National Editor

The cancer vaccine deal between Cell Genesys Inc. and Japan Tobacco Inc., already modified once, has come to an end - which means the U.S. firm now has all worldwide rights to its GVAX portfolio.

Foster City, Calif.-based Cell Genesys said it expects the near-term revenue impact of the collaboration's end to be minimal.

"Actually, we may wind up ahead," said Robert Tidwell, senior vice president of corporate development. The company's stock (NASDAQ:CEGE) closed Friday at $12.33, down 37 cents.

When it began four years ago, the deal with Japan Tobacco, of Tokyo, for prostate cancer and lung cancer vaccines was worth a potential $153 million, but the agreement was narrowed in November 2001 to include only lung cancer. (See BioWorld Today, Dec. 21, 1998.)

Tidwell said the deal had more than fulfilled its financial promise.

"We're sad to see JT go," Tidwell said. "On the other hand, it's full speed ahead on our lung program." He said JT made the decision for business reasons.

"We're not going to be specific about this, but if you look at the Japanese economy and the Japanese stock market, you'd understand," he said.

In June of this year, Cell Genesys presented positive final results of a multicenter Phase I/II trial of the lung cancer vaccine, and said it plans to conduct two Phase II trials in patients with bronchoalveolar carcinoma (who seemed particularly responsive) before starting a broad Phase III trial in non-small-cell lung cancer, of which bronchoalveolar is a subtype.

The Phase II trials, one of which will be sponsored by the National Cancer Institute, are expected to begin late this year or early next, with the Phase III trial starting in late 2003.

Tidwell, however, characterized the GVAX prostate cancer product as the "lead effort." He declined to say when a Phase III trial might begin in that indication.

GVAX vaccines are made of tumor cells irradiated and genetically modified to secrete granulocyte macrophage-colony stimulating factor, which are used to vaccinate patients to stimulate immune responses against their tumors.

Cell Genesys is testing non-patient-specific GVAX treatments for prostate cancer and pancreatic cancer, and individualized vaccines for lung cancer, leukemia and myeloma. All are in Phase II trials except for the myeloma vaccine, which is in Phase I/II.

The company also has an oncolytic virus therapy for prostate cancer, CG7060, in Phase II trials, and another for the same indication, CG7870, in Phase I/II trials.

Tidwell said the company now has a "blank slate" with regard to commercializing its products, but would not say whether another partner will be sought.

"That's still evolving," he said.