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   Biotech / MedicalImmunomedics (IMMU) - moderated

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To: Fitzhughlaw who wrote (45926)4/27/2018 1:05:11 PM
From: CelebrityEquity
   of 57174
Exciting stuff....for sure.

Listening to Dr. Tagawa makes me feel like a parent....
who, for many years, feared his child might never walk....
proud and teary-eyed....watching her perform at her first dance recital.

May the force be with us.

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From: Renmanco4/27/2018 3:12:30 PM
5 Recommendations   of 57174
Hiring a skilled pricing specialist is a smart move at this time. Drugs are priced very differently depending upon the distribution channel, including geographies being considered. Being able to justify a price is critical as the company moves forward with commercialization activities....and the best time to establish expected prices that can be charged is well in advance of the day that approval is granted so that the company can roll out its products in the higher ROI markets before having to confront less profitable venues.
As the best possible distribution channels can be defined, it will affect hiring of regional sales managers, reps, etc so that the company can target those with the most experience in the markets expected to be developed first.

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To: patlawche11 who wrote (45906)4/27/2018 5:58:51 PM
From: drtom1234
6 Recommendations   of 57174
It occurred to me this morning that this may actually be a very significant event. To my mind, it suggests that they have accrued enough patients in both hormone positive breast cancer, as well as urothelial cancer to satisfy the FDA requirements(which presumably have been communicated to the company during FDA meetings) for accelerated approval in these two indications. I suppose other alternatives are that they are planning separate P2 studies in both urothelial and breast to complete accrual of necessary patients, OR, they aren't planning on AA in one or both indications. The first of those options seems unnecessarily onerous and expensive when they could have easily accrued the patients under the auspices of the already existing basket trial. The second option seems unlikely especially in urothelial. In terms of breast, we'll know quite a bit more after June 3rd.

In terms of timing, if we assume the last urothelial patient was just dosed, and PFS for urothelial is a median of 7 months, by early next year(significantly sooner than I had initially thought) they could be ready to apply for AA. If I play devil's advocate, the Cowan presentation on the company website suggests that at least in March, the company thought they would need more patients admitted; maybe they received input from the FDA that they had enough? I don't know, but we should have more clarity from management in 37 days.

In terms of hormone receptor positive breast we have no idea of the efficacy of SG yet, but presumably PFS would be longer than for TNBC, which is about 5 1/2 months. We also know that the combo of palbociclib-plus-fulvestrant given in metastatic hormone receptor positive breast cancer patients has a PFS of 9.2 months in patients who had received one prior chemo(PALOMA3 trial). Presumably SG will be positioned as a 3rd line agent, so I would expect the requirement for PFS would be less than that, but would also expect it to be longer than the 5 1/2 months in TNBC.

Needless to say, if we were to get AA in TNBC, urothelial, AND hormone rec pos breast, even 3rd line for all indications, valuation of the company will be vastly increased, and I would expect to see huge acquisition offers from big pharma.

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To: drtom1234 who wrote (45929)4/27/2018 9:09:22 PM
From: weatherproof
7 Recommendations   of 57174
My thought is that they set out accruing a minimal amount of patients for the first stage in a 2-stage phase II. It is my sense that the response rate in both urothelial and hormone positive BC were high enough to reject the null hypothesis (drug inactive due to lower than a predetermined response rate.) I'm also doubtful that the trial was stopped for efficacy. I think we're just seeing the trial suspended as they take the numbers from the basket trial representing stage one, and now determining the sample size, and such, for the second stage. The bad news would have been that they're not proceeding with the second stage due to inactivity of the drug or some issue with toxicity. I don't believe we're seeing any signs of that.

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From: winners184/27/2018 11:12:37 PM
   of 57174
Is he still on immu payroll?

4:50 Trop-2 as a Broad Solid Cancer Target for Antibody-Drug Conjugates

David Goldenberg, ScD, MD, Founder and Former CSO, Immunomedics, Inc.

Trop-2 is a transmembrane glycoprotein that transduce cytoplasmic calcium signal, activates MAPK/ERK pathway, and affects cell-cell adhesion. Using a proprietary linker technology to site-specifically conjugate an average of 7.6 molecules of SN-38 (the active metabolite of irinotecan, which inhibits nuclear topoisomerase I) per humanized IgG, my group demonstrated effective and selective tumor inhibition in vitro and in xenograft solid tumor models, as well as in phase 2 studies of ~500 patients with advanced, heavily-pretreated diverse solid cancers (e.g., breast, NSCLC, SCLC, urothelial).

