Biotech / Medical | Immunomedics (IMMU) - moderated


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To: idahoranch1 who wrote (13153)12/7/2010 9:22:40 PM
From: li3511   of 20665
 
> Are there any examples of that happening?

The situation is unusual, and FDA knows it's a potential barrier for effective treatments reaching market. I don't know all the precedents.

For another contemporaneous example, please see: blogs.forbes.com 

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To: stockdoc77 who wrote (13151)12/7/2010 9:53:14 PM
From: li35112 Recommendations   of 20665
 
> My understanding is that the UCB buy-in is of a limited nature

The limit is spelled out in Section 6.2 of their agreement:

"The Buy-In Right for the Cancer Indication shall expire upon the first to occur of the First Commercial Sale following Approval of a Licensed Product for the Cancer Indication or the expiration or termination of this Agreement."

> allowing UCB a veto over any development even though UCB has no interest in NHL

UCB has no veto, or any other say in the matter. "Unless and until UCB exercises the Buy-In Right with respect to the Cancer Indication, then (subject to Section 6.3 [which doesn't apply here]) Immunomedics shall continue to have the exclusive right and responsibility for the Development and Commercialization of the Licensed Product in the Cancer Indication, subject to and in accordance with the terms of this Agreement."

The problem isn't developing Epratuzumab for NHL -- it's who pays the costs of doing so. The current arrangement is that the costs are on Immunomedics, but if things work out such that Immunomedics gets an oncology label, UCB can then reimburse Immunomedics the costs as part of their buy-in. Not a bad deal -- UCB has no risk. They can wait until AFTER FDA approval to decide whether or not to pay the development costs.

The question on the table involves a potential 3rd party -- another licensee, just for the oncology indications. Their best possible reward would be whatever portion of the royalty stream they could negotiate out of Immunomedics' share, and their worst possible risk would be funding all development costs, only to caught up in some UCB screw-up that tarnishes the compound and s***-can's the project. This doesn't sound like a winning hand. If Immunomedics were able to do the development themselves, that would be one thing. But I can't see a third party entering the mix unless UCB agrees to renegotiate.

> the company thinks they can resolve it in a manner
> that would allow E to move ahead in NHL

One can only hope.

The buzz used to be that Doc was not about to undervalue e-mab, his first child. One can only hope that, by now, he realizes that getting e-mab to market -- no matter how low the royalty stream might be -- would turn around the fortunes of the entire company. Its value is no longer in up-fronts and residuals, it's in giving the company enough credibility to get the rest of the pipeline done.

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To: idahoranch1 who wrote (13143)12/7/2010 10:07:34 PM
From: li3511   of 20665
 
> do you view the newer approach of the DNL version of RAIT, where there is
> significantly less exposure of normal tissue to the radiation, differently from
> the RAIT the way it is delivered now?

Do you mean DNL or do you mean pre-targeting?

I don't like RAIT the same way I don't like chalk scratching on the blackboard. It's inherently complex and expensive, it socks a huge punch to the immune system (bone marrow) as collateral damage, and it may cause secondary malignancies in magnitudes that are not now fully understood.

For most drugs the manufacturer can do all the quality controls before the product leaves the factory. However, RAIT drugs have no shelf life. The final steps of manufacturing have to be done at the clinic, and it takes special facilities and training -- cross your fingers that they actually do it right. (The radioactive isotopes are potentially harmful to everyone who has to handle them.) All this adds up to much higher costs -- both drug costs and other treatment costs.

If you're going to go down the path of conjugating a MAb with something, I personally find a chemical toxin (e.g., SN38) the more appealing option.

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To: li3511 who wrote (13158)12/7/2010 10:42:47 PM
From: idahoranch1   of 20665
 
<<Do you mean DNL or do you mean pre-targeting?>>

I was thinking of TF2 and TF10, the DNL constructs for CEA and hPAM4 which are pretarget.

E-mab and M-mab are good candidates for conjugating a toxin like SN-38 because they internalize fairly rapidly.

