Comments on: Immunogen at ASCO 2008 http://www.hammerstockblog.com/immunogen-at-asco-2008/ Biotech stock reviews Fri, 12 Mar 2010 07:52:08 +0000 http://wordpress.org/?v=2.3.1 By: Haraye http://www.hammerstockblog.com/immunogen-at-asco-2008/#comment-528 Haraye Mon, 16 Feb 2009 07:30:04 +0000 http://www.hammerstockblog.com/immunogen-at-asco-2008/#comment-528 Does anyone know where I can find free online grant applications? Does anyone know where I can find free online grant applications?

]]> By: Ohad Hammer http://www.hammerstockblog.com/immunogen-at-asco-2008/#comment-287 Ohad Hammer Sun, 17 Aug 2008 21:53:29 +0000 http://www.hammerstockblog.com/immunogen-at-asco-2008/#comment-287 Thanks Druggie. Good data from T-DM1 can certainly get IMGN higher, but in order to get to the 9-10$, they might need good IMGN901 data at ASH. Luckily, IMGN will have another shot on multiple myeloma with the Biotest ADC. I still didn't see anything exciting from the collaboration with Sanofi. AVE9633 is a flop and AVE1642 still hasn't produced positive data as well. Sanofi should publish data for SAR3419 at ASH, so this could be another catalyst. Thanks Druggie.
Good data from T-DM1 can certainly get IMGN higher, but in order to get to the 9-10$, they might need good IMGN901 data at ASH. Luckily, IMGN will have another shot on multiple myeloma with the Biotest ADC.

I still didn’t see anything exciting from the collaboration with Sanofi. AVE9633 is a flop and AVE1642 still hasn’t produced positive data as well. Sanofi should publish data for SAR3419 at ASH, so this could be another catalyst.

]]> By: druggie http://www.hammerstockblog.com/immunogen-at-asco-2008/#comment-283 druggie Thu, 14 Aug 2008 14:47:01 +0000 http://www.hammerstockblog.com/immunogen-at-asco-2008/#comment-283 your words were prophetic.. the eventual news of tras-dm1 going pivotal seems to be driving the stock price as we speak. we finally broke out of the 52 week highs.. next step is to break the intraday high of 6.24 in the spring 2007, then off to a real valuation in the high single digits.. Its time for imgn to put up or shut on 901. Its been in the clinic too long to not have hit MTD. It appears that combination trials are the future for this product, as there are too many drugs available to add a stand alone treatment at this time.. I would anticipate a combo trial with both revlimid and velcade possibly to begin in the fourth quarter. at some point in time, the drugs in the sanofy pipeline will need to be monetized into the share price. with 5 drugs already carrying imgn inside.. if sanofy drugs can begin to move into the clinic and into phase 2 trials, maybe wall street will fairly value imgn the stock... druggie your words were prophetic.. the eventual news of tras-dm1 going pivotal seems to be driving the stock price as we speak. we finally broke out of the 52 week highs.. next step is to break the intraday high of 6.24 in the spring 2007, then off to a real valuation in the high single digits..

Its time for imgn to put up or shut on 901. Its been in the clinic too long to not have hit MTD. It appears that combination trials are the future for this product, as there are too many drugs available to add a stand alone treatment at this time.. I would anticipate a combo trial with both revlimid and velcade possibly to begin in the fourth quarter.

at some point in time, the drugs in the sanofy pipeline will need to be monetized into the share price. with 5 drugs already carrying imgn inside.. if sanofy drugs can begin to move into the clinic and into phase 2 trials, maybe wall street will fairly value imgn the stock…

druggie

]]> By: Ohad Hammer http://www.hammerstockblog.com/immunogen-at-asco-2008/#comment-273 Ohad Hammer Sun, 27 Jul 2008 13:41:25 +0000 http://www.hammerstockblog.com/immunogen-at-asco-2008/#comment-273 IMGN's share price will be determined by T-DM1's phase II results, to be presented at ASCO BC conference early September and IMGN901's phase I data at ASH in December. I believe that the T-DM1 data will be positive and will result in the advancement to a pivotal trial, so the stock has still room for growth until September. As to the IMGN901 data in December, we'll have to wait and see, I'm not falling for that again... ohad IMGN’s share price will be determined by T-DM1’s phase II results, to be presented at ASCO BC conference early September and IMGN901’s phase I data at ASH in December.
I believe that the T-DM1 data will be positive and will result in the advancement to a pivotal trial, so the stock has still room for growth until September.
As to the IMGN901 data in December, we’ll have to wait and see, I’m not falling for that again…

