What is Novastra
Novastra Therapeutics is a clinical-stage biotech company developing systematic immune reprogramming therapy (XIRT™) as a novel category of cancer therapy. XIRT is an upstream immune primer that enables the generation of tumor-specific T cells that checkpoint inhibitors can then unleash. XIRT leverages Novastra's OmniAntigen™ Platform (OAP), designed to be applicable across a wide range of refractory solid tumors. Embedded proprietary activators connect the innate and adaptive immune systems via the cGAS-STING pathway, a key player in anti-tumor immunity.
IMMUNE INFRASTRUCTURE FOR ONCOLOGY
MAKE THE IMMUNE SYSTEM
SEE THE ENEMY AGAIN
Novastra Therapeutics is developing XIRT™, Systematic Immune Reprogramming Therapy, a new category of cancer immunotherapy built for the majority of solid-tumor patients who fail checkpoint monotherapy, the largest unsolved gap in immuno-oncology.
Why Novastra
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THE PROBLEM
The majority of solid-tumor patients, between 60 and 80 percent, fail checkpoint monotherapy. Protein-only and personalized mRNA platforms leave the true tumor antigen landscape unread.
THE CATEGORY
XIRT, Systematic Immune Reprogramming Therapy. Engineered upstream immune priming, structurally additive across the full immuno-oncology universe, never a replacement.
THE PLATFORM
The OmniAntigen™ Platform preserves every mutation, every subclone, every protein and non-protein antigen, exactly as the tumor expressed them. Preserve everything. Predict nothing.
OAP-101
Lead Candidate
Advanced, checkpoint-refractory melanoma. Active investigator-initiated Phase 1 proof-of-concept study. Advancing toward first US IND filing in MSS colorectal cancer in 2027.
OAP-102
Pediatric XIRT™ Program
High-risk pediatric neuroblastoma. A whole-tumor antigen immunotherapy program entering pediatric oncology. Advancing toward eligibility for FDA Orphan Drug Designation and Rare Pediatric Disease Designation.
OAP-103
In Situ XIRT-InSitu
Off-the-shelf reagent kit format. Engineered as a programmable immune companion for antibody-drug conjugate, radiotherapy, and chemotherapy franchises. Drug-product accessibility, not cell-therapy logistics.
Addressing the
“Immune Desert” Crisis
The first era of Immuno-Oncology mastered the "brakes" (Checkpoint Inhibitors, CPIs). The second era is building "bridges" (Bispecifics). Yet these therapies fail in the ~80% of patients with "Immune Deserts", environments where the T cells required for treatment are simply absent. We do not rely on pre-existing immune responses; we engineer them. Our OmniAntigen™ Platform (OAP) captures the patient's entire tumor signature and wraps it in a supramolecular organic nanocloak built from materials on the FDA GRAS list. This delivers an "Upstream Prime," generating a polyclonal T cell army and remodeling the tumor microenvironment to turn deserts into battlefields. Designed to be synergistic with every major immuno-oncology modality on the market. Additive across the immuno-oncology universe, never a replacement.
Clinical Validation
Clinical proof where nothing else has worked. XIRT was proven in the hardest possible patients by design. OAP-101 continues active evaluation in an investigator-initiated Phase 1 proof-of-concept study, enrolling patients with advanced, PD-1 refractory melanoma. Cohort enrollment continues at the lead clinical site. Every patient had exhausted chemotherapy, radiation, and checkpoint therapy and was checkpoint-refractory at enrollment, so the signals observed are consistent with OAP-101-driven upstream immune reprogramming. Emerging data show disease control signals and a reproducible pattern of immune activation across distinct molecular backgrounds. First-patient survival now exceeds twelve months, against an enrollment prognosis measured in months. Clean safety: no cytokine release syndrome, no dose-limiting toxicities. The investigator-initiated trial establishes the clinical floor. Earlier-line patient populations are expected to show larger effects.
Supramolecular Engineering
Our proprietary bio-building blocks self-assemble into a "Zero Leakage" nanocloak. This ensures potent immunostimulants are delivered strictly to immune cells, avoiding systemic toxicity while maximizing potency.
A De-Risked, Clinical-Stage Platform
Novastra operates a parallel global trial architecture engineered for velocity. Active investigator-initiated Phase 1 proof-of-concept evaluation at world-class medical research centers anchors the clinical floor. In parallel, the company is advancing toward first US IND filing in MSS colorectal cancer in 2027, with EU and additional regional filings advancing alongside. The result is a unified operating model that translates science into regulatory-compliant data across geographies, accelerating the path to registration.
Foundation Science
A decade of pioneering science, actively expanding a peer-reviewed publication record across leading scientific journals, including Science, Nature Nanotechnology, Nature Communications, Science Advances, Chemical Society Reviews, Angewandte Chemie International Edition, Advanced Materials, and Chemical Science. A clinical-grade manuscript is advancing toward top-tier peer-reviewed publication. From a decade of foundational bio-based platform science to a clinical-stage XIRT™ platform.
