At the 2012 American Society of Clinical Oncology Annual Meeting, new data from Biovest International Inc.'s (BVTI.PK) mid phase mantle cell lymphoma clinical trial of its lead product candidate BiovaxID is scheduled to be presented on June 2.
For readers who are new to Biovest, here's a brief overview of the company's pipeline and the upcoming events to watch out for...
Biovest is focused on developing personalized immunotherapy for cancers of the blood system. The company's flagship product candidate, BiovaxID, developed in collaboration with the National Cancer Institute, is a personalized, patient-specific therapeutic vaccine for the treatment of follicular non-Hodgkin's lymphoma, mantle cell lymphoma, and potentially other B-cell blood cancers.
BiovaxID vaccine is under a phase II and a phase III clinical trial in patients with follicular non-Hodgkin's lymphoma, as well as a phase II clinical trial in mantle cell lymphoma patients. The vaccine is unique in the sense that it is produced by harnessing each patient's own cancer cells and is designed to kill only cancerous B-cells.
According to Biovest, BiovaxID complements the effects of induction Rituximab chemotherapy in patients and also spare them the toxicities and relapses common to lymphomain. It is estimated that roughly 1.8 million people worldwide are living with non-Hodgkin's lymphoma, with approximately 130,000 new cases diagnosed every year in the U.S. and Europe.
The company plans to seek marketing approval for BiovaxID for the treatment of follicular non-Hodgkin's lymphoma in Canada later this year. With pre-filing meetings having been conducted in Europe, Biovest intends to seek marketing approval in the EU also for BiovaxID for follicular non-Hodgkin's lymphoma.
Looking ahead, Biovest plans to conduct meetings with the FDA to review the comprehensive clinical data of BiovaxID that will help determine the most expeditious approach to U.S. registration.
Also in the company's portfolio is an automated cell culture instrument called AutovaxID to support the planned commercialization of BiovaxID. Seeking to further develop AutovaxID and to explore potential production of additional vaccines, including vaccines for viral indications such as influenza, Biovest has a collaboration in place with the U.S. Department of Defense.
Biovest also manufactures instruments and disposables used in the hollow-fiber production of cell culture products that are employed by biopharmaceutical and biotechnology companies, medical schools, universities, research facilities, hospitals and public and private laboratories.
A quick look at the company's balance sheet...
Biovest and its parent company Accentia Biopharmaceuticals Inc. (ABPI.PK), which entered Chapter 11 bankruptcy in 2008, emerged from bankruptcy as fully restructured companies in November 2010. As of April 30, 2012, Accentia owned about 60% of Biovest's outstanding common stock.
Biovest recognizes revenue from instruments and disposables sales, contract cell production services and grant revenue.
In the quarter ended March 31, 2012, Biovest's total revenue was $1.22 million, almost unchanged from the year-ago comparable quarter. The company incurred a net loss of $5.91 million for the quarter, reversing a year-ago quarterly net income of $82 thousand.
As at the end of March quarter 2012, the company had cash of $212 thousand and debt of $34.48 million. (Data sourced from Yahoo Finance).
Taking into account Biovest's ongoing worldwide regulatory strategy to seek marketing approvals for its personalized lymphoma cancer vaccine in multiple countries, it is worth keeping an eye on this stock.
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