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Are there a lot of people that are actually saying this data is poor?
Discussion of positive Abraxane trial in pancreatic cancer, with musings on the (somewhat questionable) economics:
Just to get it out of the way, I think this regimen is approvable because all the reported endpoints (at least to date) are all strongly in favour of abraxane. The "disappointment" by the biotech investing cognoscenti is misplaced / silly.
That said, I won't disagree with the concern over the economics. But it would be nice if one of these quotes went past the usual chin stroking to some type of actual idea / initiative / discussion. I'm honestly at a loss of what to do, but I'm sure people who treat these diseases day in and day out would have some insight into what is possible. Perhaps reporters could actually ask their interviewees for some ideas rather than getting the usual quote.
OT:
Stock ticker that starts with O + in my portfolio + talk of acquisition = Bad (OSIP + Eyetech) flashbacks
no partner for imetelstat as far as I know
no other worthwhile drug in pipeline at this stage
FWIW, I think they indicated in a prior call that telomeres are very short in MF patients; seemed to suggest the drug might even work better in MF. Also, they said in a prior call that imetelstat produced stat sig PFS results in the NSCLC trial in the subset of patients that had short telomeres. So, may still be hope in solid tumors too.
CELG and ONXX are also many magnitudes higher in market cap.
So what's your take on the stock?
Geron / JP Morgan
A clear and thorough description of the data to date in essential thrombocythemia. I think the transparency provided is a reflection of the fact that the data appear rather strong, albeit in small numbers. The company also appears focused: the discussion was all imetelstat, all the time. No mention of any legacy stem cell baggage whatsoever. Some notes below
Presentation
- 90 million cash on hand as of December 31, 2012... expect to burn 33 million in 2013
- Imetelstat is the lead compound. It is a 13-mer oligo complementary to the telomerase RNA template, with a thio-phosphoramidate backbone to prevent degradation by nucleases. It has also been lipidated to increase penetration
- IC50 = 0.5 - 10 nM to inhibit telomerase in cell free system
- long half life (41 hr) and abundant distribution particularly to bone marrow, spleen, liver
- Proof of concept trial of imetelstat in essential thrombocythemia, which is an overproduction of platelets through malignant megakaryocytes
- in the trial, plan was for weekly IV dosing until hematological complete response (CR; as measured by platelets falling), and then moved onto maintenance treatment at the physician's discretion
- 14/14 patients achieved hematologic response, with 13/14 showing CR (normalization of platelets maintained for at least 4 consecutive weeks in the absence of thromboembolic events) with a mean time to response of 6.1 weeks (5.1 to 14.1 weeks range); the 14th patient showed PR
- 13/14 patients remained on therapy, 6 more than 1 year; median time on therapy 8 months
- frequency of administration reduced in maintenance phase for 11 of the 13 patients who achieved hematological CR; 5 patients eventually titrated down to every 6 week dosing
- the company also measured JAK2 V617F mutation's allele burden (% of cells carrying the JAK2 V617F mutation).... 7 of 14 enrolled patients had the JAK2 mutation, and 86% (6 of 7) of these achieved partial molecular response (defined as 60-90% suppression of malignant clones carrying JAK2 V617F)
- in comparison, jakafi shows 14% of patients showing >20% decrease in JAK2 V617F allele burden (this is in myelofibrosis i believe, but I need to double check these numbers so take it with a grain of salt... also a sicker population in MF than in this ET trial)
Q&A
- myeloid malignancies are the ones where most patients have short telomeres, hence their initial focus
- some suggestion that short telomeres may also play a role in early phase CLL, NSCLC and bladder cancer
- they eventually want to optimize a diagnostic in order to measure telomere length as part of the enrollment criteria for their registration trial
DNDN:
DNDN sells NJ manufacturing plant to NVS for $43M:
The article you linked to argues the comparatively high PAP expression in prostate tissues make it a differentiation antigen and a better target than say a ubiquitous antigen like HER2 where high affinity T cells aren't going to exist.
By the way, I know. I actually miss Blinatumomab. It is such a difference between small biotech and big one like AMGN. We barely know/hear anything about what's going on with the drug.
I dont understand why you bring up Tdm1. It is trastzmb plus endocytotic toxin delivery. of course 3 (her2 signaling blockade+ adcc antibody dependent cell mediated cytotoxicity + ADC antibody drug conjugate) is
better than 2 without ADC. the Adcc component of tmab has to be there as blocking her 2 signaling via tki alone could not achieve the same effect as tmab.
Where else will the backbone antigen PAP of Provenge be expressed after the prostate was out besides PCa cells? Do you not agree an overexpression of target antigen in tumor cell presents a therapeutic window of selective tumor cell killing which is next best to a tumor exclusive antigen.
Trastuzumab elicit adcc that's why none of the her2 tki came close.
If the target is expressed specifically on tumor target then therapeutic index allows efficacy without toxicity.
Respectifuy disagree but sipuleucel t and the new anti-pd1 antibodies counter the ipilimumab argument. trastuzumab and rituximab too.
The obvious counter examples are:
a) Provenge - which had no SAE other than mild flu-like symptoms
ONTY:
With this failure, I do think it is worth re-iterating that investors looking to invest in cancer vaccine companies should really be looking at the adverse events profile to gauge whether or not there is hope for efficacy.
