Therapy for Non-Hodgkin's Lymphoma

 

Non-Hodgkin's Lymphoma

There are approximately 65,000 new cases of non-Hodgkin’s lymphoma diagnosed each year in the US with a comparable number in Europe. Despite the use of aggressive chemotherapy and recent advances in therapy such as monoclonal antibodies (Rituxan, TM), the disease is almost invariably fatal. Follicular lymphoma (FL) patients, in particular, can have an indolent but ultimately fatal clinical course. The median relapse time for FL patients is three years, with 90% of patients dying of a tumor-related mortality within 7 years of the date of diagnosis. The clinical course is usually characterized by a series of remissions and relapses. Good response rates are seen with treatments such as chemotherapy, radiation, lymphocyte transplantation, and monoclonal antibodies. However, following initial response to treatment, the cancer invariably returns and the majority of patients relapse with resistance to all available therapy. Related B-cell derived neoplasms include multiple myeloma (approx. 15,000 cases/year in the US and chronic lymphocytic leukemia (approx. 10,000 cases/year in the US).

As the leading manufacturer of hollow fiber technology and with over 2 decades of cell culture experience, Biovest has pioneered a unique platform to commercialize patient-specific biologics.  The AutovaxID, our highly automated, exceptionally compact cell manufacturing device is central in our plans to deliver medicine custom made from each patient, for each patient. 

In the early 1990s The National Cancer Institutes recognized the potential of hollow fiber technology for patient-specific vaccines.  Biovest was chosen by the NCI to commercialize a therapeutic vaccine for non-Hodgkin's lymphoma due to its leadership position with the technology.  Now, under a Cooperative Research and Development Agreement (CRADA) with the NCI, Biovest is testing it's NHL vaccine in a pivotal phase 3 clinical trial.  

A core mission of Biovest is to use our expertise in hollow fiber to advance personalized medicine and make it a reality.  In addition to manufacturing Biovest's proprietary vaccine, we are working with other biotechnology companies to provide manufacturing services for a variety of autologus treatments.

BiovaxID Cancer Vaccine Overview

The Biovest cancer immunotherapy stems from work begun in 1986 on development of a patient-specific follicular lymphoma (FL) vaccine. The cancer vaccine evokes the power of each patient's immune system and primes it to recognize and eliminate cancerous lymphoma cells, while sparing normal B-cells. In the vaccine's cancer target, B-cell lymphoma, the process is made possible by the presence of a hallmark surface antigen of the cancer cells that is not present in non-cancerous tissue. By priming the immune system with this antigen in the form of an autologous vaccine, the vaccine induces a powerful immune response against the cancerous cells that in many cases results in pronounced, complete cancer clearance. Because each dose of Biovest's vaccine is derived from individual patient's cancerous cells, the vaccine is a true targeted, customized therapy. The vaccine's powerful anti-tumor effect vastly exceeds that of non-targeted traditional therapy, as it arises from the immune system's defense cells' innate ability to selectively target foreign antigens. Most importantly, the immune response triggered by the vaccine against the cancerous tissue is a natural disease-fighting mechanism and has almost none of the side-effects associated with the broad-spectrum chemotherapy and radiation used to traditionally treat this type of lymphoma.

       vvBiovaxID utilzes a patient specific process to create

              vvtailor-made therapeutic cancer vaccines

Phase 1 and 2 Study References

Hsu, JH, Caspar CB, et al. "Tumor-specific idiotype vaccines in the treatment of patients with B-cell lymphoma-long term results of a clinical trial." Blood 1997, 89(9):3129-3135.

Bendandi et al. "Complete molecular remissions induced by patient-specific vaccination plus granulocyte-monocyte colony-stimulating factor against lymphoma." Nature Medicine, 1999, 5(10):1171-1177.

Neelapu et al, " Phase III randomized trial of patient-specific vaccination for previously untreated patients with follicular lymphoma in first complete remission: protocol summary and interim report." Clin Lymphoma. 2005, 6(1):61-64.

Pivotal Phase 3

As a result of the promising Phase 2 results, the FDA and NCI have approved a pivotal Phase 3 study involving 375 patients. In January 2000, the NCI opened a multi-institutional Phase 3 randomized clinical trial that is scientifically designed to definitively evaluate the question of clinical benefit induced by patient-specific idiotype vaccines in follicular lymphoma patients.

Expanded Applications for BiovaxID

In addition to forms of non-Hodgkin's lymphoma other than the follicular type (FL), the vaccine technology has the potential to offer substantial benefits to other related B-cell derived neoplasms such as multiple myeloma and chronic lymphocytic leukemia. Like non-Hodgkin’s lymphoma, these neoplasms also express a specific idiotype maker on the surface of tumor cells.

 

*BiovaxID autologous vaccine is currently undergoing investigation in a phase 3 clinical trial. It is not approved for general use at this time.