Solving One of the Largest Drivers of Disease: Inflammation

NEW YORK, Sept. 30, 2020 /PRNewswire/ -- Inflammation typically occurs in the body as a natural response to threats such as infection or injury, but chronic inflammation can cause severe damage and even death. Inflammation is a well-known symptom of multiple infectious diseases. However, multidiscipline research strongly suggests that inflammation is also closely linked with a broad range of noninfectious diseases. The critical aspects of the interplay between inflammation and disease may well be the key to development of a new generation of drugs to treat previously untreatable diseases, sparking a flurry of biotech research and development in the field. At the vanguard of this new drug development, 180 Life Sciences Corp. (NASDAQ: KBLM) (180 Profile) is driving groundbreaking studies in clinical programs aimed at developing novel therapeutics that address distinct areas of inflammation, finally offering hope for vast unmet medical needs in inflammatory diseases, fibrosis, pain and more. Amgen Inc. (NASDAQ: AMGN) acquired the anti-inflammatory drug Enbrel for $4.8 billion in 2018 and, in conjunction with AbbVie Inc. (NYSE: ABBV) and others, is testing anti-inflammatory drugs in a joint COVID-19 study. Actemra, an anti-inflammatory arthritis drug from Roche Holding Ltd. (OTC: RHHBY) previously failed to meet its primary endpoint in earlier COVID trials. Johnson & Johnson (NYSE: JNJ) now owns Remicade, which was developed by the current management of 180 Life Sciences, the first tumor necrosis factor-α (TNF) inhibitor and one of the top anti-inflammatory drugs in the world with over $5 billion in sales in 2019 alone.

  • Fifty percent of deaths are attributable to inflammation-related diseases.
  • 180 Life Sciences is founded by world-renowned pioneers of anti-inflammatory research and drug development. Previous drug discoveries, such as Remicade and Tysabri, have led to multibillion-dollar buyouts.
  • Anti-inflammatory biologics market projected to reach $150 billion annually by 2027.
  • 180 Life Sciences is focusing on developing the next generation of innovative anti-inflammatory drugs to inhibit the ravages of chronic inflammation.

Click here to view the custom infographic of the 180 Life Sciences Corp. (NASDAQ: KBLM) editorial.

Disease Is inflammation, Inflammation Is Disease

This seeming paradox can best be explained in a "Nature Medicine" article that states, "One of the most important medical discoveries of the past two decades has been that the immune system and inflammatory processes are involved in not just a few select disorders, but a wide variety of mental and physical health problems that dominate present-day morbidity and mortality worldwide. Indeed, chronic inflammatory diseases have been recognized as the most significant cause of death in the world today, with more than 50% of all deaths being attributable to inflammation-related diseases such as ischemic heart disease, stroke, cancer, diabetes mellitus, chronic kidney disease, non-alcoholic fatty liver disease (NAFLD) and autoimmune and neurodegenerative conditions."

Staggering to think that 50% of all deaths are attributable to inflammation-related diseases. Multiple studies indicate that chronic inflammation triggers a cascade of disease-causing effects. The condition has also been linked to Alzheimer's disease, cancer, heart disease and diabetes among others. Periodic increases in inflammation to combat injury or infection are normal, even necessary to survive. However, the immune system doesn't shut off in chronic inflammation, continuing to act as if there's a problem — either because one still exists or because the inflammatory response isn't working correctly. This understanding opens revolutionary new possibilities for treatment and therapeutics.

Creating Solutions

180 Life Sciences Corp. (NASDAQ: KBLM) is developing novel therapeutics to treat inflammation, the fundamental basis of most disease states. The company is led by distinguished serial biomedical entrepreneurs, who were the first to successfully develop anti-inflammatory drugs such as the anti-TNF biologics and the anti-integrin inhibitors that are now on the market generating multibillions of dollars per year in sales. 180 Life Sciences' clinical-stage research is now focused on developing the next generation of innovative anti-inflammatory drugs to inhibit the ravages of chronic inflammation and provide relief for millions of patients with inflammatory disease.  

Reflective of decades of experience, the company has mitigated both the risk and the cost associated with biotechnology companies by having multiple programs in different stages of development and by using significant non-dilutive grant funding and cost-effective clinical trials. The first targets, which are in clinical stages, are Dupuytren's disease (Phase 2b/3), frozen shoulder (Phase 2 planned) and post-operative cognitive deficit (Phase 2 planned) using anti-TNF therapy, which suppresses the immune system by blocking activity in the body that can cause inflammation and lead to immune-system diseases.

Active Programs Designed for Development

180 Life Sciences has three active platforms designed to develop novel drugs in separate areas of inflammation. The initial programs offer solutions to diseases that have no effective nonsurgical therapies. The Fibrosis & Anti-TNF (Phase 2b/3 Trials) platform is based at Oxford University and is led by Jagdeep Nanchahal, a surgeon-scientist running the phase 2 trials, and Marc Feldmann, a renowned immunologist and a pioneer of anti-TNF therapy.

This platform is designed to address critical areas of inflammation: Dupuytren's contracture, a hand deformity that afflicts about 5% of the U.S. population; frozen shoulder, which causes pain and range of motion loss; and POCD (post-operative cognitive dementia), a serious post-operative complication. There are more than 350,000 coronary artery bypass procedures conducted in the United States each year; POCD is observed in over 40% of those.

