Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.
What: Shares of the clinical-stage biotech Advaxis (NASDAQ:ADXS) pushed higher by nearly 14% this morning on exceptional volume following an update for the company's anal cancer candidate ADXS-HPV. According to the press release, the company said an initial analysis of an ongoing early stage study showed that all 10 patients receiving the immuno-therapy, in combo with standard chemotherapy, exhibited a durable complete response.
Although the details are sketchy, we learned that at least some of the patients haven't relapsed in two years at this point. The company also said the therapy was generally well-tolerated, with most adverse effects being mild in nature such as fever or nausea.
So what: Advaxis has been riding the recent immuno-therapy wave, inking research agreements with industry heavyweights such as AstraZeneca and Merck. Today's positive data release should thus help to further validate the company's somewhat novel approach to immunotherapies (i.e., bacterial-based vectors), potentially leading to even more interest from larger pharmaceutical companies.
Now what: While this dataset is extremely small and the study is still ongoing, it's worth keeping in mind that big pharma has repeatedly signaled that it is willing to spend big bucks speculating on early stage immuno-oncology candidates. Now that Advaxis' platform has a couple of lines of support from various clinical trials, the tiny biopharma might be the next one to benefit from this trend.
That said, Advaxis does have a disconcerting operating history, even wiping out early shareholders due to the previous management's inability to find non-dilutive sources of funding. Indeed, this data release is somewhat symptomatic of these problems, shown by the fact that it took two years to gather data on a mere 10 patients.
Time will tell if the new management team proves more effective at advancing the company's immuno-therapy platform. Until then, investors are probably best served by sticking to the sidelines.