20-F/A [Amend] – Annual and transition report of foreign private issuers [Sections 13 or 15(d)]

BioLineRx has filed a 20-F/A [Amend] – Annual and transition report of foreign private issuers [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, BioLineRx, MAR 23, 2015, View Source [SID1234502488]).

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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."

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

GenSpera has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, GenSpera, MAR 23, 2015, View Source [SID1234502489]).

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Pfizer And Lilly Preparing To Resume Phase 3 Chronic Pain Program For Tanezumab

On March 23, 2015 Pfizer Inc. and Eli Lilly and Company reported that they are preparing to resume the Phase 3 clinical program for tanezumab (Press release, Eli Lilly, MAR 23, 2015, View Source;item=137402 [SID:1234513834]). As a result, Pfizer expects to receive a $200 million upfront payment from Lilly in accordance with their collaboration agreement. This announcement follows a decision by the U.S. Food and Drug Administration (FDA) to lift the partial clinical hold on the tanezumab development program after a review of a robust body of nonclinical data characterizing the sympathetic nervous system response to tanezumab. The data were submitted to the FDA in February 2015.
In the prior clinical studies of more than 11,000 patients, tanezumab demonstrated clinically meaningful efficacy vs. placebo and other select commonly used pain medicines. A partial clinical hold has been in place for tanezumab and all other anti-nerve growth factor antibodies since December 2012 due to adverse changes in the sympathetic nervous system of mature animals. Studies in terminal cancer pain were allowed to proceed.

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"We are pleased with the FDA’s decision as chronic pain remains an area of significant unmet medical need and we believe tanezumab has potential to offer a new, non-narcotic option," said Steve Romano, MD, senior vice president and head of Global Medicines Development at Pfizer’s Global Innovative Pharmaceuticals Business.

"We’re pleased to work with Pfizer to resume the Phase 3 program, and we’re confident that tanezumab, if approved, can be an innovative treatment with the potential to help millions suffering from painful conditions," said David Ricks, Lilly senior vice president and president, Lilly Bio-Medicines.
It is estimated that nearly one in five adults suffer from chronic pain.

About Tanezumab
Tanezumab is a humanized monoclonal antibody that selectively targets nerve growth factor (NGF), a regulator of pain processing and sensitivity. NGF levels increase as a result of injury or inflammation and in chronic pain states. Tanezumab selectively binds to NGF, thereby inhibiting this protein from activating pain-signaling neurons.

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])