BIOWORLDTM TODAY THE DAILY BIOPHARMACEUTICAL NEWS SOURCE JUNE 30 , 2016 BIOTECH’S MOST RESPECTED NEWS SOURCE FOR MORE THAN 20 YEARS VOLUME 27, NO. 126 LIPID JAM NOT OVER EASILY STOPPED FOR FUTILITY Waffle house? FDA Galena Biopharma implodes as PRESENT review fidgets endpoint, puts cancer vaccine Neuvax future in doubt outcome details; By Jennifer Boggs, Managing Editor Esperion grilled on holdup With the bulk of Galena Biopharma Inc.’s value riding on cancer vaccine Neuvax By Randy Osborne, Staff Writer (nelipepimut-S), the firm’s shares predictably plunged to a new 52-week low Wednesday as an independent data monitoring committee (IDMC) recommended the Analysts had plenty of questions but PRESENT phase III study in breast cancer be stopped for futility following a planned Esperion Therapeutics Inc. offered few interim analysis. But it’s the troubling language in the IDMC’s letter, suggesting the answers regarding the FDA’s stalling on placebo arm might actually have bested the treatment arm, that could signal the end oral, once-daily bempedoic acid (ETC- of the road for Neuvax. 1002) for lipid lowering, after the agency See Galena, page 3 See Esperion, page 4 CHINA DEALS AND M&A IN THE CLINIC Pfizer invests in Asia Merck strikes cancer SUPER ‘NOVA’ with $350M biotech vaccines deal with Tesaro shares blast plant in Hangzhou Moderna, delivering off as niraparib hits By Haky Moon, Staff Writer $200M up front PFS in ovarian cancer HONG KONG – China’s economy may By Michael Fitzhugh, Staff Writer By Marie Powers, News Editor be slowing down, but multinationals Findings from the phase III NOVA trial are positioning themselves to leverage Cancer vaccines tailored to fit tumor- specific profiles are at the heart of a new of niraparib in women with recurrent it as best they can while navigating a ovarian cancer blasted shares of still-complex regulatory environment. strategic collaboration and licensing deal between Merck & Co. Inc. and developer Tesaro Inc. to an historic See Pfizer, page 5 See Moderna, page 6 See Tesaro, page 7 THE BIOWORLD BIOME U.S. NEWS REGULATORY Cancer stem cell Jiangsu Hengrui heads AN ALTERNATIVE TO ESOPHAGECTOMY vaccine shown optimal West to grow innovative Biostage seeks orphan in adjuvant setting pipeline via $100M JV designation for Cellspan By John Fox, Staff Writer By Shannon Ellis, Staff Writer esophageal implant By Liz Hollis, Staff Writer HONG KONG – Dendritic cell-based SHANGHAI – Jiangsu Hengrui Medicine vaccine strategies that target cancer Co. Ltd. is one of China’s most profitable Months after rebranding itself, Biostage stem cells (CSCs) may be most effective non-state-run pharmaceutical firms Inc. is asking the FDA for orphan drug when they are used in the adjuvant focused on generics. With a market cap designation for its Cellspan esophageal setting, according to findings of a new of $14.2 billion, last year Jiangsu Hengrui implants, designed as an alternative to See Vaccine, page 8 See Hengrui, page 9 See Biostage, page 10 For Sales Inquiries: http://ip-science.interest.thomsonreuters.com/Bioworld_Sales_Inquiry. NORTH AMERICA, Tel: +1-855-260-5607. Outside of the U.S. and Canada, Tel. +44-203-684-1797. For Customer Service Inquiries, NORTH AMERICA, Tel: +1-800-336-4474. Outside of the U.S. and Canada, Tel. +44-203-684-1796. Or email [email protected]. Copyright ©Thomson Reuters. Reproduction is strictly prohibited. Visit our website at www.bioworld.com. THURSDAY, JUNE 30, 2016 BIOWORLD™ TODAY PAGE 2 OF 13 preferred stock at $800 per share sold directly to affiliates of FINANCINGS BVF Partners L.P. for gross proceeds of $13.8 million. Antriabio, Inc., of Louisville, Colo., said it raised approximately Cytune Pharma SAS, of Nantes, France, said it closed a $12 million from a private placement. Accredited investors €6 million (US$6.7 million) financing round from existing and institutions paid $1.10 for one share of common stock investors to advance the RLI15 lead program to phase I testing. and received warrants exercisable for five years at $1.65 for Key investor PPF Group and the founding shareholders also one share of common stock. The transaction was led by pH agreed on a full buyout of the remaining shares at the start Pharma, an affiliate of SBI Investment Korea, which was spun of phase I. RLI15 and its platform, based on a modified and out of Softbank. The company will use the proceeds for general improved IL-15, is designed to allow for combinations with other corporate purposes including preparation for phase I studies for immunotherapeutic