Companies Seek an Innovative Solution to the Growing Cancer Rates

NEW YORK, Sept. 30, 2019 /PRNewswire/ -- Cancer is among the leading causes of death in the world as countries are burdened by a lack of access to adequate healthcare. In 2018, the World Cancer Research Fund (WCRF) estimated that there were 18 million new cancer cases worldwide. Among these 18 million, 9.5 million were men and 8.5 million were women, while the most commonly diagnosed cancers were lung, breast, and colorectal. In particular, the top three diagnosed cancers accounted for over a third of total global cases. Most cases of cancer result from risk factors such as poor diet, nutrition, and physical condition. However, in some instances, cancer can be caused by hereditary factors such as genetics or environmental impacts. The WCRF mentioned that roughly 40% of cancer cases in 2018 could have been prevented if patients had a more well-rounded diet. Nonetheless, the number of cases is gradually rising, prompting pharmaceutical and biotechnology companies to develop innovative treatments. The cancer treatment market is a large sector due to the various methods and techniques companies choose to employ. For instance, chemotherapy is one of the most popular cancer treatments that uses anti-cancer drugs to either cure cancer, prolong life expectancy, or reduce symptoms. On the other hand, radiotherapy is another popular treatment that is aimed at controlling or eliminating malignant cells. Notably, immunotherapies have also become increasingly popular among cancer patients. Immunotherapy harnesses the patient's immune system in order to fight against the cancer. Additionally, immunotherapy also helps the body fight against other infections and diseases. And according to data compiled by Grand View Research, the cancer immunotherapy market is projected to reach USD 126.9 Billion by 2026 while exhibiting a CAGR of 9.6% during the forecast period. INmune Bio, Inc. (NASDAQ: INMB), Celgene Corporation (NASDAQ: CELG), Merck & Co., Inc.  (NYSE: MRK), Gilead Sciences, Inc. (NASDAQ: GILD), Pfizer Inc. (NYSE: PFE)

Immunotherapy can be used to treat other diseases such as Alzheimer's, however, it is most commonly associated with cancer treatment. Immunotherapy works by boosting the immune system, which allows the body to detect and destroy abnormal cells. Furthermore, the therapy also prevents and curbs the growth of other cancers from developing. There are several types of immunotherapies such as immune checkpoint inhibitors, T-cell transfer therapy, monoclonal antibodies, vaccines, and immune system modulators, according to the National Cancer Institute. Vaccines and T-cell transfer therapy focus on boosting the immune system and the T-cell's ability to fight against cancer. On the other hand, immune checkpoint inhibitors are drugs used to block immune checkpoints, which allows immune cells to better respond to cancer cells. Additionally, monoclonal antibodies are proteins created to bind to specific targets on the cancer cells themselves. In some instances, monoclonal antibodies will mark cancer cells, allowing the immune system to better detect and ultimately destroy them. Although immunotherapy is not as popular as chemotherapy, radiotherapy, or surgery, it is becoming an increasingly popular cancer treatment method among patients. "In 2018, there were over 900 new cancer immunotherapies in development, with over 5,000 clinical trials investigating these agents and more than half a million patients being treated with these agents," said Leonard H. Calabrese, DO, Vice Chairman of rheumatic and immunologic disease, at the Cleveland Clinic at the Seventh Annual Basic and Clinical Immunology for the Busy Clinician symposium. "Immunotherapy is now a pillar of cancer treatment — it is now ensconced as a part of this therapy."

INmune Bio, Inc. (NASDAQ: INMB) announced earlier last week that, "RJ Tesi, M.D., Co-Founder and CEO will be featured in an interview with multimedia financial reporter, Jason Lin discussing the company's accomplishments. The interview can be found by clicking here (https://www.youtube.com/watch?v=8qxsO9slZoI&feature=youtu.be ).

'Nasdaq's MarketSite is a premiere platform for INmune Bio to share our story with investors and to discuss recent developments in our programs for cancer, Alzheimer's disease and nonalcoholic steatohepatitis (NASH) liver disease,' said Dr. Tesi. 'We hope to continue reaching new milestones in the development of therapies that target the innate immune system.'

INmune Bio has four drug development programs: two that are designed to treat cancer, INKmune™ and INB03 — with recently reported positive preliminary data from the Phase 1 trial in patients with advanced cancer; XPro1595 for the treatment of neuroinflammation and Alzheimer's disease; and NeuLiv™ for the treatment of NASH.

Additionally, CJ Barnum, Ph.D., Director of Neuroscience, will present on "Approaching Alzheimer's disease as an immunological disease: role of biomarkers" at the World Immunotherapy Congress on Oct. 16 in Switzerland.

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 cancer (INB03), Alzheimer's (XPro595), and NASH (NeuLiv). The Innate Immune 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 ."

