Biomira Inc. watched its stock more than double Friday following positive Phase IIb data of its BLP25 liposome vaccine that showed a huge survival benefit for Stage IIIB non-small-cell lung cancer patients.
The company's stock (NASDAQ:BIOM) soared in the U.S. climbing 114.3 percent Friday, or $1.75, to close at $3.28. In Canada, the stock (TSE:BRA) rose 109.7 percent, or C$2.03, to close at C$3.88 (US$3.26).
Edmonton, Alberta-based Biomira and partner Merck KGaA, of Darmstadt, Germany, said that the trial still has not reached a median survival in the pre-stratified subset of locoregional Stage IIIB patients in the vaccine arm. The patients have reached the 23-month mark following the enrollment of the last patient.
The data are a six-month follow-up to results published in April that showed patients in the control arm had a median survival of 13.3 months.
"So there's a minimum of 10 months improvement of survival for the vaccine-treated patients compared to the control group," said Biomira's president and CEO, Alex McPherson. "That is astounding."
The randomized, open-label Phase IIb trial of Liposome-BLP25 was conducted in 171 men and women with NSCLC, whose disease was stable or who had responded to treatment following first-line standard chemotherapy or a combination of standard chemotherapy and radiotherapy. Patients were randomized between a control group, which received best standard care, and a treatment group, which received best standard care plus BLP25.
Lung cancer is the leading cause of cancer-related death for both men and women in North America. This year there will be about 174,000 new cases diagnosed in the U.S., and 160,000 people will die of the disease. Only a quarter of patients diagnosed with lung cancer are curable by surgery. NSCLC represents about 75 percent to 80 percent of all primary lung cancers, and about 22 percent of the patients are in Stage IIIb disease, which is locally advanced and unresectable.
"These patients, generally speaking, receive chemotherapy, and most of the patients receive a platinum compound, as well as a taxane," McPherson told BioWorld Today. "There's a wide variety of different products available for the treatment of this disease. The treatment of the Stage IIIB disease results in 11 to 12 months median survival."
Biomira internally developed BLP25, which is a synthetic MUC1 peptide vaccine designed to induce an immune response to cancer cells. It incorporates a 25-amino-acid sequence of the MUC1 cancer mucin, encapsulated in a liposomal delivery system.
Biomira's agreement with Merck and its U.S. subsidiary, EMD Pharmaceuticals Inc., was formed in May 2001. In addition to BLP25, the agreement included Theratope, which failed in a Phase III breast cancer trial in 2003. Merck returned the rights to Theratope earlier this year, and Biomira is developing the product further in a subset of women in which positive results were seen.
The agreement for BLP25 is a 50/50 co-promotion deal in the U.S. and Canada. Each company will cover 50 percent of the development and commercialization costs in return for a 50 percent share of sales. Outside North America, Biomira will receive a royalty on sales. (See BioWorld Today, May 4, 2001.)
Based on the six-month follow-up of the Phase IIb data, Biomira expects to seek early registration in a market outside the U.S. and conduct a confirmatory trial after approval, McPherson said. That was not the original intention of the trial.
"This is a trial that's looking at efficacy, but is also looking at safety," McPherson said. "So it was designed principally to help us decide whether to go forward with the product into a much larger Phase III trial."
A Phase III U.S. trial most likely would begin in late 2005, stretching a potential market launch out three years to 2008. Biomira is working with Merck on the protocol details. The company also is scheduling the manufacture of new vaccine supplies.
While McPherson could not estimate the exact amount of BLP25's market potential, he believes it's sizable.
"If one were to look at comparable costs related to chemotherapeutics, for instance, and, perhaps some of the more recent biomodulators, such as Iressa, the market is in the hundreds-of-millions-of-dollars a year [range]," he said.
Aside from Iressa, which is marketed by London-based AstraZeneca plc, another potential competitor in the NSCLC market is Tarceva. Melville, N.Y.-based OSI Pharmaceuticals Inc. and South San Francisco-based Genentech Inc. developed that product, which received approval last month. In advanced lung cancer patients, those who received Tarceva had a median survival of 6.7 months compared to 4.7 months in placebo patients. Analysts estimate Tarceva could bring in $188 million in worldwide sales in 2005 and more than $800 million its fifth year on the market. (See BioWorld Today, Nov. 22, 2004.)
Median survival is reached once 50 percent of the treated patients have died. McPherson declined to say how close the Phase IIb trial subset is to reaching median survival, but he expects to soon release detailed results in a peer-reviewed scientific presentation or journal.
The Phase IIb trial tested BLP25 in Stage IIIb and Stage IV NSCLC patients, showing that median survival in the treatment group was 4.4 months longer than in the control group. While that result was not statistically significant, BLP25 appeared beneficial in the subgroup of Stage IIIb disease patients.
"What we are talking about that's important is a relatively non-toxic product, and that's very important in these kinds of patients," McPherson said. "They go through very, very toxic chemotherapy regimens and to add another toxic program on top of these chemotherapy programs would be pretty unattractive."