180 Life Sciences Corp. $KBLM Advancing Lead Program, Plans Additional Clinical Trials

KBL Merger Corp. IV (NASDAQ: KBLM), a special purpose acquisition corporation (SPAC), announced that, in connection with its previously detailed merger agreement with 180 Life Sciences, it consummated a bridge financing on June 29, 2020, and submitted its latest S4 filing with the SEC on August 28, 2020. It expects to close the business combination in Q4 2020. Following the merger, the company will be listed on the Nasdaq Capital Market under ticker symbol ‘ATNF’.

180 Life Sciences Corp. is a clinical-stage biotechnology company focused on the development of novel drugs that fulfill unmet needs in inflammatory diseases, fibrosis and pain by leveraging the combined expertise of luminaries in therapeutics from Oxford University, the Hebrew University and Stanford University.

KBLM has valued 180 Life Sciences at $175 million, with the acquisition being carried out via a share swap through which each share of 180 Life Sciences will be exchanged for one share of KBLM.

Drug Development Programs

180 Life Sciences is leading the research into solving one of the world’s biggest drivers of disease – inflammation. The company is driving groundbreaking study into clinical programs, which are seeking to develop novel drugs addressing separate areas of inflammation for which there are no effective therapies.

The company’s primary platform is a novel program to treat fibrosis and inflammation using anti-TNF, with its lead program in phase 2b/3 clinical trials with first results expected in 2021. Further clinical trials are scheduled to begin by the end of 2020. The company has two additional programs that are in the preclinical stage and are showing promising results.

• Fibrosis & Anti-TNF (Phase 2b/3 Trials): Based at the Kennedy Institute within Oxford University, the fibrosis and anti-TNF program is being led by Professor Jagdeep Nanchahal, a surgeon-scientist who has been running the phase 2 trials, and Professor Sir Marc Feldmann, a renowned immunologist and one of the pioneers of anti-TNF therapy. The program is designed to address four critical areas of inflammation:
  1. The phase 2b/3 trial evaluating the treatment of early stage Dupuytren’s disease (DD) is a fully grant-funded and enrolled study, with top line data expected to be available by Q4 2021.
  2. The phase 2b trial studying the treatment of frozen shoulder is likewise grant-funded and is scheduled to be initiated by Q3 2021.
  3. The phase 2 trial in post-operative cognitive deficit (POCD) is anticipated to commence in Q4 2021.
  4. Preclinical studies in liver fibrosis and nonalcoholic steatohepatitis (NASH) are set to begin in late 2020.
• Inflammatory Pain (Preclinical): Directed by Professor Raphael Mechoulam at the Hebrew University in Israel, this program is focused on discovering novel compounds to treat chronic inflammatory pain.
• A7nAChR (Preclinical): Led by Professor Lawrence Steinman and Dr. Jonathan Rothbard, 180 Life Sciences is seeking to develop a treatment for ulcerative colitis in ex-smokers by targeting the a7nAChR, a nicotine receptor in the body and a central factor in the body’s method of controlling inflammation.

Market Size for Anti-Inflammatory Medication

According to a study carried out by Allied Market Research, the anti-inflammatory therapeutics market is expected to grow to an approximate $106.1 billion annual market size in 2020, registering a CAGR of 5.9% during the period from 2015 to 2020.

Ranging from asthma treatments to targeting the causes of diseases such as arthritis, multiple sclerosis, psoriasis and inflammatory bowel disease, anti-inflammatory therapeutics have seen a sharp increase in usage, particularly given that they allow for medical responses that are more targeted and effective while possessing lesser side effects relative to conventional drugs.

Management Team

Professor Sir Marc Feldmann, Co-Chairman, is known to be a pioneer of anti-TNF therapy, which seeks to suppress the immune system by blocking the activity of TNF, a substance in the body that can cause inflammation and lead to immune-system diseases. As of today, anti-TNF therapy drugs have become the world’s largest drug class, with sales estimated at over $40 billion per annum. Feldmann has received seven international awards for biomedical innovation over the years, including the Crawford and Lasker awards, and he is a member of the Royal Society.

Professor Lawrence Steinman, Co-Chairman, is a scientific luminary, having discovered the role of integrins, which led to the creation of 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, including the Charcot Prize. Prior to joining 180 Life Sciences, Steinman founded Centocor, a pharmaceutical company that was sold to Johnson & Johnson for $4.9 billion.

Dr. James N. Woody, CEO, was instrumental in the discovery of Remicade as Chief Scientific Officer at Centocor. Previously, Woody founded Avidia and Proteolix, both of which were subsequently sold to Amgen, and he was a General Partner at Latterell Venture Partners. Boasting over 25 years of pharmaceutical research and management experience, Woody was also previously the general manager of Roche Biosciences, the former Syntex Pharmaceutical Company.