Celgene Corporation (NASDAQ: CELG), headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. Celgene Corporation recently announced the first clinical results evaluating iberdomide (CC-220) in combination with dexamethasone in patients with relapsed and refractory multiple myeloma from the ongoing phase 1/2 CC-220-MM-001 study during an oral presentation at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The results included preliminary safety and efficacy data from the ongoing multicenter, open-label, dose-escalation study, which aims to determine the maximum tolerated dose and the recommended phase 2 dose of iberdomide in combination with dexamethasone. Iberdomide is Celgene's proprietary cereblon E3 ligase modulator (CELMoD®) compound with enhanced tumoricidal and immune stimulatory effects demonstrated in preclinical studies. The phase 1/2 study is expected to enroll approximately 300 participants. "Nearly half a million people globally are affected by multiple myeloma, a cancer of plasma cells. The management of patients with late relapsed or refractory multiple myeloma continues to be challenging due to the complex nature of the disease's pathophysiology. Despite the introduction of newer agents, patients continue to experience disease relapse therefore new therapeutic options are needed for patients who have failed multiple prior treatments," said Sagar Lonial, MD, Chief Medical Officer at Winship Cancer Institute of Emory University. "The early data on iberdomide in combination with dexamethasone in these heavily pretreated patients show promising activity, and we look forward to advancing our understanding of this combination's potential in this patient population."

Merck & Co., Inc.  (NYSE: MRK), for more than a century, a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Merck, known as MSD outside the United States and Canada, and Immune Design, recently announced that the companies had entered into a definitive agreement under which Merck, through a subsidiary, will acquire Immune Design for USD 5.85 per share in cash for an approximate value of USD 300 Million. Immune Design is a late-stage immunotherapy company employing next-generation in vivo approaches to enable the body's immune system to fight disease. The company's proprietary technologies, GLAAS® and ZVex®, are engineered to activate the immune system's natural ability to generate and/or expand antigen-specific cytotoxic immune cells to fight cancer and other chronic diseases. "Scientists at Immune Design have established a unique portfolio of approaches to cancer immunization and adjuvant systems designed to enhance the ability of a vaccine to protect against infection, which could meaningfully improve vaccine development," said Dr. Roger M. Perlmutter, President, Merck Research Laboratories. "This acquisition builds upon Merck's industry-leading programs that harness the power of the immune system to prevent and treat disease."

Gilead Sciences, Inc. (NASDAQ: GILD) is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. Gilead Sciences, Inc. and Carna Biosciences Inc. recently announced that the companies had entered into a research and development collaboration to develop and commercialize small molecule compounds in immuno-oncology and to access Carna's proprietary lipid kinase drug discovery platform. Under the terms of the license agreement, Gilead will license from Carna worldwide rights to develop and commercialize inhibitors against an undisclosed immuno-oncology target. In connection with this agreement, Carna will receive an upfront payment of USD 20 Million and is eligible to receive up to an additional USD 450 Million in potential milestone payments upon achievement of certain development and commercial milestones. Carna will also receive royalties on future net sales. "Gilead is committed to building a pipeline in immuno-oncology with a focus on opportunities with the potential to be first-in-class or to be meaningfully differentiated from other therapeutic options," said John McHutchison, AO, MD, Chief Scientific Officer and Head of Research and Development at Gilead Sciences. "Our Carna collaboration also reflects this strategy and we look forward to working with the Carna team to advance novel immunotherapies into clinical testing for the potential benefit of patients."

Pfizer Inc. (NYSE: PFE) applies science and our global resources to bring therapies to people that extend and significantly improve their lives. Pfizer Inc. recently announced positive top-line results from a second Phase 3 pivotal study evaluating the efficacy and safety of its investigational oral Janus kinase 1 (JAK1) inhibitor, abrocitinib, in patients aged 12 and older with moderate to severe atopic dermatitis (AD). This is the second monotherapy trial in the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program (B7451013, or JADE MONO-2). Pfizer announced positive top-line results from the first trial in the JADE program (B7451012, or JADE MONO-1) on May 15th, 2019. Complete results from JADE MONO-1 will be presented as a late-breaking abstract at a major upcoming European scientific meeting in Madrid in October 2019. Pfizer's leading JAK biology and chemistry expertise from years of JAK research experience, has enabled the company to take a different R&D approach, resulting in the broadest immunokinase inhibitor pipeline. Instead of studying a single molecule for all its potential uses, where it may not be optimal for some, Pfizer's candidates are purposefully matched to the conditions where we believe they have the greatest potential to, if approved, address unmet need. Pfizer has five unique immunokinase inhibitors in late-stage clinical trials for the potential treatment of nine immune-mediated diseases. "These findings add to a growing body of evidence supporting the potential of abrocitinib to improve the lives of people living with moderate to severe atopic dermatitis," said Michael Corbo, PhD, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development. "We look forward to continued findings from the JADE program, with results from the next abrocitinib efficacy study, using an active control, becoming available in spring 2020. This will further our understanding of abrocitinib as a potential medicine for patients who suffer from this chronic condition."

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