What are your thoughts on antibodies that don't internalize and how to make them more effective?

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To: idahoranch1 who wrote (13159)12/7/2010 11:31:14 PM
From: li3511   of 20665
 
> What are your thoughts on antibodies that don't internalize and how to make them more effective?

ncbi.nlm.nih.gov 

ncbi.nlm.nih.gov 

Sorry, but you asked.

The punch line, in simple English, is to make a bispecific antibody that (1) attaches to the cluster of differentiation (CD) of interest (e.g., CD20) and (2) activates the body's own T cells, using their CD3 receptor, in effect training the body to attack the CD of interest on its own.

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To: li3511 who wrote (13160)12/8/2010 12:34:23 AM
From: idahoranch1   of 20665
 
Don't be sorry : )

Those are 3 and 5 years old, are there any clinical trials that show how well they work?

The first one comments on lymphocytes, and blood cancers are among easiest to fight with antibodies at least as compared to solid tumors. I was thinking more in line of the tough solid tumor cancers, like colorectal, breast, prostate, pancreatic, etc. There really haven't been good gains in those yet, at least not with biologics. Maybe they are getting close, but it seems to me that they are still a ways off.

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To: idahoranch1 who wrote (13161)12/8/2010 9:11:15 AM
From: li3511   of 20665
 
> Those are 3 and 5 years old, are there any clinical trials that show how well they work?

phx.corporate-ir.net 

phx.corporate-ir.net 

(Note the part about having a conference call to discuss the ASH paper.)

> I was thinking more in line of the tough solid tumor cancers, like colorectal,
> breast, prostate, pancreatic, etc. There really haven't been good gains in those
> yet, at least not with biologics.

The BiTE antibody against EpCAM is in Phase I trials. As of May 2010 (ASCO), 28 patients with locally advanced, recurrent, or metastatic colorectal, gastric, and lung cancer had been treated at dose levels ranging from 1 to 24 micrograms per day. Out of 22 patients evaluable for response, disease stabilization was observed in nine patients, with a median duration of 91 days. The maximum tolerated dose has not been reached, and dose escalation continues.

The rights to a BiTE antibody against CEA were sold to MedImmune, which is still in preclinical research. MedImmune plans to initiate a Phase 1 trial of "MEDI-565" in patients with advanced gastrointestinal cancers in the first half of 2011. There are additional partnerships with Bayer Schering and sanofi-aventis against undisclosed targets -- again, preclinical.

(Note the part about having three big-league partners.)

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From: me otter12/8/2010 9:34:47 AM
   of 20665
 
Should be an interesting day. I would assume that the first trade, which looked to me like a day trader selling 25,000 down $.10, will provide us with a picture, by the end of trading, of how resilient IMMU is after this run up from the lows.

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To: li3511 who wrote (13162)12/8/2010 9:35:41 AM
From: idahoranch1   of 20665
 
Thanks

<<http://phx.corporate-ir.net/phoenix.zhtml?c=197259&p=irol-newsArticle&ID=1504494&highlight=>>

OK, this one looks like they are using it to "mop up" small amounts of disease after other treatment in ALL, I agree with that approach, it is really important to get rid of those few cells that cause reoccurance of the cancer down the road. Would love to see that succeed.

phx.corporate-ir.net 

It's good to see something that might be effective in NHL indications other than FL, that has been a tougher nut to crack.

Tougher yet are the solid tumors, we'll see how that goes as the trials proceed, hopefully well. I'm still expecting it will take a bigger hammer than that for the more advanced solid tumor cancers to make really good progress.

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To: me otter who wrote (13163)12/8/2010 9:39:02 AM
From: idahoranch1   of 20665
 
That looked like a trade by someone who wants the stock down, who would that be? : )

There's been a good buyer for a couple of days and I don't think it was just buying on the news (ASH). But you are right, can the shorts get control again after new, or is the buyer(s) going to accumulate for a while and cause them a lot of headache's and more borrowing than they really want to do.

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