By Chris Delporte

AlleCure Corp. is readying itself for record growth.

The company was founded in 1999 by Alfred Mann, AlleCure¿s chairman, to develop vaccines targeting allergies. Mann is best known for founding MiniMed Inc., a developer of insulin infusion pumps and related technology. Medical device giant Medtronic Inc., of Minneapolis, acquired MiniMed in August. AlleCure is part of Mann¿s MannKind Corp., which includes two other companies: CTL Immunotherapies, of Chatsworth, Calif., which is developing a cancer vaccine and diagnostics for early cancer detection, and Pharmaceutical Discovery Corp., of Danbury, Conn., which is working on drug delivery technologies, with a focus on pulmonary delivery systems.

In anticipation of the success of its technology, AlleCure is nearing completion of its 250,000-square-foot corporate headquarters in Valencia, Calif., just outside Los Angeles.

¿Our new office space will house research and development, manufacturing and administrative staff,¿ Stephen McCormack, president and CEO of AlleCure, told BioWorld Today.

AlleCure currently employs fewer than 50 people. However, McCormack predicted, ¿We¿ll be at 400 to 500 employees within the next two to three years.¿

AlleCure has been funded by private investors, without any venture capital, McCormack said. Plans for the near future call for AlleCure to go public as part of the MannKind group. ¿It could happen as early as the fourth quarter of this year, or possibly by the first quarter of next year,¿ McCormack said. ¿It¿s difficult to project, especially after what happened in New York and Washington this week, but it will be soon.¿ Information about the company¿s investors and specifics on the upcoming IPO were not disclosed.

While AlleCure has stayed true to its original goal of developing allergy therapies, the company has expanded its scope, describing itself as ¿developing technologies for restoring balance to the immune system.¿ The company is working on a portfolio of immunotherapeutic products, including drugs, vaccines, biotherapeutics and delivery systems designed to treat disorders caused by an imbalanced immune system.

McCormack broke down AlleCure¿s technology into three areas: vaccines, biotherapeutics and small-molecule therapeutics.

AlleCure said its vaccine immunization system is based on the ¿geographical model¿ of immunity, which enables the precise delivery of vaccines to the body¿s immune system in a way that improves the strength of vaccines. The company said it is able to deliver antigens more efficiently and effectively than current therapeutic approaches to re-equilibrate the immune system by altering the Th1/Th2 balance. For people with allergies, there is a defect in the regulation of helper T cells, which favors Th2 over Th1 cell types. The resulting overproduction of Th2-type IgE antibodies in response to environmental allergens is what causes the allergic reaction.

¿Our approach to treating specific allergies using vaccines will provide an option to patients that is not currently available,¿ McCormack said. ¿The company¿s AlleVax allergy vaccine system may be capable of treating specific allergies with only three to six injections within six months. In contrast, conventional allergy shots require between 50 and 100 treatments over two to five years.¿

The company plans to bring its AlleVax vaccines to market using this system, starting with treatments for allergies to insect venom, peanuts and dust mites. Michelle Lozada, AlleCure¿s manager of corporate communications, said the AlleVax vaccines are the furthest along in the company¿s product pipeline. She said the company is awaiting regulatory approval to begin Phase I/II trials in the U.S. and Canada.

The company¿s initial focus with its therapeutic proteins platform has been to develop a potent inhibitor of asthmatic response. AlleCure has developed its AlleKine biotherapeutic for this indication. AlleKine is designed to inhibit the inflammation process, altering the progression of asthma. The company plans to explore the therapeutic potential of AlleKine for other diseases, including cardiovascular disease, arthritis and immune regulation.

The third area McCormack highlighted was small-molecule therapeutics. ¿We have a very targeted screening platform to look at the Th1/Th2 balance,¿ he said. AlleCure is working to develop a high-throughput discovery effort to modulate the way the immune system responds. The company said it has identified several key pathways necessary to direct immune cell development. The pathways were targeted using small molecules to alter the immune response. AlleCure predicts this will have applications in multiple disease conditions.

¿All three platforms are complementary,¿ McCormack said.

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