A Diversified Portfolio Driven by OmniAntigen™
Three lead programs advancing in parallel, with active platform expansion across additional refractory solid-tumor indications.
One platform engineered to address the full continuum of solid-tumor resistance.
Pipeline — one platform, three lead XIRT™ programs plus platform expansion
OAP-101
Upstream Immune Priming for Checkpoint-Refractory Disease
OAP-101 is Novastra's lead clinical asset and the first XIRT™ program in human evaluation. It captures each patient's full tumor antigen profile, wraps it in a supramolecular nanocloak, and presents it to the dendritic-cell compartment with synchronized cGAS-STING activation.
The program is being evaluated in an investigator-initiated Phase 1 proof-of-concept study in advanced, low-tumor-mutational-burden, checkpoint-refractory melanoma. To date, investigators have reported no cytokine-release syndrome or dose-limiting toxicities, alongside reproducible immune activation and interim, investigator-assessed clinical observations.
In parallel, Novastra is advancing a lead US IND program in a major checkpoint-refractory solid-tumor indication toward IND-enabling studies, with a first filing targeting 2027.
DISCLAIMER: OAP-101 is investigational. Interim observations from an early-stage study do not establish safety or efficacy.
OAP-102
World's First XIRT™
in Pediatric Oncology
OAP-102 is an investigator-initiated program applying XIRT™-Cell to high-risk pediatric neuroblastoma, where each patient's tumor antigen profile is distinct and computational prediction may leave important antigens unrepresented.
By preserving the complete tumor antigen repertoire, the program is designed to generate a patient-specific, polyclonal immune response without selecting only a predicted subset of antigens.
The program will pursue FDA Orphan Drug and Rare Pediatric Disease Designations, which may carry eligibility for a transferable Priority Review Voucher if statutory and regulatory criteria are met.
OAP-103
In Situ Immune Priming for the Combination-Oncology Era
OAP-103 extends the OmniAntigen™ Platform from ex vivo cellular preparation into an off-the-shelf, in situ reagent kit.
When antibody-drug conjugates, radiotherapy, or chemotherapy disrupt tumor cells, they release a dynamic antigen landscape. OAP-103 is designed to capture and re-present those antigens with localized immune stimulation, converting cytotoxic tumor destruction into a programmed cold-to-hot immune event.
The program targets immunologically cold, checkpoint-refractory solid tumors and is designed for drug-product accessibility and scalability without patient-specific ex vivo manufacturing. OAP-103 is at the animal proof-of-concept stage and opens a partnership track distinct from OAP-101.
Built as an immune companion for the therapies partners already own.
Lead US IND Track
Novastra is advancing XIRT™ priming in a major checkpoint-refractory solid-tumor indication where low mutational burden can limit protein-only and prediction-based approaches. The program is progressing toward IND-enabling studies, with a first US IND filing targeting 2027.
Pediatric Rare Disease Track
OAP-102 is an active investigator-initiated program in high-risk pediatric neuroblastoma, alongside evaluation of potential Orphan Drug and Rare Pediatric Disease regulatory pathways.
Beyond the Lead Programs
Platform Expansion
Additional programs are being explored across refractory solid tumors, including triple-negative breast cancer and ovarian cancer. Platform extensions under evaluation include adjuvant applications in surgical oncology and combinations with antibody-drug conjugates.
Intellectual Property
Novastra is building a multi-jurisdiction patent portfolio with composition-of-matter and method-of-treatment claims covering the OmniAntigen™ Platform and its lead programs, with filings across the United States, Europe, China, Japan, and Australia.
