Beta Delta

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As I anxiously await the abstracts for the ASCO conference to be released, I cannot help but wonder what Wall Street is waiting for. ImmunoGen (IMGN), the biotech company that Wall Street has forgotten, is, with its partner, Genentech (DNA), about to take the ASCO world by storm when data is released concerning Genentech's new breast cancer treatment, Trastuzumab-DM1.

Many recent Genentech investor presentations and conference calls have highlighted this exciting new drug. Genentech has called Trastuzumab-DM1 "the single most exciting drug we have in our pipeline." Genentech even honored this drug with a mention in its most recent annual report. So, one asks, what does this drug do?

Well, if you believe anecdotal evidence, it promotes stable disease in MBC (metastatic breast cancer) patients, and in some cases, quite possibly, even CURES it. While CURE may be a strong term, soon patients everywhere will be asking for, clamoring for, Trastuzumab-DM1.

Phase 1 weekly dosed trial data about to be released in abstract form at ASCO will likely tell us that Trastuzumab-DM1 has achieved SD (Stable Disease) in about 40-50% of the patients who received it, and a true Partial Response in 25%+ of the balance of patients treated with this exciting new drug. Very few patients have been dosed long enough to consider patients a CR (Complete Response), but patients I know on this drug in trials call it a "miracle drug".

So why has Wall Street ignored ImmunoGen? I don't know.

Yes, Genentech owns the rights to Trastuzumab-DM1. But Genentech will give ImmunoGen royalties on sales for this drug once approved by the FDA, which could come as soon as late 2010 or 2011. Genentech recently announced that Trastuzumab-DM1 has achieved a POC (proof of concept) for its type of drugs, ADCs (Antibody-Drug Conjugates). Genenetech also announced that they have an entire pipeline of ADCs in which IMGN's technology will play a large role. Genentech currently owns the right to bring into clinic at least three more drugs from this partnership with ImmunoGen. For Genentech, even bringing one more new ADC into the clinic should tell the world that the concept is true. Bringing three new drugs potentially with IMGN should alert Wall Street that ImmunoGen can no longer be ignored. It's time for the Street to wake up to Immuogen, and, when they do, it will likely have a double digit stock price.

Disclosure: Author holds a long position in IMGN

This article has 4 comments:

  •  
    May 16 02:32 PM
    I agree, but I also am a long time long waiting for vindication of my decision to buy.

    Hope we will get noticed.
    Reply
  •  
    May 16 09:52 PM
    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
    Reply
  •  
    Jun 03 11:42 PM
    Interesting conspiracy discussion on the "Untold T-DM1 Story" on Investor Village with DNA lip locking IMGN. Where's the incentive to DNA to allow IMGN to relase anything worthwhile? There isn't one.
    Good points on some things that might be good to dig into.
    Reply
  •  
    Jul 30 05:57 PM
    bt redneck.. i dont think there is any conspiracy theory between dna and imgn. the phase 2 just finally dosed its 110th patient according to a patient in the trial.

    dna has also announced two other phase 2 trials, both of which could be registrational according to a top dna official, sue hellmond? sp

    With parent Roche, already opting in on trastuzumab-dm1 last sept 2007, this drug, barring a major side effect, and so far nothing even close to a major SE has been found, will have enough statistical significance between either of those two trials in the MBC setting to file for approval sometime in 2010. I suspect only that the possible announcement of a pivotal trial or P3 may be the trigger for a milestone payment, and thus genentech may be holding off until later this year. With genentech still on the hook for approx 37 million in future milestones, and about to enter phase 3, the milestone could approach the 10-15 million mark. Even for genentech, this is a significant cash outlay. But rest assured, it will be paid to immunogen, likely sooner than later.
    Reply
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