Kura Oncology Inc. (KURA) announced late this week that its product candidate (tipifarnib) for the treatment of head and neck cancer had had a successful Phase 2 trial. According to Chief Medical Officer Antonio Gualberto, “rapid and, in some cases, dramatic changes” were observed in patients treated with this drug. With the release of this news, the shares of Kura Oncology jumped up by a whopping 90% in pre-market trading on Friday. More than 17.3 million shares were traded in one day after the news broke, compared to the stock’s regular average volume of 175,000 per day.
The last 3 months have been troubled for Kura Oncology, as shares dropped 18%. This was in stark contrast to the Nasdaq Biotech ETF iShares (IBB), which was up by 14% in the same period. Even the S&P 500 went up by 1.3% in this time.
Kura Oncology Inc. was founded in 2007 by the current CEO, Troy Wilson. It is a clinical stage biopharmaceutical company which develops treatments for all kinds of cancers. Kura entered the market as a fully formed publically listed company. It is very unusual for companies to join the market as publically listed from the word ‘go’ but Wilson was able to pull it off by securing a $60 million investment along with a reverse merger.
Tipifarnib is the company’s lead cancer treatment product. In very basic terms, the drug tipifarnib binds to the human protein, farnesyl transferase and prevents it from activating the mutation of the HRAS gene which causes multiple types of cancer like AML and other solid tumor cancers.
The drug has had a troubled history. It was discovered by Johnson & Johnson, but its trials failed in Phase 1 testing and the FDA did not approve its use for cancer treatment way back in 2005. Kura took over the research and development of the drug and took sole responsibility of it in 2015. With advances in genomic sequencing, scientists are now able to identify the genetic traits of patients which can impact their responses to certain drugs. This is what is called “precision medicine”. The idea is to optimize healthcare by using drugs that will precisely work on a patient based on his/her genetic traits.
According to Wilson, tipifarnib was simply “the right drug at the wrong time” and that its use could revolutionize the treatment of cancer patients and improve their quality of life as well as increase their lifespan.
The drug was in Phase 2 trials for the treatment of squamous cell carcinomas for the head and neck, called SCCHN in short. SCCHN is one of the leading causes of death in patients suffering from cancer.
The Phase 2 trial protocol (based on RECIST 1.1 criteria; which is the world standard for assessing effectiveness of cancer treatments) requires that 4 in 18 patients should show confirmed partial responses to the treatment. The trial for tipifarnib was much better than the requirement, with 4 patients showing a confirmed partial response, as well as two patients showing disease stabilization. Additionally, 2 patients have already shown objective responses over a period of more than a year. All patients enrolled in this study have already tried other forms of cancer treatment, including chemotherapy. More patients are due to join the trial, meaning the protocols have been met even before the completion of the trial.
While the Phase 2 trials have been an overwhelming success, it is still too early to say for certain that this drug will go into production. There is still a long road ahead.