Non-Hodgkin’s lymphoma vaccine BiovaxID to get fast-track review in US: Biovest

BiovaxID, Biovest’s personalized lymphoma vaccine, has been granted Orphan Drug designation by US FDA.

BiovaxID belongs to a new class of active immunotherapy and is one of the few select late-stage patient-specific cancer vaccines vying to be among the first to reach market.

BiovaxID 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.

BiovaxID 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.

BiovaxID 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.

With FDA Orphan Drug Status, Biovest has a seven-year period of market exclusivity for BiovaxID upon approval, thereby offering competitive protection from similar drugs of the same class.

Orphan Drug Status also provides Biovest with eligibility to receive potential tax credit benefits, potential grant funding for research and development and significantly reduced filing fees for marketing applications.

Based on statistically significant Phase III study data demonstrating an extended disease-free survival benefit, Biovest expects to file a Biologic License Application (BLA) with the FDA by approximately mid-year in order to seek U.S. approval of BiovaxID.

Biovest also expects to file regulatory applications seeking approvals in Europe and Canada.

What is 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).