Yes, there is the entire possibility that an identifiable subgroup with the treatment arm responded significantly enough to warrant a more targeted patient population for phase 3.
Depending on the treatment effect observed in that subgroup, the p3 trial needn't be as large as some are suggesting.
As an example, let's assume patients with tumors that express at least 5 of the 6 antigens have much longer survival curves than not only the placebo arm but those with 4 antigens and less. With a greater survival advantage, less patients are required to demonstrate statistical significance.
Obviously, whether an easily defined and screened population does respond better is the billion dollar question.
Look, if it were at peak sales, the annual cost of treatment would come down significantly from early sales. That said, even if it were just $500 per year. With 75% of the established market we're looking at a $25B annual revenue. EPS would be multitudes higher than current SP.
There's a few more things that have to happen first, though.
Similar. It's dendritic cell therapy. The dendritic cells sensitize and activate T-Cells (along with other parts of the immune system) against antigens that have been preloaded into the DC's via a synthetic peptide.
Not sure how the other study you've mentioned uses T-cells off the bat, but it also looks promising.
Perhaps they've cut out the middle man and presented the antigens directly?
Addressable market of 60% referred to HLA popn, market would be smaller due to competition.
Estimate of $100k based on currently treatments and therapies of this indication that all circle around $100k+ and other immunotherapies (Provenge 93k, DCvax $120).
Proof of concept - 140 is not completely different. Yes, different indication and some antigens, but same platform, process and infrastructure.
Your argument that this has bearing all other protein targeting immunos grossly oversimplifies the unique processes and mechanisms of action of all parties.
You might want to redo your figures. 9,000 cases annually in the US alone. @ 60% (arguably) of the market x $100,000 = $540M per year.
Double that for Europe, the same again for R.O.W.
Also as proof of concept for ICT 140 and so on.
Things just get better from here.
Would be good to have Disco or Jet weigh in with their models to remind us that Q1 is more likely.
(And to add some value to the spam-fest this board has become, hard to separate the wheat from the chaff maybe a few thread necros are in order?)
Totally. I'm too scared to sell anything. That's where the real risk is.
Imagine what the SP would do with positive Direct results. Make's a 20% intraday profit seem painful.
I think there would be a lot of retirees on this board if that happened.
I would happily be one of them. Maybe get a new vehicle, nothing too extravagant - A 200 ft yacht.
The survival curves of immunotherapy typically have a longer tail, so those that make it over the halfway mark have a greater chance of living proportionately longer than those before it.
Just to clarify, median overall survival figures aren't the average benefit you could expect to live with treatment. It's a 50% chance of living longer than that figure. So for 6mo you'd have a 50% chance of living longer than that. Could be 6 months and 1 day or 40 years.
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Adoptive Immunotherapy 1-40
Antibody Recognition to Engage Cells of the Innate and Adaptive Immune Systems (Antibody Dependent Cell-Mediated Cytotoxicity: ADCC) 41-49
Biomarkers & Immunoscoring 50-76
Combination Approach in Cancer 77-104
Immune Monitoring* 105-127
Immunotherapy in Combination with Radiation Therapy* 128-134
The Impact of Systems Biology on Immunotherapy* 135-138
Metabolism and Immunity 139-143
Novel Agents for Delivering Immunotherapy* 144-163
Tumor Escape, Immune Editing and Role of Immune System in Preventing Oncogenesis* 164-167
Tumor Immune Resistance and Overcoming It 168-202
Tumor Microenvironment and Innate Cells Recognition 203-222