Array BioPharma, Pierre Fabre and Merck KGaA, Darmstadt, Germany Announce Phase 3 BEACON CRC Trial

Global partnership to conduct randomized, Phase 3 trial evaluating safety and efficacy of binimetinib, encorafenib and Erbitux® (cetuximab) in BRAF-mutant colorectal cancer
 
BOULDER, Colo., June 4, 2016  -- Array BioPharma (ARRY), Pierre Fabre and Merck KGaA, Darmstadt, Germany, today jointly initiated the BEACON CRC (Binimetinib,Encorafenib And Cetuximab Combined to treat BRAF-mutant Colorectal Cancer) trial, a randomized, global Phase 3 clinical trial designed to assess the safety and efficacy of binimetinib (MEK inhibitor), encorafenib (BRAF inhibitor) and Erbitux (monoclonal antibody) in comparison to Erbitux and irinotecan-based therapy in patients with BRAF-mutant colorectal cancer (BRAFm CRC). The primary endpoint is overall survival (OS) and key secondary endpoints include progression-free survival (PFS) and objective response rate (ORR).
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Cyclacel Reports Updated Data From Its DNA Damage Response Program on Seliciclib and Sapacitabine Combination in Patients With Solid Tumors at ASCO

Combination Showed 35.6% Disease Control Rate and Durable Responses including CR and PR in Heavily-Pretreated Patients with BRCA Mutations
 
BERKELEY HEIGHTS, N.J., June 06, 2016 -- Cyclacel Pharmaceuticals, Inc. (CYCC) (CYCCP) (Cyclacel or the Company), reported today updated Phase 1 data from its DNA damage response program evaluating a combination regimen of two Cyclacel product candidates, seliciclib, a cyclin dependent kinase (CDK) inhibitor, and sapacitabine, a nucleoside analogue. The regimen was orally-administered as sequential (Part 1) or concomitant (Part 2) treatment to 67 heavily-pretreated patients with advanced solid tumors. Antitumor activity was demonstrated in a subgroup of 45 patients with breast, ovarian and pancreatic cancers who tested positive for BRCA mutations (44 germline and 1 sporadic) with a 35.6% disease control rate (1 CR, 5 PR and 10 SD). Treatment durations in responders ranged between 16 and over 240 weeks. No CR or PR was observed in BRCA negative patients. Data were presented at an oral presentation at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
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VB-111 Clinical Data Presented at ASCO Demonstrate Significant Increase in Overall Survival in Platinum-Resistant Ovarian Cancer

VB-111 demonstrated a statistically significant increase in overall survival at therapeutic vs. low dose level (810 days vs. 172 days, p=0.042)
 
60% (9 of 15) durable response rate (as measured by reduction in CA-125) observed with VB-111, approximately 2x the historical response with Avastin®  plus chemotherapy in ovarian cancer
 
Clinical data supported by immunotherapeutic effect observed in biopsies following treatment with VB-111 
TEL AVIV, Israel, June 06, 2016  -- VBL Therapeutics (VBLT), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, today announced the presentation of updated clinical results from a Phase 1/2  trial of VB-111 in the treatment of patients with recurrent platinum resistant ovarian cancer.  
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Lion Biotechnologies Raises Approximately $100 Million in Private Placement

NEW YORK, NY--(June 03, 2016) -Lion Biotechnologies, Inc. (LBIO) today announced that it has entered into a securities purchase agreement with institutional and other accredited investors under which the investors have agreed to purchase a total of 9,684,000 shares of common stock and approximately 11,368,500 shares of newly authorized Series B Preferred Stock in a private placement for aggregate gross proceeds of approximately $100.0 million. The purchase price will be $4.75 for each share of common stock and $4.75 for each share of Series B Preferred Stock. The offering is expected to close on or about June 7, 2016, subject to customary closing conditions.
 
Each share of Series B Preferred Stock will become convertible into one share of common stock, subject to the approval of the company's stockholders in accordance with The NASDAQ Global Market rules. The Series B Preferred Stock is non-voting.
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Medovex Corporation Receives Positive Final Laboratory Test Results Report

ATLANTA, GA--(Marketwired - Jun 2, 2016) - Medovex Corp. (NASDAQ: MDVX), a developer of medical technology products, today announced that it has completed its first live tissue test via receipt of test positive results from January 11, 2016 non-human living tissue test of the DenerveX™ System.
 
According to Patrick Kullmann, President and COO of Medovex, "This latest test report is yet another example of the DenerveX System's potential in the intended use concept of the DenerveX System." The laboratory report conclusion stated that "The observed gross and histopathological changes at 30 and 60 days post treatment of the animal subjects were consistent with the findings expected for a radio frequency heating device combined with mechanical abrasion of the facet bone surface."
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