By Lisa Seachrist
WASHINGTON — Biomira Inc. and Biovector Therapeutics SA have agreed to co-develop Biomira's "designer" cancer vaccine, aimed at B cell lymphoma.
Under the terms of the deal, which covers developing, marketing and manufacturing the vaccine if it garners FDA approval, Biovector, of Toulouse, France, will pay Edmonton, Alberta-based Biomira up to $16 million plus royalties.
"It is part of our focus to out-license activities that don't fit into our synthetic cancer vaccine program," said Alex McPherson, Biomira's president and CEO, who predicted such arrangements between biotechnology companies are "the wave of the future."
Biomira will receive a $500,000 up-front payment from Biovector, and $15.5 million more if all milestones are met. In addition to royalty payments on the vaccine's sales, Biomira will receive transfer fees for the cost of goods on the product it manufactures.
Biomira recently filed an investigational new drug application with the FDA in order to begin Phase I clinical trials of the vaccine. That trial, if approved by the agency, will be funded through an existing Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), in Bethesda, Md.
Costs associated with additional clinical trials will be largely the responsibility of Biovector. McPherson said the NCI is likely to want to continue its involvement in the studies, and Biovector will be responsible for negotiating additional CRADA agreements.
Biomira retains manufacturing rights in North America, while Biovector has them elsewhere. Biovector will be responsible for worldwide marketing, with the exception of the Japanese market, where the company will have the rights to first refusal.
McPherson said more such deals are likely to occur as "companies begin to realize that they have to bring their resources together to get their products to the market."
In 1998, about 55,000 cases of B cell lymphoma will be diagnosed in the U.S. and about 25,000 people will die from the disease, according to American Cancer Society estimates. The incidence of this cancer has doubled since the 1970s.
Treatments for B cell lymphoma include chemotherapy and Rituxan, a newly-approved antibody agent co-developed by Genentech Inc., of South San Francisco and Idec Pharmaceuticals Corp., of San Diego, that can shrink tumors. Unfortunately, residual tumor often remains and invariably leads to relapse of the cancer. Biomira's vaccine encourages a patient's own immune system to battle the residual cancer.
Patients Inoculated With Own Tumors' Antigens
The vaccine is an idiotypic, or "designer," vaccine. Each patient is inoculated with antigen derived from his or her own tumor. The tumor antigen is isolated from the patient's cancer cells, combined with interleukin 2 (IL-2) — a cytokine that stimulates T cell and, to a lesser degree, B cell response — and encased in a liposome. The liposome targets the vaccine to the lymph nodes and spleen, where immune cells reside, and stimulates the patient's immune system to fight the cancer.
"The vaccine in the liposome carrier enhances the movement of the antigen to the immune system," McPherson said.
In partnering the bulk of the responsibilities for the development of the B cell lymphoma vaccine to Biovector, McPherson says the company intends to focus on the development of synthetic cancer vaccines.
Theratope, Biomira's breast cancer vaccine, will enter a 900-patient, multicenter, international Phase III clinical trial at the end of this year or the beginning of next. "It may be the largest cancer vaccine study yet," McPherson said. Theratope, which Biomira is developing with Emeryville, Calif.-based Chiron Corp., contains a mimic of Stn, a naturally occurring disaccharide found on cancer cells.
Biomira's stock (NASDAQ:BIOMF) closed Monday at $1.71, up $0.156. *