AWARE-1 Safety Update: More than Just Safety

Cohort 1 demonstrated widespread viral replication in the majority of tumors with the creation of a pro-inflammatory effect in the tumor microenvironment.

The Safety Committee for AWARE-1 recently met and provided a favourable assessment following the review of data from the first cohort and initial three patients from the safety run-in.  While we note that pelareorep has demonstrated safety in over 1,000 patients treated to date, it’s important to keep in mind that each trial is different: different patient population, different line of therapy and most importantly, a different combination therapy.  To this end we continue to evaluate safety in every patient, in every study and we are very happy to see that the combination with Tecentriq® was safe and well tolerated.  In addition to safety, that data also demonstrated widespread viral replication in the majority of tumors with the creation of a pro-inflammatory effect in the tumor microenvironment.  As always, very important to note that no negative effects to healthy tissue were noted.

Our Chief Medical Officer, Rita Laeufle, commented that “The study is continuing as planned, recruiting additional patients and examining the combination of pelareorep, plus the standard of care plus Tecentriq.”  Additional data will be announced in Q2 2020 will describe meaningful changes to the tumor microenvironment, evidence of tumor infection, and of course, our biomarker correlated to immunogenic response and viral replication.

For more information you can read the press release here.