On January 7, 2014 Sutro Biopharma reported that it has entered into a collaboration agreement with Memorial Sloan-Kettering Cancer Center to use Sutro’s proprietary cell-free protein synthesis technology to produce bispecific antibodies that were discovered by Memorial Sloan-Kettering for the treatment of neuroblastoma in children (Press release Sutro Biopharma, JAN 7, 2014, View Source [SID:1234500756]).

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"Neuroblastoma is the most common extra-cranial solid tumor in children, and long-term survival for children with advanced disease diagnosed after 18 months of age is unsatisfactory despite aggressive chemotherapy," said Trevor Hallam, Ph.D., chief scientific officer of Sutro. "Sutro’s technology allows the generation, and importantly, the rapid screening of a large number of variations of bispecific antibodies. This will enable us to take bispecific antibodies with the desired characteristics faster into the clinic and potentially provide pediatric neuroblastoma patients with a much needed effective treatment option to combat this disease."

Under the collaborative agreement Sutro will use its cell free protein synthesis technology to produce four different bispecific antibodies discovered by Memorial Sloan-Kettering. These antibodies will be directed against CD3 on T-cells and, as the second target, against the ganglioside GD2, which is expressed on the surface of human neuroblastoma cells, as well as in melanoma and osteosarcoma. Nai-Kong V. Cheung, M.D., Ph.D., head of Memorial Sloan-Kettering’s Neuroblastoma program, will use preclinical models to test the bispecific antibodies manufactured by Sutro.

Dr. Cheung added, "We and others have previously shown that the use of an anti-CD3 and anti-GD2 bispecific antibody has a strong scientific rationale, and anti-GD2 monoclonal antibodies targeting the ganglioside GD2 have demonstrated efficacy in clinical trials in pediatric neuroblastoma. We hope that the use of Sutro’s technology will facilitate a more rapid, high-throughput optimization of these bispecific antibodies in the future, and allow us to investigate novel variants of these molecules quickly before bringing the winner to the clinic."

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])

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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 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.

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