PIPELINE
The TransJoin™ platform is plug-and-play: one capsid, one manufacturing process, off-the-shelf delivery. We have rapidly advanced 10+ candidates across three areas — hematologic malignancies, solid tumors, and immune disorders. Two programs are now in Phase 1/2 clinical trials in the U.S., and seven additional programs are advancing through discovery and IND-enabling studies. The same chassis underlying our oncology programs also powers VNX-101-2 (CD19+ autoimmune disorders).
Both lead programs are dose-ascending Phase 1/2 trials in the U.S. VNX-101 (SENTRY-CD19) and VNX-202 (SENTRY-HER2) are enrolling adult patients. VNX-101 holds FDA Fast Track, Orphan Drug, and Rare Pediatric Disease designations; VNX-202 holds FDA Fast Track in breast and gastric cancer.
Oncology Part 1 – Blood Based Cancer
VNX-101
VNX-102
VNX-103
Oncology Part 2 – Solid Tumors
VNX-201
VNX-202
VNX-204
VNX-205
VNX-206
VNX-207
Autoimmune Programs
VNX-101-2
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.