Valneva´s partners Novartis and GlaxoSmithKline (GSK) to join forces and exchange assets
Novartis and GlaxoSmithKline (GSK) announced a major contemplated transaction, including the divestment of Novartis’ vaccine business (excluding flu) to GSK, expected to close in the first half of 2015 (Press release, Valneva, MAY 13, 2014, View Source;file=2014_05_13_Valneva_Q1_PR_EN.pdf [SID:1234502168]).
Overall, Valneva expects to benefit from its two existing strategic partners joining forces. The Company sees Valneva’s key assets partnered with Novartis as potentially highly complementary to GSK.
Valneva’s late stage Pseudomonas and C. difficile vaccines are not programs GSK already has in its R&D portfolio and may add significant value to the GSK R&D portfolio.
The Company does not expect any impact regarding its Flu/EB66 cell-culture partnership with GSK since the Novartis flu business (including their cell-culture based flu vaccine) is not part of the contemplated transaction at this point in time.

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On May 13, 2014 ASLAN Pharmaceuticals Pte Ltd reported a global license agreement to develop CSL Limited’s (ASX:CSL) anti-IL13 receptor monoclonal antibody, CSL334, currently in preclinical development for the treatment of asthma (Press release, ASLAN Pharmaceuticals, MAY 13, 2014, View Source [SID:1234512883]).
Under the agreement, ASLAN will fund and develop CSL334 through to clinical proof of concept in a development program conducted primarily in Asia, targeting patients suffering moderate persistent to severe allergic asthma whose disease is not adequately controlled by existing treatments. Upon achievement of clinical proof of concept, ASLAN will identify a global partner for phase 3 development and commercialisation.

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"Many patients with moderate and severe asthma still do not have their disease adequately controlled by current therapies, and these patients represent around half of the total burden of asthma worldwide," said Dr Mark McHale, ASLAN’s Chief Operating Officer. "Some major companies are now pursuing strategies to help these patients, many of whom live in fear of their next serious exacerbation. As one of the leaders in the biologics industry, CSL have developed a unique approach to controlling the pathways responsible for this disease."

"The IL-13 receptor signalling pathway plays a critical role in allergic airway disease, and CSL has had an interest in inhibiting this target since it was first identified at the Walter and Eliza Hall Institute of Medical Research in Australia. This led CSL scientists to discover and optimise the monoclonal antibody inhibitor known as CSL334," commented Andrew Nash, CSL’s Senior Vice President, Research. "ASLAN’s focus on efficiently designing and executing innovative clinical strategies, combined with its teams experience in asthma drug development, make it the ideal partner for moving this therapy forwards."

CSL will be entitled to share returns generated by ASLAN from partnering the project. Further financial details were not disclosed.

About CSL334 inhibitor
CSL334 is a fully human monoclonal antibody against interleukin-13 receptor α1 that has been shown to block binding and signal transduction of both IL4 and IL13. CSL334 is currently in preclinical development.

On May 13, 2014 Servier reported it has signed a strategic worldwide collaboration agreement with Novartis to develop and commercialize a series of novel drug candidates issued from Servier research programs in partnership with Vernalis in oncology, targeting apoptosis regulation pathways (Press release, Servier, MAY 13, 2014, View Source [SID:1234508829]).

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The collaboration covers the worldwide codevelopment of BCL-2 selective inhibitor candidates now entering into clinical development. Proteins of the BCL-2 family are crucial regulators of apoptosis. Dysregulation of this protein family play a major role in the aberrant survival of tumor cells.

Servier will remain responsible for research activities and will share responsibilities with Novartis to conduct a clinical development program aimed at moving swiftly toward a first indication for the benefit of patients.

Commercialization rights for products arising from the collaboration will be allocated between the parties on a geographic basis.

Jean-Pierre Abastado, Ph D, Director of the Center of Therapeutic Innovation in Oncology at Servier, said: "Small molecules tailored against specific targets can have very high therapeutic potential. This success was achieved through a comprehensive chemistry and biology research program, in collaboration with Vernalis, with our teams identifying and characterizing this exquisitely specific BCL-2 inhibitor. These new compounds further extend Servier’s portfolio beyond kinase inhibitors, HDAC inhibitors; and immunotherapeutic products."

Emmanuel Canet, MD, PhD, President of Servier R&D, commented that "this significant partnership is the recognition of Servier’s innovative approach to oncology research. By collaborating with one of the leaders in the field we are restating our commitment to provide innovative therapeutic solutions for unmet needs in patients with severe illnesses."

About the BCL-2 target:

Proteins of the BCL-2 family are crucial regulators of apoptosis, the programmed cell death. Dysregulations of this protein family play a major role in the aberrant survival of tumor cells. Within this protein family, BCL-2 belongs to the prosurvival members and is often overexpressed in tumor cells. Prosurvival BCL-2 family members have been recognized as attractive therapeutic targets in oncology for more than twenty years; but drug discovery research on this type of target is particularly challenging and requires innovative chemistry supported by structural biology.

On May 12, 2014 Verastem reported the expansion of its ongoing COMMAND study to include clinical trial sites in Japan. COMMAND is a registration-directed trial evaluating the Company’s lead candidate targeting cancer stem cells, VS-6063 (defactinib) a potent inhibitor of focal adhesion kinase (FAK), in patients with malignant pleural mesothelioma (Press release Verastem, MAY 12, 2014, View Source;p=RssLanding&cat=news&id=1929651 [SID:1234500515]). Mesothelioma is a highly aggressive form of lung cancer and a high percentage of cases contain cancer stem cells. With the inclusion of Japan, COMMAND is now accruing patients and pursuing parallel clinical development in the major markets worldwide.
Verastem recently reported the successful outcome of its Phase 1 trial of VS-6063 in Japanese patients with advanced solid tumors. The study results demonstrated that VS-6063 was well tolerated at all three dose levels tested. The data were consistent with the results from the US Phase 1 trial and there were no serious adverse events or evidence of dose-limiting toxicity. These results supported the Company’s application to the Japanese PMDA for the initiation of clinical trial sites to evaluate VS-6063 in Japanese patients with mesothelioma.

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Nothing new in cancer

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