Replies to post #142471 on Biotech Values

[mcbio]

But that modifier (ORR data) is important - ORR often doesn't translate well up the clinical benefit ladder to PFS and then OS.

Well, there is good PFS data: p=.0032 in patients with triple-negative breast cancer with high GPNMB expression.

Also note that the treatment population, if everything goes well, is perhaps 15% of the BC market (assuming that trial entry criteria captured 50% (WAG) of the BC population - but only about 1/3 of that group were subgroups that showed efficacy.). So it isn't a huge market.

I don't think CLDX needs a huge blockbuster here to move the dial on a ~$250M market cap.

That said, I don't see the data as a disappointment either. So a drop in stock price is surprising.

Agree. But I am a biased long. ; )

[bladerunner1717]

re; CLDX

Clark,

I respectfully disagree. I agree it is good data for randomized ORR data. But that modifier (ORR data) is important - ORR often doesn't translate well up the clinical benefit ladder to PFS and then OS

Dr. Vahdat seems to disagree with you. On the CC, she explicitly said that ORR, in this indication, maps very well with PFS.

Dr. Ron Garren says that CLDX will try to do a small, single-arm study with PFS as the primary endpoint under "accelerated approval." Simultaneously, CLDX will be doing a larger, randomized confirmatory trial. (This sounds so similar to ECYT--as well as the way the stock is responding, down 8% in AH on one million shares traded--that it's a bit eerie for two of my largest holdings. LOL) But CLDX needs a partner to do all this, Dr. Davis notwithstanding. I don't know if a potential partner needs to see the final data before committing. (I'd appreciate any thoughts on this final point.)


Bladerunner


Bladerunner

[pcrutch]

I used a little bit of hyperbole, but I think the point is clear. Obviously CLDX doesnt/didnt have the cash/resources to run this the way it should have been, but its a good proof of concept study. It's randomized active-controlled data, which more than we can say about most data out there.

Agree with you that ORR is a poor endpoint. Actually Ixempra's Phase 2 trial illustrated this very point. Their single-arm Phase 2 trial in heavily pre-treated(prior A/T/C) breast cancer patients, IRF-assessed ORR was 11.5% but the investigator-assessed ORR was 18.3%, which is a 59% difference. Dr. Vahdat does disagree with on the ORR to PFS point, at least in this setting. Remember the PFS data they presented were not mature.

On your last point about the population size for the drug, I think it's much too early to say where CDX-011 could fit. This is the last-line setting, so I imagine if tested much earlier or in combo, we would be seeing drastically higher responses.