Biovest's anti-cancer vaccine yields 89% survival in patients with lymphoma after 3.8 years

By Angela McDaniels

Seattle, Jan. 24 - Biovest International Inc. said follow-up data from a phase 2 trial conducted by the National Cancer Institute shows that 89% of mantle cell lymphoma patients treated with the company's BiovaxID anti-cancer vaccine were still alive after 3.8 years.

Historically, patients with this type of lymphoma have a 50% chance of surviving three years and a 20% chance of surviving five years, according to a company news release.

In the single-arm, open-label phase 2 clinical study, 23 patients with untreated mantle cell non-Hodgkin's lymphoma were given six cycles of dose-adjusted Epoch-R, a chemotherapy regimen that includes Rituxan (rituximab).

Biovest said the study also showed that, despite an almost complete depletion of normal B-cell lymphocytes due to Epoch-R therapy, BiovaxID induced anti-tumor T-cell lymphocyte responses in most patients.

Depletion of normal B-cell lymphocytes is a consequence of the combination of chemotherapy and Rituxan, but not of BiovaxID therapy. Thus, the investigators concluded that "it is justifiable to administer vaccines in the setting of B-cell depletion, but vaccine boosts after B-cell recovery may be necessary for optimal humoral responses."

B-cell lymphocytes produce antibodies ("humoral" immunity) in response to immune stimulation, and T-cell lymphocytes mediate cell responses to immune stimulation ("cellular" immunity), according to the release. B-cell lymphocytes can undergo malignant transformation to become non-Hogkins lymphoma, multiple myeloma or chronic lymphocytic leukemia.

"This is the first human cancer vaccine study to see T-cell responses in the absence of B-cells. This paves the way to use vaccines in a number of hematological cancers that are treated by eliminating diseased B-cells," lead author Sattva Neelapu of the University of Texas said in the release.

Data from the study was published in a recent edition of Nature Medicine.

Biovest said it is now enrolling patients in a pivotal phase 3 trial to test BiovaxID against follicular non-Hodgkin's lymphoma.

BiovaxID, an investigational personalized anti-cancer vaccine, stimulates the immune system to seek out and destroy tumor cells.

Worcester, Mass.-based Biovest International manufactures biologics and develops, manufactures and markets patented cell culture systems. It is a subsidiary of Accentia Biopharmaceuticals Inc.

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