Shares of Inovio Pharmaceuticals (NASDAQ:INO), a clinical-stage biotech focused on cancer and infectious diseases, jumped by 10% as of 3:45 p.m. EDT on Thursday after the company announced that its phase 3 Reveal trial has commenced.
Inovio's Reveal trial is studying its compound VGX-3100 as a hopeful treatment for cervical dysplasia caused by the human papillomavirus (HPV). The Food and Drug Administration had previously placed this study on clinical hold because it had some questions about the company's Cellectra 5PSP delivery device.
Inovio let investors know today that it has satisfied the FDA's information request related to the delivery device. As a result, the FDA has lifted the study's clinical hold. Management said that it plans to recruit patients for this study right away.
Inovio's chief medical officer, Dr. Mark Bagarazzi, offered investors some commentary on the current state of HPV treatments and on VGX-3100's potential:
Despite the availability of preventive HPV vaccines for over a decade, HPV-related cervical HSIL and cancers remain a widely prevalent problem. Unfortunately, current treatments are invasive and do not address the underlying HPV infection. VGX-3100 has the potential to be a first-in-class HPV-specific immunotherapy offering women the prospect of preventing cervical cancer without undergoing an invasive surgical procedure that may compromise their reproductive health. We are pleased to be able to immediately begin recruiting patients at the first 15 sites by the end of this month.
Investors cheered the upbeat news, which is why shares are rocketing higher today.
VGX-3100 is an exciting product candidate, so it is understandable that the market is feeling good about today's update. When adding in the long-term potential of the company's HIV vaccine, there's little doubt that Inovio is a compelling company to follow.
On the flip side, it will be a long time before investors get a look at the how the Reveal trial pans out. For that reason, I think that Inovio is a great stock to put on your radar, but I'm personally not interested in committing capital to this company just yet.