Biomira Inc. is collaborating with Inno-centre Alberta to spin out a company that will work on Liposomal Interleukin-2, the cancer drug set aside last year in favor of two others: the Phase III failure Theratope and BLP25 Liposome Vaccine, which proved encouraging in a Phase IIb study and could advance to Phase III.
"We never lost sight of the fact that it was a great potential drug," said Robert Aubrey, vice president of marketing and business development for Edmonton, Alberta-based Biomira. "It's what I call a me-better' of an existing product."
Biomira's stock (TSX:BRA) closed Thursday at C$2.19 (US$1.60), up C9 cents.
The new company will be called Oncodigm BioPharma. Inno-centre is a private, nonprofit entity that boosts technology ventures, and its arrangement with Biomira provides a senior business adviser for the new firm, which is to raise its own capital, pushing L-IL-2 back into clinical trials in 2005. The adviser is David Howard, chairman of Redmond, Wash.-based Scolr Inc. and Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia.
"They're also going to be putting a lot of at-risk money over a two-year period into the program," Aubrey told BioWorld Today. "They'll put into it what it takes to get it up and running and make it a success."
With L-IL-2, Biomira got as far as a Phase I study in patients with various types of cancer, most either melanoma or kidney cancer. Oncodigm plans to assemble a management team and start again with the drug, most likely in metastatic renal-cell carcinoma. The compound has orphan drug status in the U.S. and Europe, as well as an open investigational new drug application in both of those jurisdictions.
"We had FDA approval on a major Phase I/II trial that would have taken quite a bit of resources from our company," Aubrey said. "There was nothing wrong with that product," and Biomira is retaining 90 percent of the new company.
Meanwhile, BLP25, which yielded potentially useful though not statistically significant results in a Phase IIb trial against non-small-cell lung cancer, might move into Phase III trials after talks with regulatory agencies. BLP25 is partnered with Merck KGaA, of Darmstadt, Germany.
The BLP25 trial enrolled 171 men and women with Stage IIIb or Stage IV NSCLC and randomized them to either the control group, which received best standard care, or to the treatment group, which received best standard care plus BLP25. The primary efficacy variable of the trial was survival between those two groups and, while the standard care group saw a median survival of 13 months, investigators saw a 17.4 month median survival for the treatment group - a survival benefit that the company's advisory board said would be "an important achievement in this disease."
The two-year survival for patients with locoregional Stage IIIb disease was 60 percent for the vaccine arm (median survival not yet reached) vs. 36.7 percent for the control arm (median survival of 13.3 months). In the overall patient population, the two-year survival was 43.2 percent for the vaccine arm vs. 28.9 percent for the control arm.
Data from a Phase II study with BLP25 in prostate cancer will be reported at the upcoming meeting of the American Society of Clinical Oncology, Aubrey said.
Biomira's other drug, Theratope vaccine for metastatic breast cancer, failed last summer to reach two primary endpoints in a Phase III study, although a subset of 350 women (from a total of 1,030 patients) on hormonal treatment after chemotherapy appeared to show benefit. Biomira said it will decide by the end of June whether to start a new Phase III trial. (See BioWorld Today, June 18, 2003.)
At the end of the first quarter of 2004, Biomira had $26.7 million in cash and short-term investments, enough to sustain the firm until mid-2005.