INmune Bio Inc. Announces New Preclinical Data at AACR 2026 Demonstrating INB03 (XPro1595) Overcomes Resistance and Reduces Metastases in HER2-Positive Breast Cancer Models
MWN-AI** Summary
INmune Bio Inc. (NASDAQ: INMB) has announced significant preclinical findings for its investigational therapy INB03 (XPro1595) in treating HER2-positive breast cancer, which will be presented at the AACR Annual Meeting 2026 in San Diego. INB03, a first-in-class dominant-negative soluble TNF inhibitor, has shown promise in overcoming resistance to tyrosine kinase inhibitors (TKIs) like lapatinib and tucatinib, while also reducing metastatic spread in preclinical models.
Research conducted in collaboration with the Instituto de Biología y Medicina Experimental in Buenos Aires demonstrates that combining INB03 with TKIs leads to a statistically significant increase in the inhibition of tumor growth and migration. In vitro studies indicated that the combination therapy was superior in blocking cell proliferation and migration in HER2-positive breast cancer cell lines. Additionally, in vivo tests on nude mice revealed that tumors treated with the INB03 and TKI combination experienced markedly slowed growth compared to those receiving TKIs alone.
The data suggest that INB03 effectively lowers the incidence of metastases to critical organs, including the brain, lungs, and liver. The mechanism of action involves the selective neutralization of soluble TNF, which previously was shown to impact the expression of MUC4, a protein that can hinder the effectiveness of HER2-targeted treatments.
CEO David Moss stated that these findings reinforce the potential of INB03 to improve outcomes for patients who have developed resistance to standard TKIs and are at high risk for brain metastases. With these advancements, INmune Bio continues to explore the therapeutic potential of its platform targeting the innate immune system across various cancer types. For more information, one can visit INmune Bio’s official website.
MWN-AI** Analysis
INmune Bio Inc. (NASDAQ: INMB) has recently announced promising preclinical data on INB03 (XPro1595), which suggests a significant breakthrough in overcoming resistance to tyrosine kinase inhibitors (TKIs) in HER2-positive breast cancer. This development, presented at AACR 2026, showcases the therapeutic potential of INB03 as it enhances the efficacy of existing treatments while reducing metastatic spread.
The data indicates that combining INB03 with TKIs, such as lapatinib or tucatinib, significantly inhibits cell proliferation and migration, achieving statistically superior results compared to TKIs alone. INB03 not only slows tumor growth in vivo but also markedly decreases the incidence of metastases in critical organs like the brain and lungs. This positions INB03 as a potential game-changer for patients failing standard TKI therapies.
From a market perspective, INmune Bio is poised for considerable attention and potential upward momentum as these results could catalyze interest from investors, especially given the ongoing clinical trials and further validation of INB03. The company's innovative approach to targeting soluble TNF (sTNF) opens avenues not just in oncology but potentially also in addressing neuroinflammatory conditions.
However, potential investors should proceed with caution. Clinical trials are inherently uncertain, and while the data is compelling, the transition from preclinical successes to FDA approval is fraught with risks. Market volatility in biotechnology can be pronounced, often responding sharply to news related to clinical trial outcomes.
Investors may want to monitor developments closely, particularly as INmune Bio advances INB03 through clinical stages. Its ability to solidify partnerships or secure funding to support further research will also be pivotal. As INMB approaches critical milestones, it may present a strategic buying opportunity for those willing to navigate the inherent risks of biopharmaceutical investment.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
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
FAQ**
What are the implications of the new preclinical data for INB03 (XPro1595) by INmune Bio Inc. (NASDAQ: INMB) on future clinical trials for HER2-positive breast cancer treatments?
How does INmune Bio Inc. (NASDAQ: INMB) plan to address potential challenges related to funding for the research and development of their drug candidates, particularly INB03?
Can you explain how the mechanism of action for INB03 (XPro1595) differs from traditional TNF inhibitors, as highlighted by INmune Bio Inc. (NASDAQ: INMB) in their recent findings?
What strategies does INmune Bio Inc. (NASDAQ: INMB) have in place to mitigate risks associated with the regulatory approval process for their innovative therapies, such as INB03?
**MWN-AI FAQ is based on asking OpenAI questions about INmune Bio Inc. (NASDAQ: INMB).
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