Daratumumab, isatuximab (CD38 drugs)

Collecting all the threads we have about daratumumab:

ME/CFS
Other conditions
 
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Isatuximab Subcutaneous by On-Body Injector Versus Isatuximab Intravenous Plus Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma: Phase III IRAKLIA Study​


The Isatuximab SubQ formulation will be via an “on body injector”.

These pharma companies always need to find a way to charge more for something that could be done much more cheaply.
 
From the Fatigatio live stream today: Carmen Scheibenbogen says they have secured funds to trial Isatuximab (she mentioned a CD38 depleting drug from Sanofi and there's only one).

She says Sanofi are interested in cooperating based on recent results.



At 2:47:00, but it's in German.

Edit: Updated video at 23:50

 
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OrganicChilli said:
From the Fatigatio live stream today: Carmen Scheibenbogen says they have secured funds to trial Isatuximab (she mentioned a CD38 depleting drug from Sanofi and there's only one).

She says Sanofi are interested in cooperating based on recent results.
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Any sense of whether that's for a pilot trial or a full trial, and when it might be ready to go?

Would isatux be expected to be better/safer than dara? I'm trying to work out where this trial lies on the 'good news' scale and whether an isatux trial already being funded means that funding the dara trial would be less of a priority.
 
Sasha said:
Any sense of whether that's for a pilot trial or a full trial, and when it might be ready to go?

Would isatux be expected to be better/safer than dara? I'm trying to work out where this trial lies on the 'good news' scale and whether an isatux trial already being funded means that funding the dara trial would be less of a priority.
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No idea unfortunately. She only mentioned it briefly at the end of her presentation before she ran out of time. The study was funded privately so I wouldn't expect anything massive. But perhaps I'm underestimating the German charities. She also said they're waiting for government funding for CD19 and CD20 depleting drugs and that they want to trial everything at the same time.

Isa and dara work similarly in that they inhibit CD38. Chatgpt says Isa may be less dependend on NK cell levels, but take it with a grain of salt.

I don't think this means we should deprioritise dara. If anything, dara's biosimilar will be cheaper.
 
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OrganicChilli said:
No idea unfortunately. She only mention it briefly at the end of her presentation before she ran out of time. The study was funded privately so I wouldn't expect anything massive. But perhaps I'm underestimating the German charities. She also said they're waiting for government funding for CD19 and CD20 depleting drugs and that they want to trial everything at the same time.
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That's odd - I'd thought that the failure of rituximab (a CD20-depleter) would have meant not bothering with other CD20-depleters.
 
OrganicChilli said:
But perhaps I'm underestimating the German charities.
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German and Austrian pwME have done some unbelievable work. If my memory does not deceive me both countries had little going on 10+ years ago. I used to live in Germany for a couple of years and at least online, I feel like there was never really anything from Germany. The amount of progress has been incredible.
 
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At around 2:46:30, Carmen Scheibenbogen mentions they have private funding for an anti-CD38 study, and also interest from Sanofi to collaborate.

They seem to call it AIM-ME. Does anybody know more about this?

 
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Just wanted to put this all in one spot:

Subcutaneous Daratumumab injection schedules from Fluge’s group.

Pilot group 1 Week 0,2,8,10
Pilot group 2 0,2,4,6,14,22,30

Amendment to pilot: 0, [10], 24, 48
(Week 10 only if no response)

Phase 2 0,2,4,24,26

Based on what Fluge et al. wrote in their dara article and comments by @Jonathan Edwards that dara likely kills cells very quickly, I’d posit that the amendment protocol would be/should be effective and the most cost effective.

In the pilot there wasn’t much/any difference between the 4 and the 7 injection treatments.

Plus dara has a long half life of about three weeks.
 
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Also Fluge note that even with the high dara dosage protocols for Multiple myeloma, NK cells are not completely depleted.

They also note in their article that for other autoimmune diseases there didn’t appear to be a relationship between effectiveness and the number of dara injections.
 
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Jaybee00 said:
Also Fluge note that even with the high dara dosage protocols for Multiple myeloma, NK cells are not completely depleted.

They also note in their article that for other autoimmune diseases there didn’t appear to be a relationship between effectiveness and the number of dara injections.
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If you look at the NK cell plots for the pilot study a few of them had NK cells go to almost 0 after the first dose.


Is this because ME patients have lower NK than MM patients?
 
V.R.T. said:
Scheibenbogen seems to be doggedly perservering nonetheless...

Glad to see this isa trial though. CD38 is all the rage it seems.
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From her latest interview:

The most promising approaches are based on monoclonal antibodies that target the cells producing autoantibodies – in other words, B cells or plasma cells. More than ten years ago, there was already a pioneering study from Norway with the drug rituximab. Many of those treated responded well to it, and some even had lasting responses; some were even completely cured. Unfortunately, the subsequent multicenter clinical trial produced a negative result.

There were many reasons for this. On the one hand, the dosage was probably not sufficient; in addition, four of the centers had less experience and may not have included the right patients. Today there are more effective B-cell antibodies with fewer side effects. Moreover, the approach has gone a step further and now directly eliminates the plasma cells, that is, the mature B cells.

www.spektrum.de

ME/CFS: »Meine Hoffnung ist groß, dass wir bald wirksame Therapien haben«

Die Expertin Carmen Scheibenbogen über Ursachen von ME/CFS, den Versorgungsmangel in Deutschland und Hoffnung auf Medikamente.
www.spektrum.de www.spektrum.de
 
Jonathan Edwards said:
This is credible, I admit. Multicenter trials tend to recruit patients with little chance of response. The motivations are wrong.
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Why should it matter? If the box has no eggs inside it doesn't matter whether the imaginary eggs are green or yellow?

The response was higher to placebo than to Rituximab across the different centers and in most of the individual centers. Fluge and Mella had a higher response to the placebo than most other centers and their placebo response was substantially higher than the response to the drug. In fact it is precisely Haukeland where the response to placebo is much higher than the response to the drug (40% response to placebo, 20% response to drug), so the argument is exactly the opposite. So if they selected patients correctly and all others didn't, the eggs are still non-existent, in fact they are even more rotten in imagination.
 
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