IMGN isn't testing safety on healthy subjects for ph1. Instead, IMGN went with subjects with relapsed NHL making recruitment difficult. They are probably hoping to see good activity in that patient group and advance the drug to phase 2/3 based on that.
How come your other stock picks are making you money, but not LPTN? When am I gonna make money on this one?
Anyway, good job on MNKD. Do you think you're actually going to prefer their inhaler over other options?
I criticize the ruling...but also these outrageous drug prices despite being a biotech investor.
Folate alpha receptor peptides are loaded on to the patients’ own dendritic cells for ovarian cancer. FRs are expressed 100x more in OC cells than in normal cells.
Mabman, the difference now is that the technology is actually working for solid tumors, in addition to blood cancers. Really not an easy feat considering what happened to Lilly ADC Mylotarg.
With the Endocyte anti-FR drug failing, I have some reservations about FR being a good target. But 853 might work where ECYT's drug failed.
I am actually excited about 289 because of low ORR and high relapse for naked anti-EGFRs. Hopefully 289 will work as well or better than erbitux plus chemo. I anticipate, and am worried though, that it may have the same or more skin and GI tract toxicity than erbitux.
If IMGN can't make their fully owned ADCs to work, we can hope that they can consider a PDL-like business. Fire most everybody and collect the 500M/yr royalty payments for Kadcyla and plus the rest of the partnered drugs.
There is a good chance that approval will be on the 15th because FDA and Baxter already spent a considerable time discussing and debating about what should go on the label and post-market studies during the 3 month PDUFA postponement. If not on the 15th, end of Aug is not too far along.
1. Milestone payments as licensed drugs move into more advance stage in the clinic. Partners have probably informed Imgn already of future plants. This will show that technology is working. pps should move up whenever partner announces next trial phase. SAR3419 will transition to ph3.
2. Additional ADC licenses from partners are anticipated - early discussions have most probably taken place already for new antibodies. Again, this only means that technology is working. pps should move up whenever new license is announced.
3. Kadcyla revenues will exceed 1B next year. 2B by 2016 means 100M for IMGN? Kadcyla for gastric cancer NDA should be filed in 2015. GC is big in China, Japan, and Korea. pps should move up.
If new licenses from new partners are taken, then there will be additional revenues on top of the 3 reasons above. Those are only for the partnered drugs. If 853 results look promising, the orphan should make IMGN rich.
ASH: SAR3419, SAR650984 and BT062 data will hopefully be presented
I would like also to see ADCs used outside of cancer.
Conclusion: I think 2015 will be a huge year for IMGN, barring WWIII.
Some of that Idenix money must have moved to ACHN today.
Channel is in play. I hope Russia does not invade Ukraine. That is a weird war going on over there.
Say revs from Kadcyla will reach 10B for as long as 10 yrs, IMGN will be entitled to 500M for each of those 10 yrs, for a total of 5B. IMGN can sell all future payments to Roche for example for 1B now, or 500M plus some other fraction of future royalties. IMGN can also sell the royalties to a company like PDL, that is in the business of collecting royalties, and PDL gets all future IMGN revenue share. Something like that anyway. That way, IMGN won't need to raise money at this time for the ongoing clinical trials, so it's an advantage to us investors too.
With that monetizing question by that analyst, he is expressing concern that IMGN might do a stock offering again to fund trials, and that may be the underlying reason for the current price weakness.
If no other economic/global factors mess things up, I think pps will do much better after all the ASH updates. I hope anyway..
One positive is that one analyst ask why projected revenues for next year seems high. The explanation is that it will be because milestones will be paid as partnered compounds advance into the clinic, anticipation of new ADC licenses from existing partners, and, of course, increasing Kadcyla revenues.
One analyst did ask about the possibility of monetizing Kadcyla revenues. Some of them must be reading this MB! While it is an option, mgmt thinks that they have enough money for now to fund future expenses. Perhaps mgmt will not consider any new offering until pps is back closer to $20, i.e., after more positive trial results have been reported.
