NEW YORK, Oct. 2, 2020 /PRNewswire/ -- Innovation and breakthroughs in the biotech industry are essential to identifying and providing life-saving treatments. Companies that invest substantial amounts of time, effort, and resources in key areas of research and innovation are critical in the advancement treatment options across the board. On the front lines of research and development in the area of inflammation, which typically occurs in the body as a natural response to threats such as infection or injury can cause severe damage and even death, is 180 Life Sciences Corp. (NASDAQ: KBLM) (180 Profile). The company is focused on groundbreaking studies in clinical programs designed to develop novel therapeutics that address distinct areas of inflammation. Adaptimmune Therapeutics plc (NASDAQ: ADAP) recently announced that the European Medicines Agency (EMA) has granted the company access to the PRIority MEdicines (PRIME) initiative for ADP-A2M4 for the treatment of synovial sarcoma. Earlier this year, the FDA approved Aimmune Therapeutics Inc.'s (NASDAQ: AIMT) PALFORZIA(TM) as a first treatment for life-threatening peanut allergies. Immunovant Inc. (NASDAQ: IMVT) has announced positive topline results from ASCEND MG, a Phase 2a study of IMVT-1401 in patients with myasthenia gravis (MG). And CareDx Inc. (NASDAQ: CDNA) has partnered with Johns Hopkins University to launch the ALARM (AlloSure Lung Allograft Remote Monitoring) system, which provides home blood draws for routine transplant surveillance tests for the university's immunosuppressed transplant patients.
- More than 50% of all 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.
A "Most Important" Medical Discovery
A central concern for many biotech companies in the medical sector is inflammation. 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.
A "Nature Medicine" article observes that "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."
The idea that an estimated half of all deaths are attributable to inflammation-related diseases is sobering. In addition, inflammation has been linked to Alzheimer's disease, cancer, heart disease and diabetes among others. Of course, normal increases in inflammation to fight off infection or respond to injury are normal, even necessary to survive. The problem with chronic inflammation is that the immune system doesn't shut off, continuing to act as if there's a problem — either because one actually does exists or because the inflammatory response isn't working correctly. This insight opens new possibilities for groundbreaking treatment and therapeutics.
Developing Next-Generation Solutions
180 Life Sciences Corp. (NASDAQ: KBLM) is intent on developing novel therapeutics to treat inflammation, the fundamental basis of most disease states. The company's executive time includes 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 currently targeting the development of the next generation of innovative anti-inflammatory drugs to slow the ravages of chronic inflammation and offer relief for millions of patients with inflammatory disease.
Relying on decades of experience, the company has decreased both the risk and the cost faced by many 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, Significant Advancements
180 Life Sciences is currently focusing on three active platforms designed to develop novel drugs in distinct areas of inflammation. The initial programs offer solutions to diseases with no effective nonsurgical therapies. Based at Oxford University, the Fibrosis & Anti-TNF (Phase 2b/3 Trials) platform is led by Jagdeep Nanchahal, a surgeon-scientist running the phase 2 trials, and Marc Feldmann, a renowned immunologist and anti-TNF therapy pioneer.
The Fibrosis & Anti-TNF platform is intended to address acute areas of inflammation: Dupuytren's contracture, a hand deformity that afflicts about 5% of the U.S. population; frozen shoulder, which causes range of motion loss along with pain; and POCD (post-operative cognitive dementia), a serious post-operative complication. More than 350,000 coronary artery bypass procedures are conducted in the United States each year, and POCD is observed in more than 40% of those.
180 Life Sciences appears to be making significant advancements toward identifying 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. In addition, 180 Life Sciences has an immense intellectual property portfolio for all these indications and is developing novel agents as next-generation anti-inflammatory therapeutics for use when current anti-TNF's fail, which they are wont to do.
In addition, preclinical studies in liver fibrosis and nonalcoholic steatohepatitis (NASH) are scheduled to begin in late 2020. Numerous near-term inflection points are included in these 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 National Institute for Health Research grant.
The company's other two preclinical programs are Inflammatory Pain and A7nAChR. Led by Raphael Mechoulam at the Hebrew University in Israel, Inflammatory Pain is focused on discovering novel compounds to treat chronic inflammatory pain. α7nAChR is directed by Lawrence Steinman and Jonathan Rothbard, MD, from Stanford University. This program seeks to identify a treatment for ulcerative colitis in ex-smokers by targeting α7nAChR, a nicotine receptor in the body and a key 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 (KBLM) and filed its registration statement with the SEC. KBLM is a special purpose acquisition corporation (SPAC), some of which — such as Forum Merger II Corporation (NASDAQ: FMCI) and AdaptHealth Corp. (NASDAQ: AHCO) — 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. will receive one-for-one shares in 180 Life Sciences.
The 180 Life Sciences' team certainly looks to have the key knowledge and experience to deliver another groundbreaking drug. Team members developed the first-ever anti-inflammatory therapeutics currently on the market; these drugs 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. Woody also founded Avidia and Proteolix, both of which were sold to Amgen. In addition, he was also a general partner at Latterell Venture Partners. Woody previously served as general manager of Roche Biosciences, the former Syntex Pharmaceutical Company.
In addition, the company has a significant pipeline of drugs in different stages of clinical development, creating intellectual properties with significant patent protection. The programs currently underway generate multiple opportunities for licensing, joint ventures, the acquisition of novel compounds, and the potential for a series of blockbuster anti-inflammatory therapeutics.
Innovation and Breakthroughs
The European Medicines Agency (EMA) has granted Adaptimmune Therapeutics PLC (NASDAWQ: ADAP) access to the PRIME initiative for ADP-A2M4 for the treatment of synovial sarcoma. PRIME access provides enhanced scientific and regulatory support by the EMA to developers of medicines with the potential to significantly address unmet medical needs. ADAP, a leader in cell therapy to treat cancer, was granted access based on clinical data from its Phase 1 trial demonstrating compelling efficacy and early promising durability, with tolerable safety in patients with synovial sarcoma.
Aimmune Therapeutics Inc. (NASDAQ: AIMT) has announced FDA approval of PALFORZIA, the first approved treatment for patients with peanut allergy. PALFORZIA is an oral immunotherapy indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. PALFORZIA is approved for use in patients with a confirmed diagnosis of peanut allergy and is to be used in conjunction with a peanut-avoidant diet.
Immunovant Inc. (NASDAQ: IMVT) has released positive topline results from its multi-center, placebo-controlled Phase 2a trial of IMVT-1401. IMVT-1401 is a novel investigational Anti-FcRn antibody delivered by subcutaneous injection and was studied in patients diagnosed with myasthenia gravis. Highlights of the results include a 3.8-point mean improvement on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale, which was statistically significant vs. placebo and the fact that IMVT-1401 was observed to be generally safe and well-tolerated with no serious adverse events and no withdrawals due to adverse events.
The ALARM (AlloSure Lung Allograft Remote Monitoring) partnership between CareDx Inc. (NASDAQ: CDNA) and Johns Hopkins is in response to an emergent need to implement patient home isolation to reduce the risk of community spread and exposure to the dangerous virus. For high-risk populations who need close medical monitoring, Johns Hopkins has adopted CareDx's RemoTraC for their kidney, heart, and lung transplant patients. RemoTraC and AlloSure (dd-cfDNA) provide a potential alternative to clinical diagnostics such as bronchoscopic biopsies that have to be performed in the hospital setting.
Companies have invested substantial resources in the search for identifying and providing life-saving treatments. As a result, critical advancements have been made across the board as these companies transform modern medicine.
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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.
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