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Eleison Announces Achievement of Enrollment Milestone in its Phase II Trial of ILC for Pediatric Bone Cancer

On January 3, 2014 Eleison Pharmaceuticals LLC, a specialty pharmaceutical company developing life-saving therapeutics for rare cancers, reported that it has passed the half-way point for enrollment in the first stage of its ongoing Phase II study of ILC (Inhaled Lipid-complexed Cisplatin), for the treatment of patients with pediatric osteosarcoma (bone cancer) (Press release, Eleison Pharmaceuticals, JAN 3, 2014, View Source [SID1234517400]). The single-arm trial employs a Simon two-stage design and is evaluating the safety and efficacy of ILC. Currently, eight centers in the U.S. are open for patient enrollment, and additional sites are expected to open in the coming weeks. More information about the study may be found at the www.clinicaltrials.gov website.
"Osteosarcoma often spreads to the lungs, which unfortunately is difficult to treat and has a poor prognosis," commented Dr. Forrest Anthony, CMO of Eleison Pharmaceuticals. "ILC has been designed to treat patients with lung metastases, and thus the ongoing Phase II study is enrolling patients who have recently experienced a first or second pulmonary recurrence," indicated Dr. Anthony.
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(Press release, Advanced Vaccine Therapeutics, JAN 2, 2014, View Source [SID:1234505756])

BeiGene begins patient enrollment in phase I study of BGB-283

On December 23, 2013 BeiGene reported that it has enrolled first patient in a phase I study of BGB-283 in patients with B-RAF or K-RAS mutations. BGB-283 is an investigational, oral, selective, potent second generation inhibitor of B-RAF, making it a targeted therapeutic candidate to potentially treat and bring benefit to patients with cancers that harbour BRAF mutations and/or aberrations in the RAS-MAPK (mitogen-activated protein kinase) pathway (Press release BeiGene, DEC 23, 2013, View Source [SID:1234500417]).
BGB-283 is part of BeiGene’s two-asset strategic collaboration with Merck. Established earlier this year, the goal of the partnership is to leverage Merck’s global oncology development and commercialization expertise. The phase I multi-centre, open-label, dose escalation clinical trial of BGB-283 is designed to assess the safety, tolerability and pharmacokinetic properties of BGB-283 as a single agent. The study is expected to only enroll subjects who have B-RAF or K-RAS mutations. Key objectives in the study include determining maximum tolerated dose, pharmacokinetics, pharmacodynamics and preliminary anti-tumour activity of BGB-283. Disease-specific expansion cohorts will be enrolled at the maximally tolerated or biologically relevant dose.
The mitogen-activated protein kinase (MAPK) pathway comprises several key signalling components that play critical roles in tumourigenesis. Alteration of the RAS-MAPK pathway has frequently been reported in human cancer as a result of abnormal activation of receptor tyrosine kinases or gain-of-function mutations mainly in the RAS or RAF genes. Activating mutations of the RAS family genes (H-RAS, K-RAS, and N-RAS) comprise up to 30 per cent of all human cancers. B-RAF mutations also have been reported in seven to eight per cent of all human cancers. Accordingly, components of this pathway are important therapeutic targets for cancer treatment.

Cancer Research UK and AstraZeneca sign deal to repurpose asthma drug that could fight kidney cancer

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]).

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.

Domain Therapeutics, Université de Montréal, IRICoR and McGill University sign new licensing and partnership agreement

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]).

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.