strategies, including checkpoint inhibitors. AB101, an injectable once-weekly basal insulin for patients with Iroko Pharmaceuticals LLC, of Philadelphia, said it has type 1 and type 2 diabetes. entered a $140 million debt facility agreement with CRG LP to Argos Therapeutics Inc., of Durham, N.C., said it closed the retire an existing debt facility and provide additional working second tranche of its private financing raising a total of $29.8 capital for the company. The specialty pharma has developed million. The company sold a total of 5.47 million shares of a franchise of re-engineered low-dose Solumatrix NSAIDs common stock and warrants to purchase a total of 4.1 million that offer effective pain management options for health care shares of common stock (0.75 shares of common stock for each professionals. Cantor Fitzgerald acted as the exclusive financial share of common stock purchased), based on a purchase price advisor in this transaction. per share of common stock and accompanying warrant equal Kitov Pharmaceuticals Ltd., of Tel-Aviv, Israel, said it priced its to $5.44375. The transaction was triggered by a previously public offering of 2.37 million class A units, consisting of one announced recommendation from the company’s independent American Depositary share (ADS), traded on Nasdaq under data monitoring committee that its pivotal ADAPT phase III trial of the symbol KTOV, at $3.40 per unit, and a warrant to purchase AGS-003 to treat metastatic renal cell carcinoma should continue. one ADS, as well as 1.15 million class B units at $3.40 per unit, Bio-Path Holdings Inc., of Houston, said it agreed to sell about consisting of a non-listed, pre-funded warrant to purchase one 5.9 million shares of common stock and warrants to purchase up ADS, and a listed warrant. Gross proceeds are expected to be to 2.9 million shares in a registered direct offering to health care- approximately $12 million, with the net amount being used to focused institutional investors. Gross proceeds will total about fund the possible acquisition of new therapeutic candidates $10 million. H.C. Wainwright & Co. LLC is acting as the exclusive and for general working capital purposes. placement agent. Bio-Path is developing BP1001 (liposomal Sernova Corp., of London, Ontario, said it is increasing its non- Grb2 antisense), which is in phase II testing in blood cancers and brokered private placement to C$4.2 million (US$3.2 million), in preclinical development for solid tumors. Shares of Bio-Path equal to 16.8 million units at C$0.25 each, to accommodate (NASDAQ:BPTH) closed Wednesday at $1.97, down 22 cents. additional over-subscriptions. The company initially raised $2 Cascadian Therapeutics Inc., of Seattle, said it closed million from the sale of 8 million units in their first closing. an underwritten public offering of 40.25 million shares A further 8.8 million units will be sold to generate for C$2.2 of its common stock at $0.80 each for gross proceeds of million, in a second and final closing on June 30. Each unit $32.2 million. In addition, the company closed a previously consists of one common share and one common share purchase announced offering of 17,250 shares of series D convertible warrant, exercisable into one share at C$0.35 per share. PRACTICAL INFORMATION For Sales Inquiries: http://ip-science.interest.thomsonreuters.com/Bioworld_Sales_ BIOWORLD TODAY Inquiry. NORTH AMERICA, Tel: +1-855-260-5607. Outside of the U.S. and Canada, Tel. +44-203-684-1797. For Customer Service Inquiries, NORTH AMERICA, Tel: +1-800-336- BioWorld™ Today (ISSN# 1541-0595) is published every business day by 4474. Outside of the U.S. and Canada, Tel. +44-203-684-1796. Thomson Reuters, 115 Perimeter Center Place, Suite 1100, Atlanta, GA 30346 For ad rates & information, contact Chris Venezia toll free at (855) 260-5607 or, outside U.S.A. the U.S. and Canada, at (646) 522-6243, email [email protected]. For photocopy rights or reprints, please contact Chris Venezia toll free at (855) 260- Opinions expressed are not necessarily those of this publication. Mention of 5607 or, outside the U.S. and Canada, at (646) 522-6243, or by email at christopher. products or services does not constitute endorsement. [email protected]. All Rights Reserved. No part of this publication may be reproduced without Send all press releases and related information to [email protected]. the written consent of Thomson Reuters (GST Registration Number BUSINESS OFFICE R128870672). Donald R. 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