If you get your biomedical breaking news from the British press, you will have heard all about a very promising vaccine treatment for glioblastoma. (“Remarkably promising” – BBC. “Could add years” – The Guardian. And there’s the Daily Mail (naturally), The Independent, and more). That would be good news, because that’s a terrible diagnosis with very little in the way of effective treatment. But if you get your breaking biomedical news from the British press, then I am very sorry for you.
That’s because this is DCVax, from Northwest Biotherapeutics. And this vaccine has been twisting and turning through the clinic for ten years now, under circumstances more suited for a soap opera than for a biotech company. I’m not sure I can summarize it all – here are a couple of articles reprising the story as of last year, so start there. (If you’re a Stat Plus subscriber, go here). There have been financial troubles, allegations and investigations, clinical holds, claims and counterclaims – and through it all, the one constant has been the NWBO has never been able to explain to anyone quite what is going on. That even goes for questions like “Why did regulatory agencies put a hold on your trial?”, “Why haven’t you enrolled the number of patients you said you would?”, and “When will you have actual data to present?” Minor stuff. At one point, the company actually attempted to explain a delay by saying that members of its management team had the flu.
I last wrote about the company in 2014, during yet another bizarre development. That was when a Washington Post columnist went after Adam Feuerstein (then with TheStreet.com) for being part of a conspiracy of evil short-sellers trying to harm this innocent little company. A letter of apology was eventually produced, albeit a carefully worded and rather lawyerly one, and I would submit that the subsequent history of NWBO illustrates that no evil conspiracy has been required. They were delisted from the NASDAQ, for example, and have been trading as a penny stock.
At any rate, the company has now published some analysis of the interim data, but as that Stat Plus piece makes clear, this is not really a satisfactory way of handling things. The company itself says that it has not reached the number of overall-survival cases that it needs to declare the trial finished, so the data are supposed to still be completely blinded. Because of the trial’s crossover design (patients getting standard of care could later on receive DCvax if the glioblastoma recurred, which it almost always does), about 90% of the trial’s participants have ended up getting the vaccine. That sounds like it’s going to make the workup of the data rather complicated, and it could also make the actual comparison to standard of care tricky as well. The current paper doesn’t address these questions, because it can’t, other than to say that since the great majority of the patients got the vaccine anyway, hey, let’s just look at the still-blinded data and run with it.
They expect to hit their overall number later this summer, and at that point they’ll start working through the data. The company has already warned investors that this could take many months, so it’s anyone’s guess when we’ll see the actual results. No celebrations should take place until that occurs. The entire dendritic-cell-vaccine idea that the company is working on has been kicking around for at least twenty years now, with little success, and DCVax itself first entered the clinic in 2002. The company has also worked on a prostate cancer vaccine using the same methods, but although a Phase II trial completed about ten years ago, they have never been able to partner it with anyone to go into Phase III. Couple this with the extremely aggressive and constantly changing nature of glioblastoma itself, and it’s hard to be optimistic. Unless you read the British papers.