RE:RE:RE:RE:RE:Background to Gilead's $21 Bln acquisition of Immunomedics Taken from yahoo.com message board :
ONCY's AWARE-1 WoW study's primary endpoint was CeLTiLs score, a metric for quantifying the changes in tumor cellularity (Cel) and tumor infiltrated lymphocytes (TILs), where an increase in CelTIL is associated with a favorable response to treatment in early breast cancer. To date a 72% CelTIL response rate has been reported. More to come on this study given the plethora of data that has been generated,
Meanwhile the rationale for ONCY's Phase 2 IRENE clinical study is to demonstrate that the administration of pelareorep primes the tumor microenvironment (TME) for enhanced tumor response to INCYTE's PD-1 inhibitor retifanlimab. This benefit of pelareorep being able to turn cold tumors hot and overcome the immunosuppressive TME in advance of the addition of immune checkpoint inhibition by stimulating the innate and adaptive immune system, has already been demonstrated in the AWARE-1 study which was designed to measure CelTiLs score and not the priming of the TME by pelareorep.
Consequently the design of each study is different and measures separate yet related metrics, which traders with no scientific or clinical knowledge are trying to spin into something else.
With ONCY already demonstrating that pelareorep primes the TME in advance of the immune checkpoint inhibitor atezolizumab in the AWARE-1 study, positive results in ONCY's Phase 2 study will demonstrate reproducibility of results with a different immune checkpoint inhibitor. Otherwise, the results will demonstrate that pelareorep is synergistic with one or the other ICI or more expectedly with both ICIs.
ONCY response ...... FDA requests are being met with the intent of reducing the number of patients and cost to run a Phase 3 study - both agreeable to a big pharma/biotech partner.