On April 24, 2013 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that the U.S. Food and Drug Administration (FDA) has designated lambrolizumab (MK-3475) as a Breakthrough Therapy for the treatment of patients with advanced melanoma. Lambrolizumab is Merck’s investigational antibody therapy targeting Programmed Death receptor (PD-1) that is currently being evaluated for the treatment of patients with advanced melanoma, and other tumor types (Press release, Merck & Co, APR 24, 2013, View Source [SID1234525947]).

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"We are pleased that the FDA has designated lambrolizumab a Breakthrough Therapy for patients with advanced melanoma," said Gary Gilliland M.D., Ph.D., senior vice president and oncology franchise head, Merck Research Laboratories. "The FDA’s decision to place lambrolizumab in a category that may enable expedited development and review is an important milestone for Merck as we advance ongoing programs in multiple cancer indications."

The designation of an investigational drug as a Breakthrough Therapy is intended to expedite the development and review of a candidate that is planned for use, alone or in combination, to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. The Food and Drug Administration Safety and Innovation Act (FDASIA) includes a provision that allows sponsors to request that an investigational drug be designated as a Breakthrough Therapy. The implications of Breakthrough Therapy Designation cannot be determined at this time.

In November 2012, early interim results from a single-arm, open-label Phase Ib study of lambrolizumab (MK-3475) administered to 85 patients with advanced (inoperable and metastatic) melanoma were presented at the Society for Melanoma Research of the 9th International Congress of the Society for Melanoma Research (SMR) in Hollywood, Calif. (see news release).

Advanced melanoma

Advanced melanoma accounts for more than 80 percent of skin cancer-related deaths and one to two percent of all cancer deaths in the United States1. According to the American Cancer Society, in 2012 in the U.S. an estimated 9,180 people died from advanced melanoma.

About PD-1

Researchers have shown that several tumor types are able to hide in plain sight by establishing a "molecular camouflage" that deceives the body’s immune system into thinking they are normal and therefore allow them to grow unchecked. The interaction between the immune checkpoint receptor PD-1 (programmed death) and its ligands represents a potentially important tumor-specific immunomodulatory mechanism. By utilizing the PD-1 pathway, a tumor cell can prevent the activation of T-cells and therefore may block a key step that triggers the immune system.

About lambrolizumab

Lambrolizumab is an investigational antibody therapy designed to disrupt the action of the immune checkpoint protein PD-1 and therefore inhibit the ability of some cancers to evade the body’s immune system. Lambrolizumab is being studied in multiple cancer types including melanoma and non-small cell lung cancer

On April 23, 2013 THE CANCER RESEARCH TECHNOLOGY PIONEER FUND (CPF) reported its first investment in a collaboration with the Cancer Research UK Cancer Therapeutics Unit at The Institute of Cancer Research, London, to develop a promising class of drugs called MPS1 inhibitors to treat cancer (Press release, Cancer Research Technology, 23 23, 2013, View Source [SID1234523257]).

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Cancer Research Technology (CRT), Cancer Research UK’s commercial arm, and the European Investment Fund (EIF) launched the £50m CPF to bridge the UK funding gap between cancer drug discovery and early treatment development and appointed Sixth Element Capital to manage the fund.

Today’s investment, the first made by the CPF, will build on initial research by Cancer Research UK-funded researchers at The Institute of Cancer Research (ICR)*. Investment by the CPF will boost the ICR team, allowing them to accelerate the development of MPS1 inhibitors, and will fund early clinical trials of potential drugs developed through the collaboration.

MPS1 belongs to a family of proteins called mitotic checkpoint kinases, responsible for correctly organising cell division. When these proteins are faulty, they cause defective cell division, fuelling the disease. Previous studies have shown that MPS1 is present in high levels in many different types of cancers including breast and prostate. High amounts of the protein have also been linked to increased genetic instability in tumours – making MPS1 an attractive target for anti-cancer drug discovery.

