BXQ-350

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

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.