On August 10, 2015 shares of Inovio were up about 25% after the company announced a partnership deal with a big pharmaceutical company known as AstraZeneca (NYSE:AZN). Although one key thing to note here is that this deal is being established with MedImmune specifically, but it is the research and development arm for AstraZeneca. With this deal established AstraZeneca will gain access to INO-3112 which is a vaccine for two types of HPV — Human Papilloma Virus.
These two types of HPV are HPV-16 and HPV-18 and are known to target around 70% of pre-cancerous and cancerous cervical tumors. The good part about this INO-3112 vaccine is that it can easily treat another closely associated cancer known as — head and neck cancer. It is not clear what sparked this partnership interest from AstraZeneca but it could be for the fact that the company looked for a synergistic way to boost its own drug compounds.
This is because AstraZeneca has drug compounds that work well when enhanced upon by other technologies — in this case Inovio’s Synthetic DNA vaccine technology plus electroporation. Inovio will be receiving an upfront payment of $27.5 million for this partnership. The biggie though is that Inovio will have the potential to reach $700 million pending the fact that it meets all development and commercialization milestones.
Even better AstraZeneca will be responsible for all costs of the clinical trials for this product which leaves Inovio open to use the money for other pipeline purposes. Inovio will even receive double-digit royalty sales upon commercialization of these vaccine products. This partnership will also allow both companies to work together to add two new vaccine products to Inovio’s pipeline which will potentially boost the company’s value.
Immunocellular Therapeutics (NASDAQ:IMUC)
On August 13, 2015 shares of Immunocellular Therapeutics soared 24% after the biotechnology company announced that it had received a Special Protocol Assessment — SPA — from the FDA to run a phase 3 clinical trial in patients with Glioblastoma. This SPA means that the FDA will allow the approval of Immunocellular’s vaccine ICT-107 with particular clinical endpoints discussed in the meeting upon positive clinical results.
Since this trial is a phase 3 pivotal clinical trial the company will recruit 400 newly diagnosed patients with glioblastoma across 120 clinical trial sites. Investors though should be cautious with Immunocellular because the primary endpoint is set to be overall-survival — OS. The problem with this is because the company failed to meet the primary endpoint of overall-survival in the phase 2 trial. The trial called for a huge improvement of overall-survival in these newly diagnosed glioblastoma patients but the company did not meet statistical significance since the vaccine only increased the Overall survival by 2 months.
This phase 3 trial will probably take a few years to run and even then there is no guarantee of successful clinical results. This is especially true since the company failed to meet the primary endpoint of the phase 2 trial. The reason the FDA allowed Immunocellular to continue to a phase 3 trial is probably because the company did see a nice improvement in progression-free survival in the trial. The phase 3 clinical trial will probably enroll patients all the way up to the 3rd or 4th quarter of 2015.
Avalanche Biotechnologies (NASDAQ:AAVL)
On August 14, 2015 Avalanche fell by 28% after the company announced that it had decided that it would not run its phase 2b Wet-AMD clinical trial. Wet AMD stands for Wet Age-related macular degeneration and is an eye disease in which older patients start to lose vision due to leaky blood vessels in the eye. The company had previously reported mixed phase 2 Wet-AMD results using its AVA-101 gene therapy treatment.
The company’s AVA-101 gene therapy treatment was intended to attempt to insert a correct gene in place of a faulty one in hopes of improving vision loss in these Wet-AMD patients. The results were mixed in that AVA-101 marginally improved vision loss in these patients against a placebo compound. In addition those patients who took AVA-101 saw a greater increase in retinal thickness versus those who only took placebo.
As investors were not impressed with the mixed phase 2 Wet-AMD results the stock sold off greatly that very day — about 50% or more. The stock fell once again this past week as the company reported that it would not advance AVA-101 into a phase 2b clinical trial, thus disappointing investors once more. Avalanche will now take AVA-101 back to pre-clinical trials and may instead choose to advance its AVA-201 gene therapy.
There is a possibility that AVA-201 may have greater potential than AVA-101, and that reason is because AVA-201 is being developed in pre-clinical trials as a preventative/therapeutic form for Wet-AMD. Whereas AVA-101 was just being developed as a therapeutic only. Still the company’s platform has been not validated yet so it is dangerous to assume that this drug will too make it past phase 2 clinical trials.
To make matters worse Avalanche had a deal in place where Regeneron Pharmaceuticals (NASDAQ:REGN) had the option to license AVA-101 if it chose to do so. Considering that now Avalanche is abandoning the AVA-101 gene therapy for phase 2b trials, it might make Regeneron think twice about deciding to keep a licensing deal in place for AVA-101. Again its speculation but Regeneron may not need to license the AVA-101 gene therapy anyways. Right now Avalanche is trading roughly at cash value, so future potential is huge as long as the company can figure out how to advance one of its Wet-AMD gene therapy programs past phase 2.