would like some feedback on what your thoughts are on this. statement...
"Whether you like it or not, AF is right on target. This stock is already way over-priced. Their 2 lead drugs are: 1] a therapeutic cancer vaccine--we all know how many of those are FDA approved despite many decades of trying--the answer is 1: provenge. And we know how that drug turned out. Their 2nd drug is an ADC. Definitely a hot area of drug development, but only 2 have made it thru FDA approval. And CLDX's ADC cannot be given at the same dose as some other SGEN-based ADCs in trials because of skin toxicity. CLDX's ADC already failed in melanoma. And while they did a phase 2 trial in breast cancer, it showed interesting data only in the triple-neg subtype. That would be a nice indication given the absence of other good treatments, but there were relatively few triple-neg patients and simply not enough data to have any confidence that this ADC can make it all the way. I agree with AF; Peaker should be fired either for pumping the stock or for complete stupidity.
The comment by "Clive Barnes" reveals profound ignorance of the clinical evidence for CLDX's pipeline, and also makes illogical extrapolations from therapeutics which have nothing to do with CLDX:
1. First, Feuerstein's argument is that CLDX's valuation has gotten ahead of itself, mainly due to analyst upgrades, not that there is something wrong with the pipeline. In fact, Feuerstein has reviewed positively CLDX's pipeline in the past. Barnes however tries to make an argument that Rindo and 011 will fail to make it to market, something for which he has no evidence; actually the clinical evidence indicates efficacy and safety for both therapeutics that has has guided clinical progress to the level of pivotal trial for Rindo and soon for 011.
2. The comparison with Provenge is meaningless: Provenge is an autologous vaccine, difficult to manufacture and with lots of competitive drugs which are more effective and easier to administer than Pro. Rindo has shown robust efficacy in difficult to treat vIII(+) GBM pts, as reflected in the long term survival ( 7 years) in temozolomide resistant GBM pts who were not expected to live more than 2 years had they not been treated with Rindo. The enrollment in the ReACT trial in Avastin refractory pts has been quadrupled- it's very unlikely that the FDA would give the go-ahead unless CLDX showed them positive data.
3. """And while they did a phase 2 trial in breast cancer, it showed interesting data only in the triple-neg subtype"""
Completely false. As I posted a while back, if you correct for crossover of pts from standard of care, 011 was superior to SoC in the overall trial. 011 was also superior to SoC in high expressing GPNMB pts. The reason CLDX is targeting the TNBC group is because there is a dire need for effective therapeutics in TNBC and the regulatory path is faster for this indication.
Sentiment: Strong Buy
4. """CLDX's ADC already failed in melanoma"""
Totally false. 011 actually demonstrated clinical benefit in melanoma and AM has indicated several times, including at the Analyst Day, that 011 will be expanded into several indication other than BC, including specifically melanoma.
5. """And CLDX's ADC cannot be given at the same dose as some other SGEN-based ADCs in trials because of skin toxicity."""
This is a meaningless statement. Dosing is determined independently for each ADC, with the read out being efficacy and safety, not whether it matches the dose of some other SGEN-based ADC. Interestingly, the skin reaction is confirmation of the targeting of 011 because the skin has a relatively high level of GPNMB; this was one of the factors that convinced me that 011 has clinical activity (and I would bet not only me, but also the teams of consultants hired by institutional and hedge fund investors...)
6. """ I agree with AF; Peaker should be fired either for pumping the stock or for complete stupidity"""
Feuerstein made no statement with regard to Peaker being fired, so I don't know how Barnes came up with this one...
I for one disagree with Feurstein for several reasons:
- the ReACT, 1127 and 1135 trials are open label, where doctors, nurses and pts are all aware who got the drug and how the pts benefited
- institutions and hedge funds have networks of consultants who have their ears to the ground: Leerink alone has a subsidiary which consults with several thousand experts regarding the prospects of drugs in clinical development
- would institutions that bought $90M of CLDX offering at retail(!) commit without analyzing the prospects of the pipeline?
- if 1135 alone pans out (forget the rest of the pipeline), we're looking at a $10B+ bt in a few years
- in my experience (and I've been an investor in Genentech, Medimmune, Gilead and Cephalon among others), when a bt experiences valuation growth like CLDX has in the past 6 months, that bt will make it!
Sentiment: Strong Buy
I'd agree that the price is high for being based solely on anticipated good results. Sure, the data so far look interesting for rindo and CDX-011, but early-phase data can weaken with larger, later-phase trials. The pps is where it is based on a lot of enthusiasm and of course the usual manipulation that goes along with these stocks.
As to the comment itself:
1) I would immediately discount the nonsense about Provenge. I'm not sure why people who post bear arguments about rindo or any other drug think mentioning Provenge is some sort of talisman which makes their arguments bullet-proof. Yes, there isn't a long track record of approvals for cancer vaccines, but that doesn't mean none will ever be approved again or will be as mediocre as Provenge.
2) (a) I'm not sure where the poster got the idea that CDX-011 "failed" in melanoma. Nothing has happened after phase 2 but I don't believe CLDX has yet decided not to conduct further research in melanoma. (b) The statement that CDX-011 can't be given at the same dose as other ADCs is irrelevant. (c) The skin toxicity seen is not insurmountable; many targeted agents cause skin rashes and CDX-011 has a low incidence of high-grade toxicity. (d) While the poster is correct that there are insufficient data to make any statements on the benefit of CDX-011 in TNBC, that's why a large trial is planned. The poster has no confidence that CDX-011 can "make it all the way", but he/she also has no data which support the bear case.