NetworkNewsWire Editorial Coverage: 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) (NASDAQ: KBLMR) (NASDAQ: KBLMW) (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. (OTCQX: 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.
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.
180 Life Sciences Corp. (NASDAQ: KBLM) (NASDAQ: KBLMR) (NASDAQ: KBLMW) 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 Inc. (NASDAQ: DKNG) and Virgin Galactic Holdings, Inc. (NYSE: SPCE) — 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 KBL Merger Corp. IV (NASDAQ: KBLM) will receive one-for-one shares in 180 Life Sciences.
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.
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. (OTCQX: 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.
NetworkNewsWire (“NNW”) is a financial news and content distribution company, one of 40+ brands within the InvestorBrandNetwork (“IBN”), that provides: (1) access to a network of wire solutions via NetworkWire to reach all target markets, industries and demographics in the most effective manner possible; (2) article and editorial syndication to 5,000+ news outlets; (3) enhanced press release solutions to ensure maximum impact; (4) social media distribution via IBN millions of social media followers; and (5) a full array of corporate communications solutions. As a multifaceted organization with an extensive team of contributing journalists and writers, NNW is uniquely positioned to best serve private and public companies that desire to reach a wide audience comprising investors, consumers, journalists and the general public. By cutting through the overload of information in today’s market, NNW brings its clients unparalleled visibility, recognition and brand awareness. NNW is where news, content and information converge.
To receive SMS text alerts from NetworkNewsWire, text “STOCKS” to 77948 (U.S. Mobile Phones Only)
For more information, please visit https://www.NetworkNewsWire.com
NetworkNewsWire is part of the InvestorBrandNetwork
DISCLAIMER: NetworkNewsWire (NNW) is the source of the Article and content set forth above. References to any issuer other than the profiled issuer are intended solely to identify industry participants and do not constitute an endorsement of any issuer and do not constitute a comparison to the profiled issuer. The commentary, views and opinions expressed in this release by NNW are solely those of NNW. Readers of this Article and content agree that they cannot and will not seek to hold liable NNW for any investment decisions by their readers or subscribers. NNW is a news dissemination and financial marketing solutions provider and are NOT registered broker-dealers/analysts/investment advisers, hold no investment licenses and may NOT sell, offer to sell or offer to buy any security.
The Article and content related to the profiled company represent the personal and subjective views of the Author, and are subject to change at any time without notice. The information provided in the Article and the content has been obtained from sources which the Author believes to be reliable. However, the Author has not independently verified or otherwise investigated all such information. None of the Author, NNW, or any of their respective affiliates, guarantee the accuracy or completeness of any such information. This Article and content are not, and should not be regarded as investment advice or as a recommendation regarding any particular security or course of action; readers are strongly urged to speak with their own investment advisor and review all of the profiled issuer’s filings made with the Securities and Exchange Commission before making any investment decisions and should understand the risks associated with an investment in the profiled issuer’s securities, including, but not limited to, the complete loss of your investment.
NNW HOLDS NO SHARES OF ANY COMPANY NAMED IN THIS RELEASE.
This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “may”, “future”, “plan” or “planned”, “will” or “should”, “expected,” “anticipates”, “draft”, “eventually” or “projected”. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company’s annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and NNW undertakes no obligation to update such statements.
Additional Information about the 180 Life Sciences Business Combination and Where to Find It
KBL Merger Corp. IV (“KBL”) has filed a registration statement on Form S-4, which includes a preliminary proxy statement/prospectus for KBL’s stockholders, with the Securities and Exchange Commission. KBL’s definitive proxy statement/prospectus will be mailed to KBL’s stockholders that do not opt to receive the document electronically. KBL and 180 Life Sciences urge investors, stockholders and other interested persons to read the preliminary proxy statement/prospectus, as well as other documents that will be filed with the SEC, because these documents will contain important information about the proposed business combination transaction. Such persons can also read KBL’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019, for a description of the security holdings of its officers and directors and their respective interests as security holders in the consummation of the proposed business combination transaction. KBL’s definitive proxy statement/prospectus, which is included in the registration statement, will be mailed to stockholders of KBL as of a record date to be established. KBL’s stockholders will also be able to obtain a copy of such documents, without charge, by directing a request to: KBL Merger Corp. IV, 30 Park Place, Suite 45E, New York, NY 10007; e-mail: firstname.lastname@example.org These documents can also be obtained, without charge, at the SEC’s web site (http://www.sec.gov)
Participants in Solicitation
KBL and its directors and executive officers may be deemed to be participants in the solicitation of proxies for the special meeting of KBL’s stockholders to be held to approve the proposed transactions in connection with the business combination with 180 Life Sciences. Information regarding the persons who may, under the rules of the SEC, be deemed participants in the solicitation of KBL’s stockholders in connection with the proposed business combination with 180 Life Sciences are set forth in the amended preliminary proxy statement/prospectus included in the registration statement that was filed with the SEC on August 28, 2020. You can find information about KBL’s executive officers and directors in its Annual Report on Form 10-K for the fiscal year ended December 31, 2019, which was filed with the SEC on April 7, 2020. You can obtain free copies of these documents from KBL using the contact information above.
This communication is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed business combination between KBL and 180 Life Sciences and shall not constitute an offer to sell or a solicitation of an offer to buy the securities of KBL and 180 Life Sciences, nor shall there be any sale of any such securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.