Vironexis Biotherapeutics Secures FDA Clearance for First AAV-delivered Cancer Immunotherapy Trial
Friday, September 13, 2024
Vironexis Biotherapeutics has officially launched, unveiling its TransJoin™ AAV Gene Therapy Platform, which focuses on transforming cancer treatment through AAV-delivered T-cell immunotherapy.
Vironexis’s innovative TransJoin platform enables a patient’s body to express an engineered transgene, directing T cells to locate and eliminate tumour cells throughout the body. This single-dose treatment is designed to ensure sustained T cell-mediated tumour destruction.
The platform, which was developed based on research at Nationwide Children’s Hospital, has shown promise in overcoming the limitations of existing immunotherapies such as CAR-T and bispecific antibodies, offering potential improvements in safety, efficacy, and treatment durability.
The company has also announced clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for VNX-101, a novel gene therapy aimed at treating CD19+ acute lymphoblastic leukaemia. This milestone marks the first-ever clinical trial of an AAV-delivered cancer immunotherapy, with patient enrolment expected to begin in late 2024.
Vironexis's $26 million seed funding was spearheaded by Drive Capital and Future Ventures, alongside contributions from Moonshots Capital and Capital Factory. The company’s pipeline includes over ten product candidates targeting blood cancers, preventing solid tumour metastasis, and developing a cancer vaccine.
The company is also progressing with plans for its second programme, VNX-202, aimed at preventing metastatic HER2+ cancer, with clinical trials anticipated to start in 2025.
Vironexis is developing additional treatments for various cancers, including multiple myeloma, B-cell lymphoma, neuroblastoma, gastric cancer, pancreatic cancer, and nasopharyngeal cancer. The company is also exploring a cancer vaccine and a therapy for systemic lupus erythematosus, which it plans to further develop in partnership.
Vironexis's TransJoin technology works by enabling the continuous secretion of a bispecific protein that connects tumour cells to T cells, thereby promoting sustained tumour destruction. The low-dose AAV delivery system aims to reduce toxicity and side effects, ensuring a more manageable treatment experience for patients.
With significant progress in a short timeframe, Vironexis is set to make a strong impact on the future of cancer treatment, building on the potential of AAV technology to improve the outcomes of T-cell immunotherapy for a broad range of patients.
Source: globenewswire.com
