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ImmunoCellular Therapeutics Receives Positive Regulatory Feedback from European Medicines Agency on Advancing ICT-107 to Phase III Program

On Decemebr 1, 2014 ImmunoCellular Therapeutics reported that the European Medicines Agency (EMA) has provided scientific advice supportive of advancing ICT-107 to a registrational phase III program in patients with newly diagnosed glioblastoma (GBM) (Press release ImmunoCellular Therapeutics, DEC 1, 2014, View Source [SID:1234501034]). The EMA guidance is consistent with the positive feedback the Company received from the US FDA relative to the scope, design and endpoints of the program and the inclusion of patients based on HLA and MGMT status. ImmunoCellular intends to finalize the design of the phase III program, ensuring harmony between US and EU trial protocols, with the goal of being in position to initiate the phase III program. The Company now is evaluating options for funding the phase III program, which may enable the initiation in 2015.

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"We appreciate the EMA’s support for conducting a phase III program with ICT-107, and for their detailed guidance on the treatment design and statistical elements of the program," said Andrew Gengos, ImmunoCellular Chief Executive Officer. "The encouragement we have received from both the US and EU regulatory authorities, and from the global neuro-oncology community, increase our confidence in ICT-107’s therapeutic potential for patients with this lethal disease. We intend to complete the design of a high quality phase III program, and to explore appropriate funding alternatives to enable next steps."

Earlier this year, ICT-107 was designated as an Advanced Therapy Medicinal Product by the EU Committee for Advanced Therapies, which should provide access in Phase III to valuable services and incentives offered by the EMA, should the Company conduct the phase III program in the EU.

Momenta Pharmaceuticals’ Necuparanib Receives Fast Track Designation From the FDA for the Treatment of Patients With Metastatic Pancreatic Cancer

On December 1, 2014 Momenta Pharmaceuticals reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the investigation of necuparanib, the Company’s novel oncology drug candidate, as a first-line treatment in combination with Abraxane and gemcitabine in patients with metastatic pancreatic cancer (Press release Momenta Pharmaceuticals, DEC 1, 2014, View Source [SID:1234501038]). Momenta recently announced the successful completion of Part A of the Phase 1/2 study and has initiated the Part B (Phase 2 proof-of-concept) study.

The FDA’s Fast Track Drug Development Program is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. This designation allows for companies to interact with the FDA review team frequently to discuss issues such as study design, extent of safety data required to support approval, the structure and content of an NDA, and other critical issues. In addition, such a product could be eligible for accelerated approval and/or priority review if supported by clinical data at the time of BLA, NDA, or efficacy supplement submission. If the FDA determines, after preliminary evaluation of clinical data submitted by a sponsor, that a Fast Track product may be effective, the Agency may also consider reviewing portions of a marketing application before the sponsor submits the complete application.

“Receipt of Fast Track designation from the FDA further supports our belief in the potential of necuparanib to enhance overall survival rates in patients with metastatic pancreatic cancer, a disease for which there are very limited treatment options,” said Jim Roach, MD, Chief Medical Officer of Momenta Pharmaceuticals. “We look forward to taking full advantage of the opportunities that Fast Track designation allows in order to maximize the possibility of an accelerated path to approval.”

In October 2014, Momenta completed the Part A dose escalation component of the Phase 1/2 clinical trial evaluating necuparanib in combination with Abraxane and gemcitabine in patients with advanced metastatic pancreatic cancer, and reported positive top-line data. Part B of the Phase 1/2 trial, currently underway, is a randomized, controlled, proof-of-concept study to evaluate the antitumor activity of necuparanib in combination with Abraxane plus gemcitabine, versus Abraxane plus gemcitabine alone. Momenta expects data from Part B to be available in the first half of 2017.

EISAI SUBMITS MARKETING AUTHORIZATION APPLICATION FOR ANTICANCER AGENT LENVATINIB IN SOUTH KOREA

On December 1, 2014 Eisai reported that it has submitted its application to the regulatory authority in South Korea (Ministry of Food and Drug Safety) for marketing approval of its novel in-house developed anticancer agent lenvatinib mesylate (lenvatinib) as a treatment for progressive radioiodine-refractory differentiated thyroid cancer (Press release Eisai, NOV 30, 2014, View Source [SID:1234501033]). Following the submission of marketing authorization applications in Japan, the United States and Europe, this marks the first time Eisai has submitted a marketing authorization application for lenvatinib in Asia.

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Lenvatinib is an oral molecular targeted agent that selectively inhibits the activities of several different molecules including VEGFR, FGFR, RET, KIT and PDGFR, involved in angiogenesis and tumor proliferation. This potentially makes lenvatinib a first-in-class treatment in thyroid cancer, especially given that it simultaneously inhibits the activity of the three molecules VEGFR, FGFR and also RET via its novel binding mode.

The application submitted for South Korea was based on the positive results from a global Phase III clinical study known as the SELECT (Study of (E7080) LEnvatinib in differentiated Cancer of the Thyroid) trial. (Please refer to the following notes for further details of the trial)

An application seeking the approval of lenvatinib for the indication of thyroid cancer was submitted in Japan in June 2014 as the first in the world, followed by the submission of applications in both the United States and Europe in August 2014. Lenvatinib was granted Orphan Drug Designation for thyroid cancer in by the regulatory authorities in Japan, Europe and the United States. In addition, lenvatinib was also granted an accelerated assessment in Europe by the European Medicines Agency, and granted priority review status in the United States by the U.S. Food and Drug Administration.

The number of patients newly diagnosed with thyroid cancer in 2012 in South Korea was estimated to be 33,000, and in Asia was estimated to be 144,000. Although treatment is possible for most types of thyroid cancer, there are few treatment options available once thyroid cancer has progressed, therefore it remains a disease with significant unmet medical needs.

Eisai is committed to exploring the potential clinical benefits of lenvatinib, and is working to obtain marketing approval in each country in Asia as soon as possible in order to further contribute to patients with thyroid cancer, and their families.

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]).

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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.