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Wednesday, March 25, 2015

Implementing JOBS Act, new SEC rules aim to move Reg A off life support
Hoping to revitalize Regulation A as a viable path for small companies to raise much-needed capital, the SEC today approved final rules setting up a two-tier approach to modernize the path and protect investors. Lifting the current annual $5 million Reg A cap to $20 million for Tier 1 and $50 million for Tier 2, the rules implement part of the Jumpstart our Business Startups (JOBS) Act that Congress passed in 2012 and aim to bring new life to the once-popular capital-formation path.

VBL’s gene therapy rolls out positive data; clinical hold lifted on phase III glioblastoma trial
Upbeat news with VB-111, its gene therapy for cancer, pushed shares of VBL Therapeutics Inc. (NASDAQ:VBLT) up 31 percent in midday trading, a rise of $1.75 to $7.34. The firm disclosed statistically significant interim top-line results from the ongoing phase II study in recurrent glioblastoma, where the compound yielded an improvement in overall survival (p = 0.05) in patients given the drug as a standalone and those who got VB-111 plus Avastin (bevacizumab, Roche AG) compared to patients treated with Avastin alone when their disease progressed. Full results will be disclosed at the American Society of Cancer Oncology meeting in late May and early June in Chicago. VBL has also said top-line data show the same drug in a phase IIa study against recurrent, iodine-resistant differentiated thyroid cancer brought disease stabilization plus a good safety profile in patients who had progressed after several lines of treatment. Also, in glioblastoma, the FDA has lifted the partial clinical hold and is allowing the pivotal phase III trial to go ahead under a special protocol assessment.

Icelandic sequencing project to ‘Decode’ path to precision medicine
LONDON – Decode Genetics Inc. has raised the insight genomics brings to the understanding of human disease to a new level through the sequencing of the complete genomes of 2,636 Icelanders, an advance the Amgen Inc. subsidiary claims has deep implications for clinical translation and the rollout of precision medicine. Reykjavik-based Decode has barely scratched the surface, though four papers published in Nature Genetics this week exemplify its potential, describing rare gene variants associated with liver disease, Alzheimer’s disease and early onset atrial fibrillation; the identification of human gene knockouts; and – based on an estimate of the rate of mutations on the Y chromosome – a new calculation of the date of the most recent common male ancestor.

Lpath comes up short in renal cell carcinoma study; shares fall
Lpath Inc., a small biotech based in San Diego saw its shares tumble in heavy trading today following news that its phase IIa single-agent, open-label study of Asonep, an anti-S1P antibody formulated for systemic administration, did not meet the primary endpoint of statistically significant progression-free survival in patients with advanced renal cell carcinoma. At noon, the company’s shares (NASDAQ:LPTN) were trading at $2.45, down about 25 percent.

BioPharma Asia: Biosimilars race in Asia sees Korea, India in lead, China lagging
SINGAPORE – South Korea and India are likely to remain the leading players in the biosimilars space in Asia and widen the lead they have on China, which remains a distant third. The regulatory approach of each market, development costs and drug pricing are all factors that will determine the success of each market, said executives on Wednesday during the 2015 BioPharma Asia Convention at Suntec Singapore. Taking those factors into account, one exec said China has “zero” chance of becoming a significant global biosimilar player any time soon.

Japan’s biopharma sector cites need for capital, culture, cooperation
TOKYO – A lack of a commercial mindset is holding back Japan’s biotech industry as academics find it difficult to move ideas from paper to market. A lack of cooperation among government, business and academia is one of the primary reasons behind the reluctance among researchers to take their discoveries to market, said speakers during the BIO Asia International Conference 2015. Other factors include a lack of adequate funding and the fear of failure pervading the culture itself.

Newco news: Mucosis lays battle plans for RSV’s front line, the nose
Mucosis BV, a Dutch company developing mucosal vaccines that can be applied needle-free via the nose or mouth, is rapidly advancing toward clinical studies that could pave the way for the arrival of broad-based and durable protection from respiratory syncytial virus.

Also in the news
Avalanche, Bellerophon, Biolinerx, Casi, Celladon, Cellectis, Cellular Biomedicine, Concert, Cymabay, Cytokinetics, Cytos, Dermata, Emergent, Esperion, Lexicon, Lycera, Marinus, Merck, Novartis, Novasep, Novavax, Oncolytics, Ranbaxy, Regenerx, Regentree, Regulus, Signum, Sun Pharma, Therapure, Vericel, ZS Pharma

 

See the next edition of BioWorld Today for more on these and many other stories.