180 Life Sciences may well be on the path to a preventive therapy. The company is in Phase 2b/3 with Dupuytren's and plans on starting Phase 2 for frozen shoulder and POCD in Q3/4 2021.  The company has a vast intellectual property portfolio for all these indications and is also developing novel agents as next-generation anti-inflammatory therapeutics for use when current anti-TNF's fail, which they often do over time.

In addition, preclinical studies in liver fibrosis and nonalcoholic steatohepatitis (NASH) are set to begin in late 2020. There are numerous near-term inflection points for the anti-TNF programs; one program is already in late-stage 2b/3 trial, and two additional clinical programs are projected to start Q3/4 2021, funded by a grant awarded by the UK's National Institute for Health Research.

The other two preclinical programs are Inflammatory Pain and A7nAChR. Directed by Raphael Mechoulam at the Hebrew University in Israel, Inflammatory Pain is focused on discovering novel compounds to treat chronic inflammatory pain. α7nAChR is led by Lawrence Steinman and Jonathan Rothbard, MD, out of Stanford University and seeks to develop a treatment for ulcerative colitis in ex-smokers by targeting α7nAChR, a nicotine receptor in the body and a central factor in the body's method of controlling inflammation.

Though currently a private company, 180 Life Sciences has entered into a merger agreement with KBL Merger Corp. IV and filed its registration statement with the SEC. KBLM is a special purpose acquisition corporation (SPAC), some of which — such as DraftKings and Virgin Galactic — have performed very well this year. KBLM has successfully closed a bridge financing with proceeds used for working capital to complete the merger and advance clinical programs. The business combination is expected to close in Q4 2020. Following the merger, 180 Life Sciences will be listed on the Nasdaq Capital Market under ticker symbol ATNF, and shareholders of KBLM will receive one-for-one shares in 180 Life Sciences.

Blockbuster Potential

There's no doubt the 180 Life Sciences' team has the knowledge and experience necessary to create another blockbuster drug. Team members developed the first-ever anti-inflammatory therapeutics that are on the market today. These drugs now accrue billions of dollars a year in sales.

A pioneer of anti-TNF therapy, Feldmann is a pre-eminent immunologist and professor at the University of Oxford. He is co-chair of 180 Life Sciences and the recipient of seven International awards for Biomedical Innovation, including Crafoord and Lasker Awards, and is a fellow of the Royal Society

Steinman, also co-chair, is a Stanford University clinician and scientific luminary, having discovered the role of integrins, which led to the creation of Tysabri (Natalizumab), a highlight effective treatment for multiple sclerosis and inflammatory bowel disease. Steinman is a member of the National Academy of Sciences and has received four international awards for biomedical innovation.

CEO James N. Woody, was instrumental in the discovery of Remicade as chief scientific officer at Centocor, which was then sold to Johnson & Johnson for $4.9 billion. Previously, Woody founded Avidia and Proteolix, both of which were sold to Amgen. He was also a general partner at Latterell Venture Partners. Woody also previously served as general manager of Roche Biosciences, the former Syntex Pharmaceutical Company.

The company already has a large pipeline of drugs in various stages of clinical development, creating multiple near-term value inflection points and surrounded the intellectual properties with significant patent protection.  The multiple programs currently underway create multiple opportunities for licensing, joint ventures, the acquisition of novel compounds, and the potential for a series of blockbuster anti-inflammatory therapeutics.

Anti-Inflammatory Apostles

Amgen Inc. (NASDAQ: AMGN) acquired the anti-inflammatory drug Enbrel for $4.8 billion in 2018. The company recently announced, in collaboration with other biotech companies, the enrollment of the first patients in the I-SPY COVID Trial, which will evaluate the efficacy of Amgen's Otezla in severely ill, hospitalized COVID-19 patients who require high-flow oxygen. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that enhance health outcomes and dramatically improve people's lives.

AbbVie Inc. (NYSE: ABBV) is intent on discovering and delivering innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. The company is currently testing anti-inflammatory drugs in a joint COVID-19 study. The company's mega-blockbuster Humira, is expected to reach USD $21 billion in 2020. AbbVie is building up a robust pipeline of late-stage drugs with immunology drugs as the focal point.

Roche Holding Ltd. (OTC: RHHBY) is a Swiss multinational healthcare company that operates worldwide under two divisions: pharmaceuticals and diagnostics. Roche's anti-inflammatory drug Actemra failed to help Covid-19 patients in a late-stage clinical trial. The company has launched a new quantitative antibody test to measure SARS-CoV-2 antibodies to support the evaluation of vaccines. The new Elecsys Anti-SARS-CoV-2 S test can quantitatively measure the level of antibodies against SARS-CoV-2 in patients who have been exposed to the virus.

Johnson & Johnson (NYSE: JNJ) owns Remicade, the first tumor necrosis factor-α (TNF) inhibitor and one of the top anti-inflammatory drugs in the world with more than $5 billion in sales in 2019 alone. JNJ just announced the launch of its large-scale, pivotal, multicountry Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies. The initiation of the ENSEMBLE trial follows positive interim results from the Company's Phase 1/2a clinical study. Interestingly, the founding scientists at 180 Life Sciences discovered the anti-TNF drug class while at Centocor Biotech, which was eventually acquired by J&J for $4.9 billion.

Anti-inflammatory biologic drugs have changed the lives of millions of people across the globe. Research indicates that further focus on treating chronic inflammation could solve many of the perplexing maladies that afflict humanity.

For more information about 180 Life Sciences Corp., please visit 180 Life Sciences Corp.

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