Positive, Clinically Significant Phase III Results for Personalized Anti-Cancer Vaccine, BiovaxID®, Presented at ASCO Plenary Session

Business Wire, May 31, 2009

“BiovaxID is a 100% personalized medicine with each vaccine unique to each patient,” stated Biovest’s Chairman and CEO, Francis E. O’Donnell, Jr., M.D. “Despite the failures of other lymphoma vaccines and the skepticism in general towards patient-specific cancer immunotherapies, our unprecedented results presented today are a tribute to the more than 37 years of dedicated vision and labor by researchers dating back to the first mouse studies using this approach in the early 1970s. We congratulate and thank all that have been involved at every level in developing this ultimate targeted therapy, with special recognition to the National Cancer Institute, who with our Biovest team, advanced BiovaxID in human clinical trials. And we also offer our profound thanks to the investigators, and more importantly to the patients that participated in our Phase II and Phase III clinical trials, as their courage in fighting this insidious disease is inspiring. It is only because of their contribution, and with the support of their family and friends, that such potential breakthrough new therapies can be evaluated and ultimately made available to all patients in need.”

In addressing regulatory and commercial plans for BiovaxID, Biovest’s President and General Counsel, Samuel Duffey, commented, “We have already initiated discussions with the FDA and EMEA and are preparing for further meetings with those agencies and other international regulatory authorities in order to share our significant results and determine the most appropriate approval regulatory pathways. In addition, we plan to make BiovaxID available throughout most of Europe on a named-patient basis. This compassionate-use drug access program allows European physicians to prescribe drugs to qualifying patients before approvals are granted, assuming the protocols for each participating country are followed.”

Biovest also reported that the Company expects to publish the final comprehensive results in a peer-reviewed scientific publication later this year.

About BiovaxID®

BiovaxID is a personalized, patient-specific therapeutic vaccine designed to stimulate the patient's own immune system to recognize and destroy cancerous B-cells that may remain in the body or may arise after the patient has been treated with chemotherapy. Unlike many other approaches to treating non-Hodgkin’s lymphoma, BiovaxID is designed to kill only cancerous B-cells, with the initial indication of follicular Non-Hodgkin's lymphoma. Additionally, it is anticipated that BiovaxID could be used to treat other types of B-cell cancers, such as mantle cell lymphoma, chronic lymphocytic leukemia and multiple myeloma.

A Unique Approach to Immunotherapy Targeting B-Cell Blood Cancers

B-cells (a type of white blood cell or lymphocyte) are a vital part of the human immune system, as they produce antibodies that seek out and bind to foreign substances in the body. In lymphoma, as cancerous B-cells develop and multiply unrestrained, each malignant B-cell expresses a unique idiotype or biomarker on the cell’s surface, specific to each patient. Research at Stanford University and the National Cancer Institute led to the development of BiovaxID as a personalized, therapeutic vaccine capable of selectively targeting only cancerous B-cells, while sparing healthy cells. This is achieved by using the idiotype obtained from a sample of the patient’s tumor by biopsy, and through proprietary bioengineering techniques in a patented cell line, a patient-specific vaccine is created that stimulates the immune system by recruiting a patient’s T-cells (immune cells that kill cancerous cells) to seek out and destroy only the diseased B-cells. Unlike other failed cancer vaccine therapies that attempted to target lymphoma, BiovaxID is the only hybridoma (patient’s lymphoma cells are fused to a heteromyeloma cell line to produce the tumor specific idiotype protein) anti-cancer vaccine that consists of a high-fidelity copy of the complete idiotype, believed to be critical in mounting a full and complete immune response against the cancer, as well as “training” the immune system to maintain continuous response if cancerous cells were to return.