IFX-2.0 | Phase 3 Registration Trial

Upcoming Phase 3 Registration Trial Under Accelerated Approval

1st Line Keytruda® (pembrolizumab) With or Without Adjunctive IFx-2.0 for Advanced Merkel Cell

Enrolling ∼118 Patients

IFx-2.0 x3 weeks + Keytruda® vs Keytruda® + Placebo

20-25 US clinical centers

Randomized Placebo Controlled Phase 3 Trial

Primary Endpoint:

Overall Response Rate (ORR)

Key Secondary Endpoint:

Progression Free Survival (PFS)

We have worked with the FDA on a unique accelerated approval trial design which precludes the requirement to have at the time of BLA submission an ongoing trial to confirm clinical benefit for full approval. This trial will compare Overall Response Rates (ORR) achieved with Keytruda® (pembrolizumab), the current front line standard of care, to Keytruda® (pembrolizumab) plus adjunctive therapy with IFx-2.0.

Accelerated approval allows the use of a surrogate endpoint, like ORR, which is an endpoint likely to predict clinical benefit to bring the drug to patients with an unmet medical need sooner than using an endpoint known to have clinical benefit, like Progression Free or Overall Survival. Because ORR is a surrogate for clinical benefit, a Company is required to have ongoing at the time it submits an application for approval (BLA) a second trial designed to confirm clinical benefit.

Our accelerated approval trial utilizes dual step-wise endpoints, the primary endpoint for accelerated approval being ORR, results of which are analyzed within 6 months of the last patient enrolled in the trial. The study design also incorporates a key secondary endpoint of Progression Free Survival: an endpoint known to have clinical benefit. Progression Free Survival results may require 3 or more years after last patient enrolls in the study. As such, if successful in achieving the primary endpoint of ORR, IFx-2.0 could receive accelerated approval. If the key secondary endpoint of Progression Free Survival is achieved the accelerated approval would convert to full approval. This unique study design not only potentially accelerates the time to IFx-2.0 approval but also saves significant time and money by not being required to conduct a second trial to confirm the clinical benefit of IFx-2.0.

We expect to initiate this single registration directed trial under the FDA’s accelerated approval pathway for IFx-2.0 in the 2nd half of 2024. Enrollment is projected to take approximately 18 months, with top line results currently expected late 2025. The company anticipates conducting this trial under a Special Protocol Assessment Agreement (SPA) with the FDA. If successful, this trial would form the basis of a Biologics License Application (BLA) which the company would expect to submit to the FDA in mid 2026. The study population, dose, schedule, and study design are based on the response rates observed in the Company’s Phase 1b trial in patients with advanced Merkel cell carcinoma who exhibited primary resistance to anti PD(L)-1 checkpoint inhibitors such as Keytruda®.