On June 22, 2015 shares of Epizyme were up about 27% after the company announced that it had obtained positive phase 1 results in patients with Non-Hodgkin’s Lymphoma — NHL. The company used its drug known as EPZ-6438, which is also known as tazemetostat to treat these patients with NHL. Epizyme has developed this drug to treat these NHL patients as a monotherapy type drug.
As the name suggests monotherapy means that the drug is being given to these patients alone with no additional drug compound added. That shows the power of Epizyme’s drug because it can be given as a monotherapy and still obtain amazing efficacious results. More specifically tazemetostat was able to show a significant response in these patients with solid tumors. These patients weren’t just any normal NHL patients, because these patients specifically had a genetic mutation of their NHL known as the EZH2 tumor mutation.
This EZH2 tumor mutation protein activates these tumorous cells in patients. Tazemetostat was specifically made to inhibit the EZH2 protein in this cancer. So how powerful did tazemetostat perform in this phase 1 trial in NHL patients? Well Tazemetostat was able to produce an objective response in 9 out of the 15 patients in the study. NHL is a type of cancer that originates in the Lymphatic system. This is where a person’s white blood cells reside and it is possible for tumors to develop from these mutated white blood cells.
These phase 1 results in NHL were presented at the 13th International Conference on Malignant Lymphoma by Vincent Ribrag, M.D. Epizyme has a pipeline full other cancer candidates as well. Although Epizyme doesn’t just target one type of cancer, more specifically the company goes after genetically defined cancers with a mutation component attached to them.
On June 23, 2015 shares of Vical tumbled as much as 43% after the company reported bad results in its phase 1/2 trial in patients with Herpes. Vical had created a vaccine known as Vaxfectin to attempt to reduce shedding in these patients with Herpes. The company used monovalent Vaxfectin vaccine and a bivalent Vaxfectin vaccine as well. That means one antigen and then two or more antigens respectively to attempt to treat these patients.
The primary endpoint of this clinical trial was for either forms of Vaxfectin to reduce the viral shedding of Herpes. Well both forms of Vaxfectin failed to meet on the primary endpoint as neither vaccine was successful in reducing shedding for these patients. The Vaxfectin vaccine was safe and well tolerated with no serious adverse events noted during the trial. There was some possible efficacy seen in the secondary endpoint of the clinical trial using the bivalent Vaxfectin vaccine. Although because neither vaccine achieved the primary endpoint it wasn’t a good idea to advance this clinical trial anyways.
The only good thing Vical has going for itself now is the fact that it has a partnership with Astellas Pharma (OTCMKTS:ALPMF) in developing a vaccine for the Cytamegalovirus — CMV. Because of this partnership with Astellas and other bits of remaining cash the company is well positioned to run operations into 2017.
Although we believe it is best to avoid this company for now not only because for this failure but a previous failure as well. Before this trial failure Vical was in a phase 3 study to test its Allovectin vaccine in patients with Melanoma, a type of skin cancer. The company reported that Allovectin failed to meet on both the primary endpoint of an Objective response rate, and the secondary endpoint of overall-survial. This sent shares of Vical down by 60% and left investors with many losses. Well this failed trial in herpes is another huge blow to investors once again. It is quite possible that Vical’s vaccines just don’t have enough power to produce substantial efficacious results needed for any disease type.
Cleveland Biolabs (NASDAQ:CBLI)
On June 25, 2015 shares of Cleveland Biolabs soared as high as 106% after the company announced a private placement deal worth up to $25 million dollars. In order to accomplish this strategic investment the company sold 6,459,948 unregistered common shares of its stock for $3.87 per share. This private placement was sold to a billionaire venture capitalist investor known as David Davidovich
The price sold to David came at a higher premium of 35% over the closing price from June 23, 2015 of $2.86 per share. This deal doesn’t come at a small cost for Cleveland Biolabs though because the company must accommodate seven new board of directors, bringing the total to thirteen. Cleveland Biolabs is a biotechnology company that is primarily focused in the field of Oncology. This means that the company is looking for new drug treatments for many different types of cancer.
The company leverages its technology known as Toll-Like Receptor Activators. These TLRA’s activate many different types of pathways in cancers that eventually lead to cell apoptosis — cell death. This technology is broken down into Protectan Technology, and Curaxin Technology. Protectans prevent cell death in normal cells for the patient, but kill off cancerous cells instead. The Curaxin technology can attack multiple targets at the same time and in addition lowers the chances for the patient’s cancer to become resistant to treatment.