Hope it settles at the price of the last offering, not lower. 6.80? No failing trial; pps just went up too fast and as a Baker stock, it will be heavily played and manipulated, aside from fear in the market and the Yellen blooper.
Lust crosses blood brain barrier starting from the brain to the blood, then crosses from the blood through the blood-testes barrier, into the testes, and beyond, wherever lust desires to go.
Antibodies have a tough time crossing the blood brain barrier and the blood-testes barrier. Even if anti-PH20 are produced, negative effects on fertility and the brain are very likely to be affected. Therefore, HyQvia should not affect lust.
Baxter showed that increase in anti-PH20 in humans is transient, even at much higher doses in animals. Approval is for certain with not very much restrictions on use.
Yes, PH20 safety is no longer in question. Congratulations HALOngs!
Looks like we'll be staying in a channel again until then. Need to break that 7.50.
After 1 year in adjuvant use of Herceptin, DFS 1 yrs after treatment ~ 86%. Treatment with neratinib improves DFS by 33%. CC said 33% of 86% is ~ 91%. I am not really sure how the numbers were arrived at. Differences are highly statistically significant.
Neratinib's major AE is diarrhea in up to 30% of patients. There is no mention of other SAEs. If at 1 yr post Herceptin, I have a 14% chance of disease progression, I think I will be willing to take neratinib for 1 yr or more. If I have a problem with diarrhea then I'll stop using it. If I don't, I'll continue taking it. So really if you're looking at the numbers for efficacy, it would seem like it would make sense to exclude the subjects who decided to stop participating due to diarrhea. The unknown is diarrhea the only AEs? Will FDA ask for 2 yr DFS data? Or overall survival?
Same question will be, "If you have the BRCA1 mutation, and there is a drug that may cause diarrhea in 30% of patients, but will slow down cancer in 86% of population, will you be willing to take the drug for 1 yr or more?" I think, I will want to have the drug as an option, and I will only stop taking it if I am in the 30% who'll have diarrhea.
Now, I am thinking that mgmt made a smart decision in designing the trials. Should other drugs be tested in similar post-Herceptin adjuvant setting?
Of course, I find that FDA approvals don't always follow logic.
Yes, Roche is aiming for Kadcyla plus Perjeta. The question is why Roche did not design the Kadcyla trials such that Kadcyla would at this time be already approved for those other indications for which Perjeta is approved for. The reason is not really clear to me. I really think Roche is dragging on Kadcyla, and wants to get as much from Perjeta plus Herceptin, because if Kadcyla without Perjeta already works great, then there goes their Perj revenues. NICE actually turned down Perjeta payment bec survival benefits are not clear. On the other hand, NICE rejected Kadcyla for its price and wants pricing negotiations, and does not question efficacy.
I remember hearing or reading something about MARIANNE data in 2014. Was that mentioned in an earlier CC? Completion is not until 2016. Are they able to give updates because 1 arm is not blinded?
I guess what LPath is saying is about half of patients treated responded really well to Asonep treatment. If they can find biomarkers, like elevated VEGF, insulin, IGF or other overactive kinases, that differentiate the highly responsive group from the unresponsive group, they will be able to get PFS much longer when just treating that patient subset. How about S1P-R overexpression or overactivation? It seems like that will be a good candidate to look at. They can probably get accelerated approval if they can identify that patient subset and almost assured of Asonep approval. And, if they find the same biomarker in other cancers, then pps shoots to the moon.
If the benefits are as good as reported, and there are no serious side fx, neratinib will get approved for sure, regardless of whether physicians will put their patients on the drug for a year or not. I'll also worry because the trials were done in 41 countries and data interpretation and integrity can be questioned. Remember too that these anti-HER2 drugs are hard on the heart and liver.
Anyway, good luck to your investment and neratinib.