In the ongoing SENTRY-CD19 trial, all three anti-AAV antibody-naïve patients with relapsed/refractory acute lymphoblastic leukemia (ALL) have achieved MRD-negative complete responses following a single administration of VNX-101
Responses have demonstrated encouraging durability for all three patients, with the first patient remaining MRD-negative through Day 260
VNX-101 is a novel, one-time, off-the-shelf immunotherapy that enables the body to produce a CD19/CD3 T-cell–engaging protein, demonstrating durability through at least 9 months
Data demonstrate a first for the field: a systemically delivered, one-time in vivo therapy can translate into durable clinical activity in patients with cancer
Vironexis also has appointed former Amgen CEO Kevin Sharer as Chairman of its Board of Directors and Nobel Prize laureate Dr. James Allison to its Scientific Advisory Board
SAN DIEGO, Sept. 21, 2026 (GLOBE NEWSWIRE) — Vironexis Biotherapeutics today announced encouraging clinical results from the ongoing SENTRY-CD19 study of VNX-101, its investigational, one-time in vivo immunotherapy, in patients with relapsed or refractory CD19-positive hematologic malignancies. VNX-101 is designed to turn a patient’s own liver into a “biofactory” capable of producing GP101, a CD19/CD3 bispecific T-cell–engaging protein, following a single administration.
Among the first three patients with relapsed/refractory (R/R) ALL who were antibody negative at baseline, all three achieved measurable residual disease (MRD)-negative complete responses following a single administration of VNX-101. All three MRD-negative complete responses were confirmed by clonoSEQ. In addition, one of the three patients who also had extensive extramedullary disease achieved a complete response at all disease sites on PET imaging by 28 days.
Importantly, the responses observed to date in these three patients have shown encouraging durability in this difficult-to-treat population. The patients all remain MRD-negative, with the first patient showing complete response through Day 260, at which point the treating physician elected to proceed to hematopoietic stem cell transplantation while the patient was in MRD-negative complete response. Additionally, the T-cell-engaging protein was still detected at therapeutic levels post transplant, proving durability through at least 9 months post infusion.These observations are particularly notable given that VNX-101 is administered once, rather than through repeated or continuous protein infusions.
“While early, these results are highly encouraging after delivering just a single, off-the-shelf administration of VNX-101, which enables the body to produce a CD19/CD3 T-cell–engaging protein,” said Samit Varma, Chief Executive Officer of Vironexis. “These three patients have tried multiple lines of therapy and, sadly, exhausted available treatment options. We believe the depth, consistency, and emerging durability of these responses provide important clinical validation of our in vivo therapeutic protein platform, and compelling proof of concept for its potential to transform the body into a meaningful, durable source of highly active cancer therapeutics.”
Mr. Varma continued, “Further, we believe VNX-101 has achieved an important first for the field: demonstrating that a systemically delivered, one-time in vivo therapy can translate into clinical antitumor activity in patients with blood cancer and extramedullary disease.”
The safety profile observed to date is consistent with the potent immune activation expected from a CD19/CD3 T-cell-engaging therapy and is informing ongoing dose optimization. Immune-mediated events, including cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), were observed during dose escalation and completely resolved with standard of care. The Company continues to evaluate dose and treatment-management approaches as part of the ongoing study.
The broader SENTRY-CD19 study has dosed nine patients at sites in the U.S., across multiple CD19-positive hematologic malignancies, including ALL, diffuse large B-cell lymphoma, follicular lymphoma, and chronic lymphocytic leukemia. Based on the emerging clinical profile, Vironexis intends to prioritize development of VNX-101 in antibody-naïve relapsed/refractory ALL.
International expansion is also underway, with SENTRY-CD19 study sites in South Korea approved and expected to activate in the coming weeks.
Board Appointments
Vironexis also announced today the appointments of Kevin Sharer, former Chief Executive Officer of Amgen, as Chairman of the Company’s Board of Directors, and Nobel Prize laureate James Allison, Ph.D. to its Scientific Advisory Board. Dr. Allison is the Regental Professor and Chair of Immunology, Vice President of Immunobiology and Founding Director of the James P. Allison Institute™ at The University of Texas MD Anderson Cancer Center.
Mr. Sharer commented, “I’m delighted to join Vironexis’ Board of Directors as Chairman at this exciting time for the company, as it unveils highly encouraging initial clinical data demonstrating the potential of its revolutionary new approach to one-time, off-the-shelf in vivo immunotherapy. I look forward to contributing my experience as Vironexis continues to build momentum advancing VNX-101 and its broader pipeline targeting cancer and other serious diseases.”
About VNX-101
VNX-101 is an investigational, one-time in vivo immunotherapy designed to enable the body to produce GP101, a CD19/CD3 T-cell–engaging protein, following a single administration. By delivering the genetic instructions for therapeutic protein production directly in vivo, Vironexis is developing an approach intended to combine the potency of T-cell-engaging therapeutics with the potential convenience and durability of a one-time treatment. VNX-101 has received U.S. FDA Fast Track, Orphan Drug, and Rare Pediatric Disease designations.
About the SENTRY-CD19 Clinical Trial
The SENTRY-CD19 Clinical Trial [NCT06533579] is a Phase 1/2, first-in-human, open-label, dose-escalating study designed to assess the safety and efficacy of VNX-101 in patients with relapsed or refractory CD19 positive hematologic malignancies. The trial is currently active across nine national clinical sites, with the core principal site at UT MD Anderson Cancer Center. Visit the clinicaltrials.gov listing for more information on the trial.
About Vironexis Biotherapeutics
Vironexis Biotherapeutics is a clinical-stage biotechnology company developing in vivo therapies designed to enable the body to produce therapeutic proteins following a single administration. Our platform is being developed across oncology and other serious diseases with the goal of transforming medicines that traditionally require repeated administration into durable, potentially one-time therapies. Our lead programs, VNX-101 (SENTRY-CD19) and VNX-202 (SENTRY-HER2), are currently enrolling adult patients in Phase 1/2 trials in the U.S. Visit us at vironexis.com to learn more.
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