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Cancer Research UK to collaborate with AstraZeneca in screening for new cancer medicines at the AstraZeneca MRC UK Centre for Lead Discovery

On November 28, 2014 AstraZeneca and Cancer Research UK reported that they have signed a memorandum of understanding through which Cancer Research UK drug discovery investigators would be given access to state-of-the-art drug discovery facilities at the new AstraZeneca MRC UK Centre for Lead Discovery to be built in Cambridge (Press release, Cancer Research Technology, NOV 28, 2014, View Source [SID1234523217]).

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As part of the five-year collaboration scientists from Cancer Research UK, through it’s Drug Discovery Units, will benefit from unprecedented access to over two million molecules in AstraZeneca’s compound library and world class screening tools at the facility which will be located within the new AstraZeneca site at the Cambridge Biomedical Campus.

High-throughput screening methods will be used to identify lead compounds within the compound library including fragment-based lead generation, in which small chemical fragments are screened against drug targets; screening of a collection of compounds potentially useful for blocking kinase drug targets, and phenotypic screens to identify active compounds within cells that could be starting points for new drugs.

Cancer Research UK and AstraZeneca screening scientists will work alongside each other on up to five drug screens annually. Cancer Research UK will decide which novel cancer drug discovery projects to investigate and AstraZeneca has the option to negotiate a commercial license with Cancer Research Technology, Cancer Research UK’s commercial arm, to progress the most promising candidates through further drug discovery and development.

Alexa Smith, Cancer Research UK’s Head of Translational Research Funding said: "Having access to AstraZeneca’s extensive compound library and innovative drug discovery technology will help our researchers quickly translate new discoveries into patient benefit. We hope this initial proposed agreement will develop into a longer term arrangement that will boost our drug discovery capabilities further, with scope to develop similar strategic partnerships with other leading drug discovery organisations in future."

Chris Watkins, Director of Translation and Industry at the MRC, said: "It’s fantastic to see the AstraZeneca MRC UK Centre for Lead Discovery attracting another potential innovative collaboration so soon after its inception. Cancer Research UK will bring world-leading expertise in oncology research that fits well with the collaborative spirit of the planned MRC and AstraZeneca partnership and contribute further to building a thriving UK research base and closer engagement between academic and industry scientists."

Menelas Pangalos, Executive Vice President, Innovative Medicines and Early Development, AstraZeneca said: "We’re delighted to build on our strong relationship with Cancer Research UK. This research programme at the AstraZeneca MRC UK Centre for Lead Discovery demonstrates how we will create a truly permeable research environment at our new site in Cambridge. We intend for our scientists to work alongside leading Cancer Research UK scientists, taking advantage of our world-class facilities, to push the boundaries of science and accelerate oncology drug discovery."

Launch of Sustained-Duration G-CSF Product G-Lasta in Japan

On November 27, 2014 Kyowa Hakko Kirin reported that sustained-duration G-CSF product G-Lasta subcutaneous injection 3.6mg (G-Lasta) [generic name: pegfilgrastim (genetical recombination)] will be launched in Japan on November 28, 2014 (Press release Kyowa Hakko Kirin, NOV 26, 2014, View Source [SID:1234501021]).

G-Lasta is a sustained duration form of Granulocyte Colony-Stimulating Factor (G-CSF) product, which is produced by PEGylation of filgrastim, for decreasing the incidence of chemotherapy-associated febrile neutropenia. While filgrastim requires repeated daily doses over several days, G-Lasta shows comparable efficacy with a single dose per chemotherapy cycle. G-Lasta is therefore expected to reduce the burden of drug administration and to decrease frequent hospital visits of outpatients undergoing chemotherapy. Also, prophylactic administration of G-Lasta prior to febrile neutropenia is expected to reduce risks of infection, which results in clinical benefits such as improving the compliance with doses and schedules of chemotherapy.

Pegfilgrastim, originally generated by Amgen, Inc., was licensed from Kirin-Amgen Inc., to Kyowa Hakko Kirin. It has already been approved in 107 countries and regions around the world.

Kyowa Hakko Kirin is focusing on the oncology area, along with three other focused areas as our category-based strategy. Kyowa Hakko Kirin is expecting to contribute to the treatment of cancer patients through the approval of drugs in accordance with medical needs.

