RE:RE:RE:RE:The dynamics of the $3.2 Billion acquisition of Translate x Noteable wrote: The USFDA asked that ONCY not use the brand name 'Reolysin' since it sounded too much like a different and already approved drug, so the USFDA gave ONCY's modified TD3 reovirus the generic name "pelareorep'.
ONCY's plans to run a registrational study began with ONCY's Phase 2 IND-213 study which revealed that a set of mBC patients with HR+/HER2 negative mBC patients benefited the greatest from treatment with the pelareorep + paclitaxel doublet combination resulting in a doubling of overall survival in these patients as companred to the paclitaxel control group and led to this group of mBC patients being studied in the AWARE-1 study which has now led to the Phase 2 BRACELET-1 study because of the high degree of OS success using pelareorep in this group of patients.
The window of opportunity (woo) AWARE-1 study was run to confirm the IND-213 results showing that pelareorep + chemotherapy (paclitaxel) doubled overall survival in HR+/HER2 negative mBC patients and these results are expected to be reproduced in the BRACELET-1 study which will have a pelareorep + paclitaxel + Bravencio cohort with all HR+/HER2 negative trial patients being selected with a T-cell clonality biomarker which was validated in the AWARE-1, This woo study showed that CD8+ lymphocytes (TiLs) were enhanced in these HR+/HER negative patients and were responsible for overcoming the immunosuppressive TME by tipping the balance away from immunosuppressive TREGs and toward positive CELTILs scores that are greater than 30% from baseline measurements.
In summary, the Bracelet study will further confirm the findings of both earlier studies. These findings including demonstrated pelareorep overcoming of the immunosuppressive TME, CD8+ TiLs cloning and proliferation, adaptive immune system priming, T-cell trafficking and infiltration into the tumor cell, cytokine production in the TME and immune response, OS, etc involving the IO combination of pelareorep + ICI in the treatment of HR+ metastatic breast cancer. So the IND213, Aware-1 and Bracelet-1 are 3 separate, yet progressively related mBC studies, that are revealing the synergistic affects of combining pelareorep with other IO agents (i.e. ICI) resulting in a treatment effect in which the combined whole is greater than the monotherapy parts.
ONCY's older H&N trial was a trial designed around using reovirus as a monotherapy and what had been discovered that neither an oncolytic virus or an immune checkpoint inhibitor are effective as monotherapies BUT when combined they become synergistically effective as a doublet therapy of an OV+ ICI. This has resulted in the initiation of the Phase 2 Bracelet clinical trial which is intended to be rolled into a partner sponsored Phase 3 registration study in H1'22.
Thanks for the history on why the name change to pelareorep.
The stage 3 H&N results, from May 2014, still puzzles me. I don't see any references to H&N in the Bracelet trial. Maybe I need to go through the trials again:
https://tinyurl.com/4rwcyczf The combination approach appears to be favoured these days, as the results support this approach. That's encouraging.
It looks like we should see some results from the BRACELET-1 Study in June of '22, according to the clinical trials website. Other than that, I think the phase 1
Recurrent Plasma Cell Myeloma trial results could be released on Oct '21.
Are there any other dates to add to the calendar for 2021-2022?
Thanks again for the great info.