180 Life Sciences is creating breakthrough therapeutic innovations for pain and inflammation. CEO Dr. Jim Woody and his life science experts are on a mission to provide humanity with therapeutic programs that address some of the most prevalent diseases human kind is facing today. Find out more in this exclusive TechBullion interview with Dr. Jim Woody, CEO and Director of 180 Life Sciences.
Please tell us more about yourself?
I am Dr. James Woody, CEO of 180 Life Sciences Corp (180LS). By training I’m a Pediatric Immunologist, having trained at both Duke University and Boston Children’s Hospital. Following my pediatric training, I was drafted into the US Navy, to manage their radiation injury program. I assembled a group of innovative immunologists and clinicians that worked together to discover how to perform bone marrow transplants while avoiding rejection of the new marrow. We discovered that very specific HLA matching was required. From this discovery our group founded the National Marrow Donor Program, which has helped well over a hundred thousand patients who needed bone marrow transplants but didn’t have a matched donor.
I left the Navy and went on to become Chief Scientific Officer of an early biotech company called Centocor. At Centocor we developed the very first anti TNF biologic inhibitor called Infliximab, or Remicade. With my colleague doctor Marc Feldmann, who discovered that TNF was driving the inflammation and joint destruction in Rheumatoid Arthritis (RA), we were the first to ever treat such patients, who had an amazing beneficial clinical response. This therapy now allows RA patients to live a normal life. There are no RA patients in wheelchairs worldwide because of the anti TNF drugs. We subsequently discovered that Remicade was also effective in Psoriasis, Crohn’s disease, and Ulcerative Colitis. J & J acquired Centocor and, to this day, still sells Remicade. There are now many versions of anti TNF biologics, which are the largest selling biologics in the marketplace at over $40 billion per year.
I left Centocor and became general manager of Roche Bioscience in California, the former Syntex pharmaceutical company. After 8 years, I left and helped start several companies, and subsequently joined a Venture capital group, where we founded many biotechnology companies. More recently I helped start several new companies on my own and was approached by the founders of 180 Life Sciences to be CEO of their new company.
What is 180 Life Sciences and what inspired this business?
180 Life Sciences is a combination of three programs with a focus on developing novel new therapies to treat fibrosis, inflammation, and pain. Since our original discoveries for the use of Remicade in rheumatoid arthritis, Crohn’s disease, psoriasis, and ulcerative colitis, few new indications have emerged for use of this potent anti-inflammatory. Our founders reasoned that anti TNF therapy could be very useful in a variety of other conditions which had not yet been discovered in order to address unmet medical needs. They felt that anti TNF therapies might be useful in treating other diseases.
Inflammation is a major driver of numerous diseases worldwide, could you give us some statistics on how these inflammatory diseases are impacting patients worldwide?
Inflammation and pain are significant worldwide problems. Estimates show that nearly 125 million Americans are living with chronic inflammatory conditions of some type and over 61 million have more than one type. Over 400 million people in developed countries worldwide suffer from persistent pain often associated with inflammatory diseases. In the USA there are about 1.3 million patients with Rheumatoid Arthritis, 3 million with Crohn’s, 7.5 million with psoriasis, and 800 thousand with ulcerative colitis.
As the Director of 180 Life Sciences, could you give us an elaborate detail of what your company is doing to develop solutions for the treatment of arthritis, pain, inflammation and other health issues?
We aren’t treating arthritis however we are exploring new innovative frontiers by administering anti TNF for inflammation driven fibrosis in two programs, and anti TNF to prevent the neuro inflammation of postoperative dementia in a third.
The first fibrotic disease that we are treating is called Dupuytren’s contracture. It starts as a small nodule in the palm of your hand and overtime collagen fibrotic cords are formed that pull the fingers together so that you are unable to button clothes, type, play an instrument etc. The current therapies only treat people after they have the disability. Current treatments use a collagenase enzyme to try to dissolve the fibrous cords that are formed, or try to mechanically disrupt them, or eventual surgery to cut them out. The focus of our program is to prevent the disability from forming altogether. Our scientific team found that TNF was driving the nodules to form the fibrous cords, and that injecting the nodules with anti TNF stopped this process. We conducted a large 140 patient trial that showed that anti TNF injections stopped the nodule from growing, while saline injections did not. This was published in Lancet Rheumatology. We are using this to seek regulatory approval to be able to market this preventative therapy, which we have patented. Most everyone would like to avoid having the fingers contracted, we believe.
A second need is with a condition known as frozen shoulder. In this case, the shoulder becomes extremely painful and immobile, and fibrous tissue forms in the joint that eventually has to be removed by surgery. It turns out that half of these patients have Dupuytren’s, so we think that the fibrosis process is similar. We organized a small trial to inject shoulders with anti TNF as soon as they become painful. We don’t have the results of a small trial as of yet.
