On December 9, 2025 Novastra Therapeutics ("Novastra"), a Boston-founded, clinical-stage biotechnology company developing next-generation immune reprogramming therapies for cancer, reported that its lead program, OAP-1 from its OmniAntigen XIRT platform, has entered a Phase 1b clinical study in patients with advanced solid tumors. First-in-human data show encouraging effects on how the immune system recognizes and attacks cancer in people with very advanced disease whose tumors have continued to grow despite multiple prior treatments, including chemotherapy, immunotherapy and, for some, radiation therapy. These "last-line" patients have very few remaining standard treatment options and are among the hardest cancer cases to treat.
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OAP-1 is a new type of personalized cancer treatment that focuses on "immune reprogramming." Instead of targeting just one or a few markers, OAP-1 uses a patient’s own tumor cells and coats them with a special ultra-thin nano-layer. This layer helps preserve the full "fingerprint" of the cancer while giving the immune system a strong and coordinated push to see the tumor as a threat again. The goal is to safely "retrain" the immune system to fight the patient’s cancer more effectively.
"Many people benefit from today’s cancer immunotherapies, but too often the cancer finds a way to escape and patients run out of options," said Junling Guo, PhD, Founder of Novastra Therapeutics. "Our next-generation OmniAntigen XIRT platform is designed for system-level immune reprogramming. We want to keep the full picture of each patient’s cancer and, at the same time, give the immune system a stronger, more organized second chance to respond."
OAP-1 is made using a same-day process that is designed to be performed near the patient. Tumor samples are collected, processed, and returned as a personalized dose within hours, without the need for gene editing or complex factory-style manufacturing. This approach aims to make personalized immunotherapy more practical and more accessible over time.
The ongoing Phase 1b clinical study is enrolling patients with advanced solid tumors whose cancer has continued to grow after treatment with PD-1/PD-L1 checkpoint inhibitor drugs, a common type of cancer immunotherapy. The main goals of this study are to evaluate safety and feasibility, and to understand how OAP-1 affects the immune system and tumor behavior over time.
So far, in the initial patients treated, OAP-1 has been well tolerated, with no unexpected safety concerns observed. Tests on blood and tissue samples show several highly encouraging cancer-related immune reprogramming effects, including a clear rise in a natural immune signal called interferon-alpha (IFN-α) which helps "wake up" the body’s defenses, followed by a substantial and sustained increase in specific "attacker" signals (interferon-gamma/IFN-γ). This pattern indicates stronger activation of immune cells that can recognize cancer and more T cells that appear to be targeting the patient’s own tumor. In line with these immune changes, early scan results in some patients suggest that their tumor growth has been brought under control, with signs that the tumors have stopped growing and, in some cases, may even be starting to shrink.
"The early clinical data on these immune reprogramming effects are very encouraging, especially in patients whose cancers have already stopped responding to standard immunotherapy," said Yunxiang He, PhD, Co-Founder of Novastra. "We believe that a next-generation, system-level immune reprogramming approach like OAP-1 could eventually serve as a flexible backbone that works together with existing checkpoint inhibitors and other cancer treatments."
About OmniAntigen XIRT
OmniAntigen XIRT (next-generation immune reprogramming therapy) is Novastra’s platform for rapidly turning patient-derived cells into same-day cancer immunotherapies. Each dose is designed to preserve a wide spectrum of tumor antigens – the unique "fingerprint" of a patient’s cancer – while adding a proprietary ultra-thin coating and immune-stimulating components that help "wake up" and reprogram the immune system at multiple levels. The platform is designed for closed-system, near-patient manufacturing in just a few hours, with the goal of making personalized immune reprogramming practical and scalable.
OAP-1, the first clinical candidate from the OmniAntigen XIRT platform, is currently being evaluated in a Phase 1b clinical trial in advanced solid tumors with prior exposure to checkpoint inhibitor therapy.
(Press release, Novastra Therapeutics, DEC 9, 2025, View Source [SID1234673478])