Just as was the case yesterday, today is all about fresh trial data. This has been something of a pretty strong season in biotechnology data sector and, as readers will soon find out, the data-driven strength is continuing into the end of this week.
Here is a look at two of the biggest movers so far this week, what’s moving where things will likely go next. The two companies in our crosshairs for today are Kura Oncology, Inc., (NASDAQ:KURA) and NewLink Genetics Corporation (NASDAQ: NLNK).
So, let’s get to it.
One of the biggest end of the week movers in the biotechnology space was Kura. The company just put out data from a phase 2 trial of one of its lead development assets – a drug called tipifarnib. Kura is currently running a development program targeted towards the approval of the drug in a target indication of patients with HRAS mutant relapsed or refractory squamous cell carcinomas of the head and neck (HNSCC). HNSCC has a pretty poor prognosis associated with it and, especially if discovered in the later stages, patients have very little in the way of treatment options available to them.
Early-stage treatment involves the standard chemotherapy and radiotherapy, but due to the location of the cancer (which means it can be difficult to surgically resect, and also dangerous to introduce too much radiation), there is a real unmet need in terms of efficacy from this first line.
So, Kura is trying to change that with tipifarnib, and it looks like the company is doing a pretty good job so far. As per the latest release, the trial in question hit its primary endpoint even before enrollment was completed suggesting a rapid and potentially strong effect in this patient population.
Don’t get too excited just yet, however. The drug is seemingly effective, but the trial only investigated impact (as far as the latest data is concerned, that is, in six patients and, of the six patients, there were four confirmed, partial responses and two patients with disease stabilization.
Safety profile seems relatively clean so far, so that’s another tick for the trial, but we want to see some degree of expansion going forward (and, further, a replication of these results on the back of said expansion) before we can say for sure whether the drug has the potential to go the distance.
In other words, one to watch, but there’s still a ways to go along this particular development pathway.
Despite the size of the trial, markets are trading open on Kura, with the company surging close to 30% during after-hours trading and looking set to appreciate further as standard participation ensues at the bell on Friday.
Next up, NewLink.
As mentioned above, this one is also a data-driven move and, in line with the above description of Kura, this one is also a positive development. On Thursday, the company put out updated data from an ongoing phase 2 trial of an asset called indoximod, with the trial investigating the potential efficacy of the drug when used in combination with Keytruda. Many reading will likely already be familiar with Keytruda. For those not, it is Merck & Co., Inc. (NYSE:MRK)’s oncology blockbuster and it is a well-established and widely used drugs in the cancer space as things stand.
NewLink wants to know whether the addition of its own drug, the above-mentioned indoximod, can improve on the established efficacy of Keytruda in its target population, which in this instance is advanced melanoma.
As per the release, the data showed an improvement in Complete Response (CR) to 20% (which amounts to 10 out of the 51 patients trialed) compared to CR of 12% (6 out of the 51 patients). Further, the Progression-Free Survival (PFS) by RECIST criteria (which is an industry gold standard in this space) was 56% at one year with median PFS (mPFS) of 12.9 months.
These are pretty impressive results and present a very strong case for this combination treatment being added as a standard of care regimen going forward in this indication. Add to that the fact that the drug disappointed in a breast cancer trial earlier this year and the market response is going to be all the more impressive.
And that’s just what we’ve seen.
At close on Thursday, NewLink was up more than 75% and chances are, just as with Kura, we will see an extension of this run during the session on Friday.