INmune Bio Opens Phase II in High Dose Cohort of INKmune(TM) Trial in Prostate Cancer
MWN-AI** Summary
INmune Bio Inc. (NASDAQ: INMB), a clinical-stage biotechnology firm, has announced the advancement of its Natural Killer (NK) cell therapy, INKmune™, into the Phase II high dose cohort of its ongoing clinical trial targeting metastatic castration-resistant prostate cancer (mCRPC). This progression follows the successful completion of the Phase I trial, which demonstrated an exemplary safety profile and no significant safety issues, as confirmed by the Scientific Review Committee (SRC).
INKmune™ is designed to convert a patient’s resting NK cells into memory-like NK cells that effectively kill tumors. It is formulated as a pharmaceutical-grade, replication-incompetent human tumor cell line that primes the immune response without the need for pre-medication, making it suitable for outpatient administration. The ongoing CaRe PC trial has been structured with ascending dose cohorts, which will provide insights into the therapeutic efficacy of the treatment in higher doses.
The SRC's recent decision to open all Phase II cohorts for patient enrollment marks a pivotal step in the trial's progress. Dr. RJ Tesi, CEO of INmune Bio, highlighted the immunologic effects noted in the low-dose cohort and expressed optimism regarding the insights that the higher dose cohorts will yield.
Furthermore, Mark Lowdell, Chief Scientific Officer and inventor of INKmune™, is set to present findings from the trial at the 10th Annual Innate Killer Summit in March. INKmune™ is positioned to address a broad spectrum of NK-resistant tumors, thus holding potential beyond prostate cancer. The company continues to recruit patients for this promising investigational therapy, intending to leverage its innovative platform for treating various cancers while targeting the innate immune system.
MWN-AI** Analysis
INmune Bio Inc. (NASDAQ: INMB) has recently made a significant advancement in its clinical development of INKmune™, a genetic therapeutic solution aimed at treating metastatic castration-resistant prostate cancer (mCRPC). The completion of the Phase I portion of the CaRe PC trial, coupled with the unanimous decision by the Scientific Review Committee (SRC) to progress to Phase II, positions INmune Bio favorably in the oncology market.
The absence of safety issues in Phase I cohorts suggests that INKmune™ has a robust safety profile, an attractive feature for investors since safety is often a primary concern in early-stage clinical trials. As the company moves forward to the high-dose cohorts of Phase II, continued monitoring of efficacy alongside safety will be crucial. The data outcomes presented at the 10th Annual Innate Killer Summit could serve to further validate their approach and may influence both institutional and retail investment sentiments.
The uniqueness of INKmune™, which primes a patient's own NK cells to enhance anti-cancer activity without the need for pre-medication or extensive procedures, enhances its marketability. The ease of use as an outpatient treatment presents additional appeal in terms of patient compliance and potential healthcare cost savings.
With patient recruitment proceeding on target, there's a strong likelihood that the subsequent data releases will highlight the therapeutic advantages of INKmune™, potentially unlocking its value in treatment paradigms for multiple types of cancer—beyond prostate cancer.
Investors should closely monitor recruitment rates, interim data releases, and the outcomes from the forthcoming summit. The eventual market approval of INKmune™, while contingent on trial outcomes, could position INmune Bio as a transformative player in immunotherapy, making it a compelling investment opportunity in the biotech sector. However, given the inherent uncertainties in clinical trials, a cautious approach is warranted, with a diversified strategy advised for risk management.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
- Medical review of Phase 1 cohorts demonstrated no safety issues
- Data to be presented at the 10 th Annual Innate Killer Summit, March 3-5
BOCA RATON, Fla, Feb. 12, 2025 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology and inflammation company, continues to advance its Natural Killer (NK) cell therapy, INKmune™, in a Phase I/II trial (the “CaRe PC” trial) for men with metastatic castration-resistant prostate cancer (mCRPC). The Company is pleased to announce completion of the third and highest dose cohort of the Phase I portion of the trial allowing opening of the Phase II high dose cohort.
The Scientific Review Committee (SRC) charter is to review the safety data from the patients treated in the Phase I portion of the trial as required by the FDA. Yesterday, the SRC held the third meeting evaluating the safety in INKmune™ therapy in men with mCRPC. The SRC unanimously voted to open all Phase II cohorts of the CaRePC trial to enrollment.
“INKmune™ can be given to men with mCRPC in an out-patient setting and so far has an exemplary safety profile,” said RJ Tesi, MD CEO of INmune. “Data from the low dose cohort has shown immunologic effects of INKmune™ therapy. The higher dose cohorts will help us understand the therapeutic benefits of INKmune™ therapy in treating men with mCRPC.”
Mark Lowdell, CSO of INMB and inventor of INKmune™, has been invited to speak at the 10 th Annual Innate Killer Summit in San Diego on March 4 th on the use of INKmune™ to treat men with mCRPC in the CaRe PC trial. The trial has a Bayesian design with three ascending dose cohorts. Now that the initial three patients in each cohort have passed medical review, there is a six patient Phase II extension at the two higher dose levels. Patient recruitment continues to meet expectations.
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 up-regulated 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.
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: 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 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 and is currently in trials in metastatic castration-resistance prostate cancer. The third program, CORDStrom, is 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. INmune Bio’s product platforms utilize a precision medicine approach for diseases driven by chronic inflammation and 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 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. CORDStrom, 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.
David Moss
Co-founder and Chief Financial Officer
(858) 964-3720
info@inmunebio.com
Daniel Carlson
Head of Investor Relations
(415) 509-4590
dcarlson@inmunebio.com
FAQ**
How does INmune Bio Inc. (NASDAQ: INMB) plan to leverage the exemplary safety profile of INKmune™ observed in Phase I to enhance patient recruitment for the Phase II cohorts of the CaRe PC trial?
What specific immunologic effects have been observed in the low dose cohort of the INKmune™ therapy by INmune Bio Inc. (NASDAQ: INMB), and how might these inform dosing in the Phase II trial?
Can you explain how the Bayesian design of the CaRe PC trial by INmune Bio Inc. (NASDAQ: INMB) helps optimize patient outcomes during the Phase I and II assessments of INKmune™ therapy?
What strategies does INmune Bio Inc. (NASDAQ: INMB) have in place to manage potential risks associated with the ongoing clinical trials of INKmune™ and ensure compliance with FDA regulations?
**MWN-AI FAQ is based on asking OpenAI questions about INmune Bio Inc. (NASDAQ: INMB).
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