ohad

]]> By: 4_reasons_unknown http://www.hammerstockblog.com/immunogen-at-asco-2008/#comment-272 4_reasons_unknown Fri, 25 Jul 2008 23:41:24 +0000 http://www.hammerstockblog.com/immunogen-at-asco-2008/#comment-272 Ohad Thanks for taking the time, this piece is very informative. What are your near term expectations from IMGN. Do you see the 5$ level as a basis for further price increase? Ohad

Thanks for taking the time, this piece is very informative.
What are your near term expectations from IMGN. Do you see the 5$ level as a basis for further price increase?

]]> By: Ohad Hammer http://www.hammerstockblog.com/immunogen-at-asco-2008/#comment-267 Ohad Hammer Wed, 16 Jul 2008 20:27:21 +0000 http://www.hammerstockblog.com/immunogen-at-asco-2008/#comment-267 Why wouldn't DNA run a phase III in Tykerb refractory patients? It would enable them to get T-DM1 in the market very early as you write. Although Tykerb user base is still limited, many physicians might use it off label before turning to Tykerb+xeloda. btw, if I were DNA, I would start a Xeloda+T-DM1 trial. Xeloda is Roche's drug so no problem here, there are no antganism issues like with Taxotere and most importantly, they may kick Tykerb out of Herceptin-resistant market. Sometimes the best defense is a good offense. Why wouldn’t DNA run a phase III in Tykerb refractory patients? It would enable them to get T-DM1 in the market very early as you write. Although Tykerb user base is still limited, many physicians might use it off label before turning to Tykerb+xeloda.

btw, if I were DNA, I would start a Xeloda+T-DM1 trial. Xeloda is Roche’s drug so no problem here, there are no antganism issues like with Taxotere and most importantly, they may kick Tykerb out of Herceptin-resistant market. Sometimes the best defense is a good offense.

]]> By: druggie http://www.hammerstockblog.com/immunogen-at-asco-2008/#comment-266 druggie Wed, 16 Jul 2008 12:38:01 +0000 http://www.hammerstockblog.com/immunogen-at-asco-2008/#comment-266 ohad.. what are your thoughts / experiences regarding the requirements on the phase 2.. for tras-dm1 ... must have prior tykerb/xeloda therapy. this very much sounds like dna may not run a phase 3 in this setting. do you know of any other drugs which have been approved in the phase setting under a situation like this. dna likely will only need 1 year to enroll this trial, and six months more of data maturation. equals xmas of 2009 , to apply for approval and likely approval by summer 2010.. druggie ohad..

what are your thoughts / experiences regarding the requirements on the phase 2.. for tras-dm1 … must have prior tykerb/xeloda therapy. this very much sounds like dna may not run a phase 3 in this setting.

do you know of any other drugs which have been approved in the phase setting under a situation like this. dna likely will only need 1 year to enroll this trial, and six months more of data maturation. equals xmas of 2009 , to apply for approval and likely approval by summer 2010..

druggie

]]> By: Ohad Hammer http://www.hammerstockblog.com/immunogen-at-asco-2008/#comment-265 Ohad Hammer Tue, 15 Jul 2008 20:38:13 +0000 http://www.hammerstockblog.com/immunogen-at-asco-2008/#comment-265 Thanks druggie. Judging by DNA's recent CC, they are seeing a very nice activity in the phase II. Thanks druggie.

Judging by DNA’s recent CC, they are seeing a very nice activity in the phase II.

