PIPELINE
Leveraging our TransJoin™ AAV Gene Therapy Platform, we’ve rapidly built a pipeline of 10+ product candidates across three pillars: blood-based cancers, solid tumor metastasis prevention, and a cancer vaccine. In addition, our pipeline includes a product candidate for immune disorders, also based on the TransJoin platform, which we intend to partner for development.
We have received FDA clearance of our IND application for our first program, VNX-101, for the treatment of CD19+ B-cell acute lymphoblastic leukemia and plan to start a Phase 1/2 trial in the fourth quarter of 2024. VNX-101 has received both Fast Track Designation and Rare Pediatric Disease Designation from the FDA.
Pillar 1 – Blood Based Cancer
VNX-101
FDA Fast Track Designation
FDA Rare Pediatrics Designation
FDA Orphan Drug Designation
VNX-102
VNX-103
Pillar 2 – Solid Tumors
VNX-201
VNX-202
VNX-203
VNX-204
VNX-205
VNX-206
VNX-207
VNX-208
Pillar 3 – Cancer Prevention
VNX-301
Partner Programs
VNX-101-2*
*Vironexis plans to partner this program for further development.
Expanded Access Policy
The 21st Century Cares Act, enacted as US law in 2016, requires manufacturers of investigational drugs intended to treat serious diseases or conditions to make publicly available their policy for providing expanded access to such products. Expanded access, also referred to as compassionate use, is a mechanism for enabling the use of an investigational therapy outside of a clinical trial when the primary purpose is to diagnose, monitor, or treat a serious condition in patients. This is in contrast to clinical trials, where more comprehensive safety and efficacy data are generally collected.
While Vironexis understands the importance of Expanded Access Programs (EAPs) in certain circumstances, our perspective at this time is that participation in our clinical studies is the most appropriate way for patients in the US to gain access to a Vironexis investigational therapy. Accordingly, Vironexis does not have an EAP for our products under development.
We encourage patients and their healthcare providers to discuss if participation in one of our planned or ongoing clinical trials is appropriate. Please contact us if you have any questions about our clinical trial programs or individual clinical trials.
As more clinical data on the safety and efficacy become available, Vironexis will review and may update its policy on expanded access. This web page will be updated accordingly, and appropriate information on how to apply for expanded access will be provided.