skitahoe

Why is Wall Street Ignoring ImmunoGen?

I don't believe they'll be ignoring IMGN much longer. The Abstact for once a week dosing of T-DM1 shows spectacular results, this should only get better as we see more patients and confirmed Partial Responses in the ASCO presentation which should include nearly six months of additional data.

Add to this the fact that the Clinical Trials database now shows two new Phase II Trials intended to start in July that will greatly expand the potential use of T-DM1 and you can see that DNA with the concurrence of the FDA is looking to rapidly develop this drug.

I've heard it said that a blind man could see this drug is headed for approval, I believe it's not only true, but the FDA themselves might shorten the process as the data's so overwhelming.

I believe all the new trials, as well as perhaps the current trials, could be using Pivotal Material which DNA now has the capability of making, instead of drug supplied by IMGN. The importance of this is DNA cannot gain approval unless the FDA approves its manufacturing capability, this may already have been done.

It's only a matter of time, and I believe this drug will fly through Pivotal Trials once they're started.

Gary

Immunogen's Bright Future (Part II)

Ohad,

I agree with much you say, and you certainly have much greater technical expertice than me, but my understanding of a few things is different from yours. Please check if I'm wrong.

As I understand it DM4 does bind more securely than DM1, but I think each will work with IMGN's various different linkers. Likewise IMGN's different linkers will work with Taxanes they've developed, and also DC's which haven't been mentioned in some time.

Back when C242-DM1 was in trials there were two patients, I believe with colon cancer, who nearly had partial responses. The benefits they got from the drug may have been sustained for over a year. To me this is saying that with the right patient mix and the right protocol C242-DM4 should work in a manner that's superior to the DM1 based product. I believe the key is the right patients, and perhaps a protocol that includes other forms of chemo. If this drug were in the hands of someone with far more funds, I believe several trials would be run to determine how to best utilize the drug.

From their comments it appears that SNY has done this with My9-6-DM4 and now they're saying they have POC. They haven't said what exactly that means, but we should find out at ASH when it's anticipated they'll be discussing the drug. If POC means to SNY what it normally means, the drug should advance in trials shortly.

Gary

The "Naked" Truth About Antibodies For Cancer Therapy

I believe IMGN's latest guidance is for 2 to 4 drugs by June 2008, the end of their fiscal year. Eight targets currently are licensed to IMGN's partners, and the CEO has guided that SNY will claim at least ten targets to license from IMGN's pipeline by the end of August, 2008. By the end of 2009 the potential of going substantially higher than 4 to 6 new drugs is great.

Something we have almost no knowledge of is just how much work has been done preclinically since the SNY partnership took place. We know SNY has a choice of up to 20 targets from IMGN's pipeline, and that the choice was from 40 or more targets in the pipeline. If over the five years of the partnership many of these 20 to 40 targets they've been looking at have advanced substantially preclinically, by the end of 2009 either IMGN or SNY may put one or more of these in the clinic. Today we know of at least one that SNY intends to bring to the clinic as it appears on SNY's website, even though the drug's not yet licensed with IMGN.

I hope everyone knows when I'm referring to a target it actually represents potentially many different drugs. PSMA was the target IMGN licensed with MLNM, who also had the rights to J591 an MAB developed by BZL which targets it. There are other MAB's that also target PSMA, IMGN won't license them as long as MLNM holds the target rights. While MLN2704 didn't go to Phase II, it was a conjugate of J591 with DM1 with one of IMGN's oldest linkers. Today IMGN could conjugate that MAB with different linkers as well as different effector molecules. It could also conjugate other MAB's targeted at PSMA, but only for MLNM, or if MLNM agreed to sell or abandon its license with IMGN. No one outside the partnered companies seem to know how long licenses are for, so it's also possible that in time they expire if drugs are not being actively pursued from the license.

I believe that Tras-DM1 could be the first approved TAP drug, though there are other possibilities. As I see it, ten or twenty years from now DNA could come back to IMGN and improve on the drug with a better linker, effector molecule, or both, as I don't believe the license would expire just because a drug was approved from it.

These are just my opinions, but I've been invested in the company almost from the beginning.

Gary