The Genesis of the AWARE-1 Study with SOLTI and Roche and our Search for a Predictive Biomarker

During our presentation at the BIO CEO Investor conference, CEO Matt Coffey provided the backstory on the genesis of our AWARE-1 window of opportunity study and the intention to find a biomarker that would support a phase 3 registration study in metastatic breast cancer.

“SOLTI, a well-regarded cooperative breast cancer research group in Spain, recognized the fact that progressing into a phase 3 study of pelareorep without a biomarker was to do so at risk, as a biomarker discovered after the study has started could not be used retrospectively to review data – only prospectively, if a biomarker is already identified. These comments resembled similar feedback we had received from regulatory agencies and pharma companies. In our conversations with Dr. Aleix Prat at SOLTI, he expressed confidence that he could identify a biomarker in a window of opportunity study with pelareorep. Thirty-six women with breast cancer will be given standard of care plus pelareorep. They'll be treated for three weeks, and then they'll undergo their mastectomy. The mastectomy is standard of care, but it also allows us to examine the tumor tissue and the pro-inflammatory cytokines within the tumor and in the peripheral blood, where we can look for certain markers correlated with response to treatment.

Meanwhile, we had shown Roche our plans for our phase 3 breast cancer program as well as the SOLTI window of opportunity program, and they said this is exactly the study that we would like you to run. They asked SOLTI if they could add Tecentriq to half of the patients in the pelareorep window of opportunity study, with the goal here to see whether or not the addition of pelareorep can create and/or enhance the pro-inflammatory response required for checkpoint blockade.” 

Our study with SOLTI is now underway, and data emerging later this year.

Listen to the complete replay of the presentation at the BIO CEO Investor Conference here.