| | | I agree, disappointing call on a few fronts. IMO postponing early ALTA readout to ASCO (2 wks. after stating they would disclose sooner) is related to a non-disclosure agreement with a potential bidder. Ultimately 12-month PFS data is what matters for approval, not response rate, so there is no real delay to the data, just to the disclosure. No doubt they have a data set to shop around, it was submitted to AACR-EORTC meeting and then subsequently withdrawn.
Regarding '788, AACR abstracts are due Dec. 1st, and will be posted online March 16th. But, IMO the patent application will publish this year, with or without a new CEO ribbon cutting. Think about the timeline, if you believe the website '788 was designed and nominated in one year (2014). In June of 2014 (ASM) Tim C. said they were "very far along" and already conducting IND-enabling studies. We also know Ariad registered as a CRO in June of 2014 in order to conduct in-house these studies, and thus avoid any potential disclosure to third parties. Given the above I believe a provisional patent app was filed in Q2 '14, with full patent app in Q2'15 and therefore will publish any given Thursday from now until EOY (18 months from 1st filing).
And given what we know to date, I think '788 is likely a next-gen, pan-EGFR inhibitor, addressing all forms (Ex. 19, 20, and 21) of primary and secondary resistance in EGFRm and Her-2+ NSCLC, but would likely be focused, initially, on unmet need of T790M- (negative) population, 45% of frontline EGFR TKI resistance. Her-2+ represents ~30% of this 45% resistant population. There are a few competitors in the pipeline with OR rates ranging from 20-50%. |
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