QBS72S / Quadriga Biosci - LARVOL DELTA

Interim analysis of a phase IIa trial of LAT1-targeted QBS72S in breast cancer leptomeningeal disease (SNO 2025) - "Overall, QBS72S was reliably detected in CSF, well tolerated, and showed long term (six- and eight-month) radiographic improvement or stability in two patients. These findings support further investigation into QBS72S as a targeted therapy for LMD, addressing a critical unmet need in metastatic breast cancer."

P2a data • Breast Cancer • Leukopenia • Oncology • Solid Tumor

LAT1 expression scale and adaptive design for a phase IIa trial of QBS72S in breast cancer brain metastases (SNO 2025) - P2 | "This adaptive clinical trial design may facilitate rapid enrollment and allow for tailored endpoints for patient cohorts with disparate baseline outcomes. Our LAT1 staining protocol will support ongoing trials in glioblastoma (NCT02977780) and future studies in additional brain-trophic metastatic cancers with high LAT1 expression to correlate drug efficacy, while our exploratory endpoints may facilitate identification of more rapid and reliable biomarkers of LMD treatment response and resistance."

P2a data • Brain Cancer • Breast Cancer • Glioblastoma • Oncology • Solid Tumor

Interim analysis of a phase IIa trial of LAT1-targeted QBS72S in breast cancer leptomeningeal disease (SNO 2025) - "Overall, QBS72S was reliably detected in CSF, well tolerated, and showed long term (six- and eight-month) radiographic improvement or stability in two patients. These findings support further investigation into QBS72S as a targeted therapy for LMD, addressing a critical unmet need in metastatic breast cancer."

P2a data • Breast Cancer • Leukopenia • Oncology • Solid Tumor

LAT1 expression scale and adaptive design for a phase IIa trial of QBS72S in breast cancer brain metastases (WFNOS 2025) - P2 | "This adaptive clinical trial design may facilitate rapid enrollment and allow for tailored endpoints for patient cohorts with disparate baseline outcomes. Our LAT1 staining protocol will support ongoing trials in glioblastoma (NCT02977780) and future studies in additional brain-trophic metastatic cancers with high LAT1 expression to correlate drug efficacy, while our exploratory endpoints may facilitate identification of more rapid and reliable biomarkers of LMD treatment response and resistance."

P2a data • Brain Cancer • Breast Cancer • Glioblastoma • Solid Tumor

Interim analysis of a phase IIa trial of LAT1-targeted QBS72S in breast cancer leptomeningeal disease (WFNOS 2025) - "Overall, QBS72S was reliably detected in CSF, well tolerated, and showed long term (six- and eight-month) radiographic improvement or stability in two patients. These findings support further investigation into QBS72S as a targeted therapy for LMD, addressing a critical unmet need in metastatic breast cancer."

P2a data • Breast Cancer • Leukopenia • Oncology • Solid Tumor

Interim analysis of a phase IIa trial of LAT1-targeted QBS72S in breast cancer leptomeningeal disease (WFNOS 2025) - "Overall, QBS72S was reliably detected in CSF, well tolerated, and showed long term (six- and eight-month) radiographic improvement or stability in two patients. These findings support further investigation into QBS72S as a targeted therapy for LMD, addressing a critical unmet need in metastatic breast cancer."

P2a data • Breast Cancer • Leukopenia • Solid Tumor

INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT) (clinicaltrials.gov) - P2 | N=460 | Recruiting | Sponsor: Patrick Wen, MD | Trial completion date: Apr 2027 ➔ Apr 2028 | Trial primary completion date: Feb 2027 ➔ Feb 2028

Trial completion date • Trial primary completion date • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • IDH1

A preclinical ex vivo model for glioblastoma captures patient heterogeneity in drug response (AACR-NCI-EORTC 2025) - "As controls, we included Staurosporine (maximum killing), Temozolomide (one of the few options and standard of care for GBM), as well as investigational drugs currently in clinical trials: QBS72S (Alkylating Agent) and Panobinostat (Histone Deacetylase (HDAC) Inhibitor). Our results demonstrate the novel PDCs' great potential over standard of care Temozolomide, highlighting its promise as a more effective therapeutic strategy for GBM. The EVPT platform effectively aided in lead compound selection, with a clear assay window between less and more potent compounds. Moreover, drug response heterogeneity was accurately captured between patients."

