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DRUG:

BXQ-350

i
Other names: BXQ-350, BXQ 350, SapC-DOPS, SapC, SapC-DOPS nanovesicles, Saposin C–dioleoylphosphatidylserine complexes
Associations
Trials
Company:
Bexion, Cincinnati Children's Hospital Medical Center
Drug class:
Apoptosis stimulant, S1P activator
Associations
Trials
3ms
KONQUER: A Study of BXQ-350 in Children With Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) or Diffuse Midline Glioma (DMG) (clinicaltrials.gov)
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
Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
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BXQ-350
3ms
ASIST: BXQ-350 in Newly Diagnosed Metastatic Colorectal Carcinoma (clinicaltrials.gov)
P1/2, N=195, Recruiting, Bexion Pharmaceuticals, Inc. | Phase classification: P1b/2 --> P1/2
Phase classification • Combination therapy • Metastases
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Avastin (bevacizumab) • BXQ-350
3ms
ETERNITI: Continued Treatment for Participants Enrolled in Studies of BXQ-350 (clinicaltrials.gov)
P1, N=50, Enrolling by invitation, Bexion Pharmaceuticals, Inc. | Trial completion date: Jul 2024 --> Dec 2024 | Trial primary completion date: May 2024 --> Sep 2024
Trial completion date • Trial primary completion date
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BXQ-350
3ms
RETRO: BXQ-350 Pharmacokinetic/Pharmacodynamic Study in Cancer Patients (clinicaltrials.gov)
P1, N=21, Active, not recruiting, Bexion Pharmaceuticals, Inc. | Recruiting --> Active, not recruiting
Enrollment closed
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oxaliplatin • BXQ-350
11ms
Clinical • P1/2 data • Combination therapy • Metastases
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Avastin (bevacizumab) • BXQ-350
over1year
BXQ-350: A phase 1b/2 placebo-controlled, double-blind study on the efficacy and safety of BXQ-350 in combination with mFOLFOX7 and bevacizumab in newly diagnosed metastatic colorectal carcinoma (ESMO-GI 2023)
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.
Clinical • P1/2 data • Combination therapy • Metastases
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Avastin (bevacizumab) • BXQ-350
over1year
BXQ-350: A novel biologic with an innovative mechanism of action targeting sphingolipid metabolism that induces cancer cell death and repolarizes the tumor microenvironment (AACR 2023)
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.
IO biomarker
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CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • CXCL8 (Chemokine (C-X-C motif) ligand 8) • CD4 (CD4 Molecule) • IL2 (Interleukin 2) • IL10 (Interleukin 10)
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BXQ-350
2years
ASIST: BXQ-350 in Newly Diagnosed Metastatic Colorectal Carcinoma (clinicaltrials.gov)
P1b/2 | N=195 | Recruiting | Sponsor: Bexion Pharmaceuticals, Inc. | Not yet recruiting ➔ Recruiting
Combination therapy • Enrollment open
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Avastin (bevacizumab) • BXQ-350
over3years
[VIRTUAL] BXQ-350, a first-in-human nanovesicle formulation of the lysosomal protein Saposin C, reprograms the tumor microenvironment and synergizes with Immune Checkpoint Inhibitors (CIMT 2021)
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 data • Checkpoint inhibition
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CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • CXCL8 (Chemokine (C-X-C motif) ligand 8) • CD4 (CD4 Molecule) • IL2 (Interleukin 2) • IL10 (Interleukin 10)
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BXQ-350
over3years
Phase 1 Study of BXQ-350 in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov)
P1, N=86, Completed, Bexion Pharmaceuticals, Inc. | Active, not recruiting --> Completed
Clinical • Trial completion
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ALB (Albumin)
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BXQ-350
over4years
[VIRTUAL] BXQ-350 to target to the lysosome and kill glioblastoma (GBM) cells via activation of apoptotic caspases in vitro. (ASCO 2020)
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.
Preclinical
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CASP3 (Caspase 3) • CASP9 (Caspase 9) • CASP7 (Caspase 7)
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BXQ-350