INmune Bio, Inc. Announces First Patient Dosed in Phase 2 Trial of Quellor™ for Pulmonary Complications in COVID-19 Patients
LA JOLLA, Calif, Nov. 09, 2020 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the, “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, announced today that the first patient has been dosed in its Phase 2 clinical trial evaluating Quellor™ for the treatment of pulmonary complications from COVID-19. Quellor™ is a selective soluble Tumor Necrosis Factor (sTNF) inhibitor designed to potentially prevent the progression of immune mediated pulmonary complications resulting from SARS-CoV-2 viral infection.
“Clinical evidence over the last several months has shown that while infection with COVID-19 virus makes people sick, it’s the uncontrollable immune response and subsequent cytokine storm that is responsible for their admission to a hospital,” stated RJ Tesi, M.D., Chief Executive Officer of INmune Bio. “By neutralizing TNF, the master inflammatory cytokine of the cytokine storm with Quellor, we believe Quellor™ can blunt the symptoms of this dysregulated immune response. This US based clinical trial expands both our geographic and therapeutic footprint with our DN-TNF platform.”
The dosing of the first patient took place at UofL Health – Jewish Hospital, Louisville, KY. As the largest academic health system in Kentucky, UofL Health is committed to increasing regional access to leading edge treatments and therapies.
The double-blind, randomized, placebo-controlled Phase 2 clinical trial (NCT04370236) will enroll 366 COVID-19 high risk patients in two equal sized cohorts: standard of care (SOC), which may include remdesivir, and SOC plus Quellor™ given as a 1mg/kg subcutaneous injection on admission to the hospital. A second dose of Quellor™ may be given a week later if the patient remains hospitalized. High risk patients include the elderly, patients with diabetes, cardiovascular disease, obesity, African American or Hispanic ethnicity. The primary study endpoint is the need for mechanical ventilation during the 28 days following admission to the hospital, including CPAP, BiPAP or intubation. Secondary endpoints include transfer to the ICU, new onset neurologic, cardiovascular or thromboembolic disease, development of renal failure or death. The first 100 patients randomized into the study will provide proof-of-concept and inform a “go/no go” decision by the Data Safety Monitoring Board (DSMB). If the DSMB recommends that the trial continue, the remaining 266 patients will be enrolled.
Quellor™ is a next-generation inhibitor of tumor necrosis factor (TNF) that is different from currently existing non-selective TNF inhibitors. Quellor™ neutralizes soluble TNF (sTNF) using a novel dominant-negative biology that importantly does not affect trans-membrane TNF (tmTNF) or TNF receptors. Currently approved TNF inhibitors block both sTNF and tmTNF. Quellor™ could have beneficial effects in patients with immune mediated complications from COVID-19 by decreasing inflammation and inflammatory immune complications such as endothelial cell activation, a potentially important cause of COVID-19-related coagulopathy which is increasingly blamed for end-organ dysfunction in lungs, kidneys, heart and brain. By targeting only sTNF, Quellor™ does not cause immunosuppression that is typical of most anti-cytokine therapies including currently approved anti-TNF and anti-IL-6 therapies. This may be an advantage when treating patients with a life-threatening viral infection.
About UofL Health
UofL Health is a fully integrated regional academic health system with five hospitals, four medical centers, nearly 200 physician practice locations, more than 700 providers, the Frazier Rehab Institute and James Graham Brown Cancer Center. With more than 12,000 team members – physicians, surgeons, nurses, pharmacists and other highly skilled health care professionals, UofL Health is focused on one mission—one purpose—delivering patient-centered care to each and every patient—each and every day.
About UofL Health – Jewish Hospital
Jewish Hospital, part of UofL Health, is an internationally renowned, high-tech tertiary referral center, developing leading-edge advancements in hand and microsurgery, heart and lung care, orthopedics and sports medicine, neuroscience, organ transplantation and outpatient care. The hospital is the site of the world’s first successful hand transplant and AbioCor® implantable replacement heart procedures, in addition to the first trial of adult cardiac stem cells in chronic heart failure. Jewish Hospital continues to be recognized for its specialized heart care procedures, including the implantation of ventricular assist devices (VAD), and transcatheter aortic valve replacement (TAVR). The UofL Health – Trager Transplant Center is in a select group of hospitals nationwide that perform heart, lung, liver, kidney, pancreas and hand transplantation. The center also includes a Pancreas Disease Center, a GI Motility Clinic, and Advanced Heart Failure and Ventricular Assist Device programs.
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. The DN-TNF product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and mechanistic target of many diseases. DN-TNF is currently being developed for COVID-19 complications (Quellor™), cancer (INB03™), Alzheimer’s (XPro1595), and NASH (LIVNate™). The Natural Killer Cell Priming Platform includes INKmune™ aimed at priming the 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 malignancies, solid tumors and chronic inflammation. To learn more, please visit www.inmunebio.com.
Information about 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™, Quellor™, XPro1595, LIVNate™, and INKmune™ are still in clinical trials and have not been approved and there cannot be any assurance that they will be approved 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
Meredith Sosulski, Ph.D.