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ISA Moving HPV Vaccine into Phase II with $10.5M Round
ISA Pharmaceuticals BV raised €8 million (US$10.5 million) in an internal financing round to fund a Phase II trial of its therapeutic vaccine for cervical cancer, ISA-HPV. The vaccine is based on the company's synthetic long peptide (SLP) technology, which was originally developed by Cornelius Melief at Leiden University Medical Center (LUMC) in the Netherlands. It already completed a Phase II trial in vulvar intraepithelial neoplasia (VIN), a precancerous condition also caused by humanBy Cormac Sheridan | BioWorld International | Wednesday, January 9, 2013 -
Anti-Inflammatory Strategy Could Reduce Miscarriage Risk
LONDON – For a healthy pregnancy to have the best chance of surviving, the cells lining the uterus must undergo a short-lived burst of inflammatory activity about five days after ovulation, which must come to a halt 48 hours later, researchers have found. The discovery suggested new ways of treating women who suffer recurrent miscarriages. A pilot randomized controlled trial in which women who previously had several miscarriages were treated with an anti-inflammatory drug or with a placeboBy Sharon Kingman | BioWorld International | Wednesday, January 9, 2013 -
Other News To Note
Actavis Inc., of Zug, Switzerland, recently acquired by Watson Pharmaceuticals Inc., of Parsippany, N.J., filed an abbreviated new drug application (ANDA) with the FDA for bortezomib, a generic version of Millennium: The Takeda Oncology Co.'s Velcade, a drug approved for multiple myeloma. Millennium filed a suit against Actavis on Dec. 21 in the U.S. District Court of Delaware to prevent Actavais from commercializing its bortezomib before expiration of some patents. The lawsuit filing includesBioWorld International | Wednesday, January 9, 2013 -
arGEN-X Expands Shire Deal; Starts Phase Ib Cancer Trial
LONDON – arGEN-X BV is making strides in the commercialization of its antibody platform, announcing an extension of its existing collaboration with Shire plc in rare diseases and at the same time advancing the lead in-house program into a Phase Ib first-in-man trial. The partnership with Shire began in March 2012, using arGEN-X's Simple (Superior Immunodiversity with Minimal Protein Lead Engineering) technology to discover antibodies with the potential to achieve orphan drug status. Based onBy Nuala Moran | BioWorld International | Wednesday, January 9, 2013 -
Heptares' GPCR Platform Lands Cubist Collaboration
LONDON – Heptares Therapeutics Ltd. convinced another partner of the power of its G protein-coupled receptor (GPCR) technology, sealing a deal with Cubist Pharmaceuticals Inc. around one – or possibly two – targets to be nominated by the quoted U.S. biotech. The full terms of the deal were not made public, but Heptares will receive $5.5 million up front and about $4 million in research funding for the first target, with milestones and royalties to follow if a program moves forward. Malcolm WeirBy Nuala Moran | BioWorld International | Wednesday, January 9, 2013 -
Swiss Kareus Therapeutics Aims Its KU-046 at Alzheimer's
Undeterred by the recent string of high-profile failures in the field, Kareus Therapeutics SA moved its first-in-class drug candidate for Alzheimer's disease, KU-046, into a Phase I trial in healthy volunteers. The company, based in La Chaux-de-Fonds, Switzerland, is taking a novel approach to the condition by focusing on events upstream from the deposition of amyloid beta (Abeta) peptide, which is considered one of the pathological hallmarks of the disease. It is testing a hypothesis thatBy Cormac Sheridan | BioWorld International | Wednesday, January 9, 2013 -
GlycoVaxyn Finalizes Deal to Fund Bioconjugation Program
LONDON – After landing the all-important validation of a deal with GlaxoSmithKline Biologicals (GSK) in December, GlycoVaxyn AG is expecting to finalize an agreement to fund development of its lead in-house program and seal further collaborations around its conjugated vaccine technology platform in 2013. Vaccines development and manufacture is a small world, explained GlycoVaxyn CEO Philippe Dro. "A biotech like us can make contact with most of the players in the field, and the research teamsBy Nuala Moran | BioWorld International | Wednesday, January 2, 2013 -
