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TANOX BIOSYSTEMS' AL-901 ANTI-IgE MAb TO ENTER CLINIC IN 1992

Executive Summary

TANOX BIOSYSTEMS' AL-901 ANTI-IgE MAb TO ENTER CLINIC IN 1992, the monoclonal antibody R&D firm said in a Jan. 24 prospectus for an initial public offering. AL-901 is licensed to Ciba-Geigy under a May 1990 agreement ("The Pink Sheet" May 21, 1990, In Brief). "Following completion of animal toxicology studies scheduled to begin during the first quarter of 1992, an IND is expected to be filed under Ciba-Geigy's sponsorship," the prospectus says. "A Phase I clinical trial is expected to begin during the second half of 1992." AL-901 is a chimeric MAb (part murine, part human) that targets IgE antibodies, which are implicated in allergic reactions, the prospectus says. AL-901 binds to circulating IgE and IgE bound to B-cells but does not bind when IgE is already attached to basophils or mast cells. "Ordinary anti-IgE monoclonal antibodies can also mimic the effect of allergens by cross-linking IgE on basophils and mast cells," the prospectus says. The company will investigate AL-901 as a treatment for severe allergic rhinitis and asthma. Tanox' lead compound, licensed to Ciba-Geigy under a separate agreement, is the chimeric antibody AIDS-439, which targets the gp120 envelope protein of the AIDS virus. Phase I/II trials, initiated in Zurich in March 1991 and concluded in October, showed that "AIDS-439 was very well tolerated," the prospectus says. "Tanox and Ciba-Geigy are currently planning additional Phase II clinical trials." The Ciba-Geigy/Tanox AIDS agreement was signed in February 1989 and called for the development of three chimeric anti-HIV antibodies. A second such antibody, AIDS-519, is in development, Tanox said. Tanox is studying the 519 MAb for synergies with AIDS- 439 and expects to "begin production of AIDS-519 for clinical trials in collaboration with Ciba-Geigy by the end of 1992." Under terms of its two agreements with Tanox, Ciba-Geigy has provided $9.7 mil. in funding, including a 7.3% equity stake purchased for $2 mil. The agreement commits Ciba-Geigy to provide up to $17.7 mil. more in research funding and to purchase $4.5 mil. more in equity, the prospectus states. Ciba-Geigy intends to purchase $2 mil. worth of equity (about 95,000 shares) in the public offering, the prospectus states. In addition to allergy and AIDS monoclonal antibodies, Tanox is developing proprietary migis antibodies. These will target specific subpopulations of B-cells identified by peptides on the cell membrane that anchor membrane-bound antibodies (mIg). These peptides are known as the "migis epitope." Disease targets include B-cell lymphomas and leukemias and autoimmune diseases. Tanox is seeking over $30 mil. from the offering of 1.75 mil. shares at an estimated price of $21 per share. The company will use proceeds for R&D activities, facilities expansion, and possibly for acquisitions, the prospectus says. The offering is being managed by Merrill Lynch, Vector Securities and Dillon, Read. Houston-based Tanox was founded in 1986 by two former Centocor researchers. Chairman, President and CEO Nancy Chang, PhD, was formerly Centocor's molecular biology group research director. Chief Scientific Officer Tse Wen Chang, PhD, was formerly Centocor's VP-research. The company's chief operating officer, David Anderson, was previously a private practice attorney. Tanox' board of directors includes former SmithKline Beecham Pharmaceuticals Chairman John Chappell and former Warner-Lambert Exec VP Donald O'Neill, who is now chairman of Nova Pharmaceutical. Tanox currently employs 39 people. The company has raised about $7.1 mil. in private equity to date.

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