INmune Bio Inc. Announces New Preclinical Data at AACR 2026 Demonstrating INB03 (XPro1595) Overcomes Resistance and Reduces Metastases in HER2-Positive Breast Cancer Models
BOCA RATON, Fla., April 16, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ:INMB) (the "Company"), a clinical-stage biotechnology company focused on developing therapies that harness the patient's innate immune system, today announces new preclinical data for INB03 (XPro1595 for oncology). The data will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2026 in San Diego on April 17-22.
The poster, titled, "Soluble TNF blockade overcomes tyrosine kinase inhibitors resistance in HER2-positive breast cancer," details how INB03 ("XPro™"), a first-in-class dominant-negative soluble TNF (sTNF) inhibitor, significantly enhances the anti-tumor activity of the tyrosine kinase inhibitors (TKIs) lapatinib and tucatinib while reducing metastatic spread to the brain, lungs, and liver in HER2-positive breast cancer models. It was authored by collaborators from the Instituto de Biología y Medicina Experimental (IBYME-CONICET) in Buenos Aires, Argentina.
Key Scientific Findings:
- Overcoming Resistance in Vitro: The combination of INB03 (10 µg/mL) with either lapatinib (1 µM) or tucatinib (10 µM) produced statistically superior inhibition of cell proliferation and migration in both HER2+ JIMT-1 and brain-metastatic JIMT-1 Br3-luc cell lines compared to TKIs alone (p < 0.05 to p < 0.0001).
- Enhanced Tumor Control In Vivo: In female nude mice bearing JIMT-1 or JIMT-1 Br3-luc tumors, INB03 + TKI combinations markedly slowed tumor growth compared to TKIs alone.
- Reduction of Metastatic Spread: The addition of INB03 significantly reduced the incidence of metastases to brain, lung, and liver (quantified by ex-vivo IVIS luminescence imaging). Notably, it further enhanced tucatinib's effect on lung metastases (p < 0.05 to p < 0.0001).
- Mechanism of Action: These results support prior research showing that selective sTNF neutralization with INB03 down-regulates MUC4, a protein that shields the HER2 molecule and prevents therapies from binding effectively.
"These results build on our prior work showing that selective sTNF neutralization with INB03 down-regulates MUC4, restoring sensitivity to HER2-targeted therapies," said Roxana Schillaci, Ph.D., lead investigator. "The ability of INB03 to overcome TKI resistance and limit metastatic dissemination, including to the brain, highlights its potential to address key unmet needs in advanced HER2-positive breast cancer."
David Moss, CEO of INmune Bio, added, "INB03 continues to demonstrate broad therapeutic potential across solid tumors by targeting the soluble TNF pathway. These AACR data reinforce our confidence in advancing INB03 combinations in the clinic for patients who have developed resistance to standard TKIs or who are at high risk for brain metastases."
The poster will be available for viewing during the AACR 2026 meeting on April 21st.
About XPro™ (INB03)
XPro™ is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and acts differently than currently available TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro™ could have potential substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication visit this section of INmune Bio's website.
About INmune Bio Inc.
INmune Bio Inc. is a publicly traded (NASDAQ:INMB), clinical-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. INmune Bio has three product platforms: (1) CORDStrom™, a proprietary pooled, allogeneic, human umbilical cord-derived mesenchymal Stromal/Stem cell (hucMSCs) platform that recently completed a blinded randomized trial in recessive dystrophic epidermolysis bullosa; (2) XPro™, a Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform designed to selectively neutralize soluble TNF, a key driver of inflammation and innate immune dysfunction; and (3) INKmune®, a cell-based medicine designed to prime a patient's natural killer cells to eliminate minimal residual disease in patients with cancer. To learn more, please visit www.inmunebio.com.
Forward Looking Statements
Clinical trials are in early stages and there is no assurance that any specific outcome will be achieved. Any statements contained in this press release related to the development or commercialization of product candidates and other business and financial matters, including without limitation, trial results and data, including trial results, timing of key milestones, future plans or expectations, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates, may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to several risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements because of these risks and uncertainties. CORDstrom™, XPro1595™ (XPro™, pegipanermin), and INKmune®™ have either finished clinical trials, are still in clinical trials or are preparing to start clinical trials and have not been approved by the US Food and Drug Administration (FDA), the UK MHRA or any regulatory body and there cannot be any assurance that they will be approved by the FDA, the UK MHRA or any regulatory body or that any specific results will be achieved. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company's ability to produce more drug for clinical trials; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company's filings with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K, the Company's Quarterly Reports on Form 10-Q and the Company's Current Reports on Form 8-K. The Company assumes no obligation to update any forward-looking statements to reflect any event or circumstance that may arise after the date of this release.
INmune Bio Contacts:
David Moss
Chief Executive Officer
(561) 710-0512
info@inmunebio.com
Daniel Carlson
Head of Investor Relations
(415) 509-4590
dcarlson@inmunebio.com