A third trial using anti TNF is in a condition called postoperative dementia. It often occurs in patients after major surgery such as hip repair or cardiovascular surgery. It has been thought this was due to anesthesia, but we have evidence that the tissue trauma releases TNF, which causes inflammation in the cognitive areas of the brain. In about 20% of cases the dementia persists, and patients end up in nursing homes. We will be initiating a trial treating patients undergoing hip repair at the time of surgery with anti TNF to determine if we can prevent this form of neuroinflammatory dementia.
In another program area we are producing totally synthetic cannabinoid analogs that we know are both anti-inflammatory and analgesic. We will be utilizing these in various conditions trying to reduce both inflammation and pain.
Tell us more about the 180 Life Sciences’ real alternative to unregulated cannabidiol, who are the brains behind this program, how does this work and what makes it different?
One of the companies that merged into 180 Life Sciences had formed several scientific research projects with Professor Raphael Mechoulam, of Hebrew University, who was one of the co-founders of 180 Life Sciences. Dr. Mechoulam was the father of cannabinoid research and discovered the human endocannabinoid system.
Under the agreements his laboratory created, several totally synthetic forms of cannabinoid compounds were found, in animal models, to have both anti-inflammatory and analgesic properties. The over-the-counter common cannabis has over 100 compounds in it, some of which may cause unusual and unwanted effects. A pure single synthetic version with the desired activity, avoids all the other potential complications.
Another issue is that the cannabinoid compounds are not absorbed in the GI tract when taken orally. So one is never certain what the correct dose might be for any kind of therapy. On the other hand, these synthetic cannabinoids may be able to be formulated in a fashion that would make them uniformly absorbed in the GI tract, so one could actually tailor an effective dose. 180 Life Sciences has filed a number of patents surrounding these compounds and their potential use in various situations.
Unfortunately, Professor Mechoulam recently passed away, however much of the work may continue in his laboratory with his colleagues. We are hoping to be able to make compounds that are orally available, are not psychogenic, are not addictive, and are effective both in inflammatory and painful conditions.
On The Smoking cessation induced Ulcerative Colitis (UC) program, could you give us an overview of this therapy and why it is important today?
As it turns out, the A7 nicotinic acid receptor agonist can stimulate receptors that are anti-inflammatory. We know that some patients who discontinue smoking subsequently develop ulcerative colitis. We think an orally active A7 agonist compound would be able to reverse this with its anti-inflammatory properties. It turns out that the chemistry for these compounds is very difficult and the program has been challenging to create effective lead molecules. Such compounds could also likely be used in a wide variety of other inflammatory diseases.
What is next on your pipeline and where do we see the future of the LifeScience industry?
With the three programs that we have in place with anti TNF, as well as the synthetic cannabinoid programs, and the A7 programs, we are continuing to work on inflammation, fibrosis, and pain. In the TNF area it turns out there are two TNF receptors. When TNF binds to one of the receptors it causes inflammation, when TNF binds through the 2nd receptor it is anti-inflammatory. In the future we could envision specific drugs for each of these receptors, one perhaps to shut off the inflammatory receptor while activating the anti-inflammatory receptor at the same time, which could possibly give real benefits to patients and might avoid some of the infectious disease complications currently seen with the anti TNF biologics.
Do you have any available opportunities for investors and partnerships to assist you in this journey to save humanity?
We are a publicly traded company on Nasdaq under the ticker symbol ATNF. Potential investors can purchase our common stock in the open market through their brokers. As a pre-revenue biotech company, we also periodically raise outside capital. Investors who wish to participate in these offerings are welcome get in touch with our investor relations department by completing the contact form on our website. Further information for our investors can also be found on our investor relations website at https://ir.180lifesciences.com/.
Would you like to share some of your success stories so far with these programs? Any more tips to share with our readers today?
Our clinical scientists worked out and published the scientific detail and exact metabolic pathways leading to the finger contraction and patient disability in Dupuytren’s disease. They found that the palm nodules drove the formation of the fibrous cords that pull the fingers together. In some elegant experiments they showed that the process was being driven by TNF, and that injecting the nodule with anti TNF could stop this process, and possibly prevent the progression to the finger deformity. This was demonstrated with the largest randomized placebo controlled preventative trial ever conducted. The results were amazing, in that the nodules became smaller and softer with the anti TNF injections. We believe we may have a truly preventative therapy, rather than patents waiting to see if their fingers contract, because all current therapies are used only after the contraction and disability is present.