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.
Roche has formally dumped MAXY’s Maxy-Alpha interferon for HCV. This outcome was effectively sealed two months ago when Roche revealed that Maxy-Alpha causes immunogenicity (#msg-23053145). Roche has now ended both of its collaborations with MAXY — the other collaboration was for Maxy-VII (a follow-on biologic to NVO’s NovoSeven), which Roche ended in March (#msg-17854630). Is it fair to say that Roche thinks MAXY’s technology platform is less than it is touted to be? I think so (#msg-22016210).
REDWOOD CITY, Calif., Nov. 26 /PRNewswire-FirstCall/ -- Maxygen, Inc. (Nasdaq: MAXY ) announced today that Roche and Maxygen have agreed to terminate development of MAXY-alpha, also known as R7025, and to end the agreement under which Maxygen licensed MAXY-alpha to Roche. The news follows Maxygen's announcement of September 21, 2007, that Roche had voluntarily placed a hold on the program.
"While we are disappointed, we recognized and had advised earlier that termination of the program was one of the likely possibilities," said Russell Howard, Maxygen's chief executive officer. "Tremendous potential remains in Maxygen's portfolio and we look forward to 2008, a key year for our two lead programs, MAXY-G34 and MAXY-VII."
The MAXY-alpha program was fully funded by Roche, with no milestone payments expected in 2007 or 2008. As such, Maxygen expects no near-term impact on its financials as a result of the termination. Upon termination of the agreement, all rights to Maxygen's interferon variant product candidates revert back to Maxygen.
About MAXY-alpha
MAXY-alpha was designed to be a next-generation alpha interferon for the treatment of Hepatitis C and Hepatitis B virus infections. Alpha interferon is a natural protein that is produced by many cell types, including T-cells and B-cells, macrophages, fibroblasts, endothelial cells, and osteoblasts, and is an important component of the anti-viral response, stimulating both macrophages and natural killer (NK) cells. MAXY-alpha was being developed under a 2003 agreement between Maxygen and Roche to develop novel interferon alpha and beta products for a wide range of indications.
About Maxygen
Maxygen is a biopharmaceutical company focused on developing improved versions of protein drugs. We look for opportunities where our proprietary protein modification technologies can address significant therapeutic needs. Our lead program, MAXY-G34, is designed to be an improved version of G-CSF for the treatment of neutropenia. MAXY-G34 is currently in Phase II clinical trials. Also in our pipeline is a novel Factor VIIa for the treatment of hemophilia. Maxygen's approach to drug discovery and development may allow us to leverage the established development and regulatory paths of approved drugs. We believe this advantage translates to a greater chance of successfully bringing important new drugs to market. http://www.maxygen.com <<
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