| Type | Public |
|---|---|
| Industry | Biomedicine |
| Headquarters | Tampa, Florida, USA |
| Key people | Samuel S. Duffey, Esq (President) Francis E. O'Donnell (Chairman) |
| Products | BiovaxID |
| Services | Cancer vaccines |
| Parent | Accentia Biopharmaceuticals |
| Website |
http://www.biovest.com/index.html http://www.accentia.net/ |
Biovest International, Inc (OTC Markets Group: BVTI) is a Tampa-based biotechnology company that is the majority-owned subsidiary of Accentia Biopharmaceuticals. Their flagship product candidate, BiovaxID, is a cancer vaccine whose first indication is intended to be indolent follicular Non-Hodgkin's Lymphoma.
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Unlike a preventative vaccine, such as for measles or mumps, BiovaxID is administered as a cancer treatment, designed to stimulate and "train" the patient's immune system to respond and attack cancerous cells, even long after therapy has been stopped — each vaccine being unique to that particular patient. Beginning with an excisional (>2cm) lymph node biopsy, tumor cells are fused with our proprietary mouse/human heterohybridoma in order to induce secretion of normally surface-bound tumor immunoglobulin (idiotype or Id). Id-secreting clones are identified by comparing their unique idiotype sequence to the tumor’s after which they are cultured (expanded) in the AutovaxID™ bioreactor system. During culture, supernatant (containing idiotype) is collected until sufficient amounts have been produced to yield adequate dosage of vaccine. This supernatant is purified by affinity chromatography and conjugated (bonded) to KLH carrier protein, resulting in a finished vaccine that can be shipped and administered to patients. In the Phase III clinical trial, manufacturing success was approximately 95% of treated patients.[1]
The BiovaxID vaccine is manufactured through a process known as rescue fusion hybridization.[2] Since BiovaxID is a personalized vaccine, each patient’s vaccine is individually manufactured from a tissue biopsy obtained from a patient’s own tumor. This approach is used because there is a unique protein called an “idiotype” expressed exclusively on the cancerous B-cells. So, when a full, high-fidelity copy of the idiotype is linked to a foreign protein (KLH), and administered with an immune-enhancing agent (GM-CSF), the resulting vaccine can mount a highly-specific anti-lymphoma attack that “trains” the body’s own immune system to solely recognize the idiotype as a “foreign invader”, thus stimulating and recruiting the patient’s own immune system to destroy micro-pockets of cancer cells that may remain following chemotherapy and potentially target and destroy newly arising lymphoma cells, thus delaying or preventing cancer recurrence. As such, through its unique mode of action, and exemplary safety record, BiovaxID represents a new therapeutic approach to treating follicular lymphoma.[1]
BiovaxID obtained Orphan drug status with the FDA and has obtained positive Phase III clinical trial results.[3] After a median follow-up of 4.71 years (56.6 months, range: 12.6 - 89.3 months), the median disease-free survival in the BiovaxID arm was 44.2 months compared with 30.6 months in the control arm, which is a clinically and statistically significant difference (p=0.045).[4] Among the 75 patients receiving BiovaxID in the study, 35 received BiovaxID manufactured with an IgM isotype and 40 received BiovaxID manufactured with an IgG isotype with each treatment vaccine produced to correspond with the patient’s tumor immunoglobulin isotype. Of 40 patients receiving control, 25 had tumors with IgM isotype and 15 had tumors with IgG isotype. Two of the patients in the vaccinated treatment/control population had a tumor with mixed IgM/IgG isotypes and were excluded from this analysis. Among 35 patients with IgM tumor isotype receiving BiovaxID manufactured with an IgM isotype, median time to relapse after randomization was 52.9 months versus 28.7 months in the IgM tumor isotype control-treated patients (log-rank p=0.001; HR=0.34 (p=0.002); [95% CI: 0.17-0.68]. Among 40 patients with IgG tumor isotype receiving BiovaxiD manufactured with an IgG isotype, median time to relapse after randomization was 35.1 months, versus 32.4 months in control-treated patients with IgG tumor isotype (log-rank p=0.807; HR=1.1 (p=0.807): [95% CI: 0.50-2.44].[5]
The approval of Dendreon's Provenge on April 29, 2010 indicates the FDA's willingness to accept a new class of drugs called cancer vaccines, of which BiovaxID is one. BiovaxID is also in phase II trials for Mantle Cell Lymphoma and is being investigated in the treatment of other Non-Hodgkin's Lymphomas as well. On November 2, 2011, BiovaxID was granted seven years of U.S. market exclusivity for Waldenstrom’s Macroglobulinemia, a third and rare type of Non-Hodgkin’s Lymphoma.[6]
Biovest has been granted many patents, including the following: Perfusion Bioreactors, Cell Culture Systems, and Methods for Production of Cells and Cell-Derived Products,[7] Method and System for the Production of Cells and Cell Products and Applications Thereof,[8] and Extra-Capillary Fluid Cycling System and Method for a Cell Culture Device.[9]
As for additional patents, Biovest’s President, Mr. Samuel S. Duffey, states, "We believe that [the IgM isotype treatment data] may have potentially paradigm-changing implications to the future of cancer vaccine development and accordingly, we have filed new patent applications in order to add another layer of protection for BiovaxID, as well as potentially covering other new vaccines and products that may be developed based on this technology.[5]