re: CLDX
Pretty interesting interview with CEO, Marucci, today at "Biofest"
1. 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. Marucci left the door open to this possibility, depending on what happens with the FDA meeting in early 1Q13. 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. Triple-negative, high-espressors are about 6% of the total breast cancer population and Marucci thinks this is a good market to target.
2. CLDX has had a number of opportunities to partner Rindo, but Marucci has turned them all down. He wants CLDX to commercialize the drug on its own. He sees a $300 million or more market opportunity.
3, CDX-1127 will see solid tumor data in 2013 and lymphoma data late in the year. Marucci seemed more enthusiastic about the possibilities in lymphoma. He sees CLDX doing combo Phase II studies in lymphoma.
4. CDX-1135 in dense deposit disease is well-differentiated from Alexion's drug.
5. Important 011 data in breast cancer will be presented this Saturday at SABC.
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.
Bladerunner
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