Hi All, I would have thought Imugene would have lined up their announcements/agreements ahead of time, however the regulatory approval process will take an indiscriminate amount of time. Despite CF33 gaining regulatory approval for CHECKvacc and VAXinia, the three preclinical studies below use a different combination and would still require regulatory approval with this specific combination.
My thoughts are that Imugene's next ANN might be more centred around what studies are to be conducted after these preclinical results.
To me these results & conclusions warrant the need for further in-human trials. As Davy has said, these findings validate CF33 (oncolytic virus) as an effective tool to activate CD19s tumour cell killing ability, when used in combination.
Re- 305 "Results: Tumors infected with CF33-CD19t along with blinatumomab show specific tumor cell killing in vitro and robust anti-tumor efficacy using in vivo human triple-negative breast cancer xenograft models."
"Conclusions: Using this approach, we show that a clinically-approved CD19-directed BiTE can be combined with oncolytic viruses to activate and redirect endogenous anti-tumor immunity against solid tumors."
ie. Using this approach, we can see that CF33 is doing its job, will it work the same way in in-human trials? Using CF33, the tumors appear to light up like a Christmas tree.
Re- 368 "Results: When administrated after onCARlytics, CD19 ARTEMIS® T cellswere ableto induce potent cytolytic activity against HCC tumor cells and demonstrated robust in vivo anti-tumor efficacy against human HCC tumor xenografts."
"Conclusions: In summary, ARTEMIS® CD19 T cells combined with onCARlytics is a potentially effective immunotherapy strategy for the treatment of patients with HCC and can be applied to other solid tumors."
ie. Won't know for sure until we conduct a phase 1 trial, but we like what we see.
Re- 847 "Results: CYCART-19 T cells induced potent cytolytic activity against solid tumor cells infected with onCARlytics. Interestingly, while we observed comparable anti-tumor activity between PBMC-derived CD19-CAR T cells and CYCART-19, significant differences in cytokine secretion were detected. This warrants the possibility that the placental-derived CAR T product may elicit reduced CRS potential in patients with maintained or improved efficacy. This combination approach demonstrated impressive in vivo anti-tumor response in human tumor xenograft models."
"Conclusions: In summary, our results have demonstrated that further development of this combination immunotherapy for the potential treatment of a wide array of solid tumors is warranted."
ie. Obviously, they like what they see, however it doesn't look great for Cellularity's product CYCART-19, which appears to induce significant cytokine secretion over PBMC-derived CD19-CAR T cells. IMU may be wary to continue with a study with Cellularity if that is the case given our non-toxic and safe record to date.
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