Novastra Therapeutics to Present First-in-Human Data for OAP-101 in Checkpoint-Refractory Advanced Melanoma at SITC 2026 Annual Meeting

• Feasibility and innate-to-Th1 pharmacodynamics for candidate OAP-101, built on proprietary OmniAntigen™ Platform (OAP)
• OAP enables systematic immune reprogramming therapy (XIRT™) to overcome resistance of cold solid tumors to current therapies, including checkpoint inhibition

CAMBRIDGE, Mass., Oct. 29, 2026 (GLOBE NEWSWIRE) -- Novastra Therapeutics, a clinical-stage biotechnology company developing a novel category of cancer immune therapy, today announced that first-in-human data from an ongoing investigator-initiated Phase 1 study of OAP-101 in anti-PD-1-refractory advanced melanoma will be presented at the Society for Immunotherapy of Cancer (SITC) 41^st Annual Meeting, taking place November 4-8, 2026, in Phoenix, Arizona.

Novastra’s OmniAntigen™ Platform (OAP) enables systematic immune reprogramming therapy (XIRT™), with off-the-shelf in situ and autologous approaches designed to coordinate tumor-antigen presentation with innate immune activation, priming tumor-directed immunity. These approaches aim to overcome resistance of cold solid tumors to checkpoint inhibition and to act as an immune amplification companion for antibody-drug conjugates (ADCs), chemotherapy, and radiotherapy.

Presentation details
Presentation type: Poster
Primary category: Clinical Trials In Progress
Title: First-in-human autologous whole-tumor-cell immunotherapy in a supramolecular metal-organic nanocloak, with anti-PD-1, in checkpoint-refractory melanoma: feasibility and innate-to-Th1 pharmacodynamics
Presenting author: Junling Guo, PhD, Chief Executive Officer, Novastra Therapeutics
Date and time: Saturday, November 7, 2026, 10:00 am – 2:00 pm and 6:00 pm – 8:10 pm MST
Abstract number: 568

The poster will feature first-in-human data on the feasibility and pharmacodynamics of Novastra's OAP/XIRT approach, which is designed to engage the innate immune system and drive an adaptive T helper 1 (Th1) immune response. The Phase 1 study investigates OAP-101 in patients with advanced metastatic melanoma refractory to multiple lines of current therapy, including anti-PD-1 checkpoint inhibition.

The full abstract will be available as of 9:00 am EST on November 3, 2026, and will be published on the SITC website and in the Journal for ImmunoTherapy of Cancer (JITC), SITC’s official open-access journal, as part of the SITC 2026 abstract supplement.

Reaching more patients with cold solid tumors who are currently left behind
Despite advances in checkpoint inhibition and ADCs, many patients with solid tumors still experience treatment resistance. For immunotherapy, a key challenge is the absence of an effective anti-tumor immune response because the tumor hides from immune recognition.^1-3

Built on OAP, XIRT is designed to overcome this challenge by priming the immune system. OAP enables rapid antigen encapsulation with a supramolecular nanocloak for effective presentation to the immune system. The nanocloak is designed to combine antigen delivery with innate immune stimulation, including activation of the cGAS-STING pathway, connecting the innate and adaptive immune systems.⁴ OAP enables the preservation of a broad repertoire of tumor-cell antigens in autologous settings. For in vivo applications, Novastra is designing an in-situ approach where the nanocloak self-assembles within the tumor, capturing tumor-derived antigens released by ADCs, chemotherapy, or radiotherapy.

About Novastra Therapeutics
Novastra is a clinical-stage biotechnology company developing systematic immune reprogramming therapy (XIRT™) as a novel category of cancer therapy to overcome the resistance of cold solid tumors to current therapies by priming the immune system. XIRT is built on Novastra’s proprietary OmniAntigen™ Platform (OAP), which is designed for use across a wide range of refractory solid tumors. Novastra is advancing a pipeline of autologous and off-the-shelf in situ programs.

OAP enables rapid antigen encapsulation with a supramolecular nanocloak for effective presentation to the immune system. The nanocloak is designed to combine antigen delivery with innate immune stimulation, including activation of the cGAS-STING pathway, connecting the innate and adaptive immune systems. OAP enables the preservation of a broad repertoire of tumor-cell antigens in autologous settings. Autologous candidate OAP-101 is supported by preclinical evidence and initial results from an investigator-initiated Phase 1 study in advanced, checkpoint-refractory melanoma. For in vivo applications, Novastra is designing an in-situ approach where the nanocloak self-assembles within the tumor, capturing tumor-derived antigens released by ADCs, chemotherapy, or radiotherapy.

Novastra Therapeutics is headquartered in Cambridge, Massachusetts, with an operations hub in Shanghai. Explore more at www.novastra.bio.

Forward-Looking Statements
This press release contains forward-looking statements regarding Novastra Therapeutics, including statements about the development of its therapy candidates, the conduct and timing of clinical studies, anticipated regulatory milestones, and the company’s strategic and financial plans. Forward-looking statements are based on current expectations and involve risks and uncertainties, including but not limited to clinical study outcomes, regulatory decisions, and availability of capital, that could cause actual results to differ materially from those expressed or implied. Interim or early clinical data may not be predictive of future results. Novastra undertakes no obligation to update forward-looking statements except as required by law.

Contact
Arne Naeveke, PhD
Head of Strategic Communications
media@novastra.bio

References

1. Shen et al. J Immunother Cancer. 2024
2. Haslam & Prasad, JAMA Netw Open. 2019
3. Haslam et al. Int J Cancer. 2025
4. He et al. Angew Chem Int Ed. 2024;63:e202314501