Welcome to your weekly roundup of EP Vantage’s snippets – short takes on smaller news items.
This week, October 3-7, 2016, we had thoughts on the following: Theranos cuts 340 jobs to save one; Astra’s Brilinta fails to shine; Spectral Medical haunted by trial failure; Carrick scores $95m investment; Getting bispecific: Celgene looks to keep hold on haematological cancer space; Boehringer makes olmutinib a Hanmi-back.
These snippets were previously published daily via twitter.
Theranos cuts 340 jobs to save one
October 6, 2016
Effectively given a choice between retaining its core technologies or its leader, Theranos has opted for the latter. In July the Centers for Medicare and Medicaid Services banned the group’s founder and chief executive, Elizabeth Holmes, from running a laboratory in California for two years, and rather than walk away from the Palo Alto-based company Ms Holmes has decided to shut all of Theranos’s labs. The decision will “impact” around 340 workers – 40% of the group’s staff. Having now dropped both its Edison and much-vaunted nanotainer technologies, Theranos will now focus on its new miniLab device, a blood testing system that can be sold to customers like any other medical device, and thus does not require Theranos to operate a laboratory. But the miniLab has taken a hit already: in August Theranos sought emergency clearance of a Zika virus blood test run on the platform but was forced to pull the filing after the FDA found that a study of the new test had been improperly conducted.
Astra’s Brilinta fails to shine
October 4, 2016
AstraZeneca’s hopes of expanding into new indications with its blood thinner Brilinta appear to be all but over after failure in the Euclid study in peripheral arterial disease. The company still has the ongoing Themis trial in type 2 diabetes to cling onto, but a previous disappointment in stroke – and mixed data in long-term use – do not provide much cause for optimism. Astra did not disclose any more data from Euclid except saying the trial did not meet its primary endpoint of time to occurrence of cardiovascular death, myocardial infarction and ischaemic stroke versus Plavix; it will present more data at the AHA meeting in November. Brilinta is set to be Astra’s second-biggest drug in 2022, but current consensus shows sales peaking at just under $2bn, a far cry from the $3.5bn predicted during the Pfizer takeover bid.
Spectral Medical haunted by trial failure
October 4, 2016
Spectral Medical’s share price fell 85% yesterday after the Canadian company announced the failure of the pivotal US trial of the Toraymyxin blood filtration device. The 450-patient Euphrates trial (NCT01046669) showed that the device, intended to remove toxins from the bloodstream of patients with septic shock, was no better than sham control on the primary endpoint of 28-day mortality. Toraymyxin is already on sale in Canada and Japan, where it is used along with Spectral’s FDA-cleared sepsis diagnostic, the Endotoxin Activity Assay. The device won FDA expanded access in June, permitting its use at some of the US hospitals that had participated in the Euphrates study on a compassionate use basis. Spectral has licensed North American rights to Toraymyxin from Japanese group Toray Industries and had intended to complete a US PMA filing by the end of this year; it now says that further trials using more perfusion columns might permit a US filing in 2018.
Carrick scores $95m investment
October 4, 2016
Oncology has shown again that it is a hot ticket for venture funding, with the newly-launched Anglo-Irish cancer specialist Carrick Therapeutics reeling in $95m. The University of Cambridge spin-out, which is headquartered in Dublin, is not giving many details about its projects, but did say it was not limiting itself to a single compound or biological mechanism, and would develop first-in-class drugs that target aggressive and resistant forms of cancer. Instead, Carrick bigged up its management team, which includes chief executive Elaine Sullivan, formerly vice-president of R&D at Eli Lilly and AstraZeneca, and scientific advisory board member Steve Jackson, who helped develop Astra’s ovarian cancer drug Lynparza. Investors in the round, the fourth biggest in biopharma this year, include ARCH Venture Partners, Woodford Investment Management and Google Ventures. Carrick says it wants to become Europe’s leading oncology company. Roche, with a market cap of $215bn, might have something to say about that – and a lot more information will be needed to judge whether Carrick has any chance of success.
Getting bispecific: Celgene looks to keep hold on haematological cancer space
October 3, 2016
Celgene has joined the bispecific craze with takeout of privately held Swiss group Engmab. The deal, which media reports put at $600m, will give Celgene two new assets aimed at activating an immune response to cancer cells by binding to both to a T cell receptor and a tumour antigen. At ASH 2015, Engmab published preclinical data on an agent binding to CD3 receptors on T cells and B-cell maturation antigen, frequently expressed in multiple myeloma. Celgene has a strong position in the haematological cancer space with Revlimid and Pomalyst, and has carved out a space in immuno-oncology with its partnership with Juno Therapeutics’ and Bluebird Bio’s CAR-T projects. However, bispecific antibodies are drawing more attention as CAR-Ts have experienced hiccups, and Celgene likely wants to hedge its immuno-oncology bets with a bispecific play.
Boehringer makes olmutinib a Hanmi-back
October 3, 2016
What a difference a day makes. After celebrating a potentially $910m deal with Roche on Thursday for its pan-RAF inhibitor HM95573, Hanmi Pharmaceutical was back in the doldrums on Friday after Boehringer Ingelheim returned rights to its EGFR targeted therapy olmutinib. The drug, previously known as HM61713, is only approved in Hanmi’s home territory of South Korea for EGFR T790M mutation-positive lung cancer – and it looks like it might stay that way. The decision leaves a clear path for AstraZeneca’s Tagrisso, which won FDA approval in the T790M mutant population last November. Clovis Oncology’s rociletinib also fell by the wayside in May after response rates turned out to be less compelling than originally thought – on top of worries over hyperglycaemia. Boehringer did not mention this side effect but did say it strives for best-in-class breakthrough cancer medications. Whether it has seen a problem with olmutinib, or just believes it will not be able to catch Astra, this is now Hanmi’s problem.