Bristol-Myers Squibb and ZAI Lab Enter Licensing Agreement to Develop,Manufacture and Commercialize Brivanib in China

On March 23, 2015 Bristol-Myers Squibb Company (NYSE: BMY) and ZAI Lab Limited (ZAI Lab), a leading innovative biotech company based in China, reported that the companies have signed a definitive agreement under which ZAI Lab will acquire exclusive rights in China (including Hong Kong and Macau) to develop, manufacture and commercialize brivanib, an orally available kinase inhibitor in Phase 3 development for oncology indications including hepatocellular carcinoma (HCC).

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ZAI Lab will be responsible for developing, manufacturing and commercializing brivanib in China. Bristol-Myers Squibb will be eligible to receive developmentbased milestone payments and tiered royalties from the commercial sales of brivanib in China, if brivanib is approved for marketing by Chinese authorities. Bristol-Myers Squibb also will have the option to co-promote brivanib in China with ZAI Lab and share commercial profits. Bristol-Myers Squibb retains all development and commercialization rights to brivanib outside of China, Macau and Hong Kong. Additional terms were not disclosed.

"HCC is the most common form of primary liver cancer and patients with intermediate-stage HCC typically live only 20 months after diagnosis on average," said Karl Lintel, president, Bristol-Myers Squibb China. "We are pleased to partner with ZAI Lab to further investigate brivanib as a potential treatment for patients living with HCC in China. Earlier studies of brivanib in this patient population suggest brivanib may be an effective therapy, prolonging time to progression to advanced disease for patients who have no other effective treatment options."

Samantha Du, Ph.D., founder and CEO of ZAI Lab said: "We are very excited about this agreement. Brivanib has already been tested in multiple global Phase 3 studies with a large number of Chinese HCC patients participating in the trials. Encouraging
efficacy data have been observed among the Chinese HCC patients with an acceptable safety profile. China accounts for more than 50% of global annual incidence of liver cancer, with more than 400,000 new cases and 371,000 deaths in 2012. Based on the
preliminary analysis of the extensive Phase 3 data, brivanib may offer a new treatment option for Chinese HCC patients."

FORMA THERAPEUTICS AND CANCER RESEARCH TECHNOLOGY FORM TWO VIRTUAL COMPANIES TO ADVANCE DEUBIQUITINATION ASSETS

On March 23, 2015 FORMA Therapeutics and Cancer Research Technology, Ltd. (CRT) reported the formation of two new virtual Asset Discovery and Development Companies (ADDCos) with novel chemical matter targeting undisclosed deubiquitinating enzymes (DUBs) (Press release, Forma Therapeutics, MAR 23, 2015, View Source [SID:1234509334]). ADDCos are virtual companies seeking to achieve rapid innovation in a compelling scientific area through the collaboration of academic thought leaders, FORMA drug discovery scientists and a world class development network.

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This builds on an ongoing initiative between FORMA and CRT, the commercial arm of Cancer Research UK, to discover innovative tools, technologies and therapeutic drug candidates against a variety of DUBs that regulate protein homeostasis. Under their agreement, FORMA is pairing its ultra-efficient drug discovery capabilities with expertise from CRT’s Discovery Laboratories (CRT-DL) in translating academic discoveries and the exclusive world class academic network of Cancer Research UK scientists.

Protein ubiquitination, a highly regulated cellular process controlled in part by DUBs to maintain protein homeostasis with appropriate protein levels and function, contributes to a large number of wide-ranging human diseases when aberrantly dysregulated. DUBs, as members of diverse protein complexes, are key regulators of ubiquitin recycling, processing, proofreading and disassembly. DUBs contain a catalytic domain surrounded by one or more accessory domains, some of which contribute to target recognition, and collectively represent molecular features ideally suited for therapeutic intervention.

"DUBs continue to prove to be highly attractive drug discovery targets warranting further exploration," stated Steven Tregay, Ph.D., President and CEO, FORMA Therapeutics. "A tremendous impact has been made by organizing diverse scientific disciplines within a consortia framework to advance protein homeostasis research and discoveries into active research. Additionally, this partnership’s discovery programs, by virtue of structural and computational insights, have already helped accelerate new advances in medicinal chemistry."

These virtual companies represent the collective efforts of a collaborative consortium consisting of FORMA, CRT-DL and five Cancer Research UK scientists including:

Professor Michael Clague – University of Liverpool, Liverpool, UK
Dr. Benedikt Kessler – The University of Oxford, UK
Dr. David Komander – Medical Research Council, Laboratory of Molecular Biology, Cambridge, UK
Dr. Huib Ovaa – Chemical Biology Laboratory, Netherlands Cancer Institute, The Netherlands.
Professor Sylvie Urbé – University of Liverpool, Liverpool, UK

Keith Blundy, CEO of Cancer Research Technology, said, "The unique structure of this partnership unites complementary skills and capabilities to develop this very exiting emerging area of biology. The teams behind the newly formed virtual companies have proven expertise in translating research discoveries into potential new drugs – that may ultimately bring breakthrough cancer treatments to patients."

In vitro & in vivo potency against B-ALL of pro-apoptotic a-fucosylated anti CD19 MAb

IDD001 MAb exhibited the highest Complement Dependent Cytotoxicity (CDC) efficiency on B-ALL sample

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From its proprietary MAb library, iDD biotech has generated:
· next-generation, humanized, Fc optimized and afucosylated anti CD19 MAb,
· with higher level of apoptosis compared with MAbs anti CD19 under development,
· with enhanced binding of FcRIIIa and ADCC (patent WO/2012/010561/01056),
· against a broad range of B-lymphoma and leukaemia cell lines,
· with or without complement binding ability (MAb IDD001 versus MAb IDD002),
· produced using generic wild type CHO cell lines.

(Poster, iDD biotech, View Source [SID:1234502457])

Circumventing Rituximab resistance for B-CLL treatment by using anti CD19 MAb

Both IDD001 and ID002 exhibited antitumor efficacy and induced inhibition of tumor growth in vivo, demonstrating that CD19 is an attractive alternative target to circumvent Rituximab resistance for B-CLL treatment (Poster, iDD biotech, Circumventing Rituximab resistance for B-CLL treatment by using anti CD19 MAb, View Source [SID:1234502458]).

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IBI305

IBI305 is a biosimilar version of bevacizumab which is under development by Innovent Biologics for the treatment of colorectal cancer, lung cancer and other malignancies (Company Pipeline, Innovent Biologics, MAR 20, 2015, View Source;type=IBI305 [SID:1234502442]).

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