Open Norway: Plasma cell aimed treatment with daratumumab in ME/CFS - Haukeland University Hospital

Utsikt said:
The patent for Dara is apparently set to expire next year. A phase 3 for a biosimilar is planned by Celltrion. Which might explain why J&J doesn’t want to spend any money on it.
www.biospectrumasia.com

Mitigating Patent Cliff Fallout

Mitigating Patent Cliff Fallout
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That's disturbing. So they don't stand to reap a sustained profit if it works because biosimilars might flood the market in a few years?
 
Posted before posts on the topic in another thread were moved in to this thread

Crossposting from another thread. A plausible explanation for why the manufacturer doesn’t want to participate in the study:
Utsikt said:
The patent for Dara is apparently set to expire next year. A phase 3 for a biosimilar is planned by Celltrion. Which might explain why J&J doesn’t want to spend any money on it.
www.biospectrumasia.com

Mitigating Patent Cliff Fallout

Mitigating Patent Cliff Fallout
www.biospectrumasia.com www.biospectrumasia.com
Click to expand...
Jonathan Edwards said:
Well, there's your answer. No brainer.
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The silver lining is that Dara (or it’s equivalents) might become significantly cheaper in the not too distant future.
 
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Jaybee00 said:
JNJ could change one minor component in the formulation to get a patent extension and thus an indication for MECFS

Evergreening - Wikipedia

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Fluge & Mella have already applied for a patent for ME/CFS. I have no idea of that impacts things as well.

WO2021038097A1 - Method for the treatment of chronic fatigue syndrome using an inhibitory or cytotoxic agent against plasma cells - Google Patents

The present invention relates in a first aspect to a method for the treatment of chronic fatigue syndrome (CFS) comprising administering to a patient in need thereof a therapeutically effective amount of inhibitory or cytotoxic agent against plasma cells. In a further aspect, the present...
patents.google.com
 
Utsikt said:
Fluge & Mella have already applied for a patent for ME/CFS. I have no idea of that impacts things as well.

WO2021038097A1 - Method for the treatment of chronic fatigue syndrome using an inhibitory or cytotoxic agent against plasma cells - Google Patents

The present invention relates in a first aspect to a method for the treatment of chronic fatigue syndrome (CFS) comprising administering to a patient in need thereof a therapeutically effective amount of inhibitory or cytotoxic agent against plasma cells. In a further aspect, the present...
patents.google.com
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What are the implications of them applying for a patent?
 
ChatGPT says;
Yes, the Norwegian team has successfully filed a method-of-use patent (WO2021038097A1) for daratumumab in ME/CFS. They’re using a well-established lifecycle extension strategy:
  • Patent the new method-of-use (WO2021038097A1).
  • Generate clinical safety/efficacy data to support the patent’s validity and commercial attractiveness.
  • Progress through phased clinical trials—from pilot to Phase 2/3—to potentially establish an ME/CFS-specific indication exclusive under patent rights.
  • If further trials confirm efficacy, they would hold exclusive IP for this application—strengthening potential licensing or commercial interest.
 
I trust Drs Fluge and Mella but I'm a bit surprised that anyone can patent a drug for a specific application, including the pharma company that created it. What is the purpose?
 
butter. said:
Hi @Jonathan Edwards, you have apparently been somewhat critical about the idea to use dara and/or cyclo in the past, what data/research/events made you change your mind? Thank you!
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It is a matter of the detail of risk benefit analysis. The risk benefit analysis for cycloo has always been poor and will continue to be. For Dara the question is whether ME/CFS is dependent on a population of long-lived plasma cells, specifically. That has seemed relatively unlikely, but possible. Recently, I have been thinking that the case for antibody being involved is stronger than I thought. A trial of Dara that would test the role of long lived plasma cells seems to me legitimate. Whether it would be a practical therapy I am much less certain, but with rituximab the drug turned out to be useful despite the B cell dynamics being different from our original prediction.

The continuing problem will be that if it is necessary to knock down long lived plasma cells then all your long term humoral immunity to viral infections will be wiped out. There must be a high risk of things like zoster or much worse. We know that antibody depletion increases risk of progressive multifocal leucoencephalopathy, for instance, even if marginally and only in certain contexts.
 
Sasha said:
I trust Drs Fluge and Mella but I'm a bit surprised that anyone can patent a drug for a specific application, including the pharma company that created it. What is the purpose?
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This was done with Rituximab for ME/CFS as well. As far as I understand this is common practice?

Should it ever result into some profit it will go to the public health institution Helse Bergen which is the "owner" of the patent, and not into the researcher's own pockets.
 
Jonathan Edwards said:
The continuing problem will be that if it is necessary to knock down long lived plasma cells then all your long term humoral immunity to viral infections will be wiped out. There must be a high risk of things like zoster or much worse. We know that antibody depletion increases risk of progressive multifocal leucoencephalopathy, for instance, even if marginally and only in certain contexts.
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So all the immunity we've built up to things over our lives would go, including that from vaccines (measles, etc.)? This sounds awful. Are people currently on such therapies for other things, and if so, what happens to them?
 
Jonathan Edwards said:
The continuing problem will be that if it is necessary to knock down long lived plasma cells then all your long term humoral immunity to viral infections will be wiped out. There must be a high risk of things like zoster or much worse.
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Can’t a person be re-vaccinated post Daratumumab (or other cd-38 depleter)?
 
Jaybee00 said:
Can’t a person be re-vaccinated post Daratumumab (or other cd-38 depleter)?
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You would need to re-vaccinate them against lots of things. And we don't have any particular reason to think that the resulting antibodies would be any less harmful than the ones removed by Dara, do we? Your long lived plasma cells are in theory just producing antibodies to things you have been vaccinated against or met as an infection. Why would the new lot be different?
 
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