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 in Advaxis (NASDAQ:ADXS) jumped by over 10% earlier today following news that the FDA had signed off on a planned phase 2 trial for its ADXS-HPV in cervical cancer.
So What: Advaxis has high hope for ADXS-HPV, an immunotherapy that reduces cancers ability to suppress a patient's immune system.
Advaxis is already studying ADXS-HPV as a therapy for three cancers associated with human papillomavirus, or HPV, including invasive cervical cancer, head and neck cancer, and anal cancer.
This latest trial will study ADXS-HPV alone or in combination with Incyte Corporation's (NASDAQ:INCY) epacadostat in stage I, II, and IIIb patients under a clinical trial collaboration agreement inked between the two companies in February. The study is part of Advaxis' strategy of expanding the potential market for ADXS-HPV by showing that it can be effective as part of combination therapies too.
Now What: The concept of making it more difficult for cancer to hide from the immune system is incredibly intriguing; however, investors should recognize that this is a clinical stage company and that a lot can -- and often does -- go wrong in human clinical trials for oncology drugs.
Having said that, Advaxis has posted some intriguing early stage research for its ADXS-HPV, and that could suggest that this drug is one to keep an eye on. In March, Advaxis reported that all 10 anal cancer patients taking ADXS-HPV in its phase 1/2 study responded to the treatment.
Advaxis is also developing additional therapies, including ADXS-PSA, that could be used to treat other forms of cancer. Investors will need these studies to pan out given that costs associated with Advaxis' clinical trials are climbing. However, for now Advaxis' financials appear solid following a secondary stock offering in April. Regardless, the risks associated with cancer trials suggests that this is one company best suited only to risk-tolerant investors.