Biotech Values

[poorgradstudent]

Re: Immunogenicity

FWIW Humira's immunogenicity is fairly well known. I've seen it in lots of papers. From memory 20 to 40 percent develop antibodies. Haven't seen any such references for enteracept, and the one paper I found (just now) was under 10 percent. Yet humira is a far better drug.

And a lot of ERTs also induce immunogenicity and yet still work. Agree it is a theoretical risk, and likely to be an efficacy reducer, but does anyone have an example of a drug that failed due to immunogenicity?

I agree with your comments. However, I think the important metric would be the degree of immune response and its impact on efficacy. This paper (pdf link) suggests that degree of immune response is a factor in efficacy of Humira; I think that makes scientific and intuitive sense. I'm not suggesting that any small change in immunogenicity over baseline is a negative prognostic for efficacy.