Ian Miscampbell, managing partner of Sixth Element Capital, said: "We’re delighted to announce the first project to be funded by the CRT Pioneer Fund and to be collaborating with the ICR team.

"This investment will pave the way for potential new cancer drugs to be taken into Phase I clinical trials. If the first studies are successful we’ll seek industry partners to further develop and commercialise these drugs."

Professor Paul Workman, deputy chief executive of The Institute of Cancer Research and director of its Cancer Research UK Cancer Therapeutics Unit, said: "We are delighted to work with the CRT Pioneer Fund to help accelerate progress on the exciting MPS1 inhibitors we have discovered at the ICR. This type of funding is absolutely essential to bridge the innovation gap so that patients can benefit quickly from the range of promising new molecularly targeted cancer drugs that we are discovering for personalised medicine."

Dr Keith Blundy, chief executive of Cancer Research Technology, said: "It’s fantastic news that this key investment from the CRT Pioneer Fund is already enabling scientists to take steps to bridge the development gap in UK drug discovery.

"Without this vital investment, development of these promising compounds might have been delayed for years. We’re delighted that this collaboration will progress these new promising treatments from the laboratory right through to completion of the first clinical trial – accelerating research to bring potential new treatments to patients as quickly as possible."

(Press release, Horizon Discovery, APR 22, 2013, View Source [SID:1234504950])

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On April 22, 2013 BIND Therapeutics and AstraZeneca reported that they have entered into a strategic collaboration to develop and commercialize an Accurin, a targeted and programmable cancer nanomedicine from BIND’s Medicinal Nanoengineering platform, based on a molecularly targeted kinase inhibitor developed and owned by AstraZeneca (Press release BIND Therapeutics, APR 22, 2013, View Source [SID:1234500587]).

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The collaboration is based on emerging data suggesting that nanomedicines like Accurins selectively accumulate in diseased tissues and cells, leading to higher drug concentrations at the site of the tumor and reduced exposure to healthy tissues.

Under the terms of the agreement, the companies will work together to complete Investigational New Drug (IND)-enabling studies of the lead Accurin identified from a previously-completed feasibility program. AstraZeneca will then have the exclusive right to lead development and commercialization and BIND will lead manufacturing during the development phase. BIND could receive upfront and pre-approval milestone payments totaling $69 million, and more than $130 million in regulatory and sales milestones and other payments as well as tiered single to double-digit royalties on future sales.

"We are excited to grow this collaboration with AstraZeneca, a leading global biopharmaceutical company committed to developing innovative medicines for patients," said Scott Minick, President and CEO of BIND. "One year ago, BIND started several feasibility projects with major pharmaceutical companies. Our collaboration with AstraZeneca is the first one completed and had very successful results. Due to the advanced nature of this program, we now plan to move an Accurin with optimized therapeutic properties quickly into product development."

"AstraZeneca believes that targeted therapies which specifically address the underlying mechanisms of disease are the future of personalized cancer treatment," said Susan Galbraith, Head of AstraZeneca’s Oncology Innovative Medicines Unit. "Our oncology teams are actively exploring a range of platforms to deliver targeted therapies, with a strategic focus on unlocking the significant potential of nanoparticles as an approach to cancer treatment. We view BIND’s targeted nanomedicines as a leading technology in this field."

On April 22 2013 BioInvent reported that the first patient has been treated in a phase II study of the drug candidate BI-505, developed for the treatment of multiple myeloma (Press release BioInvent, APR 22, 2013, http://www.bioinvent.com/investors/press-releases/release.aspx?releaseid=765492 [SID:1234500564]). The study is conducted in patients with asymptomatic myeloma (called "smoldering multiple myeloma"). Smoldering myeloma patients have not developed symptoms of disease and the condition can be detected only in laboratory tests. The current study involves up to 10 patients and evaluates disease activity following treatment with BI-505. Secondary objectives include safety, pharmacokinetics and assessment of biomarkers.

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