Selenium-Containing Stroke Drug Has Novel Antibiotic Mechanism
LONDON – A candidate drug that has previously been evaluated as a treatment for stroke turns out to be able to kill some types of pathogenic bacteria, an international team of researchers has found. As the mechanism of action identified is completely different to those used in current antibiotics, it may be possible to develop new types of antibiotics to treat multidrug-resistant bacteria, the researchers said. Arne Holmgren, professor of biochemistry at the Karolinska Institute in StockholmBy Sharon Kingman | BioWorld International | Wednesday, January 2, 2013 -
Four Decades of Work Yields Single European Patent System
LONDON – More than 40 years after it was first proposed, a single European patent will come into effect on Jan. 1, 2014, after a compromise deal was endorsed last month. The new patent will be cheaper and more effective in protecting intellectual property (IP), with one patent grant covering the 25 countries that are committed to joining the system. The European Commission estimated that obtaining a patent under the unitary scheme will cost €4,725 (US$6,245), compared to the current averageBy Nuala Moran | BioWorld International | Wednesday, January 2, 2013 -
Other News To Note
AstraZeneca plc, of London, and CytImmune Sciences Inc., of Rockville, Md., entered an agreement to study the feasibility of a new cancer nanomedicine that will bind an oncology compound from AstraZeneca to CytImmune's CYT-6091 nanomedicine platform. CYT-6091, which is comprised of gold nanoparticles bound with an immune avoiding molecule (PEG-Thiol) and tumor necrosis factor alpha (TNF), has been successfully tested at the National Cancer Institute in a Phase I trial in advanced-stage cancerBioWorld International | Wednesday, January 2, 2013 -
BioWorld's Top 10 Countdown of 2012's Most Impactful Stories
In the six decades since Watson and Crick discovered the structure of DNA, rarely has a year passed in the biopharmaceutical sector which could be defined as boring. The scientific revelations continue to yield intellectual property for businesses to develop. And investors scramble to identify and back potential blockbuster targets. 2012 was no different. BioWorld's editorial team huddled and voted on the 10 most poignant stories which emerged. Drum roll, please . . . 1. At Pharma's Long-DreadedBy BioWorld Staff | BioWorld International | Wednesday, January 2, 2013 -
Study Reveals New HIV Receptor on Antigen-Presenting Cells
LONDON – In a discovery that has important implications for the future of HIV therapy, an international team of researchers has identified the molecule by which the virus enters the immune cells known as dendritic cells. Those cells, which have a role in antigen presentation, are known to pick up HIV and deliver it to the virus' main target, the CD4-positive T cells. The latter become infected, instead of killing the virus. Now scientists from the AIDS Research Institute IrsCaixa in BarcelonaBy Sharon Kingman | BioWorld International | Wednesday, December 26, 2012 -
Medivir's Simeprevir Aces Three Phase III HCV Trials
Top-line data from three Phase III trials of simeprevir (TMC435) in patients with hepatitis C virus (HCV) genotype 1 infection appear to confirm what Medivir AB has always maintained – that it has a potentially best-in-class protease inhibitor on its hands. In two trials in treatment-naive patients, QUEST-1 (n = 394) and QUEST-2 (n = 391), simeprevir, administered once daily in combination with pegylated interferon and ribavirin (Peg/Riba), achieved sustained virologic response 12 weeks afterBy Cormac Sheridan | BioWorld International | Wednesday, December 26, 2012 -
Poxel Adds $17M in Series B for Diabetes Drug Imeglimin