Limitations of First-Generation ADCs in Solid Cancers

David Goldenberg, ScD, MD, Founder and Former CSO, Immunomedics, Inc.

Prospects for next-generation ADCs in solid cancersRole of antigen target, drug-antibody ratio, nature of drug, conjugation chemistry, drug resistance.

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To: weatherproof who wrote (45930)4/27/2018 11:38:36 PM
From: drtom1234
   of 57174
I agree that RR based on available information is likely to be quite good. I don't think the trial was stopped for efficacy either, I just wonder if they have accrued enough patients in those indications to satisfy FDA requirements for AA. Starting studies up is expensive, and I'm not sure why they would need or want to spend that money on two new P2 studies(urothelial and ER+ breast), when they could satisfactorily accrue those patients under the umbrella of the pre-existing basket trial, just as they did with the TNBC indication.

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To: winners18 who wrote (45931)4/28/2018 12:12:16 AM
From: dorightbythem
   of 57174
First, oy. Second, 500 patients larger than expected.

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From: dorightbythem4/28/2018 8:08:12 AM
   of 57174
Third, let's hope he doesn't pull another fiasco, inadvertently.

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To: drtom1234 who wrote (45932)4/28/2018 8:18:06 AM
From: weatherproof
3 Recommendations   of 57174
I was wondering if "active, not recruiting" simply means they're temporarily halting the trial as they work the numbers in the first stage of the analysis and plot out the next stage. That wouldn't be inconsistent with how they handled TNBC. In fact, I recall that Chau believed that after the pause in TNBC accrual, and then subsequent resuming of the trial with the recommended additional patients for the second stage, that resumption (and the inferred FDA nod) would be a positive share price event. It turned out not to be but I cannot recall if that was due to a market yawn, a terrible financing, and/or the FIASCO happening concurrent with said resumption.

In retrospect, I get the basket approach and why moving forward with the second stage of the 2-stage analysis for TNBC should have been a stock moving event. I'd be surprised to learn that IMMU didn't frame out the resumption of stage 2 for urothelial, for instance, in that context. I'm thinking it may be worthy of a press release if and when that trial resumes, signifying that stage 2 is moving forward.

Two stage approaches are common in phase II studies. You can look at a minimal patient population so as not to potentially subject a larger group to ineffective treatments, assuming the null hypothesis (drug ineffective) to be true. After all, in most cases a drug does fail in phase II. It also is a way to mitigate the financial strain of funding a larger study. I don't know how IMMU structured the 2-stage analysis, but one can contemplate that:

1. There is some threshold in terms of response rate below which the study won't move on to the second stage.
2. There is some RR above which the trial may be halted due to efficacy, which will result in going straight to the AA application.
3. I think what we're seeing here is something in between. IMMU-132 in urothelial, for instance, is seemingly active and efficacious. Given the results in the first stage of the analysis, and given a desired significance level, say 5%, and study power, how many patients do they need to accrue in the second stage for the alternative hypothesis to be borne out.. They can increase the power by raising the significance level from 5% to something larger, but by doing so, they'll increase Type 1 errors (reject null hypothesis when it was true, meaning that they move forward when the drug is really inactive.)

I don't mean to get in the weeds, but it has always been my impression that to understand how things have been moving forward over the past couple years, one would need to understand the premeditated 2-stage approach to these phase II trials. And, by the way, I do not for a second pretend to be any kind of expert in this statistical arena.

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To: weatherproof who wrote (45935)4/28/2018 10:18:33 AM
From: Smoke Reader
1 Recommendation   of 57174
For what is worth, I am quoting from the Glossary of Terms at
Recruitment status: clinical study
Not yet recruiting: The study has not started recruiting participants.
Recruiting: The study is currently recruiting participants.
Enrolling by invitation: The study is selecting its participants from a population, or group of people, decided on by the researchers in advance. These studies are not open to everyone who meets the eligibility criteria but only to people in that particular population, who are specifically invited to participate.
Active, not recruiting: The study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled.
Suspended: The study has stopped early but may start again.
Terminated: The study has stopped early and will not start again. Participants are no longer being examined or treated.
Completed: The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).
Withdrawn: The study stopped early, before enrolling its first participant.
Unknown: A study on whose last known status was recruiting; not yet recruiting; or active, not recruiting but that has passed its completion date, and the status has not been last verified within the past 2 years

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