this and previous post from IV thread,,,
Allovectin-7 - Did It Pass D Miller's "Finding the Next Dendreon" Test? See IR's Answers
I thought David Miller's article "Finding the next Dendreon" was excellent. Given that, I took the questions in Miller's article & asked them to VICL's IR dept. Below is the response from IR & a link to the David Miller article that inspired me.
So, after reading the below responses, does the board feel Allovectin-7® could pass the David Miller test?
-----Original Message-----
Dear XXX,
I'll assume you're talking about Allovectin-7®, our gene-based immunotherapy for metastatic melanoma and potentially other solid tumors. This was the subject of yesterday's news release.
Regarding your specific questions:
What’s your manufacturing success rate?
We have successfully manufactured all of the Allovectin-7® used in research, preclinical and clinical trials since its initial development in the early 1990s. We have produced a number of other plasmids both for internal programs and under manufacturing contracts. We use a standardized fermentation and purification process for all of these plasmids, and all are manufactured in the same equipment. Our capacity is sufficient for the commercial launch of Allovectin-7® as well as our TransVax™ CMV vaccine.
How fast can you manufacture each individual's infusion?
Allovectin-7® is an off-the-shelf product. It is not patient-specific, and it does not contain any patient-derived material. We use a batch manufacturing process and we store and ship product in bulk or in vials as needed for end use.
Does your treatment focus on just one antigen at a time or multiple antigens simultaneously?
Allovectin-7® does not encode any tumor-specific antigens. It uses a generic immunotherapeutic approach with multiple mechanisms of action. Allovectin-7® contains (multiple copies of) a single plasmid encoding both HLA-B7 and beta-2 microglobulin. Together, these components form an MHC Class 1 complex, which is designed to trigger a potent immune response against the tumor cells from which it is expressed. The beta-2 microglobulin also acts with the inherent MHC components already in the tumor cells to restore immune system recognition of tumor antigens. Allovectin-7® is formulated with a cationic lipid complex, which also triggers a local inflammatory effect at the site of injection into a tumor.
Do you train immune cells inside or outside the body, and which immune cells are you focusing on?
Allovectin-7® is an in vivo immunotherapeutic delivered by intratumoral injection, and it relies on multiple immune system resources as noted above. It is designed to invoke primarily a T-cell immune response directed toward tumor cells.
Does your trial have an SPA?
Our Phase 3 protocol was developed under the Special Protocol Assessment process with the FDA and is subject to an SPA agreement. The trial design and endpoints are set by this agreement.
Is your target overexpressed or is it uniquely expressed on cancer cells?
As noted above, there are multiple mechanisms invoked by Allovectin-7®. The gene encoding HLA-B7 is introduced into tumor cells, and for those individuals who are HLA-B7 negative, this would result in unique expression triggering an immune response similar to a mismatched organ transplant rejection. For individuals who are HLA-B7 positive, this would result in overexpression of HLA-B7 by the tumor cells. For both groups, introduction of beta-2 microglobulin would result in upregulation and expression of multiple tumor antigens.
Is your target present on normal tissue?
HLA-B7 is a human antigen normally present in about 20% of Caucasians, and foreign to about 80%.
What percentage of patients express your target and do you screen for the target in your clinical trials?
We do screen for HLA-B7, but do not restrict trial entry based on HLA-B7 status because the multiple mechanisms of Allovectin-7® allow it to work in both groups. |
