Imugene (IMU-ASX) still looking like a slow boat to China in 2025. Unfortunately I might add.
Potential 2025 Catalysts
Azer Cel presents a potential catalyst in late 2025 with the prospect of a registration trial being granted by the FDA. Swimming in the competitive blood cancer market the recently acquired Imugene Allogeneic therapy needs to shoot the lights out in its Phase 1b study to support conditional registration, and the foundation for a solid Phase 2b/3 Trial.
Results in Vaxinia's Bile Tract expansion cohort are of interest in 2025 as is the forthcoming optimal biological dose rate for their planned Phase 2 Trial. The Phase 2 Trial should really occur with a partner in toe IMO, as participation numbers really need to extend beyond Imugene's meagre capital base if the drug is too springboard into contention as a player in the OV market. Final read outs for patients dosed in Vaxinia's Phase 1 Trial, in particular those dosed at 10 parts to the 8, are key here with shareholders banking on continued stable disease outcomes with potentially one or two more partial or even complete responses. Let's wait and see on that front. Obviously the fast track designation for the bile tract condition has supported Vaxinia, but the results from that expansion cohort must be sound if the drug is to progress toward becoming a recognised treatment option for future cholangiocarcinoma patients.
A data update from the OASIS trial wherein Imugene's promising Oncarlytics treatment arm is being put to the test is of significant interest. Yet being a Phase 1 shootout the most to gain is proof of concept and a resultant OBD for the drug. Unfortunately this treatment arm, like the OV platform mentioned above, still has a little while to run before cents could potentially convert into dollars.
Where to now in 2025
Standing on the outside looking in as Chisel would say, or should I say sing, Imugene appears to still require a real shot in the arm. Although a BP partner or large corporate investor would dilute shareholders even further, I don't envisage any strong outcomes in 2025 and thereafter 2026 unless the existing and ensuing clinical trials are sped up considerably and bolstered with increased participation rates. If not it all looks "same old, same old" when it comes to a review of Imugene's most recent September 2024 Investor Presentation, and the road ahead in 2025. From where I sit the only way to awaken Imugene from their ongoing slumber is to throw plenty of money at their OV and Oncarlytic's treatment arms, by way of grandiose Phase 2 Trials with massive patient participation at their maximum OBD's. Without doubt Imugene's innovative approach to treating "target less tumours' is of interest to all players in the field of oncology, in particular those wishing the play in the solid tumour space, the caveat being many if not most are looking for significant sample sizes and data to hang their hat on before stepping up to the plate.
"Please oh please", as Billy Connolly would say, let Oncarlytics be THE ONE..
Perhaps the advent of a registration trial for Azer cel could lure in a big fish, or good results from Vaxinia's 10 to the 8 participants, or thereafter its bile tract expansion cohort, or even "please oh please" a CR in the current OASIS Trial for Oncarlytic's. But as with all things Imugene, including their beleaguered and rather tired management team, I wouldn't be holding my breath. Unfortunately...
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