Protocols

GSK launches PhIII lupus combo study with Benlysta/rituximab; Cipher snatches Canadian drug portfolio from Cardiome

→ GSK says it’s launching a Phase III combo study to see how its lupus drug Benlysta (belimumab) will work when combined with rituximab. The monoclonal antibody rituximab has historically been used to treat cancers like leukemia and lymphomas, but also has been effective fighting rheumatoid arthritis. GSK hopes combining Benlysta (the only biologic approved to treat lupus) with rituximab will push lupus into remission. “Belimumab has already demonstrated its consistent efficacy in reducing disease activity for patients with SLE, with four successful Phase III trials,” Gijs van den Brink, GSK’s global head for immuno-inflammation R&D, said in a statement. “The underlying biology of the disease, combined with the results from a small investigator-sponsored study in severe refractory SLE (lupus), provide a strong scientific rationale for initiating this study. Our aim with this study is to assess whether the combination treatment will not only achieve a state of low disease activity, but potentially also achieve clinical remission in patients living with this chronic and unpredictable disease.”

→ Vancouver’s Cardiome Pharma Corp is selling its Canadian business portfolio to Ontario’s serial acquirer Cipher Pharmaceuticals for $25.5 million CAD ($19.5 million USD). The deal gets Cipher commercial and pipeline hospital products, including Brinavess (vernakalant IV), Aggrastat (tirofiban hydrochloride), Xydalba (dalbavancin hydrochloride), and Trevyent (a drug device combo that delivers treprostinil). Brinavess and Aggrastat are currently on the market in Canada.  Xydalba, which is approved and marketed by Allergan in the US as Dalvance, could get approval in Canada as early as the end of 2018.  A Canadian regulatory filing for Trevyent is planned in 2019, according to a Cipher statement.

→ San Diego biotech OncoSec $ONCS put out a curious press release Tuesday noting a cost-cutting measure to significantly downsize its office and lab space. The company said its essentially rented out its old – much larger – space to a third party and leased a space less than half its former size. OncoSec said the new situation puts $65,000 back in its pocket per month, and trades a “$14 million liability with a $2 million liability.” Although the company’s new space is about 22,000 square-feet smaller, OncoSec made no mention of a downsized staff in its press release. However, a recent regulatory form filed with the SEC note the company’s staff has indeed slimmed down in recent years. Back in 2015, the company’s then-CEO Punit Dhillon said OncoSec employed 55 people. As of October 2017, that number has dwindled to 35 employees. OncoSec’s lead program, ImmunoPulse IL-12, is in clinical development for metastatic melanoma and triple-negative breast cancer. The program is geared toward patients with melanoma who are refractory or have relapsed on anti-PD-1 therapies.

→ An international group of investors is behind Oxford Nanopore’s latest £100 million ($140 million) round to drive its DNA/RNA sequencing technology, including China Construction Bank International, Singapore’s GIC and Australia’s Hostplus. The British firm — known for a portable real-time DNA/RNA sequencer called MinION — aims to scale up its operations across R&D, manufacturing and sales with the proceeds. Two devices with bigger capabilities in animals, plants and the environment will join the current suite comprising MinION and its desktop counterpart GridION. The money will also be invested in a new manufacturing facility, to be built on a science park south of Oxford, as well as the expansion of the commercial team.

Zealand Pharma $ZEAL celebrated a step forward today with Phase III data showing that dasiglucagon did not induce or boost anti-drug antibodies in patients with type 1 diabetes. Designed to evaluate dasiglucagon in the treatment of severe hypoglycemia, or extremely low blood sugar, the trial pits the drug against reconstituted glucagon powder. Previous Phase II results has suggested that the rescue pen-fitted glucagon analog boosted plasma glucose better than the active comparator. The Copenhagen-based biotech hopes it would happen again in a separate Phase III efficacy trial, with results expected in the second half of this year.


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RAPS Convergence 2018

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Molecular Templates Austin, TX
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Aldevron Boston or San Francisco
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Codiak BioSciences Cambridge, MA
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Aldevron Fargo, ND
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Codiak BioSciences Cambridge, MA

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