Companies selling the concept of a vaccine against self-antigens that has efficacy but no AE are selling a fantasy: breaking immune self tolerance is a scary thing and we should expect serious AEs at this stage of development. See Ipilimumab. And in a similar vein, the T cell transplant at Children's Hospital is also a valid example: patients are severely sick as a result of the biology that is triggered by the treatment.
I've also read some comments by people saying that ONTY missed because the target was not ideal. I think that's incorrect and missing the forest for the trees.
OT:
I Bought 1000 Jan 20 calls at the close Friday. I am looking for some positive broker opinions for tomorrow.
Not entirely true. Sprycel doesn't have a black box warning. Tasigna does, but it is different than that of Iclusig's. However, I think the black box and safety findings with Iclusig are more problematic than those of Sprycel or Tasigna because there is significantly less follow-up and experience with Iclusig, and long-term data is a major factor in CML.
So they did get a broad second-line label, but with a fair amount of fanfare around AEs and CV risks. I don't think that bodes well for use ahead of 2G TKI.
PPHM:
I for one welcome our new bavituximab overlords. Sadly this means, once again, that Project Minotaur goes on the backburner.
On a more serious note, I find it a little sad that traders and pump and dump schemers at shady trading firms have nothing better to do than to write these ridiculous posts on investment boards. I'm all for buyer beware and that jazz, but working to purposefully deceive your fellow man is pretty despicable.
PPHM:
Out of the box thinking. The NIH buys Peregrine for $50 billion. They then run trials on all cancers. Bavi is provided at cost to all patients. Medicare costs plummet.
Cortes on Pona
I'll take that bet, but not for share price but rather for drug approval.
You choose a PPHM drug, I'll choose one from a company in my portfolio. First drug approved wins.
Deal?
I.e., the smaller number of patients in the trial should make it much more difficult to attain stat sig results yet the results were robust enough to do just that.
I have always respected those who have made great achievements so I do not apologize for respecting Dr.Thorpe and Dr. Garnick(formerly of Genentech)who are both behind PPHM's programs.
PD-991:
These or maybe other concerns might explain why PFE conducted so few trials themselves on PD991.
CDKs / Seliciclib:
Not much thought on this drug, but let me point out a neat feature of seliciclib that shows why i was skeptical of targeting CDKs:
- as you note, CYCC says it hits CDK2, 7 and 9
- Cayman says it hits CDK2, 5, 7 and 1
- Enzo says it hits CDK1, 2 and 5
I guess the consensus is that it hits CDK2, with a dash of CDK1, 5, 7 and 9
PD-991:
This drug is target two of the cyclin dependent kinases. These proteins have vital roles in the cell cycle as well as some transcription regulation activity. My two biggest concerns:
- There were too many of them (10 or so CDKs) to be able to discretely target just 1 or 2.
- Playing around with the cell cycle was very high risk and opened the patient up to AEs and maybe even lead to transformation of normal cells.
I think the advancement of structure determination methods and combinatorial chemistry has made my first concern moot. As for the second, perhaps my concerns were overblown.
Pd-991:
That makes sense, thanks. This compound has been in warner lambert / PFE's hands from pretty much day one, so I just threw out 5% as the upper boundary more than anything else.
I've been skeptical that this area of cell biology could be reasonably targeted. It's encouraging to see progress.
PFE's PD-0332991+letrozole vs. letrozole
GNVC:
From a fundamentals basis, it's hard for me to rationalize an investment in a company with a three-time loser technology.
Bluntly put, the only thing attractive about GNVC is its market cap provided you ignore the fact that it coincidentally happens to be a biotech company that has proven an inability to get even close to selling a drug.
My only potential interest for a position would be if I thought that tiny $15M valuation could rebound in the next year or two (before they go bankrupt if no additional funding).
I know less than zero about it. eom.
I believe success in either one of these (both could fail obviously) could drive ARRY towards an EXEL-type valuation.
A number of posters on this board, including me, made a lot of money on ARIA when Ponatinib wasn't its lead molecule. You never even mentioned 614 when discussing ARRY. The trick is, IMO, to get in when maybe the best drug in the pipeline is not necessarily the lead drug.
lol, so, i guess you don't have much respect for ARRY.
Also thought you might prefer ARRY given that ONXX seems to be in at least some talks regarding ARRY-520 and I know you like ONXX. I respect your opinion, of course, and may turn out to be way off on this. We shall see.
EXEL:
I think anyone buying at these levels with the expectation of sales in PC is being foolish. There are no solid data to merit any meaningful level of off-label sales, nor is there a compendium listing.
From my view, the approval says:
1) They can get a drug on the market.
2) They can start to gather some sales experience, while making a small amount of change.
3) Approval makes it easier for teaching centers to get their hands on the drug for pilot studies.
As for the market cap, your mileage may vary. I'd rather buy EXEL at 1 bill MC than ARRY at 0.4 bill MC, but I'd rather buy ONXX at 5 bill MC over both of them. Life is full of paradoxes
EXEL approval:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm330143.htm
The U.S. Food and Drug Administration today approved Cometriq (cabozantinib) to treat medullary thyroid cancer that has spread to other parts of the body (metastasized).
EXEL:
If some of the rumblings about the last stock offering are true, then a short isn't too bad a move.
I don't think MTC approval should have much of an impact on the share price. If they're able to get 10 million or so in sales next year then at least it'll put in a decent floor on the share price while we wait for prostate and melanoma news.