Biotech Values

[DewDiligence]

> REGN – The CNTF [Axokine] failure made me question REGN. They found a high percentage of neutralizing antibodies to CNTF in a phase III trial… I just don't see how they could have missed this in the Phase I and II trials… Neutralizing antibodies could be an issue with their VEGF trap, a non-native fusion protein.<

A few points:

1. Axokine was developed with the intention of eliminating the neutralizing antibodies found in REGN’s first-generation CNTF compound. Thus, the presence or lack of neutralizing antibodies was very much in focus throughout the Axokine program. Why REGN didn’t see them until phase-3 is mystifying, but it’s not because they didn’t look for them.

2. Axokine was not a “trap” molecule, and hence I’m unclear as to why you think VEGF-Trap could be burdened by neutralizing antibodies.

3. In AMD, REGN is planning to test very high doses of VEGF-Trap relative to the approved dose of Lucentis. This can be interpreted in two ways: 1) REGN is confident that neutralizing antibodies are a non-issue and hence they don’t need to hold back on dosing; or 2) REGN is concerned about neutralizing antibodies and they are dosing unnecessarily high (in terms of efficacy) in order to prove to the FDA that antibodies are not a problem. We may not know which of these cases is the dominant one until we see more clinical data.