Replies to post #153466 on Biotech Values

[mcbio]

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.

Thanks. I listened to the call rather quickly and didn't catch all of these points. If they are indeed focused on 3rd and 4th line, that could well signal no partner on hand as I would think a big pharma partner would be inclined to at least also pursue earlier lines. That said, is the current trial in 3rd/4th line? If so, perhaps I'm reading too much into this.

5. Important 011 data in breast cancer will be presented this Saturday at SABC.

This is what I'm anxious to see. This will include both an update on PFS and preliminary OS data. This is a pretty big event for CLDX I think. Hope the data is good. I intend to hold my position in full through this, for better or worse.

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

Most important thing near-term I think is that data on Saturday. Let's see what that brings.

[BTH]

I spoke with the CFO last week; my vibe is they are nowhere near a partner. Got the old, "they want to see more mature data and/or see how the FDA meetings go"

If they can do a small single arm pivotal study for 011, I would prefer they go it without a partner because all a partner would bring to the table is money, and would most likely delay the trial for 6 months or more. If they need to do a large scale 800 person trial, they will NEED to partner because these guys would screw it up on their own. Either way, theyre gonna be raising more capital in 2013 I can guarantee you that.

BTW, did CEO say if they have dose any patients in 1135 yet?

CLDX

[pcrutch]

Re CLDX

I am happy they aren't talking up the partnership angle much. Those who protest too much about interested parties seem to always have the worst luck in delivering on those promises.

[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.

[iwfal]

CLDX -

CLDX will pursue high-expressors of GPNMB in triple-negative breast cancer with OS as the primary endpoint in 3rd or 4th line therapy.

Good on them! One of the concerns I stated 6 months ago was that they would pursue a ph iii consistent with the way they presented data several months ago (they kept talking about the wonderful high expressors data overall - when, in fact, virtually all the benefit was in the group that were both high expressors and TN).