Servier enters into a global collaboration agreement for the development and the commercialization of new drugs candidates targeting apoptosis in oncology

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.

10-Q – Quarterly report [Sections 13 or 15(d)]

Nothing new in cancer

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10-Q – Quarterly report [Sections 13 or 15(d)]

Celator Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing 10-Q , Celator Pharmaceuticals, MAY 12, 2014, View Source [SID1234500520]).

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10-Q – Quarterly report [Sections 13 or 15(d)]

RXDX-102 has been designated as a back-up compound to RXDX-101 and with respect to which the company will not devote further development resources unless the development program for RXDX-101 is unsuccessful (Filing 10-Q , Ignyta, MAY 12, 2014, View Source [SID:1234500513]).

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Verastem Announces Initiation of COMMAND Study in Japan

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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