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) (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.
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 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 (OTC: 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. (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.
For more information about 180 Life Sciences Corp., please visit
180 Life
Sciences Corp and see the 180 Life Sciences
Company Presentation
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