Biotech Values

[jq1234]

CLDX will pursue high-expressors of GPNMB in triple-negative breast cancer with OS as the primary endpoint in 3rd or 4th line therapy. This surprised me, because my understanding had been that that CLDX would pursue a PFS strategy in a small single-arm study.

You can't run a single arm trial with PFS as endpoint for accelerated approval because there is nothing to compare to. It has to be ORR as endpoint with duration of response where ORR needs to be over 20% with lower bound over 10% to have a chance for last line treatment.

The patients in 3rd and 4th line therapy have such a terrible prognosis that Marucci thinks that 011 could very well show an OS benefit rather quickly.

I suppose the potential good news is it implies there is at least strong survival trend from ph2 data for this subgroup [high-expressors of GPNMB in triple-negative breast cancer].

6. Long-term, Marucci sees CLDX as a commercial drug company, not a buyout candidate. Uh, huh.

7. No word on partnerships at all. Not a good sign, IMO.

Every small biotech want to be a commercial drug company. The problem with not partnering is they can't run a large ph3 trial efficiently, and they can't develop the drug fully to its potiential in early lines of treatment or in different indiations for CDX011.