domain Therapeutics. "The scientific quality of Dr. Michel Bouvier’s lab and his international reputation offer our company tremendous expertise in the future use of this technology."

"The combination of our innovative approaches leading to a joint project that brings together our complementary expertise is extremely good news, since improving the efficacy of existing drugs and developing new drugs require establishing innovative partnerships like this one with Domain Therapeutics," notes Michel Bouvier, principal investigator at IRIC and CEO of IRICoR.

Under the terms of the agreement with the UdeM, Domain Therapeutics will make an upfront payment on signing. The company will also pay an annual access fee for the technology, as well as royalties on income earned from sales of screening services and sales of drugs resulting from its own research and partnership activities. Domain Therapeutics will also provide financial support for the discovery of new biosensors.

"We welcome this highly promising partnership to develop the drugs of tomorrow between Domain Therapeutics and a seasoned team from our University, led by Michel Bouvier, an international expert in basic molecular pharmacology research and an innovative mind," says Geneviève Tanguay, Vice-Rector of Research, Creation and Innovation at the Université de Montréal.

"McGill University has a proud history of innovation and product development in numerous fields, especially the life sciences," states Dr. Rose Goldstein, McGill’s Vice-Principal (Research and International Relations). "We very much look forward to continuing this tradition through our partnership with Domain Therapeutics and Université de Montréal – a collaboration that has the potential to create new and better treatments for patients."

About G-protein coupled receptors and biosensor technology
G-protein coupled receptors (GPCRs) belong to the family of membrane receptors and constitute one of the main classes of therapeutic targets for many indications of the central nervous system, metabolic disorders and cardiovascular, respiratory, urinary or gastrointestinal diseases. The binding of a hormone or a specific ligand to a receptor’s binding site activates one or several pathways for intracellular signalling, which enables the cell to provide an adapted response to the change in its environment. The many drugs that target GPCRs represent about 40% of all treatments on the market, but only address 15% of GPCRs. Industry scientists in the sector are now researching treatments that work on the remaining 85% of GPCRs, treatments better adapted to patients’ physiology and with fewer risks of side effects. The molecules in question are called allosteric modulators and biased ligands. Biosensor technology enables us to understand the signalling pathways that are activated by each candidate molecule and thus predict its pharmacological profile. This approach makes it possible to choose at a very early development stage the molecule(s) that have the best chance of being active without presenting side effects or inducing tolerance to treatment.

On December 17, 2013 Provectus Pharmaceuticals, Inc. (OTCQB:PVCT) (http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, reported that shareholders in a special meeting voted to change the Company’s name to Provectus Biopharmaceuticals, Inc. and reincorporate in Delaware effective promptly upon regulatory filings in Delaware and Nevada. The company’s common stock will continue to trade under the symbol "PVCT" on the Over-the-Counter exchange. The name change and reincorporation proposals both had support from over 99% of shareholders who voted.

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Dr. Craig Dees, PhD, CEO of Provectus, said, "We thank our shareholders for their support as the Company takes these two important steps to protect their interests and communicate our plans for the future."

Dr. Dees added, "We felt that a change in the corporate name to ‘Provectus Biopharmaceuticals, Inc.,’ better communicates to the public the current and future nature of the Company’s business operations and enables the Company to better implement its business plan. In particular, the Company’s drug product candidates (pharmaceutical preparations) in both the oncology and dermatology therapeutic areas have either shown, or are expected to show through independent research, a capacity to harness the immune system of those patients treated. For oncology patients, this means using their bodies’ own disease-fighting capabilities to aid in reducing their tumor burden in various cancer indications. For dermatology patients, these same immune-system abilities can reduce the inflammation of their various inflammatory dermatoses. Both of these approaches to treat disease relate to properly utilizing the patient’s biologic or immune system and not just the direct treatment of his or her disease. Thus, ‘biopharmaceutical’ is a more apt term. The new name does not affect our business, operations, reporting requirements or stock price but will require a new CUSIP."

Dr. Dees also said, "Reincorporation in Delaware gives us more flexibility, clarity and predictability with respect to our corporate governance. Generally, the corporate laws of the State of Delaware are more comprehensive, widely-used and extensively interpreted than the corporate laws of other states, including Nevada. In addition, Delaware provides a recognized body of corporate law that is consistently interpreted by Delaware courts, which we believe will facilitate corporate governance by our officers and directors. All of this will enhance transparency to the benefit of our shareholders."

At the same time, Provectus announced that it has appointed Bob Miglani, Senior Director, External Medical Affairs at Pfizer Inc., to its Corporate Advisory Board. Bob also serves on the Board of Directors of the Alliance For US India Business (AUSIB), and as an Advisor on the Health Systems Strengthening Task Force at the Public Health Foundation of India (PHFI), where he is a leading advocate for elevating the Indian-American voice in the public conversation, both in the US and India. An active volunteer, Bob helps to mentor high school students in underprivileged areas around the world as part of the Albert Schweitzer’s Leadership for Life Program.

Mr. Miglani said, "I am delighted to join the Corporate Advisory Board of Provectus and look forward to using my extensive pharmaceutical industry knowledge and experience to help Provectus move its novel therapeutics forward on both the clinical and commercial fronts."

Dr. Dees stated, "We are thrilled to welcome Bob Miglani to our Corporate Advisory Board and are confident that he will make valuable contributions to our Company. Bob’s big pharma background and broad experience in sales, marketing, reimbursement strategy, medical affairs and alliance building are a unique fit with our strategic initiatives. His appointment will enhance our efforts to increase visibility and awareness among key audiences."

On December 12, 2013 BIND Therapeutics reported that it has amended its development and commercialization collaboration agreement with Amgen Inc. to extend the period during which Amgen may exercise its option by six months (Press release BIND Therapeutics, DEC 12, 2013, View Source [SID:1234500589]). BIND entered into a global collaboration agreement with Amgen on January 7, 2013 to develop and commercialize a kinase inhibitor nanomedicine for treating a range of solid tumors based on BIND’s platform for targeted and programmable nanomedicines and Amgen’s undisclosed proprietary kinase inhibitor. Under the agreement, Amgen had twelve months from the effective date to exercise its option to select a novel Accurin candidate for further development. The option period under the amended collaboration agreement has been extended to July 7, 2014 to allow for completion of the research plan. None of the other terms of the original agreement have been changed.

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Amgen has the exclusive right to pursue development and commercialization of an Accurin kinase inhibitor against solid tumor targets to be selected by Amgen. Both companies are working together on preclinical development and agreed that Amgen would assume responsibility for any future development and commercialization. BIND is eligible to receive up-front and development milestone payments totaling $46.5 million, up to an additional $134 million in regulatory and sales milestone payments for the first therapeutic indication and additional payments for target exclusivity. BIND will receive tiered royalties on potential future sales.

(Press release, Boehringer Ingelheim, DEC 10, 2013, View Source [SID:1234505083])

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