BXQ-350

P1, N=10, Terminated, Bexion Pharmaceuticals, Inc. | Trial completion date: Dec 2025 --> Oct 2024 | Active, not recruiting --> Terminated; Bexion Pharmaceuticals has decided to close the BXQ-350.AD study to enrollment prior to the anticipated enrollment goal. Justification for this decision is due to slow enrollment and the competitive landscape of the indication.

P1/2, N=195, Active, not recruiting, Bexion Pharmaceuticals, Inc. | Recruiting --> Active, not recruiting

P1, N=5, Terminated, Bexion Pharmaceuticals, Inc. | N=50 --> 5 | Enrolling by invitation --> Terminated; Bexion Pharmaceuticals no longer has open studies in which subjects would be eligible to rollover and continue treatment under the BXQ-350.AE protocol. Therefore, no additional subjects will be enrolled in this trial.

P1, N=21, Active, not recruiting, Bexion Pharmaceuticals, Inc. | Trial primary completion date: Sep 2024 --> Dec 2024

P1, N=10, Active, not recruiting, Bexion Pharmaceuticals, Inc. | Recruiting --> Active, not recruiting | N=22 --> 10 | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Dec 2024

P1/2, N=195, Recruiting, Bexion Pharmaceuticals, Inc. | Phase classification: P1b/2 --> P1/2

P1, N=50, Enrolling by invitation, Bexion Pharmaceuticals, Inc. | Trial completion date: Jul 2024 --> Dec 2024 | Trial primary completion date: May 2024 --> Sep 2024

P1, N=21, Active, not recruiting, Bexion Pharmaceuticals, Inc. | Recruiting --> Active, not recruiting

Available Phase 1b data will be presented. Clinical trial information: NCT05322590.

The design of the phase 2 is as follows (double-blinded, placebo controlled study): Eligible patients (up to 160 patients) will be randomized in a 1:1 fashion to receive either BXQ-350 (at the RP2D established at Stage 1) or placebo with mFOLFOX7Primary and secondary objectives of the phase 2 include efficacy, safety and CIPN incidence. As of March 2023, enrollment in cohort 1 of phase 1b has been completed and enrollment in cohort 2 will begin at 16 US sites after the planned safety monitoring review.Clinical trial identification: NCT02859857.Legal entity responsible for the study: Bexion Pharmaceuticals.

Preclinical and clinical results demonstrated that BXQ-350 modulates sphingolipid metabolism leading to cancer cell death and stimulating the tumor microenvironment. Additional studies are ongoing to further understand BXQ-350’s MOA.

P1b/2 | N=195 | Recruiting | Sponsor: Bexion Pharmaceuticals, Inc. | Not yet recruiting ➔ Recruiting

BXQ-350 also repolarizes tumor-associated macrophages (TAMs) from a predominant M2 to a predominant M1 phenotype, and promotes maturation of dendritic cells (DCs) and induces CD4+ and CD8+ Tcells expansion and enhances the cytotoxicity of T-cell immunity. As a result, the combination of BXQ-350 with an anti-PD-1 immune checkpoint inhibitor results in a synergistic effect.

P1, N=86, Completed, Bexion Pharmaceuticals, Inc. | Active, not recruiting --> Completed

BXQ-350 tracks to the lysosomal membrane where it initiates the cascade of enzymes necessary to cause apoptosis. Caspases 3/7 are the effector caspases and are necessary for the completion of the apoptotic pathway. The higher activity levels of these caspases show the cells are committed to cell death not allowing these cells to subvert apoptosis.