Biovest
This article reads like a press release or a news article and may be largely based on routine coverage. (August 2017) |
Company type | Chief Executive Officer) |
---|---|
Products | BiovaxID (dasiprotimut-T) |
Services | Autologus active immunotherapy (cancer vaccines) |
Number of employees | 50 |
Website | www.cellculturecompany.com |
Biovest International, Inc (
BiovaxID (dasiprotimut-T)
Unlike a
The BiovaxID vaccine is manufactured through a process known as rescue fusion hybridization.[5] 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.[4]
BiovaxID obtained Orphan drug status with the FDA and has obtained positive Phase III clinical trial results.[6] 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 (adj. p=0.029).[7] 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].[8]
In its multi-center, randomized, controlled Phase 3 clinical study, BiovaxID demonstrated that it can induce powerful anti-tumor immune responses while providing a median disease-free survival benefit of over 15 months, and a reduction of 42% in the risk of relapse, and in the company's Phase 2 clinical trial, 28% of patients who received BiovaxID remain in continuous remission at a median of 12.7 years of follow-up.[9]
The approval of
Regulatory status
In December 2013, Biovest reported that the European Medicines Agency (EMA) accepted the Company's Marketing Authorization Application (MAA) for BiovaxID (submitted to EMA as “Dasiprotimut-T Biovest”), a personalized cancer vaccine for the treatment of non-Hodgkin's follicular lymphoma. The MAA validation confirms the submission is complete and begins the formal EMA review process intended to secure approval to market BiovaxID in the European Union and to allow prescription and sale of BiovaxID for the treatment of non-Hodgkin's follicular lymphoma in patients who have achieved a first complete remission.
Biovest submitted its MAA following the successful completion and long-term follow-up of two Phase 2 clinical trials and of one multi-center, randomized, Phase 3 clinical trial (all conducted in partnership with the U.S. National Cancer Institute) in which BiovaxID demonstrated it could induce powerful anti-tumor immune responses, eradicate residual tumor cells from patients’ blood following chemotherapy, and improve the duration of complete remissions by a median of 15.4 months relative to control.
Patents
Biovest has been granted many patents, including the following: Perfusion Bioreactors, Cell Culture Systems, and Methods for Production of Cells and Cell-Derived Products,[11] Method and System for the Production of Cells and Cell Products and Applications Thereof,[12] and Extra-Capillary Fluid Cycling System and Method for a Cell Culture Device.[13]
See also
Notes
- ^ "Biovest International, Inc. Files for Bankruptcy" (Press release). BioVest. March 8, 2013. Retrieved July 8, 2023 – via BioSpace.
- ^ "European Medicine Agency Recommends Refusal of the Marketing Authorisation for Dasiprotimut-T". European Society for Medical Oncology. April 28, 2015. Retrieved July 8, 2023.
- ^ "Form REVOKED Biovest International Inc. REVOKED - Commission order revoking Exchange Act registration [Section 12(j)]". SEC.report. October 4, 2017. Archived from the original on August 5, 2021. Retrieved July 8, 2023.
- ^ a b "BIOVAXID PERSONALIZED CANCER VACCINE". 1 Dec 2011. Archived from the original on 17 December 2011. Retrieved 2 December 2011.[self-published source]
- ^ Dimond, Patricia F (October 18, 2010). "What Comes After Dendreon's Provenge?". Genetic Engineering & Biotechnology News. Mary Ann Liebert. Archived from the original on October 31, 2010. Retrieved July 8, 2023.
- ^ "Idiotype vaccine therapy (BiovaxID) in follicular lymphoma in first complete remission: Phase III clinical trial results". American Society of Clinical Oncology. Archived from the original on 27 September 2011. Retrieved 2 May 2010.
- ^ "BiovaxID Phase III results". Archived from the original on 2009-06-05.
- ^ "Biovest Reports a Significant Discovery in Cancer Vaccines for Lymphoma: Vaccine Isotype Determines Improvement in Disease-Free Survival Following Vaccine Therapy". BusinessWire. Archived from the original on 5 December 2011. Retrieved 1 Dec 2011.
- ^ "European Medicines Agency Accepts Marketing Authorization Application for Biovests Cancer Vaccine for Treatment of Non-Hodgkin's Follicular Lymphoma". 13 January 2014.
- ^ "Biovest plans to market vaccine for a third type of non-Hodgkin's lymphoma". Star Tribune. Retrieved 1 Dec 2011.
- ^ "PERFUSION BIOREACTORS, CELL CULTURE SYSTEMS, AND METHODS FOR PRODUCTION OF CELLS AND CELL-DERIVED PRODUCTS". Biovest. Retrieved 1 Dec 2011.
- ^ "METHOD AND SYSTEM FOR THE PRODUCTION OF CELLS AND CELL PRODUCTS AND APPLICATIONS THEREOF". Biovest. Retrieved 1 Dec 2011.
- ^ "EXTRA-CAPILLARY FLUID CYCLING SYSTEM AND METHOD FOR A CELL CULTURE DEVICE". Biovest. Retrieved 1 Dec 2011.