INmune Bio Inc.’s Chief Scientific Officer, Mark Lowdell, Ph.D. to Present Plenary Talk at International Society of Cell & Gene Therapy

Rhea-AI Summary

INmune Bio Inc. (NASDAQ: INMB) announces that its Chief Scientific Officer, Mark Lowdell, Ph.D., will deliver the opening plenary lecture at the International Society of Cell and Gene Therapy (ISCT) in Paris on May 31st. The talk, titled 'The Future of Immune Effector Cell Therapies for Cancer, Tumor-Primed Memory NK Cells – from Heresy to Clinical Trials,' will focus on INKmune™, the company's proprietary Natural Killer (NK) cell platform.

Dr. Lowdell's team has discovered that INKmune™ primes NK cells to a unique cancer-killing population of memory-like NK cells, differing from cytokine-primed NK cells. This breakthrough could potentially avoid complications associated with cytokine therapy. The company recently received FDA acceptance of its Investigational New Drug Application (IND) for treating metastatic castrate-resistant prostate cancer, with a Phase I/II study set to begin enrolling patients in the US later this year.

• Presidential Plenary Lecture to be Presented Wednesday, May 31 at the ICST Opening Session

BOCA RATON, Fla., May 24, 2023 (GLOBE NEWSWIRE) --  INmune Bio Inc. (NASDAQ: INMB) announces that Mark Lowdell, Ph.D., INmune Bio’s CSO, will be giving the opening plenary lecture of the Presidential Symposium at the International Society of Cell and Gene Therapy (ISCT) in Paris, France on May 31^st.

Dr. Lowdell’s lecture titled, “The Future of Immune Effector Cell Therapies for Cancer, Tumor-Primed Memory NK Cells – from Heresy to Clinical Trials,” will describe how INKmune™, INmune Bio’s proprietary Natural Killer (NK) cell platform, primes the patient’s NK cells to alter their phenotype to a cancer-killing population of memory-like NK cells that differ from single-cytokine or multiple-cytokine (IL-12, IL-15, IL-18) primed NK cells. The Company believes this is a critical breakthrough to avoid the complications associated with cytokine therapy and obtain NK cells ideally suited for attacking cancer.

Dr. Lowdell’s team at INmune Bio has shown that NK cells primed by INKmune™ or by the triple cytokine combination of IL12/15/18 (CIML-NK) consist of a complex mix of cell subsets with a unique memory associated phenotype. Using high-dimensional flow cytometry to simultaneously analyze 31 cell surface proteins, the team analyzed resting NK cells, IL-15 LAK (LAK=lymphokine activated killer cells), CIML-NK and INKmune-primed (TpNK) side-by-side. The data showed at least 8 clusters of NK cell types, one of which was restricted to CIML-NK and TpNK. This last cluster has never been described. “Whilst the existence of “memory-like” NK cells based on function has been known for over 10 years, it’s safe to say no-one has identified a unique cell surface phenotype for these cells,” said Dr. Lowdell. “Our interest in activating NK cells with INKmune™ to kill cancer provided a unique opportunity to better define these cells by comparison with CIML-NK.”

The team has reported previously that TpNK function better in the hostile tumor microenvironment (TME) than CIML-NK or IL15 LAK because of upregulation of nutrient receptors and mitochondrial survival proteins leading to increased metabolic activity and resistance to exhaustion. “The latest data show that TpNK are at an intermediate stage between single-cytokine primed cells and CIML-NK. CIML-NK contains a large population of terminally activated cells with loss of spare respiratory activity, which is absent from TpNK. Since tumor-infiltrating NK cells have mitochondrial insufficiency, they cannot kill cancer cells. We believe INKmune™ may overcome this critical point of failure,” added Dr. Lowdell.  Further details of this work will be presented in a manuscript currently under review.

