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BioNotebook: Zafgen, PaxVax, Genmab/Janssen, Ligand

This article was originally published in Scrip

Zafgen raises $45m; PaxVax garners $22m; Genmab, Janssen expand collaboration; and Ligand boosts 2013 guidance.

Zafgen completes $45m Series E fundraising for Phase IIb trial

Zafgen raised $45m in Series E venture capital, which the Cambridge, Massachusetts-based company will use to finance a Phase IIb clinical trial for its weight loss drug beloranib. The twice-weekly injectable therapy is a selective inhibitor of methionine aminopeptidase 2 (MetAP2), an enzyme that controls the production and utilization of fat. Beloranib is designed to improve fat metabolism by reducing the production of fatty acid molecules by the liver and helping to convert fat into useful energy.

RA Capital Management, Brookside Capital, Venrock, Alta Partners, an undisclosed blue chip investor and an unnamed private investor backed Zafgen's Series E round. President and CEO Thomas Hughes told Scrip in October that Zafgen was happy to maintain its independence by conducting a Phase IIb clinical trial with new venture capital to increase the value of beloranib before engaging a pharmaceutical partner or launching an initial public offering to fund Phase III development (scripintelligence.com, 11 October 2013).

Zafgen reported in June that beloranib-treated individuals lost up to 10kg, or about 22lbs, after 12 weeks of treatment in an interim analysis of data from 19 people enrolled the company's 148-patient Phase II clinical trial (scripintelligence.com 25 June 2013). The company's recently presented final analysis of data from the 122 severely-obese patients who completed the study showed significant weight loss and improvements in cardiometabolic risk factors for people treated with beloranib. The average weight loss ranged from 5.5kg to 10.9kg across the three doses tested versus 0.4kg in the placebo arm of the study (p<>

PaxVax raises $22m in Series B funds for Phase III oral cholera vaccine

Menlo Park, California-based PaxVax raised $22m in Series B venture capital from existing investors Ignition Growth and Ignition Ventures plus new investor Blue Haven Initiative. The cash brings the company's total private funding total to $68m, but PaxVax also has government funding for some of its experimental vaccines. The new venture capital will finance an ongoing 3,000-patient Phase III clinical trial program for the single-dose oral cholera vaccine PXVX0200. The US FDA granted fast track status for PXVX0200, but the development program appears to be at least a year behind schedule. The company told Scrip in March 2012 that it planned to begin clinical trials in 2012 and submit a new drug application (NDA) to the FDA by the second half of 2013 (scripintelligence.com, 20 March 2012).

Janssen doubles interest in Genmab's bi-specific antibodies

The Danish biotechnology company Genmab and Janssen Biotech expanded their collaboration to develop bi-specific antibodies using Genmab's DuoBody technology platform from up to 10 programs to as many as 20 programs. Janssen paid Genmab $2m (DKK11m) upfront and agreed to pay $174m (DKK956m) to $219m (DKK1.2bn) per program in milestone fees plus royalties. The company earned a $3.5m (DKK21m) upfront payment with potential milestone fees of up to $175m (DKK1.1bn) per development program plus royalties under its original collaboration agreement with Janssen in July 2012 (scripintelligence.com, 16 July 2012).

Ligand raises 2013 financial guidance based on Captisol material sales

Ligand Pharmaceuticals gained $1.56, or 2.9%, to close at $55.13 per share on 4 December after the San Diego-based company raised its revenue guidance to a range of $48m to $48.5m from a range of $45m to $46m based on high-than-expected Captisol material sales. The company's Captisol technology is designed to improve the solubility and stability of drugs. It is used in several investigational and marketed therapies, including the multiple myeloma drug Kyprolis (carfilzomib) from Amgen (formerly Onyx Pharmaceuticals) and GlaxoSmithKline's Promacta (eltrombopag) for thrombocytopenia (scripintelligence.com, 23 July and 20 November 2012). Ligand also raised its non-GAAP earnings per share guidance from a range of $0.77 to $0.79 to a range of $0.86 to $0.87. The company's market cap is $1.1bn.

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