By Randall Osborne
Less than six months after ImmuLogic Corp. cut its work force by 28 percent, blaming clinical-trial delays of its two lead products, the company said it will restructure again — this time stopping development of both products, reducing staff and paring net cash spending from a projected $18 million to $3 million per year.
Cheryl Bourque, manager of marketing and business development for Waltham, Mass.-based ImmuLogic, said it was unclear how many staffers would be laid off from its roster of 55 full-timers.
In June, ImmuLogic downsized to 94 full-time employees, which cost $650,000 and was expected to save $2.6 million per year. At the time, the company said it wanted to reduce costs in order to focus on the two lead products: Allervax Cat, for feline allergies, and Allervax Ragweed, for ragweed allergies. (See BioWorld Today, June 19, 1997, p. 1.)
Allervax products used allergy-causing proteins to teach the immune system not to respond to a specific invading allergen, such as ragweed pollen or cat dander.
Results from a Phase III trial reported in April 1996 showed Allervax Cat produced statistically significant benefit in only one of four dosing regimens: 750 mcg twice weekly for two weeks.
Results from a pivotal Phase III trial of Allervax Ragweed reported in January of this year showed statistically significant benefit at one dose level, but did not repeat the benefit observed in an earlier Phase II/III trial, using another dosing regimen. The data were insufficient for a product license application filing, and ImmuLogic planned to conduct another Phase III trial this year. (See BioWorld Today, June 30, 1997, p. 1.)
Now, trials of both products have been nixed. The company said costs of commercializing the Allervax pair would be too high, in light of other strategic alternatives.
"Those are peptide approaches, from the cat and ragweed allergens," Bourque said. "We are not going to pursue that approach with these two programs." The company may use recombinant forms of the allergens for diagnostic or therapeutic uses, she said.
Hambrecht & Quist Inc., of San Francisco, will help with the upcoming changes at ImmuLogic, which also has programs in vaccines for drugs of abuse.
The company has filed an investigational new drug application with the FDA for its cocaine vaccine, which uses a cocaine derivative bound to an immunogenic carrier and elicits cocaine-specific antibodies that bind cocaine — thus inhibiting its transport into the brain (where cocaine is believed to block the re-uptake of dopamine, producing the pleasurable effect).
Cocaine Vaccine Trials Ready
Clinical trials with the cocaine vaccine are expected to begin early next year, Bourque said. The company also will continue its research into a nicotine vaccine. "We're still selecting our product candidate," Bourque said.
ImmuLogic's stock (NASDAQ:IMUL) has taken beatings over the years. In March 1996, when Hoechst AG, of Frankfurt, Germany, pulled out of its collaboration on Allervax Cat and Allervax Ragweed, prices fell 22 percent, from $17 to $13.25. That collaboration began with Marion Merrell Dow Inc., of Kansas City, Mo., acquired in 1995 by Hoechst AG, the parent company of Hoechst Marion Roussel, the subsidiary that partnered with ImmuLogic.
In December 1996, ImmuLogic's president and CEO left the company, along with its chief financial officer. Stock plummeted from $9.50 to $7.875.
The company's shares have priced as high as $9.75 during the past 52 weeks, but closed Tuesday at $2.312, down $0.313, or 12 percent.
As of Sept. 30, ImmuLogic had $36.3 million in cash and $18 million in long-term investments, with a net loss of $2.78 million for the quarter ending Sept. 30.
Revenues for the first nine months of 1997 totaled $1.38 million, mostly in research funding from Schering AG, of Berlin, which is collaborating with ImmuLogic on myelin-basic protein peptides injected subcutaneously for multiple sclerosis. Their drug, for which an investigational new drug application has been filed with the FDA, aims at turning off the T cells responsible for triggering the inflammatory response that destroys the myelin sheath surrounding nerves.
Other partnerships will be sought, Bourque said, and Hambrecht & Quist was retained to "look into opportunities."
Allergy products have been a major focus. ImmuLogic has a worldwide patent portfolio that includes the recombinant production of the most common environmental allergens, including those from cedar, mites and grass.
The recombinant approach to allergies that ImmuLogic will pursue, although different from the Allervax peptide strategy, is a vast improvement over crude extracts used in many vaccines, Bourque said.
"It's very characterizable, reproducible," she said. "It's very specific, and you don't have any contaminants." *