Snippet roundup: Gilead's NASH mishmash and Roche's Avastin fumble

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Welcome to your weekly roundup of EP Vantage’s snippets – short takes on smaller news items.

This week, October 17-21, 2016, we had thoughts on the following: why Gilead’s NASH hopes might no longer lie in simtuzumab; Roche’s Avastin heir falls flat; Intersect ENT noses ahead; Apitope alone as German Merck shelves multiple sclerosis vaccine.

These snippets were previously published daily via twitter.

Why Gilead's NASH hopes might no longer lie in simtuzumab

October 21, 2016

Gilead is awaiting two major phase II readouts with its most advanced NASH asset, simtuzumab, but it now looks like a different project, selonsertib, might have better chances of success. This is the early sign from a small, uncontrolled trial of a combination of simtuzumab, an anti-Loxl2 MAb, and selonsertib (GS-4997, an Ask-1 inhibitor). While the combined data certainly show sufficient hints of efficacy to keep the dream alive, a breakdown provided in the late-breaking abstract due to be presented at the AASLD meeting next month suggests that simtuzumab has modest efficacy – and zero additive effect over selonsertib alone. Of course, too much cannot be read into a trial this small, which moreover provides no baseline values or safety data, and which is of 24 weeks’ duration – likely too short to see a real effect on fibrosis. Simtuzumab has already flunked pancreatic cancer and idiopathic pulmonary fibrosis trials, and Gilead yesterday revealed that selonsertib development in pulmonary arterial hypertension and diabetic kidney disease was being halted after phase II failures. Still, with most NASH development in the hands of small biotechs, Gilead’s five-strong clinical NASH pipeline makes it an underappreciated threat.

Roche’s Avastin heir falls flat

October 20, 2016

Roche’s lifecycle strategy has worked out reasonably well for the biologicals Herceptin and Rituxan, but Avastin is a different story. Today the group said its Avastin follow-on vanucizumab – an anti-Ang2/anti-VEGF bispecific – was to all intents and purposes being abandoned. This was the result of the failure of McCave, a study pitting vanucizumab versus Avastin head to head in metastatic colorectal cancer. Roche’s R&D chief, Daniel O’Day, told today’s third-quarter financials meeting that vanucizumab was the latest of several attempts to improve on Avastin, and that McCave had set a high bar that ultimately proved insurmountable. Avastin will at some point succumb to biosimilars competition, and in the meantime its US sales fell 4% to CHF2.3bn ($2.3bn) in the first nine months of 2016. Two other vanucizumab trials will continue to data readout, but “we’re not suggesting that we’ll be beginning new studies”, Mr O’Day added.

Intersect ENT noses ahead

October 17, 2016

Intersect ENT’s Resolve sinus implant has met both primary endpoints in the Resolve II trial, setting it up for US approval. Resolve releases mometasone furoate directly into the sinus lining to target inflammation, and was assessed in 300 patients with chronic sinusitis after sinus surgery, all of whom were indicated for revision surgery – the current standard treatment. At 90 days, bilateral Resolve placement permitted statistically significant reductions in nasal congestion and polyp burden compared with a sham procedure (both p=0.007). One serious device-related adverse event, an intranasal bleed requiring intervention, was seen. Intersect ENT plans to submit an NDA at the beginning of next year, but reimbursement for devices implanted in the doctor’s office, as Resolve is, is less established, so uptake could be slow at first. The company’s shares rose 4% on the trial hit, but this does not nearly make up for the 35% fall they suffered in early May when its first-quarter 2016 sales missed expectations. Intersect ENT beat forecasts in the second quarter, but shares did not recover.

Apitope alone as German Merck shelves MS vaccine

October 17, 2016

Apitope maintains that it was not negative data that spurred Merck KGaA to hand back rights to its therapeutic multiple sclerosis vaccine ATX-MS-1467. Results from a phase II trial are due by the end of the year, but Apitope's chief executive, Keith Martin, told EP Vantage that the companies were not yet privy to the data. Maybe Merck feels it has a more promising candidate in the similarly acting Tcelna, the subject of a partnership with Opexa. Whatever the reason, Apitope now faces going it alone or trying to find another partner. The company’s technology aims to dial down the inappropriate immune response seen in diseases like MS by increasing the number of regulatory T cells, which in turn suppress the helper T cells responsible for the autoimmune reaction. This approach aims to stop the demyelination of nerve cells – making it distinct from remyelinating agents such as Biogen’s failed opicinumab.

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