OS2966 / Renovaro Biosci - LARVOL DELTA

Convection-enhanced Delivery of OS2966 for Patients With High-grade Glioma Undergoing a Surgical Resection (clinicaltrials.gov) - P1 | N=7 | Terminated | Sponsor: OncoSynergy, Inc. | Trial completion date: Oct 2025 ➔ Feb 2023 | Active, not recruiting ➔ Terminated | Trial primary completion date: Oct 2023 ➔ Feb 2023; Slow enrollment and financial constraints.

Trial completion date • Trial primary completion date • Trial termination • Anaplastic Astrocytoma • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Trial Update -Results of a phase I window of opportunity trial evaluating a first-in-class CD29 inhibitor, OS2966, in recurrent high-grade glioma (SNO 2022) - "Initial data demonstrate the safety and feasibility of direct intracranial delivery of OS2966."

P1 data • Brain Cancer • Glioblastoma • Glioma • Immunology • Oncology • Solid Tumor • ITGB1

The Role of Integrin Beta-1 in the Chemoresistance of Acute Myeloid Leukemia (ASH 2022) - "AML cell lines were treated in vitro with the anti-human ITGB1 monoclonal antibody OS2966 in combination with Ara-C chemotherapy and we determined effects on cell viability by flow cytometry and on cell signaling using RNA-sequencing. Integrin alpha subunit expression is dependent on ITGB1 expression, supporting our hypothesis that targeting integrin beta 1 affects alpha integrin units. ITGB1 inhibition with OS2966 combined with chemotherapy significantly decreases cell viability of AML cell lines in vitro and prolongs survival of xenograft mice in vivo. Our findings will allow for better understanding of the role of ITGB1 in drug resistance of AML and of ITGB1 as a preclinical target in AML."

Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • CD61 • FLT3 • ITGA4 • ITGB1 • ITGB2

Convection-enhanced Delivery of OS2966 for Patients With High-grade Glioma Undergoing a Surgical Resection (clinicaltrials.gov) - P1 | N=7 | Active, not recruiting | Sponsor: OncoSynergy, Inc. | Recruiting ➔ Active, not recruiting | N=24 ➔ 7 | Trial completion date: Apr 2024 ➔ Oct 2025 | Trial primary completion date: Apr 2023 ➔ Oct 2023

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Anaplastic Astrocytoma • Astrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Targeting an ECM protein involved in breast cancer brain metastases with an oncolytic HSV-1 (SNO 2022) - "Previously, we identified that combination of oHSV and humanized CD29 blocking antibody (OS2966, aCD29) enhanced viral replication by reducing antiviral immune response, increased tumor cell killing, and rendered survival benefit to tumor bearing mice with intra-tumoral, but not systemic, oHSV administration...We anticipate that compared to our control virus, HSV-aCD29 will block CD29 activity which will reduce antiviral immune responses and enhance tumor cell lysis, thus improving oHSV efficacy. Together, this study proposes the blockade of CD29 with the targeted delivery of a CD29 blocking antibody mediated by a novel oHSV as a potential synergistic therapy against BCBM."

Breast Cancer • Herpes Simplex • Immunology • Melanoma • Oncology • Solid Tumor • ITGB1

Convection-enhanced Delivery of OS2966 for Patients With High-grade Glioma Undergoing a Surgical Resection (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: OncoSynergy, Inc. | Trial completion date: Dec 2023 ➔ Apr 2024 | Trial primary completion date: Dec 2022 ➔ Apr 2023

Trial completion date • Trial primary completion date • Anaplastic Astrocytoma • Astrocytoma • Brain Cancer • Glioblastoma • Glioma • Oncology • Solid Tumor

Convection-enhanced Delivery of OS2966 for Patients With High-grade Glioma Undergoing a Surgical Resection (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: OncoSynergy, Inc.; Trial completion date: Jul 2023 ➔ Dec 2023; Trial primary completion date: Jul 2022 ➔ Dec 2022

Trial completion date • Trial primary completion date • Anaplastic Astrocytoma • Astrocytoma • Brain Cancer • Glioblastoma • Glioma • Oncology • Solid Tumor • MRI

Initial results of a phase I window of opportunity trial evaluating a first-in-class CD29 inhibitor, OS2966, in recurrent high-grade glioma (SNO 2021) - "Pharmacodynamic analysis via tissue-level biomarkers is ongoing and will be presented. CONCLUSION Initial data demonstrates the safety and feasibility of direct intracranial delivery of OS2966."

P1 data • Brain Cancer • Glioblastoma • Glioma • Immunology • Oncology • Solid Tumor • ITGB1

Role of c-Met/β1 integrin complex in the metastatic cascadein breast cancer. (PubMed, JCI Insight) - "OS2966, a therapeutic antibody disrupting c-Met/β1 binding, decreased breast cancer cell invasion and mesenchymal gene expression...Thus, the c-Met/β1 complex drives intravasation of triple-negative breast cancer cells and preferential affinity for bone-specific matrix. Pharmacological targeting of the complex may prevent metastases, particularly osseous metastases."

Journal • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • MET

OncoSynergy Announces First Patient Treated in First-in-Human Clinical Trial of OS2966 in Recurrent Glioblastoma (PRNewswire) - “OncoSynergy, Inc…announced today that the first patient was treated in the Company's First-in-Human Phase 1 clinical trial evaluating OS2966 for the treatment of recurrent glioblastoma at Moffitt Cancer Center in Tampa, Florida.”

Trial status • Glioblastoma • Oncology

Convection-enhanced Delivery of OS2966 for Patients With High-grade Glioma Undergoing a Surgical Resection (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: OncoSynergy, Inc.; Trial completion date: Mar 2022 ➔ Jul 2023; Initiation date: Oct 2020 ➔ Mar 2021; Trial primary completion date: Mar 2021 ➔ Jul 2022

Clinical • Trial completion date • Trial initiation date • Trial primary completion date • Anaplastic Astrocytoma • Astrocytoma • Brain Cancer • Glioblastoma • Glioma • Oncology • Solid Tumor

Convection-Enhanced Delivery of a First-in-Class Anti-β1 Integrin Antibody for the Treatment of High-Grade Glioma Utilizing Real-Time Imaging. (PubMed, Pharmaceutics) - "The present study design leverages multiple innovations including: (1) the latest CED technology, (2) 2-part design including neoadjuvant intratumoral administration, (3) a first-in-class investigational therapeutic, and (4) concentration-based dosing."

Journal • Glioblastoma • Glioma • Oncology • Solid Tumor • MRI

[VIRTUAL] Role of c-Met/β1 integrin complex in the metastatic cascade (SNO 2020) - "We previously identified a structural complex between receptor tyrosine kinase c-Met and β1 integrin in metastases that form under certain biological and therapeutic inducers, including bevacizumab...OS2966, a therapeutic B1 integrin blocking antibody, disrupted c-Met/β1 binding as well, and decreased invasion, mesenchymal gene expression, and mesenchymal morphology of breast cancer cells...Thus, our research suggests the c-Met/β1 complex drives breast cancer cell intravasation and preferential affinity for bone tissue-specific matrix. Pharmacological targeting of the complex may prevent metastases, particularly osseous metastases."

Breast Cancer • Oncology • Solid Tumor • MET

Convection-enhanced Delivery of OS2966 for Patients With High-grade Glioma Undergoing a Surgical Resection (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: OncoSynergy, Inc.

Clinical • New P1 trial • Anaplastic Astrocytoma • Astrocytoma • Brain Cancer • Glioblastoma • Glioma • Oncology • Solid Tumor