BACIT seeks shareholder approval to commit £20m and join CRT Pioneer Fund as a limited partner

On November 26, 2014 Cancer Research Technology Limited (CRT), The European Investment Fund (EIF) and BACIT Limited (BACIT) reported that BACIT is seeking shareholder approval to permit an investment into the CRT Pioneer Fund (CPF) (Press release, Cancer Research Technology, NOV 26, 2014, View Source [SID1234523218]). BACIT would invest alongside CPF’s two existing investors, taking the total capital committed to the Fund to £70m.

BACIT’s commitment is subject to obtaining the approval of its shareholders at a shareholder meeting which is scheduled for 15 December 2014.

The CPF was established in 2012 by the EIF and CRT as a specialist fund focused on investing in oncology assets to take them from late discovery through to entry to Phase II clinical trials thereby plugging a gap in the UK funding of drug discovery. Through its relationship with CRT, the Fund has access to drug discovery and development programmes supported by Cancer Research UK, the world’s largest independent funder of oncology research.

BACIT’s potential commitment follows a decision earlier in the year by EIF and CRT to commit a further £25m to double the size of the Fund from its initial first close of £25m.

To date the CPF has invested in four novel cancer projects, comprising early stage lead optimisation and later stage pre-clinical assets. The Fund is managed by Sixth Element Capital LLP (6EC), an FCA authorised fund manager set up to implement novel solutions to bring finance and innovation together within the healthcare sector.

Commenting on today’s announcement, Dr Robert James, Managing Partner of 6EC, said: "We are delighted that BACIT has chosen the CPF as the vehicle through which it can best manage its investments in oncology drug discovery. This decision validates the approach that we have been adopting to identify investment opportunities in the oncology sector. By increasing the size of the CPF to £70m we will be able to further diversify the portfolio of investments made by the Fund thereby increasing the chances of benefiting the cancer patient and maximising the chances of a successful outcome for all of our investors".

Dr Piyush Unalkat, Principal – Equity Investments, commented: "Since its inception the CPF has met its milestones for establishing what is becoming an increasingly diversified and commercially attractive portfolio with CRT continuing to deliver a pipeline of outstanding projects. The EIF will be very pleased to welcome BACIT as a like-minded, long-term investor committed to bring oncology treatments to the market faster for the benefit of patients."

Dr Keith Blundy, CEO of Cancer Research Technology, said: "This additional investment in the CPF will enable us to fund more projects in drug discovery and early development to bring potential new treatments to patients as quickly as possible. Through our research, Cancer Research UK has contributed to the discovery or development of nearly 50 drugs now being tested in clinical trials. These drugs could, if successful, save many thousands of lives in the future."

Vargatef® (nintedanib*) approved in the EU for lung cancer patients with advanced adenocarcinoma after first-line chemotherapy

On November 27, 2014 Boehringer Ingelheim reported that the European Commission has granted EU marketing authorisation for Vargatef (nintedanib), valid for the 28 countries within the EU (Press release Boehringer Ingelheim, NOV 26, 2014, View Source [SID:1234501020]). Vargatef in combination with docetaxel is indicated for use in adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology, after first-line chemotherapy.

“The approval of nintedanib offers a much needed new treatment option for adult lung cancer patients with advanced adenocarcinoma in the second-line setting,” commented PD. Dr Martin Reck, Head of Department of Thoracic Oncology, Lung Clinic Grosshansdorf, Germany and lead investigator of the LUME-Lung 1 trial. “The clinical data has shown that patients receiving nintedanib plus docetaxel experienced over one year overall survival with no further compromise to their quality of life, compared to docetaxel alone.”

Adenocarcinoma is the most common type of lung cancer and the majority of patients are diagnosed in an advanced stage. Most patients will experience disease progression during or after first-line chemotherapy and there is a significant unmet need for new, effective second-line treatments.

“We are delighted by the European Commission’s decision to approve Vargatef in the EU and feel extremely proud that our long standing commitment to oncology research and development has brought a new option to lung cancer patients with this specific type of disease,” said Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim. “The approval of Vargatef expands our oncology portfolio, following last year’s approval of GIOTRIF (afatinib) for another specific type of lung cancer. In the idiopathic pulmonary fibrosis indication, nintedanib has recently been approved by the U.S. FDA.”

