Edison Investment Research - Sunesis Pharmaceuticals (SNSS) Redirection after EMA application pulled

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Edison Investment Research

Maxim Jacobs

Redirection after EMA application pulled

Sunesis reported in May 2017 that it has pulled its application to the EMA for the approval of vosaroxin for the treatment of acute myeloid leukemia, based on feedback from the agency. The program has been de-emphasized and the new lead is SNS-062, the company’s Bruton's tyrosine kinase (BTK) inhibitor with potential efficacy in Imbruvica-resistant chronic lymphocytic leukemia (CLL). The SNS-062 program will be initiating a Phase Ib/II clinical trial in Q217.

10/05/2017 5 EN

Underlying

Sunesis Pharmaceuticals

Sunesis Pharmaceuticals is a biopharmaceutical company focused on the development of new targeted inhibitors for the treatment of solid and hematologic cancers. The company's primary activities are conducting research and development internally and through corporate collaborators, in-licensing and out-licensing pharmaceutical compounds and technology and conducting clinical trials. The company's primary program is vecabrutinib, a non-covalent inhibitor of Bruton's Tyrosine Kinase. The company is also developing SNS-510, a phosphoinositide-dependent kinase-1 inhibitor licensed from Millennium Pharmaceuticals, Inc., a wholly-owned subsidiary of Takeda Pharmaceutical Company Limited.

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US8673287004 United States

Provider

Edison Investment Research

Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisors and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting.

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Analysts

Maxim Jacobs

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Sunesisâ€™s task in realigning the company towards its new lead asset SNS-510 is twofold. First, it is examining the precise direction it intends to take the drug, and it has found synergies both with certain genetic subtypes of cancer as well as with other cancer drugs. Secondly, the company is both raising capital and reducing costs in order to provide the drug a runway into the clinic, and it estimates that it has cash through most of 2021.

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Sunesis announced on 23 June that it would not be advancing vecabrutinib to the Phase II portion of its Phase Ib/II study following the results from its highest dose (500mg) cohort. The cohort had three stable disease (SD) responses out of six patients enrolled in the cohort, and Sunesis determined that this level of activity was not sufficient to warrant advancing the program. The company will now refocus efforts on developing its PDK1 inhibitor SNS-510, for which it expects to file an IND by the end of 2020.

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Redirection after EMA application pulled

Sunesis Pharmaceuticals - A shift of gears

Sunesis Pharmaceuticals - Vecabrutinib not to progress, SNS-510 elevated

Thanks to a better fundamental star rating, SUNESIS PHARMS.INCO. sees an upgrade to Neutral

Actinogen Medical - Funding in place through key catalysts

Henderson Opportunities Trust - A differentiated exposure to smaller companies

CLIQ Digital - Increased churn weakens FY24 outlook

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