Biotech Values

[DewDiligence]

ADXS—I expect the CC on 11/2/18 (#msg-144491220) to make it official that the phase-3 AIM2CERV trial of AXAL in cervical cancer will be wound down. ADXS does not have the financial strength to continue running this trial, which would take until 2020 (or later) to report efficacy data. The long wait for data is because the trial is testing patients in the adjuvant (non-metastatic) setting who are presumed to be disease-free on trial entry.

Moreover, the competitive landscape in cervical cancer has changed since AIM2CERV was designed a few years ago. Keytruda is now approved in second-line cervical cancer for PD-L1≥1% (#msg-141487168), and it won’t be long (IMO) until Keytruda (or another checkpoint inhibitor) becomes used in the first-line and adjuvant settings. AIM2CERV wouldn’t be able to show whether AXAL + Keytruda works better than Keytruda alone because the trial tests AXAL vs placebo.

If ADXS could find some company to assume the cost of running AIM2CERV, we would probably have heard about such a deal by now. Given the discussion above, however, it’s hardly surprising that there have been no takers.

I continue to own a small ADXS position based on the prospects for ADXS-NEO, which is a neoantigen vaccine in phase-1 that is partnered with AMGN (https://clinicaltrials.gov/ct2/show/NCT03265080, #msg-124255981).