Biotech Values

[DewDiligence]

ADXS shows* AXAL/Durvalumab phase-2 data in cervical/H&N cancers:



Discussion: There were 11 patients in this phase-2 trial, where the intention was to treat everyone with three doses of ADXS’s cancer vaccine, AXAL, and AZN’s PD-L1 inhibitor, Durvalumab (a/k/a Imfinzi). During the progress of the trial, the FDA imposed a clinical hold on AXAL (#msg-117519581) that was lifted two months later when the FDA was satisfied that there was no safety issue (#msg-119198020).

So, how much did the 2-month FDA clinical hold on AXAL affect the results of the phase-2 trial in question? Not much, IMO, according to the graphic reproduced above.

Patients #7-11 were not affected by the AXAL clinical hold because they started treatment after the hold was lifted.

Patient #2 and patient #5 (the sole complete responder) resumed AXAL treatment after the hold was lifted.

Patients #1, #3, and #4 received only two of the three planned doses of AXAL, so their results might have been compromised to a small degree.

Only one patient (#6) was unable to receive AXAL at all due to the clinical hold.

All told, despite the one CR, these results were not what AZN was hoping to see from combining AXAL and Durvalumab, as far as I can tell. I presume that’s why AZN is no longer involved with the development of AXAL.

Feedback welcome.

*Belatedly; the graphic above is from ADXS’ Aug-2017 slide set (https://www.advaxis.com/lm-technology/corporate-presentation/ ).