The approval of nintedanib, a triple angiokinase inhibitor, is based on the outcomes of the LUME-Lung 1 clinical trial which enrolled 1,314 patients with NSCLC, after first-line chemotherapy. Data from the study, published in Lancet Oncology (Feb 2014), demonstrated that compared to docetaxel alone, nintedanib* when added to docetaxel significantly extended median overall survival from 10.3 to 12.6 months (p=0.0359; HR: 0.83) for patients with adenocarcinoma, with a quarter of patients surviving for two years or more (survival at 24 months – nintedanib plus docetaxel, 25.7% of patients vs. placebo plus docetaxel, 19.1% of patients, p=0.0359; HR: 0.83).

Nintedanib demonstrated a manageable adverse event profile without further compromising patients’ overall health-related quality of life. Adding nintedanib to docetaxel did not significantly increase discontinuation rates, compared to docetaxel alone.

Nintedanib is an oral, twice-daily treatment and is the second approved compound in the Boehringer Ingelheim oncology portfolio. GIOTRIF (afatinib) was the first oncology drug from the portfolio to be approved to treat non-small cell lung cancer patients with distinct types of EGFR-mutation positive NSCLC.

Xenetic Biosciences Provides Update on Substantial Patent Grants and Allowances in U.S. and Worldwide

On November 25, 2014 Xenetic Biosciences, Inc. (OTCBB:XBIO), a biopharmaceutical company focused on developing next-generation biologic drugs and novel oncology therapeutics, reported an update on recent patent grants and allowances worldwide (Press release, Xenetic Biosciences, NOV 25, 2014, View Source [SID1234537817]).

Since May 2014, the Company has been issued 10 patents, including six in the U.S., two in Japan and one each in New Zealand and India. In addition, 13 patents have been allowed, including seven in the U.S., two each in Japan and South Korea, and one each in Russia and Canada. Xenetic Biosciences now has over 140 issued patents worldwide and approximately 80 pending patents.

Select key patents issued recently by the U.S. Patent and Trademark Office include Patent No. 8,796,207, Derivatisation of erythropoietin (EPO), which relates to novel polysaccharide derivatives of EPO and methods for producing such derivatives. The derivatives are useful for improving the stability, pharmacokinetics and pharmacodynamics of EPO. This same patent was also issued in Japan during the third quarter.

U.S. Patent No. 8,735,557, Activated sialic acid derivatives for protein derivatisation and conjugation, was also recently granted and relates to polysialic acid and derivatives of polysialic acids which have terminal sialic acid units. This patent covers the targeted conjugation of polysialic acid and its derivatives to therapeutics such as peptides, proteins, drugs, drug delivery systems, etc.

Also issued during the third quarter was U.S. Patent No. 8,828,405, Method to Enhance an Immune Response of Nucleic Acid Vaccination. This patent relates to a composition comprising liposomes associated with a nucleic acid operatively encoding an antigenic protein and with an assistor protein. The composition provides an improved immune response compared with mixtures of liposomes, some of which are associated with the nucleic acid and some of which are associated with the assistor protein.

"Xenetic Biosciences has a substantial patent portfolio to rival any biotech company many times our size. This work results directly from our previous strategy focused on research. Now that we have transformed into a clinical development company, we are well positioned for potentially monetizing our extensive intellectual property portfolio. We expect to add 13 additional patents over the next three months," said M. Scott Maguire, chief executive officer of Xenetic Biosciences. "We are particularly pleased with our intellectual property position in Japan as those patent grants are typically difficult to secure. Our IP relates not only to our ‘bio-better’ EPO, our lead candidate, but also to improving availability of a number of protein-based drugs. We recently received an allowance for a U.S. patent relating to novel polysaccharide derivatives of granulocyte colony-stimulating factor (GCSF) and methods for producing such derivatives. The derivatives are useful for improving the stability, pharmacokinetics and pharmacodynamics of GCSF. Our expectations are that we will have strong intellectual property protection for many years after our lead compounds have progressed through the U.S. regulatory process," Mr. Maguire added.