Heterogeneity • Preclinical • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

Study Assessing QBS72S For Treating Brain Metastases (clinicaltrials.gov) - P2 | N=21 | Active, not recruiting | Sponsor: Stanford University | Recruiting ➔ Active, not recruiting | N=35 ➔ 21 | Trial completion date: Aug 2026 ➔ Nov 2025

Enrollment change • Enrollment closed • Trial completion date • Breast Cancer • Lung Cancer • Oncology • Solid Tumor

A Phase IIa Study to Evaluate NBQ72S (clinicaltrials.gov) - P2 | N=10 | Recruiting | Sponsor: Nantong Bencao Quadriga Medical Technology Co. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Oncology • Solid Tumor

Adaptive cohort design and LAT1 expression scale: study protocol for a Phase 2a trial of QBS72S in breast cancer brain metastases. (PubMed, BMC Cancer) - P2 | "Adaptive clinical trial design enables rapid enrollment and tailored endpoints for patient cohorts with baseline disparate outcomes. Our LAT1 staining protocol will allow ongoing trials in glioblastoma (NCT02977780) and future studies in brain metastases to correlate LAT1 expression to drug efficacy. Our exploratory endpoints may facilitate identification of more rapid and reliable biomarkers of LMD treatment response and resistance."

Journal • P2a data • Brain Cancer • Breast Cancer • Glioblastoma • Oncology • Solid Tumor

Study Assessing QBS72S For Treating Brain Metastases (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Melanie Hayden Gephart | Trial primary completion date: Feb 2025 ➔ Aug 2025

Trial primary completion date • Breast Cancer • Lung Cancer • Oncology • Solid Tumor

A Phase IIa Study to Evaluate the Efficacy and Safety of NBQ72S (clinicaltrials.gov) - P2 | N=10 | Not yet recruiting | Sponsor: Nantong Bencao Quadriga Medical Technology Co. Ltd.

New P2 trial • Breast Cancer • Oncology • Solid Tumor

Safety lead-in results for QBS10072S in the Individual Screening Trial of Innovative Glioblastoma Therapy (INSIGhT) trial, a randomized adaptive platform trial for newly diagnosed MGMT unmethylated glioblastoma (SNO 2024) - P2 | "QBS10072S can cross the blood-brain barrier, exhibits potential for cytotoxicity with a mechanism distinct from temozolomide and has low off-target effects. QBS10072S, concurrent and adjuvant to radiation therapy, was well-tolerated in patients with newly diagnosed unmethylated MGMT glioblastoma. QBS10072S 18mg/m2 is being evaluated as a treatment arm in phase 2 testing in the ongoing INSIGhT trial."

Clinical • Brain Cancer • CNS Tumor • Fatigue • Glioblastoma • Oncology • Solid Tumor • MGMT

Safety lead-in results for QBS10072S in the Individual Screening Trial of Innovative Glioblastoma Therapy (INSIGhT) trial, a randomized adaptive platform trial for newly diagnosed MGMT unmethylated glioblastoma (SNO 2024) - P2 | "QBS10072S can cross the blood-brain barrier, exhibits potential for cytotoxicity with a mechanism distinct from temozolomide and has low off-target effects. QBS10072S, concurrent and adjuvant to radiation therapy, was well-tolerated in patients with newly diagnosed unmethylated MGMT glioblastoma. QBS10072S 18mg/m2 is being evaluated as a treatment arm in phase 2 testing in the ongoing INSIGhT trial."

