Tanox

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Tanox was a

In 1996, after a 3-year long lawsuit between Tanox and Genentech[16] was settled out-of-court, Genentech made its first payment of $16 million to Tanox,^[17] and Tanox, Novartis, and Genentech formed a tripartite partnership to develop the anti-IgE program.^[18] A humanized anti-IgE antibody from Genentech, omalizumab, with identical key binding characteristics as CGP51901, was chosen by a joint program steering committee for further development, because it had a better developed manufacturing process.^[18]

Omalizumab, with the trade name

Among the humanized antibody drugs Tanox developed by itself or with corporate partners:

• Xolair
• TNX-901, also referred to as talizumab. Two leading allergy researchers, Donald Leung and Hugh Sampson, led a team of clinical investigators and performed a double-blinded, randomized, dose-ranging, multi-center trial of TNX-901 in 84 patients with a history of immediate hypersensitivity to peanut and found that a 450-mg dose of TNX-901 significantly and substantially increased the threshold of sensitivity to peanut on oral food challenge from a level equal to approximately half a peanut (178 mg) to one equal to almost nine peanuts (2805 mg). The team concluded that this result is very significant, because it represents an effect that should translate into protection against most unintended ingestions of peanuts.^[19] The study has been widely regarded as an important milestone in the search for an effective treatment for the often frightening peanut allergy that affects many families with young children with extreme sensitivity to peanut.^[20]
• The "anti-CεmX (or anti-M1’) approach". In 1990, Tse Wen Chang invented the “migis concept” for developing therapeutic approaches that target membrane-bound
  monoclonal antibodies against CεmX in 2001.^[23] Since Genentech acquired Tanox in 2007, the anti-M1’ program has been carried out in a fast pace^[24] and favorable results have been obtained from two Phase I and one Phase IIa clinical trials on a humanized antibody, 47H4 (also referred to as MEMP1972A, or quilizumab). These clinical trial results have shown that the anti-M1’ antibody is safe and can block the synthesis of allergen-specific IgE and associated allergic response upon the challenge of the allergens.^[25] Quilizumab is now being studied in a Phase IIb trial.^[26]
• human immunodeficiency virus (HIV). TNX-355 inhibits HIV entry into host target cells without interfering with T cell function. The antibody, which was licensed from Biogen in 1997, is a new-concept drug and the first in its class.^[27] After Tanox was acquired by Genentech in 2007, the TNX-355 technology and its development right were licensed to a Taiwanese company, TaiMed Biologics.^[28] TNX-355 is now in expanded phase II trials in many countries.^[29]
• TNX-650, also referred to as "MILR1444A" or"Lebrikizumab", a humanized antibody that blocks interleukin 13 (IL-13). When Genentech acquired Tanox in 2007, a satisfactory Phase I trial had been performed. Subsequently, Genentech accomplished several Phase II trials on patients with asthma.^[30]
  Lebrikizumab is now in two Phase III trials on patients with asthma uncontrolled with corticosteroids and an additional medication.
• TNX-224, an anti-Factor D Fab, the antigen-binding fragment of a humanized monoclonal antibody targeting Factor D of the human complement system.[31] The product candidate is also referred to as "FCFD4514S" or "RG7417". The drug is designed to inhibit complement activation and chronic inflammation in tissues. Complement Factor D is a member of the trypsin family of peptidases and is a component of the alternative complement pathway. When Genentech acquired Tanox in 2007, Tanox scientists had already demonstrated the efficacy of the candidate drug in blocking complement and leukocyte activation in baboon model of cardiopulmonary bypass.^[32] Genentech is evaluating anti-Factor D for geographic atrophy associated with dry age-related macular degeneration in a Phase II clinical trial.^[33]

Other major technologies

Other than the therapeutic antibodies, which target the IgE allergic pathway, immune factors, and CD4, Tanox also possessed several other major patented technologies. Among those, two sets of patents represent landmark inventions in their respectively related fields. Largely because these patents were awarded too far ahead the maturation of the peripheral technologies, they did not bring material financial impact on Tanox. Nonetheless, the creation of these technologies helped germinate the two important fields and enhanced Tanox as a pioneer in the antibody field.

• “
  human immunodeficiency virus (HIV
  ), which was causing expanding epidemic in the 1980s and 1990s. However, the anti-IgE program and other therapeutic antibody programs eventually absorbed all resources Tanox had, and the antibody matrix program was not pursued further.
• The concept and methodology of “selecting low-frequency antigen-specific single
  B lymphocytes for performing PCR for making antibodies”,^[37] which was invented by Tse Wen Chang in 1992. The set of patents pertain to the generation of monoclonal antibodies, especially human monoclonal antibodies, by identifying and sorting out low-frequency B lymphocytes, which express antibodies specific for certain desired antigens, and then performing polymerase chain reaction
  on those single B cells to obtain V_H and V_L sequences. In the past few years, an increasing number of research groups in academia and industry have employed similar methodologies to generate human monoclonal antibodies.