Post by deadally on Aug 11, 2014 13:05:25 GMT
Hi guys,
I was asked to give my thoughts on a few companies, given my experience with oncology.
First, I want to tell you my credentials, since I'm kind of new here:
1) I have a PhD in Biochemistry and Molecular Biology, where I focused on cellular biology of breast cancer. I only have two published papers in peer-reviewed journals, which is ok for a student-level career. One was in Oncogene, and the other was in Molecular Cancer Research.
2) I have been a medical writer for two years, focused primarily on cancer
3) I have had a job as a medical writer now for a medical education company that specializes in oncology
So given those things, I want to be very upfront about my position on Advaxis. I am very highly discouraged from investing in oncology companies. Any promising company could potentially be a client in the future, and conflicts of interest would be very, very troubling for an education company, whose primary goal is to maintain balance.
That said, I've taken a little bit of time to look at Advaxis's pipeline, and my first pass is quite positive! I'm not a big fan of trying to analyze pre-clinical data, especially in cancer. This is because things almost never go as you hope when making the transition from animals to humans. So ADXS-cHER2 and ADXS-PSA aren't really in my purview for this rudimentary analysis.
What I assume you all are interested in immediately is ADXS-HPV, especially for cervical cancer. I'm not an expert in this branch of oncology, but a quick look says it's pretty grim. One drug approved in 2006 (topotecan), and aside from bevacizumab (imminent approval), you have one drug reaching somewhat late stage: ADXS-HPV!
Point there is cervical is low-hanging fruit, assuming the drug works. I saw that interim data from the Phase II India trial were released, noting a durable response of 9.5 months, and a 22% long-term (>18-month) survival rate. These are not standard criteria that I often see in cancer trials, but they look really promising compared with topotecan, whose Phase III back in 2004 showed a 4.6-month progression-free survival when combined with cisplatin. Please note that durable response is not the same thing as progression-free survival, but logically they should correlate. If you do, in fact, end up doubling the progression-free survival, there might be something interesting there. And that long-term survival rate noted in the interim data look promising, as well. In addition, you get the benefit whether you have cisplatin or not. That means that patients don't need this highly-toxic chemo to see benefit. Therefore, even if it does NOT improve over topotecan+cisplatin, the more tolerable safety profile might make it a really useful alternative.
The major impediment I could foresee might be cost/scaling. These types of immunotherapies are new ground for cancer research, and it's making a lot of headways in the world, especially in diseases like myeloma and others. Can we get to the point where we can make the treatments reasonably quickly? Not a question for me, but for the engineers and pharma companies. I think it's early to say, but this looks promising. Cervical cancer looks pretty damn grim, especially in the phase you're testing it (metastatic, recurrent disease). Having an additional, targeted therapy could make a huge difference. And it doesn't really look like there's a bunch of competition. I imagine recruitment to the trial is kind of slow, given the relative rarity of this disease, and BioMedTracker anticipates that the US Phase II trial will finish in 2018. I imagine that's a little disappointing to hear, but if you make a serious dent, you might be able to achieve some sort of fast tracking.
So all in all, Advaxis looks like an interesting long-term play. I have no idea about their business structure, but I see that ADXS-HPV does not have big partners. It wouldn't surprise me in the least if they partner with a big pharma at some point in the relative near future. So I would feel comfortable about an investment in this. I don't think they're going to be able to go it alone forever, though, due to the complexity of generating this type of treatment. It's just not something that a small company can handle, I expect. Of course, I could be wrong! Those are just my thoughts.
I was asked to give my thoughts on a few companies, given my experience with oncology.
First, I want to tell you my credentials, since I'm kind of new here:
1) I have a PhD in Biochemistry and Molecular Biology, where I focused on cellular biology of breast cancer. I only have two published papers in peer-reviewed journals, which is ok for a student-level career. One was in Oncogene, and the other was in Molecular Cancer Research.
2) I have been a medical writer for two years, focused primarily on cancer
3) I have had a job as a medical writer now for a medical education company that specializes in oncology
So given those things, I want to be very upfront about my position on Advaxis. I am very highly discouraged from investing in oncology companies. Any promising company could potentially be a client in the future, and conflicts of interest would be very, very troubling for an education company, whose primary goal is to maintain balance.
That said, I've taken a little bit of time to look at Advaxis's pipeline, and my first pass is quite positive! I'm not a big fan of trying to analyze pre-clinical data, especially in cancer. This is because things almost never go as you hope when making the transition from animals to humans. So ADXS-cHER2 and ADXS-PSA aren't really in my purview for this rudimentary analysis.
What I assume you all are interested in immediately is ADXS-HPV, especially for cervical cancer. I'm not an expert in this branch of oncology, but a quick look says it's pretty grim. One drug approved in 2006 (topotecan), and aside from bevacizumab (imminent approval), you have one drug reaching somewhat late stage: ADXS-HPV!
Point there is cervical is low-hanging fruit, assuming the drug works. I saw that interim data from the Phase II India trial were released, noting a durable response of 9.5 months, and a 22% long-term (>18-month) survival rate. These are not standard criteria that I often see in cancer trials, but they look really promising compared with topotecan, whose Phase III back in 2004 showed a 4.6-month progression-free survival when combined with cisplatin. Please note that durable response is not the same thing as progression-free survival, but logically they should correlate. If you do, in fact, end up doubling the progression-free survival, there might be something interesting there. And that long-term survival rate noted in the interim data look promising, as well. In addition, you get the benefit whether you have cisplatin or not. That means that patients don't need this highly-toxic chemo to see benefit. Therefore, even if it does NOT improve over topotecan+cisplatin, the more tolerable safety profile might make it a really useful alternative.
The major impediment I could foresee might be cost/scaling. These types of immunotherapies are new ground for cancer research, and it's making a lot of headways in the world, especially in diseases like myeloma and others. Can we get to the point where we can make the treatments reasonably quickly? Not a question for me, but for the engineers and pharma companies. I think it's early to say, but this looks promising. Cervical cancer looks pretty damn grim, especially in the phase you're testing it (metastatic, recurrent disease). Having an additional, targeted therapy could make a huge difference. And it doesn't really look like there's a bunch of competition. I imagine recruitment to the trial is kind of slow, given the relative rarity of this disease, and BioMedTracker anticipates that the US Phase II trial will finish in 2018. I imagine that's a little disappointing to hear, but if you make a serious dent, you might be able to achieve some sort of fast tracking.
So all in all, Advaxis looks like an interesting long-term play. I have no idea about their business structure, but I see that ADXS-HPV does not have big partners. It wouldn't surprise me in the least if they partner with a big pharma at some point in the relative near future. So I would feel comfortable about an investment in this. I don't think they're going to be able to go it alone forever, though, due to the complexity of generating this type of treatment. It's just not something that a small company can handle, I expect. Of course, I could be wrong! Those are just my thoughts.
