Biotech Values

[poorgradstudent]

Re: TRIL

But wouldn't we see that effect show up as a lack of preclinical efficacy? If the doses were too short lived for the mice to mount an immune response to this unnatural Fc region, would it show/be looked for in GLP tox studies (presumably in the form of antibodies to the Fc region)?

I was not thinking that the Fc region would be the culprit, but rather the amino acid stretch that they used to join the SIRP and Fc region. That stretch would likely be something man made and therefore the only place that I would be curious about.

As for showing up as a lack of efficacy: often the mouse models are in immune deficient mice that do not efficiently generate an antibody response. Therefore, I would not expect those models to be capable of addressing my concern.

They can test the response in normal, immune competent mice rather easily. They may have even done it already, but just not published the results.