At Biovest International, Inc., we believe in the power of the individual. We bring each patient’s immune system into the fight against cancer: Our vaccines are tailor-made to fight non-Hodgkin’s lymphoma, one patient at a time.
European Medicines Agency Accepts Marketing Authorization Application for Biovest’s Cancer Vaccine for Treatment of Non-Hodgkin’s Follicular Lymphoma Full article
On July 8, 2013, Dr. Carlos Santos was appointed as our Chief Executive Officer. Since 2009, Dr. Santos has managed all key aspects of our personalized immunotherapy platform, including our clinical and regulatory affairs, while also leading the development of our manufacturing systems essential to personalized cancer vaccine production. He designed and led the transition of the company’s vaccine manufacture into an automated process by developing software for automated systems integral to autologous vaccine manufacture. Dr. Santos has authored numerous peer-reviewed publications in the fields of active immunotherapy, oncology, and bioinformatics. He is a graduate of the University of Michigan, where he earned a Ph.D. in Bioinformatics, and Washington University (St. Louis), where he earned a B.S. in Computer Science. At the University of Michigan, Dr. Santos developed automated natural language processing systems to integrate high-throughput genomic experimental data with known protein interaction pathways in metastatic prostate cancer progression. He also led the development of a large-scale automated search and summarization engines for biomedical documents at the University of Michigan’s National Center for Integrative Biomedical Informatics. From 1998 to 2001, Dr. Santos was a researcher at Washington University’s Institute for Biomedical Computing (now the Center for Computational Biology).
Robert Farrell, Esq. was appointed as our Chief Financial Officer and designated to serve as our Principal Financial Officer and Principal Accounting Officer effective December 1, 2013. Prior to that time, Mr. Farrell served as Chief Financial Officer of Sanovas, Inc., a medical device company from 2012 to 2013. Prior to that, he was employed by Titan Pharmaceuticals, Inc., a diversified public biotechnology company, where he served as President and Chief Executive Officer from 2008 to 2010 and as Executive Vice President and Chief Financial Officer from 1996 to 2008. From 1990 to 1996, Mr. Farrell served as Corporate Group Vice President and Chief Financial Officer of Fresenius USA. From 1982 to 1990, Mr. Farrell was employed by Genstar Corporation, serving as Vice President of Marketing within Genstar’s Financial Services Division from 1982 to 1989, and as President of TXL Securities from 1987 to 1990. Mr. Farrell also served as Associate General Counsel of Brae Corporation from 1979 to 1982, and as an Associate Attorney for Crane & Hawkins from 1977 to 1979. Mr. Farrell received a J.D. from University of California, Hastings College of Law and a Bachelor of Arts degree in Government and Economics with a Minor in Accounting from University of Notre Dame. Mr. Farrell is a Member of the California Bar.
Dr. Mihaela Popa joined Biovest in 2009 to direct the clinical development program of BiovaxID™ (dasiprotimut-T) and related regulatory affairs. Dr. Popa graduated Medical School in Romania, received a Ph.D. in Aging Studies from the University of South Florida, and pursued a postdoctoral fellowship in the Senior Adult Oncology Clinic at the H. Lee Moffitt Cancer Center. She published in high impact peer-reviewed journals and presented at national (American Society of Clinical Oncology, American Association for Cancer Research, the American Society of Hematology) and international meetings (Romanian Society of Medical Oncology).
Dr. Amy McCord directs the manufacture and control of BiovaxID. Dr. McCord received her Ph.D. from the Department of Molecular Medicine at the University of South Florida College of Medicine in 2005. She subsequently devoted several years to cancer biology research as a postdoctoral fellow at the H. Lee Moffitt Cancer Center in the Drug Discovery program. Dr. McCord’s basic research background encompasses bacterial pathogenesis, angiogenesis, and DNA repair mechanisms of cancer stem cells. She authored several peer-reviewed manuscripts and abstracts presented at national meetings including the American Society of Clinical Oncology and the American Society of Hematology. Dr. McCord joined Biovest in 2009 to support the regulatory and scientific development of BiovaxID.
Dr. Daniel Chen manages the initiative to expand Biovest’s capabilities in automated process R&D and cGMP manufacturing. As a bioinformatics expert with a decade of bench research experience, Daniel is well versed in both the technological and biomedical domains. Prior to joining Biovest in 2013, Daniel’s research focused on the development and application of ad hoc analytical pipelines to problems in developmental biology, cardiac hypertrophy, and obesity. Daniel received his Bachelor of Science in Molecular Genetics from University of Toronto. He also holds a doctorate in Computational Biology from Washington University in St. Louis.
Biovest collaborates with leading academic and commercial research centers including:
Our lead product BiovaxID® was developed in partnership with the National Cancer Institute (NCI). It is a late-stage (Phase 3 clinical trial-completed) patient-specific cancer vaccine that targets follicular non-Hodgkin’s lymphoma, mantle cell lymphoma, and potentially other B-cell cancers.
This vaccine represents the first true patient-specific protein vaccine to treat non-Hodgkin’s lymphoma and has demonstrated superiority (15.4 months improvement in remisison duration) in a multi-center, randomized Phase 3 clinical trial.
Today, a significant number of FL patients achieve a response with first line therapy and rely upon currently approved therapies (largely rituximab maintenance) to maintain this response. Furthermore, rituximab maintenance, which targets only CD20, often leads to the development of resistant disease. A high unmet need therefore exists for new consolidation options not limited to the CD20 target.
As expected for an autologous therapy, our Phase 3 trial demonstrated that BiovaxID therapy was safe and well-tolerated: grade 3-4 adverse events and severe adverse events were rare and there were no BiovaxID related deaths. Furthermore, as an active immunotherapy, BiovaxID does not induce immunosuppression and spares patients from the serious potential side effects related to extended immunosuppression or radiation exposure. Thus, BiovaxID therapy prolongs remission duration without the risks associated with currently available consolidation therapies.
BiovaxID offers a non-immunosuppressive option as a consolidation therapy for FL. By its mechanism of action, BiovaxID eliminates the risk of development of rituximab resistance.
Because of its mode of action, safety, efficacy, and specific tumor target, BiovaxID may indeed be a nearly ideal consolidation agent for FL.
Biovest manufactures a proprietary line of automated hollow fiber bioreactor systems, including the innovative AutovaxID™. It is a production platform for the scalable manufacture of difficult-to-produce biologics, including personalized medicines, monoclonal antibodies, cell culture vaccines, and therapeutics targeting highly infectious agents. AutovaxID is the production system used in the manufacture of BiovaxID, Biovest’s personalized cancer vaccine, and it is also being evaluated by the U.S. Naval Health Research Center as a novel production system for viral vaccines.
Since 1981, Biovest has offered its clients a wide range of instrumentation and cell culture contract manufacturing services dedicated to clinical grade biological products. These services include cell line stabilization, master and working cell banks, process development and optimization, protein production and purification, and downstream processing.
300 South Hyde Park Avenue, Suite 210
Tampa, FL 33606 USA
8500 Evergreen Blvd.
Minneapolis, MN 55433 USA
(763) 786-0302 Ext. 256
8500 Evergreen Blvd.
Minneapolis, MN 55433 USA
(763) 786-0302 Ext. 215
Proudly manufacturing instruments and offering cell services since 1983, our facility in Minneapolis, MN features automated systems which allow for global manufacturing of personalized vaccines. We pioneered personal-scale process automation in cell culture by developing automated micro-footprint AutovaxID bioreactor systems, disposable personal-scale protein purification instruments, and have recently deployed advanced liquid hardware and software to automate the cGMP process for personalized vaccines.