Catalyst overview
Research summary
This catalyst tracks a Phase 3 initiation for ELI-002 7P in Pancreatic cancer, Cancer. The expected timing is based on the latest available company guidance and may change.
AMPLIFY-7P trial. 1/11/24- First patient dosed. 12/3/24- Completed enrollment in Ph2 portion. 8/7/25- Secured alignment w/ FDA on planned Ph3 study. 9/29/25- Initiate Ph1 IIT in H1 2026. 11/7/25– 99% mKRAS-specific T cell responses data presented at SITC’25. 11/13/25:- Ph2 AMPLIFY-7P DFS primary analysis expected H1 2026; Ph1 IIT neoadjuvant PDAC trial initiation also anticipated H1 2026. 12/11/25:- Ph2 AMPLIFY-7P subset showed 87% antigen spreading with broad non-mKRAS neoantigen T cell responses. 03/12/26:- DFS primary analysis still expected H1 2026. Oral AMPLIFY-7P updates at WVC and AACR 2026. 05/11/26:- AMPLIFY-7P DFS primary analysis still expected mid-2026. Fewer events observed; remains blinded. EoPh2 FDA meeting planned. 06/15/26:- AMPLIFY-7P Ph2 missed DFS; post-hoc R0 benefit. Ph3 planned, timing TBA. 06/17/26:- 3 post-ELI-002 7P pts had confirmed CRs on nivolumab-based therapy. Plans Ph1 metastatic combo study. 08/10/26:- Ph1 neoadjuvant IIT NCT07671339 opened in resectable/borderline resectable PDAC; enroll 20. 08/13/26:- AMPLIFY-7P Phase 2 subgroup analyses continue to refine the Phase 3 strategy. Neoadjuvant Phase 1 trial has been activated.
Verification
Confirm timing and program details against the company announcement or filing.