Why IMU is a multi multi bagger, page-24695

Thank you or your response.

The ability to combine with third parties is but one part of a calculated strategy to seek FDA approval. If other therapies have existing approval in particular indications at specific stages of cancer (i.e., stage 2 or stage 3), then management is in a position to seek approval in that indication and at that stage if indeed their combination adds to the safety and efficacy of the existing therapy or SOC.

Clearly Imugene is looking to achieve two things with their ongoing dose escalation trials prior to commencing Phase 2 trials. Firstly to show additional signs of efficacy to that achieved in the bile duct indication (i.e., in gastrointestinal cancer or perhaps melanoma), with a view to being granted further fast track designations from the FDA. Secondly to ascertain which indications are best suited to the Vaxinia (and thereafter Oncarlytics) treatment regimes, and in what form of administration (e.g., mono therapy IT or IV). By then the optimal biological dose rate shall clearly exist. Therefore in answer to your question, or comment, Imugene shall aim to fire as many shots across the bow of the FDA in their existing Phase 1 trial(s), with a view to attaining a registration trial for their drug(s). The reason they are going to conduct a Phase 2 Trial is obviously to determine whether the new treatment has sufficiently promising efficacy to warrant further investigation in a large-scale randomized phase 3 trial, as well as to further assess safety. That said if the subsequent Phase 2 proves ground breaking or indeed efficacious enough, there may not even be the need for a Phase 3 Trial.

Imugene management have been clever in leaving multiple pathways open from which their immunotherapies can grow and spread. Taking in "any type of cancer" in the existing trial(s) opens the door for any if not all indications to be assessed in a Phase 2 environment. Whilst adding additional therapies, including but not limited to Keytruda and Blincyto provides them with the opportunity to benefit from the past success and approvals of these existing drugs. But rest assured, Imugene is working day and night to ensure their therapy works effectively as a stand alone vessel, capable of adding meaningful benefit to both late and early stage solid tumour sufferers. The key for me now is to ensure they ascertain the most appropriate mode of delivery, and the best form of administration, prior to incepting their Phase 2 hit out. I'd be pretty confident given the medical prowess they have on their existing team they'd be all over this.

Once again it's all results dependant, whether we are talking Phase 1 2 or 3. But from where I sit Imugene are in a strong position given the broad based FDA IND'a they already have in place, the promising results thus far (circa November 2023), and the open dialogue existing between them and the FDA.

DYOR