Cytokine treatments to activate patient natural killer cells have shown promise in enhancing the immune response against cancer for decades but have failed to reach clinical utility due to several challenges and limitations including high cost, and risk of systemic toxicity to the patient. can induce severe side effects. Cytokines such as interleukin-2 (IL-2) and interleukin-15 (IL-15) activate both NK cells and resident T cells, leading to unwanted inflammatory responses and cytokine release syndrome, limiting use in many patients .The short half-life of cytokines necessitates frequent administration, which further increases the risk of toxicity and complicates treatment schedules.  Lowering the dose of cytokine therapy compromises the anti-tumor immune response and does not overcome the difficulties of a hostile TME that prevents tumor killing.  We believe INKmune™ may solve these issues with its unique upregulation of proteins that produce a “fitter” memory-like NK cell that has a longer therapeutic effect in the hostile TME without the need to give the patient supplementary cytokine therapy.

On May 8, 2023, the Company announced the FDA’s acceptance of its Investigational New Drug Application (IND) for the treatment of metastatic castrate resistant prostate cancer. Dr. Matt Rettig M.D., Professor of Medicine and Urology, Medical Director of the Prostate Cancer Program at the David Geffen School of Medicine at UCLA and member of the Jonsson Comprehensive Cancer, is the principal investigator of the Phase I/II study.  Dr. Rettig is a consultant to INmune Bio.   The trial uses a novel Bayesian design to allow safety and anti-tumor effects of multiple doses of INKmune™ to be tested simultaneously. The trial should begin to enroll patients in the US later this year.

"Mark Lowdell's unwavering dedication to NK cell research has been focused on unraveling the mystery behind why a patient's natural killer cells fail to combat cancer, which is a fundamental factor contributing to the development of cancers in the first place,” said RJ Tesi, M.D. INmune Bio’s CEO. “His tireless effort in the development of INKmune™, the quest to enhance the efficacy of NK cell therapies for solid cancers, and the identification of memory NK cells exemplify his relentless pursuit."

About INKmune™ 

INKmune™ is a product designed to improve the function of the patient’s own NK cells.  INKmune™ is a clinical-grade, replication-incompetent human tumor cell line which conjugates to resting NK cells and delivers multiple, essential priming signals, akin to treatment with at least three cytokines in combination. INKmune™ is stable at -80^oC and is delivered by a simple IV infusion. The INKmune:NK interaction triggers multiple activating and co-stimulatory molecules on the NK cell and enhances its avidity of binding to tumor cells; notably those resistant to normal NK-mediated lysis. Tumor-primed NK (TpNK) cells can lyse a wide variety of NK-resistant tumors including leukemias, lymphomas, myeloma and solid tumors including prostate, renal cell, ovarian, nasopharyngeal, lung and breast cancer. INKmune™ therapy does not require any type of conditioning, pre-medication or cytokine support. 

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™), Mild Alzheimer’s disease, Mild Cognitive Impairment 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, 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, CFO (858) 964-3720
info@inmunebio.com

Investor Contact:

Jason Nelson
Core IR
(516) 842-9614 x-823

FAQ

What is INKmune™ and how does it differ from cytokine therapy for NK cells?

INKmune™ is INmune Bio's proprietary Natural Killer (NK) cell platform that primes NK cells to a unique cancer-killing population of memory-like NK cells. Unlike cytokine therapy, INKmune™ avoids complications associated with cytokine treatments and produces NK cells better suited for attacking cancer in the hostile tumor microenvironment.

When will Dr. Mark Lowdell present his plenary talk at the ISCT conference?

Dr. Mark Lowdell, CSO of INmune Bio (NASDAQ: INMB), will present his plenary talk at the International Society of Cell and Gene Therapy (ISCT) conference in Paris, France on May 31, 2023.

What recent FDA approval did INmune Bio (INMB) receive for INKmune™?

On May 8, 2023, INmune Bio (NASDAQ: INMB) announced that the FDA accepted its Investigational New Drug Application (IND) for INKmune™ in the treatment of metastatic castrate-resistant prostate cancer.

How does INKmune™ potentially overcome the limitations of cytokine therapy for cancer treatment?

INKmune™ potentially overcomes cytokine therapy limitations by producing 'fitter' memory-like NK cells that have a longer therapeutic effect in the hostile tumor microenvironment without the need for supplementary cytokine therapy, avoiding systemic toxicity and inflammatory responses associated with cytokine treatments.