reported that the Phase III study with BiovaxID
®, its personalized anticancer vaccine, achieved its primary endpoint of prolonging disease-free survival in follicular non-Hodgkin’s lymphoma
patients. The firm’s shares went up 300% from $0.49 to $1.50.
The company is preparing to meet with the FDA and EMEA to decide on the best path to approval, according to president and general counsel, Samuel Duffey. This marks another victory for the field of cancer immunotherapies, with Dendreon reporting positive results with Provenge last month.
The randomized, multicenter, double-blind trial was carried out over eight years in 177 patients. Patients who received BiovaxID experienced a median disease-free survival of 44.2 months compared to 30.6 months for those who received a control vaccine, according to Biovest. In the study, with a median follow-up of 4.7 years, patients receiving BiovaxID experienced a 38% lower risk of disease recurrence, the firm adds.
BiovaxID is individually manufactured from a tissue biopsy obtained from a patient’s own tumor and selectively targets cancerous B cells while sparing healthy cells, Biovest explains. The final vaccine is administered as a subcutaneous injection along with granulocyte-macrophage colony-stimulating factor (GM-CSF) and keyhole limpet hemocyanin (KLH), which together enhance the potency of the immune response induced by BiovaxID. In the trial, patients in the control arm received only GM-CSF and KLH.
Further studies are planned to examine the role of BiovaxID in patients with other B-cell lymphomas such as mantle cell lymphoma, chronic lymphocytic leukemia, and multiple myeloma. In addition, new lymphoma studies will evaluate the addition of BiovaxID booster maintenance therapy.