Company Announcements

Publication of detailed analysis on INKmune biology compared to cytokine stimulated cells demonstrates important anti-tumor memory like NK cell characteristics

BOCA RATON, Fla., July 23, 2024 (GLOBE NEWSWIRE) -- -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage inflammation and immunology company developing treatments that harness the patient’s innate immune system to fight disease, announced the publication of our landmark paper in Journal Immunotherapy of Cancer co-authored by Mark Lowdell, PhD, INmune’s Chief Scientific Officer, titled,  “ Proteomic and phenotypic characteristics of memory-like Natural Killer cells for cancer immunotherapy.” Link to paper: https://jitc.bmj.com/content/12/7/e008717

The study demonstrates that memory-like natural killer (mlNK) cells, generated by either cytokine or INKmune^TM priming, show increased cytotoxicity against multiple tumor types, offering promising potential for cancer immunotherapy. Importantly, while most studies are conducted on NK cells from healthy volunteers, this study demonstrated that mlNK from cancer patients are equally as potent as those generated from healthy volunteers further supporting INKmune’s in vivo treatment methodology. The research also provides new insights into the metabolic and physiological mechanisms underlying NK cell memory, paving the way for innovative treatments in both hematological malignancies and solid tumors.

“The study of NK cell biology is evolving rapidly. This is the first study to identify the unique characteristics of tumor killing memory like NK cells and points to ways to enhance their potential further for cancer immunotherapy,” said Mark Lowdell PhD, CSO of INmune Bio and inventor of INKmune^TM. “INKmune^TM priming increases proteins which protect NK cells in the hostile tumor microenvironment which is exciting for our ongoing clinical trial in metastatic castration-resistant prostate cancer. This research study, led by INmune Bio, was a commercial and academic collaboration over several years and we are delighted to see it published in a high impact, peer-reviewed scientific journal.”

Most significantly, this study is the first to demonstrate in vivo generation of mlNK cells; something which cannot be done with the cytokine cocktail used in vitro. The researchers successfully showed that these mlNK cells, primed by INKmune^TM, can be found in patients after treatment, a critical step in proving our claimed mechanism of action.

Additionally, the paper highlights the enhanced metabolic function of the NK cells primed by INKmune^TM, predicting improved performance in the tumor microenvironment (TME). “This research is particularly noteworthy as NK cell dysfunction in the TME is often due to impaired metabolism,” stated RJ Tesi, INmune’s CEO. “The findings suggest that INKmune priming can overcome these metabolic barriers, leading to more effective NK cell resposes against tumors.”

INmune Bio is currently conducting a trial of INKmune^TM in the treatment of metastatic castration-resistant prostate cancer. Preliminary results from that trial are expected later this year.

About INKmune™

INKmune™ is a pharmaceutical-grade, replication-incompetent human tumor cell line which conjugates to resting NK cells and delivers multiple, essential priming signals to convert the cancer patient’s resting NK cells into tumor killing memory-like NK cells (mlNK cells).  INKmune™ treatment converts the patient’s own NK cells into mlNK cells. In patients, INKmune™ primed tumor killing NK cells have persisted for more than 100 days. These cells function in the hypoxic TME because due to upregulated nutrient receptors and mitochondrial survival proteins.  
INKmune™ is a patient friendly drug treatment that does not require pre-medication, conditioning or additional cytokine therapy to be given to the patients. INKmune™ is easily transported, stored and delivered to the patient by a simple intravenous infusion as an out-patient. INKmune™ is tumor agnostic; it can be used to treat many types of NK-resistant tumors including leukemia, lymphoma, myeloma, lung, ovarian, breast, renal and nasopharyngeal cancer.  INKmune™ is treating patients in an open label Phase I/II trial in metastatic castration-resistant prostate cancer in the US this year.

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 two product platforms that are both in clinical trials: The Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and a mechanistic driver of many diseases. DN-TNF product candidates are in clinical trials to determine if they can treat cancer (INB03™), Early Alzheimer’s disease and treatment-resistant depression (XPro™). The Natural Killer Cell Priming Platform includes INKmune™ developed to prime a patient’s NK cells to eliminate minimal residual disease in patients with cancer. INmune Bio’s product platforms utilize a precision medicine approach for the treatment of a wide variety of hematologic and solid tumor malignancies, and chronic inflammation. 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 that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995.  Any statements contained in this press release that do not describe historical facts 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 a number of risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. INB03™, XPro1595 (XPro™), and INKmune™ are still in clinical trials or preparing to start clinical trials and have not been approved by the US Food and Drug Administration (FDA) or any regulatory body and there cannot be any assurance that they will be approved by the FDA 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 in order to reflect any event or circumstance that may arise after the date of this release.

INmune Bio Contact:

David Moss
Chief Financial Officer
(858) 964-3720

Daniel Carlson
Head of Investor Relations
(415) 509-4590
dcarlson@inmunebio.com

Investor Contact:
Mike Moyer
Managing Director – LifeSci Advisors
mmoyer@lifesciadvisors.com