ASLAN Pharmaceuticals signs agreement with CSL to develop novel therapy for asthma

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.

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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8-K – Current report

In January of 2014, patient enrollment in its Phase 3 study of the CPX-351 in patients 60-75 years of age with high-risk (secondary) AML, reached 50% of the study’s planned enrollment of 300 patients (Filing 8-K , Celator Pharmaceuticals, MAY 12, 2014, View Source [SID:1234500519]). Patient enrollment is currently on track to be completed in the fourth quarter of 2014.

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

As of April 2014, it is in the 7th cohort of patients. The dose escalation continues to progress as they have not yet observed any DLTs or the MTD (Filing 10-Q , CellCeutix, MAY 12, 2014, View Source [SID:1234500521]). The company anticipates this endpoint will be reached in the second half of 2014.

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