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ONC 201 in France

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  • ONC 201 in France

    I'm very conflicted on this issue. On one hand I'm happy that kids with DIPG will get a chance to try a drug that has shown some promise, especially those outside the U.S. who hadn't had a chance up to now.

    On the other hand, I have some idea how much it has cost up to now to test ONC201, and if companies have no chance to make their money back, let alone profit from the drug, what future research will get done.

  • #2
    I tried using google translate and it didn't come out too clear... are they saying that a patient reverse engineered a drug, got a local hospital to make it and the government gave it approval? Does France obey patent laws? Is that insane?


    • #3
      better information below.

      Last edited by davidfinn; 11-05-2021, 02:54 PM.


      • #4
        That is wild. Doesn't patent law apply?
        There was a big announcement about Onc-201 today..


        • #5
          Interesting developement
          Last edited by davidfinn; 11-05-2021, 02:54 PM.


          • #6
            Dear Al,
            This is Fabrice, Anatole's father

            Here are two links, in French, which could help to understand the situation:
   with a link to a doc with the detailed protocol.
            And a FAQ on the Gustave Roussy hospital website

            From my contacts in Gustave Roussy and from what I understand, there is no legal issue, it has been discussed with Chimerix, and it is a temporary solution before the ONC201 can be introduced in the Biomede2.0 protocol (in final discussion with Chimerix and which should begin beginning 2022). The hospital Gustave Roussy can produce the ONC201 in "preparation magistrale" as far as the ONC201 from Chimerix is used experimentally and not yet commercialised. This process will stop as soon as it is approved by the FDA. A bit the same way ONC201 is available in Germany. The big difference is that it will be free and secured in France in contrary of Germany. Not clear yet how it will work for all European patients though, the production capacity is very limited.
            At your disposal for additional questions if I can


            • #7
              Thanks for clarifying it. I also spoke to Chimerix and they said the same thing. That is great. I wish we could do that in the USA.
              How is Anatole? I think of him often.


              • Fabrice
                Fabrice commented
                Editing a comment
                Anatole has lately been experiencing odd symptoms (dizziness, sometimes pain in left leg) but fortunately with no sign of any progression. Still investigating. Otherwise in super good mood, currently enjoying life and the wonders of Corsica in the Mediterranean sea! All the very best!

            • #8
              Glad to hear no progression.. Sorry about the other problems.


              • #9
                ONC201 is indeed available via certain clinics in Germany -- and at an affordable cost at that. It is surely indicated for h3k27m mutations and DIPG / DMG, however it is unclear what subset of rGBMs can also be targeted by ONC201. What piece of information should we check in the pathology report whereby one would infer that a particular rGBM could be targeted by ONC201? I have not seen any explicit information pertaining to this detail even in the eligibility criteria of the ongoing clinical trials.


                • #10
                  The first round of trials was for GBM, and they found that the H3K27M marker gave you a much better chance at responding.. it is rare in elderly but more common in kids and young adults, especially if the tumor is in the midline.. so they probably figured it would be easier and faster to get approval if they targeted that marker. That - along with low EGFR and no EGFRvIII. However, we do not know if adding an egfr inhibitor would help those with high egfr respond to onc201. I have seen preclinical research of a few combinations where Onc-201 played a large role... but unfortunately we do not know yet how to treat GBMs with onc-201. I expect we really won't know until it gets approved and we can try the combinations outside of trials.