Author: [email protected]

(Filing, 20-F, Compugen, FEB 18, 2014, View Source [SID:1234503784])

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Novartis investigational compound LDE225 met primary endpoint in pivotal trial for patients with advanced basal cell carcinoma

On February 19, 2014 Novartis announced that the pivotal trial of LDE225 (sonidegib) in advanced basal cell carcinoma met its primary endpoint of demonstrating an objective response rate among patients within six months of treatment (Press release Novartis, FEB 18, 2014, View Source [SID:1234500094]). Objective response included complete response (clinically significant tumor response with complete absence of disease) and partial response (clinically significant tumor shrinkage).
Full study results will be presented at a future scientific meeting.

Cellectis (Alternext: ALCLS), an expert of allogeneic CAR T cell therapies, today announced that it has signed a strategic collaboration agreement with Servier, the first independent French pharmaceutical research company, to develop and commercialize novel product candidates targeting leukemia and solid tumors

On February 17, 2014 Cellectis announced that it has signed a strategic collaboration agreement with Servier (Press release Cellectis, FEB 17, 2014, View Source [SID:1234500089]).
The partnership covers the development and potentially the commercialization of Cellectis’ lead product candidate, UCART19. Engineered allogeneic CD19 T-cells currently stand out as a real therapeutic innovation for treating various types of leukemias and lymphomas.
The agreement also included research, development, and potentially the commercialization of five other product candidates targeting solid tumors.
Cellectis will be responsible for the R&D of certain product candidates through the end of Phase I. Servier may exercise an exclusive worldwide option for a license on each product candidate developed under the agreement. Upon exercising each option, Servier will be responsible for taking over clinical development, registration and commercialization of each product.
The financial terms of the collaboration include an upfront payment of $10 million and up to $140 million for each of the six product candidates potentially developed, spread over various milestones in the development and commercialization phases. In addition, Cellectis will receive royalties on the sales of commercialized products.

Novartis expands cancer immunotherapy research program with acquisition of CoStim

On February 17, 2014 Novartis announced the acquisition of CoStim Pharmaceuticals Inc., a Cambridge, MA-based, privately held biotechnology company focused on harnessing the immune system to eliminate immune-blocking signals from cancer (Press release Novartis, FEB 17, 2014, View Source [SID:1234500084]). With this acquisition Novartis is adding late discovery stage immunotherapy programs directed to several targets, including PD-1.
Financial terms are not disclosed.

REGiMMUNE Completes $9.2 Million Series D Financing

On February 14, 2014 REGiMMUNE Corporation reported the closing of a Series D financing earlier this month (Press release, REGimmune, FEB 14, 2014, View Source [SID1234642236]). The company raised $9.2 million US in this new round, which was led by Japan Asia Investment Corporation (JAIC) and Nippon Venture Capital Corp (NVCC). Additional investors participating in this round are new investors Mizuho Capital, Nissei Insurance, KSP, Inc., the core business entity that operates the Kanagawa Science Park, and Mitsui Sumitomo Insurance Venture Capital Co.,Ltd.. Existing investors SMBC Venture Capital Co., Ltd., the VC arm of Sumitomo Mitsui Banking Corporation, and Mitsubishi UFJ Bank Capital also invested in this financing. Proceeds from this funding will be used primarily to support the company’s early stage product development.
REGiMMUNE successfully completed a Phase I study of RGI-2001 for Graft versus Host Disease (GvHD) and recently announced it has initiated a Phase II clinical trial for RGI-2001. Data from the Phase I study showed no safety concerns up to the highest dose and some preliminary signs of efficacy were observed.
Haru Morita, President and Chief Executive Officer, said "We now have positive human clinical data that validates the usefulness of our immune-regulating technology platform. The financing announced today will allow us to fund new programs based on our proprietary technology including therapeutics for type 1 diabetes, celiac disease, and inhibitor formation in enzyme replacement therapies (ERT) such as hemophilia and lysosomal diseases."

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