]]> By: druggie http://www.hammerstockblog.com/immunogen-at-asco-2008/#comment-264 druggie Mon, 14 Jul 2008 12:43:31 +0000 http://www.hammerstockblog.com/immunogen-at-asco-2008/#comment-264 ohad.. thanks for your update... its my opinion that the tras-dm1 trial using tykerb/xeloda as a prerequisite of treatment will be the registrational trial everyone hopes for, whether announced as such or not. dna can make the trial pivotal based on the fact these patients have tried and failed the presumed LAST LINE OF DEFENSE, AND WONT have to repeat or run a control arm. the second trial tras-dm1 vs herc/taxotere will be a long running trial. but truly does have the makings of a heavyweight fight. with tras-dm1 the number one ranked contender and herc /taxotere the current standard. having seen the data ... i still believe tras-dm1 will blow this combo away.. with response rates of 80% in the very treatment experienced patient pop they ran the phase 2 trial. getting tras-dm1 into a naive treatment population should yield similar strong response rates/PR/CR .. regarding go /no go on a pivotal trial.. this decision was made a year ago when dna put into place multiple manufacturing suites in multiple locations around the world.. the rest is a poorly kept secret in my world. good luck with gary.. and his marketing theories. druggie ohad.. thanks for your update… its my opinion that the tras-dm1 trial using tykerb/xeloda as a prerequisite of treatment will be the registrational trial everyone hopes for, whether announced as such or not.

dna can make the trial pivotal based on the fact these patients have tried and failed the presumed LAST LINE OF DEFENSE, AND WONT have to repeat or run a control arm.

the second trial tras-dm1 vs herc/taxotere will be a long running trial. but truly does have the makings of a heavyweight fight. with tras-dm1 the number one ranked contender and herc /taxotere the current standard. having seen the data … i still believe tras-dm1 will blow this combo away.. with response rates of 80% in the very treatment experienced patient pop they ran the phase 2 trial. getting tras-dm1 into a naive treatment population
should yield similar strong response rates/PR/CR ..

regarding go /no go on a pivotal trial.. this decision was made a year ago when dna put into place multiple manufacturing suites in multiple locations around the world.. the rest is a poorly kept secret in my world.

good luck with gary.. and his marketing theories.

druggie

]]> By: Ohad Hammer http://www.hammerstockblog.com/immunogen-at-asco-2008/#comment-263 Ohad Hammer Mon, 14 Jul 2008 05:14:15 +0000 http://www.hammerstockblog.com/immunogen-at-asco-2008/#comment-263 Gary Both trials will involve every three weeks adminsitration and can be turned into phase IIIs. I don't think it has anything to do with marketing because in late stage cancer dosing schedule is not regarded as a meaningful factor. It's all about the data. The go/no go decision should be made sooner rather than later, as DNA has plenty of PFS data to make a decision. Ohad Gary

Both trials will involve every three weeks adminsitration and can be turned into phase IIIs. I don’t think it has anything to do with marketing because in late stage cancer dosing schedule is not regarded as a meaningful factor. It’s all about the data.

The go/no go decision should be made sooner rather than later, as DNA has plenty of PFS data to make a decision.

Ohad

]]> By: Gary Mohilner http://www.hammerstockblog.com/immunogen-at-asco-2008/#comment-257 Gary Mohilner Sun, 13 Jul 2008 23:35:53 +0000 http://www.hammerstockblog.com/immunogen-at-asco-2008/#comment-257 We may learn more about the two new DNA Trials tomorrow. I believe it's very possible that both may be run with Pivotal Quality Material, supplied directly by DNA rather than the unqualified material previously used in trials whict to now has all been supplied by IMGN. If I'm correct about this, whether DNA announces the trials as Pivotal or not with the FDA's concurrence they can be upgraded to Phase II/III's. I'm not certain either or both of these trials will be using the once a week dosing routine, as you suggest. While I do believe results are somewhat better, the marketing people may be pushing the once every three week protocol as being more marketable, and the results certainly warrant approval at that protocol as well. Perhaps a once every two week protocol would be a good compromise, but it would require another Phase I and no one may want to spend more time that way. Perhaps we'll know more tomorrow. Gary We may learn more about the two new DNA Trials tomorrow. I believe it’s very possible that both may be run with Pivotal Quality Material, supplied directly by DNA rather than the unqualified material previously used in trials whict to now has all been supplied by IMGN. If I’m correct about this, whether DNA announces the trials as Pivotal or not with the FDA’s concurrence they can be upgraded to Phase II/III’s.

I’m not certain either or both of these trials will be using the once a week dosing routine, as you suggest. While I do believe results are somewhat better, the marketing people may be pushing the once every three week protocol as being more marketable, and the results certainly warrant approval at that protocol as well. Perhaps a once every two week protocol would be a good compromise, but it would require another Phase I and no one may want to spend more time that way. Perhaps we’ll know more tomorrow.

Gary

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