LONDON – Poxel SA raised €13 million (US$17.3 million) in a Series B round that is intended to see its lead Type II diabetes treatment, imeglimin, through Phase IIb and into the arms of a commercialization partner. "I'm definitely pleased with the round. It was raised with historic investors who have been on board since 2010. They have good knowledge of the company," Thomas Kuhn, CEO, told BioWorld International. The majority of the proceeds will go to fund the six-month, 400-patient doseBy Nuala Moran | BioWorld International | Wednesday, December 26, 2012 -
Other News To Note
Addex SA, of Geneva, said scientific findings published in the Journal of Pharmacology and Experimental Therapeutics described the discovery and characterization of ADX71743, a potent and selective negative allosteric modulator of the metabotropic glutamate receptor 7. Data showed the compound was active in rodent models of anxiety and obsessive compulsive disorder. AIMM Therapeutics NV, of Amsterdam, the Netherlands, entered a strategic partnership with Cosmo Pharmaceuticals SpA, of MilanBioWorld International | Wednesday, December 26, 2012 -
Oncothyreon in Stock Plunge on Stimuvax Phase III Miss
Oncothyreon Inc. lost more than half its value during early trading last Wednesday after partner Merck KgaA disclosed that its cancer vaccine, L-BLP25 (Stimuvax), failed to meet the primary endpoint of overall survival in a pivotal Phase III trial in non-small-cell lung cancer (NSCLC). Merck, of Darmstadt, Germany, did say that "notable treatment effects were seen for L-BLP25 in certain subgroups," but other than that it remained completely tightlipped about the outcome of the trialBy Cormac Sheridan | BioWorld International | Wednesday, December 26, 2012 -
GSK Spinout NeRRe Begins with $19M, Neurokinin Drugs
LONDON – A third spinout has emerged from GlaxoSmithKline plc's neurosciences research portfolio, with the formation of NeRRe Therapeutics Ltd. The new company begins life with a portfolio of four neurokinin-1 receptor antagonists – of which two are ready for Phase II – and £11.5 million (US$18.7 million) in venture capital funding. NeRRe's co-founder and CEO is Emiliangelo Ratti, who was senior vice president of neurosciences drug discovery at GSK's Medicines Research Centre in Verona, ItalyBy Nuala Moran | BioWorld International | Wednesday, December 26, 2012 -
Karolinska Lands $34M Portfolio Investment from Rosetta Capital
Karolinska Development AB is getting an SEK220 million ($33.7 million) cash injection from Rosetta Capital Ltd. for 13 of the 25 companies in its portfolio. The new money will go a long way toward helping the firms, which are all early stage, gain enough maturity to find partners or buyers. "It gives us enough cash to reach all the major inflection points in our portfolio," Torbjörn Bjerke, CEO of Solna, Sweden-based Karolinska Development, told BioWorld International. The 13 companies spanBy Cormac Sheridan | BioWorld International | Wednesday, December 26, 2012 -
Vaccines Firm Goes to Vivalis in All-Share Deal Worth $175M
LONDON – The French vaccines manufacturing technology company Vivalis SA is acquiring Austrian vaccines discoverer and developer Intercell AG, of Vienna, in an all-share deal valued at €133 million (US$175 million). At the same time the merged company, to be named Valneva, is raising €40 million in a rights issue to strengthen the balance sheet and advance ambitions to become a fully integrated vaccines and antibody specialist. Valneva will be based in Lyon, France, with listings on the NYSEBy Nuala Moran | BioWorld International | Wednesday, December 19, 2012 -
Dutalys Gets First Taker for Bispecific Antibody Platform
Dutalys GmbH, an early stage company developing a bispecific antibody platform, entered a research collaboration with a top 10 pharmaceutical firm that could evolve into a product licensing alliance. The unnamed pharma company has obtained a research license, which provides it with access to the Dutalys technology, and it has signed an option agreement that would allow it to develop and commercialize up to three potential products. Dutalys, of Vienna, Austria, is receiving an annual technologyBy Cormac Sheridan | BioWorld International | Wednesday, December 19, 2012
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