Clinical • Brain Cancer • CNS Tumor • Fatigue • Glioblastoma • Oncology • Solid Tumor • MGMT

INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT) (clinicaltrials.gov) - P2 | N=460 | Recruiting | Sponsor: Patrick Wen, MD | Trial completion date: Dec 2025 ➔ Apr 2027 | Trial primary completion date: Mar 2025 ➔ Feb 2027

Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • IDH1

INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT) (clinicaltrials.gov) - P2 | N=460 | Recruiting | Sponsor: Patrick Wen, MD | N=250 ➔ 460

Enrollment change • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • IDH1

Study Assessing QBS72S For Treating Brain Metastases (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Melanie Hayden Gephart | Phase classification: P2a ➔ P2

Phase classification • Breast Cancer • Oncology • Solid Tumor

Successful anti-tumor effects with two novel bifunctional chemotherapeutic compounds that combine a LAT1 substrate with cytotoxic moieties in aggressive T-cell lymphomas. (PubMed, Leuk Res Rep) - "The findings demonstrated decreased survival of T-cell lymphoma lines with both compounds. Overall, the results demonstrate that LAT1 is a valuable biomarker for aggressive T-cell lymphoma counterparts and QBS10072S and QBS10096S are successful therapeutic options for these aggressive diseases."

Journal • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Leukemia • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma • SLC7A5

INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT) (clinicaltrials.gov) - P2 | N=250 | Recruiting | Sponsor: Patrick Wen, MD | Trial primary completion date: Dec 2024 ➔ Mar 2025

Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • IDH1

INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT) (clinicaltrials.gov) - P2 | N=250 | Recruiting | Sponsor: Patrick Wen, MD | Active, not recruiting ➔ Recruiting | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Enrollment open • Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • IDH1

Quadriga BioSciences Announces Dosing of First Subject in Phase 2 Study Evaluating QBS72S For Brain Metastases of Breast Cancer (PRNewswire) - "Quadriga BioSciences...announced the dosing of the first subject in a Phase 2 study evaluating QBS72S for the treatment of brain metastases of breast cancers."

Trial status • Brain Cancer • Breast Cancer • CNS Tumor • Oncology • Solid Tumor

Quadriga BioSciences Announces Dosing of First Subject in Phase 2 Study Evaluating QBS72S For Glioblastoma (PRNewswire) - "Quadriga BioSciences...announced the dosing of the first subject with QBS72S in the Phase 2 INSIGhT study, evaluating QBS72S against the standard of care (temozolomide) for the potential treatment of newly diagnosed glioblastoma....The Phase 2 study is funded by a Small Business Innovation Grant (SBIR)."

Trial status • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Study Assessing QBS72S For Treating Brain Metastases of Breast Cancer (clinicaltrials.gov) - P2a | N=40 | Recruiting | Sponsor: Melanie Hayden Gephart | Trial completion date: Oct 2025 ➔ Aug 2026 | Trial primary completion date: Apr 2024 ➔ Feb 2025

Trial completion date • Trial primary completion date • Breast Cancer • Oncology • Solid Tumor

Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QBS10072S (clinicaltrials.gov) - P1 | N=15 | Completed | Sponsor: Quadriga Biosciences, Inc. | Active, not recruiting ➔ Completed | N=50 ➔ 15

Enrollment change • Metastases • Trial completion • Anaplastic Astrocytoma • Astrocytoma • Biliary Cancer • Bladder Cancer • Brain Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Glioblastoma • Head and Neck Cancer • Hepatology • Kidney Cancer • Liver Cancer • Lung Cancer • Malignant Pleural Mesothelioma • Melanoma • Mesothelioma • Oncology • Oral Cancer • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Renal Cell Carcinoma • Sarcoma • Solid Tumor • Thymic Carcinoma • Thymus Cancer • Tongue Carcinoma • Urothelial Cancer