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Re: ghmm post# 52641

Friday, 09/21/2007 12:27:42 PM

Friday, September 21, 2007 12:27:42 PM

Post# of 252581
MAXY, GTCB – That Maxy-alpha has turned out to be immunogenic places MAXY’s entire platform in doubt, IMO. The raison d’etre of MAXY’s technology was to tweak an endogenous protein for enhanced efficacy, tolerability, or duration of action without causing immunogenicity. CEO Howard Russell even boasted on CC’s that investors need not be concerned about immunogenicity because MAXY’s scientists knew exactly how to design around the problem.

Maxy-alpha is not the first drug candidate from MAXY to run into trouble: Maxy-seven, a tweak of NVO’s NovoSeven brand of FVIIa, was recently dropped by Roche (#msg-17854630). MAXY said this was merely a “portfolio reassessment” by Roche and there was nothing wrong with the drug, but I didn’t fully accept the explanation (#msg-19911920).

MAXY’s troubles highlight what I like so much about GTCB: a business model based on a novel production technique for non-novel proteins such as antithrombin (ATryn) and FVIIa. Although the drugs produced by GTC’s transgenic platform are not identical to their endogenous counterparts, they are very much closer to them than the tweaked proteins from Maxygen. GTC’s ATryn (which is already approved in Europe) has never produced immunogenicity in any recipient.

Am old post on this topic (#msg-22016210) holds a prominent position in the GTCB ReadMeFirst.

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