Clinical trial of novel innate immune system checkpoint inhibitor targeting myeloid derived suppressor cell (MDSC)

LA JOLLA, Calif. (May 23, 2018) – via NetworkWire – INmune Bio, Inc., an immunotherapy company developing therapies that reprogram the patient’s innate immune system to treat cancer, today announced that it has initiated a Phase 1 clinical trial of its drug candidate INB03™ in patients with advanced solid tumors. INB03 is a novel innate immune system checkpoint inhibitor that targets MDSCs, cells of the innate immune system which create an immunosuppressive shield around the tumor and inhibit the patient’s immune system from attacking the cancer. By preventing the proliferation and function of MDSC, the company believes patients will have a stronger immune response to their tumor and may respond better to other cancer treatments including immunotherapy such as checkpoint inhibitors (CPI).

“MDSC are a high priority target for the next advance in immuno-oncology,” said RJ Tesi, MD, CEO and co-founder of INmune Bio. “INB03 decreases proliferation and function of MDSC. By eliminating the immunosuppressive effects of MDSC in the tumor microenvironment, we hope to provide therapeutic options for patients who are resistant to immunotherapy because of elevated levels of MDSC. This Phase I trial is the first step to meeting our goal of improving the response to CPI in patients who fail therapy due to increased MDSC in their tumor.”

“In less than three years, INmune Bio has developed two immunotherapy platforms, INKmune and INB03 from bench-to-bedside. Both programs will enter the clinic this year,” said Tim Schroeder, CEO of CTI Clinical Trials and Consulting Services (CTI) and an INmune Bio board member. “The company has remained focused on reprograming the patient’s innate immune system to better attack their cancer. By targeting the oft-ignored innate immune system, INmune Bio has a chance to make a difference in patients’ lives.”

CTI Clinical Trial & Consulting Services Australia Pty Ltd., a subsidiary of CTI, is the CRO managing the INB03 Phase I clinical trial.

MDSCs are myeloid cells that appear in patients with cancer and other chronic inflammatory diseases. In patients with cancer, the number of MDSC in the blood and/or tumor microenvironment predict the severity of the cancer and prognosis. The more MDSC, the worse the prognosis. MDSC are recognized as a risk factor in predicting failure to immunotherapy including CPI. By eliminating MDSC, INB03 should allow an improved response to immunotherapy as well as an increased ability of the patient’s own immune system to attack the tumor. The INB03 Phase I trial uses biomarkers to select patients who should benefit from treatment. There are currently no approved drugs that have been developed to target MDSC.

About INmune Bio, Inc.

INmune Bio Inc. is a clinical stage biotechnology company that is developing new immunotherapies that reprogram a patient’s innate immune system to allow the immune system to fight cancer. Our drug candidates, INKmuneTM and INB03™, can be used alone or in

combination with other cancer therapies to help eliminate disease in a wide variety of cancers. They can also boost the effectiveness of other immunotherapies designed to enhance immune response to specific tumors. The development of new immunotherapies is revolutionizing cancer care. INmune Bio is at the forefront of that revolution with novel products that take the brakes off of the most powerful weapon in the fight against cancer: the patient’s immune system.

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About CTI Clinical Trial and Consulting Services

CTI Clinical Trial and Consulting Services is a global, privately held, full-service contract research organization (CRO), delivering a complete spectrum of clinical trial and consulting services throughout the lifecycle of development, from concept to commercialization. CTI’s focused therapeutic approach provides pharmaceutical, biotechnology, and medical device firms with clinical and disease area expertise in rare diseases, regenerative medicine/gene therapy, immunology, transplantation, nephrology, hematology/oncology, neurology, infectious diseases, hepatology, cardiopulmonary, and pediatric populations. CTI also offers a fully integrated multi-specialty clinical research site that conducts phase I-IV trials. CTI has a passion for helping life-changing therapies succeed in chronically and critically ill patient populations. With clinical trial experience across 6 continents, CTI partners with research sites, patients, and sponsors to fulfill unmet medical needs. CTI is headquartered in the Greater Cincinnati, OH area, with operations across North America, Europe, Latin America, and Asia-Pacific.

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INmune Bio:
David Moss, CFO
(858) 964-3720
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CTI Clinical Trial & Consulting Services:
Allison L. Schroeder, MBA
Senior Manager, Marketing and Corporate Communication
(513) 598-9290
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Antenna Group
Nechama Feuerstein\
(201) 373-2228
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