IMMUNE INFRASTRUCTURE FOR ONCOLOGY
Reprogramming the Immune System
to Combat Solid Tumors.
Novastra Therapeutics is developing XIRT™, Systematic Immune Reprogramming Therapy, a first-in-class category of cancer immunotherapy built for the ~80% of solid-tumor patients left behind by checkpoint monotherapy. It takes on the largest unsolved gap in immuno-oncology.
What is Novastra？
Novastra Therapeutics is a clinical-stage biotechnology company developing Systematic Immune Reprogramming Therapy (XIRT™) as a new category of cancer therapy on its exclusive OmniAntigen™ Platform (OAP).
XIRT™ is an upstream immune primer designed to generate the tumor-specific T cells that checkpoint and cellular franchises presuppose but cannot create on their own.
The OmniAntigen™ Platform preserves the tumor's full antigen repertoire, protein and non-protein, and presents it with synchronized cGAS-STING activation to connect innate and adaptive immunity.
Why Novastra ？
The Unmet Need
Up to ~80% of solid-tumor patients fail checkpoint monotherapy. Protein-only and prediction-based platforms leave the true tumor antigen landscape unread.
The New Category
XIRT™, Systematic Immune Reprogramming Therapy. Engineered upstream immune priming, structurally additive across the full immuno-oncology universe.
The Exclusive Platform
The OmniAntigen™ Platform preserves the tumor's full antigen repertoire, protein and non-protein, without computational down-selection. Preserve everything. Predict nothing.
Why Novastra？
The Unmet Need
Up to ~80% of solid-tumor patients fail checkpoint monotherapy. Protein-only and prediction-based platforms leave the true tumor antigen landscape unread.
The New Category
XIRT™, Systematic Immune Reprogramming Therapy. Engineered upstream immune priming, structurally additive across the full immuno-oncology universe.
The Exclusive Platform
The OmniAntigen™ Platform preserves the tumor's full antigen repertoire, protein and non-protein, without computational down-selection. Preserve everything. Predict nothing.
One Platform. Three Lead Programs.
OAP-101
Lead Candidate
The lead XIRT™-Cell program is in an active investigator-initiated Phase 1 proof-of-concept study in advanced, checkpoint-refractory melanoma. In parallel, Novastra is advancing toward a first US IND filing in a major checkpoint-refractory solid-tumor indication, targeting 2027.
OAP-102
World’s First XIRT™ in Pediatric Oncology
An XIRT™-Cell program for high-risk pediatric neuroblastoma, where each patient's tumor antigen profile is distinct and difficult to predict computationally. The program will pursue FDA Orphan Drug and Rare Pediatric Disease designations.
OAP-103
In Vivo XIRT™-InSitu
An off-the-shelf XIRT™-InSitu reagent kit designed for immunologically cold, checkpoint-refractory solid tumors and for combination with antibody-drug conjugates, radiotherapy, and chemotherapy.
Start the Engine,
Not Just Release the Brakes
Checkpoint inhibitors release the brakes on existing T cells. In immune-desert tumors, however, the tumor-specific T cells required for treatment are absent or insufficient.
XIRT™ is designed to rebuild that missing response upstream.
Preserve · Capture the patient's complete tumor signature, including protein and non-protein antigens.
Activate · Deliver localized innate immune stimulation through the cGAS-STING pathway.
Prime · Generate a broad, polyclonal T-cell response and convert immune deserts toward inflamed, T-cell-rich environments.
Additive across the immuno-oncology universe.
Clinical Evidence ·
The Hardest Patients, First
OAP-101 is being evaluated in an investigator-initiated Phase 1 proof-of-concept study in advanced, low-tumor-mutational-burden, checkpoint-refractory melanoma.
Safety Observations
To date, investigators have reported no cytokine-release syndrome and no dose-limiting toxicities within the study.
Immune Activation
A reproducible, dose-coupled pattern of immune activation has been observed across treated individuals with distinct molecular backgrounds.
Interim Clinical Observations
Interim, investigator-assessed observations include disease stabilization or tumor growth-rate deceleration within the OAP-101 treatment window. In the lead evaluable patient, investigators have reported overall survival exceeding twelve months and continuing, against an enrollment prognosis of only a matter of months.
OAP-101 is investigational. These interim observations are from an early-stage study and do not establish safety or efficacy.
Supramolecular Chemistry,
Built for the Clinic
Single-Cell Nanocloak Engineering
Supramolecular engineering, built for the clinic, in the coordination-chemistry lineage recognized by the 2025 Nobel Prize in Chemistry. Proprietary bio-building blocks self-assemble into a sealed nanocloak designed to deliver potent immunostimulants to immune cells while limiting systemic exposure.
An Integrated Innovation Engine
Clinical proof-of-concept, a multi-jurisdiction patent portfolio, and a decade of peer-reviewed science underwrite the platform's path to regulatory-grade development.
Foundation Science
The platform is grounded in a growing publication record across journals including Science, Nature Nanotechnology, Nature Communications, Science Advances, Angewandte Chemie International Edition, Advanced Materials, and Chemical Science.
