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Celldex Therapeutics, Inc. Message Board

  • long_vrts2 long_vrts2 Nov 12, 2013 12:53 AM Flag

    PII ReACT abstract

    The abstract on the ReACT trial contains preliminary results that were available as of May'13 which was the submittal date for the abstract. As a result of this, the more mature data- that will be presented Nov 24- is not included in the abstract, and we need to look at the whole clinical process to see the positive implications of the preliminary ReACT results. There are several aspect to consider:

    1. Patient population: Avastin refractory EGFRvIII(+) GBM pts.
    Avastin treatment in GBM causes a shift to a more aggressive cancer once the pts progress. This Avastin effect is unique to GBM cancer, and there are no clinically meaningful treatments to improve on this outcome. So once pts progress on Avastin- and they invariably do- the prognosis is dismal. EGFRvIII(+) pts have an even worse prognosis because vIII produces a more aggressive cancer.

    2. Initial ReACT phase: the initial cohort enrolled 25 Avastin refractory pts. and enrollment was completed in Aug '13. Due to anti-tumor activity observed up to this point, CLDX decided to add 75 pts to confirm the earlier results. It's important to keep in mind that unlike chemo, immunotherapy has a lag period and it takes longer to kick in. So from May to August there was no deterioration in the positive results presented in the Abstract or else why would CLDX have gone to the trouble and expense of quadrupling the trial?

    3. The abstract shows that Rindo induces a robust immune response and that there is a dose response: the pt with the highest anti EGFRvIII titer had the best response (complete response). This means that combination treatment with immune activators could produce an even more effective immunotherapy against GBM.

    4. The abstract was accepted for oral presentation at the conference. Typically, oral presentations are reserved for important, practice changing studies. Since Rindo + Avastin is not currently part of GBM treatment protocol, there is only one conclusion that can be drawn, and it's one

    Sentiment: Strong Buy

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    • cont'd

      that is highly favorable for Rindo being considered for standard practice in Avastin refractory pts.

      5. Size of the confirmatory ReACT expansion cohort: Rindo demonstrated efficacy in the initial group of 25 pts. If the aim is just to confirm the initial results, why not go with another 25 pts as in the first group? The final 100 pt cohort is in the range where the FDA has previously approved cancer therapies for severe, unmet indications.

      Based on the above, my conclusions:

      - Rindo is the first treatment to show clinically meaningful benefit in Avastin refractory GBM pts
      - consistent with the preliminary trial data, the more mature Rindo ReACT results presented Nov 24 will be positive
      - the fact that CLDX is having a CC to discuss the results reinforces this conclusion
      - there is a high probability of accelerated approval by the FDA for Rindo in Avastin refractory EGFRvIII GBM pts after the successful completion of the expanded ReACT trial

      Sentiment: Strong Buy

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