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Artelo Biosciences: Using Cutting-Edge Science with Lipid-Signaling Modulation to Improve Treating People with Cancer

Marko Höynälä | CEO & Founder | Artelo Biosciences
Marko Höynälä | CEO & Founder | Artelo Bio

A challenge while delivering care is assisting patients with both acute and chronic pain management. Particularly so for people living with cancer.

The initial stage of treating any disease or ailment is diagnosing the cause and treating it with appropriate interventions, including drugs or varied therapeutic approaches as required. However, a standard diagnosis-treatment-healing paradigm doesn’t always work well for a person living with cancer.

Through the cancer treatment journey, a person diagnosed with cancer may encounter considerable peripheral pain (neuropathy), bone inflammation, gastrointestinal infection, low musculoskeletal functionality, or other complications. A 2020 public health research indicates that around 20% to 50% of cancer survivors experience pain. Yet, 30% of those who do not receive relief from their pain experience a negative impact on their quality of life. As cancer advances, pain can intensify by up to 80%, severely impacting a person’s quality of life. These statistics motivate the research community to discover new and robust solutions.

One potential alternative emerging from clinical research on cancer pain has spotlighted the role of the body’s own Endocannabinoid System (ECS). This cell-signaling network is one of the largest in the body and is associated with regulating pain sensation.

At Artelo Biosciencesa clinical-stage company using cutting-edge science to improve patient care, drug development based upon targeting the ECS is showing promise. The company applies leading-edge scientific, regulatory and commercial disciplines to develop innovative therapies, with a particular focus on the needs of the cancer patient. Realizing the merit of targeting the ECS, Artelo is on a mission to alter the course of treatment for those diagnosed with cancer and other serious conditions.

Spearheading Artelo with innovation, conviction and leadership is the company’s President and Chief Executive OfficerGregory D. Gorgas. Committed to improving the lives of millions of patients worldwide with a cancer diagnosis, he recruited a team of like-minded researchers, clinical professionals and business executives in San Diego and abroad to create Artelo.

Acknowledging such progress at Artelo, we crossed paths with Gregory Gorgas to learn more about the company and its mission to meaningfully impact cancer care.

Let’s dive in to know more!

Artelo Biosciences—at a Glance!

Artelo is a story of empathy, innovation, and scientific revolution. Being enriched with the vision and operational experience of its CEO—Gregory Gorgas, the company aims to transform the care of a large number of people suffering through multiple diseases and conditions, including cancer, pain, anorexia, anxiety, neuropathy, and inflammation with the help of its novel product candidates in development designated as ART27.13, ART26.12, ART12.11. Aware of the tremendous promise of targeting the ECS with lipid-modifying drugs to treat cancer, pain and central nervous system (CNS)-related conditions, Artelo initiated its quest for innovative research early in 2017. By the end of that year, the company had acquired rights to multiple technologies and filed a patent on its own invention. In sum, Artelo’s portfolio represents the broadest spectrum in the pharmaceutical industry of methods targeting the ECS for the improvement of health.

In early 2023, Artelo expects to start enrolling patients in the Phase 2 stage of the Cancer Appetite Recovery Study (CAReS) with its lead clinical program, ART27.13. Cancer anorexia (loss of appetite or aversion to food) affects over 60% of people with a cancer diagnosis and is a leading cause of death for cancer patients. ART27.13 was designed to arrest the anorexia and resulting weight loss experienced by the majority of cancer patients. Like the other programs at Artelo, ART27.13 targets the receptors of the ECS. It leverages a known effect on hunger without the undesired CNS effects of cannabis. And the company is well-funded to complete the CAReS trial as its last reported cash was nearly $20 million.

Another complication of cancer is pain secondary to the toxic effects of certain cancer chemotherapies. A key initiative of Artelo is to bring its second drug candidate into the clinic within the next 18 months. In multiple preclinical animal studies, ART26.12 has shown remarkable promise in treating painful neuropathies associated with chemotherapy. Artelo’s researchers showed that ART26.12 was able to not only successfully treat the pain, but also prevent the neuropathic pain from even starting. Currently, there are no FDA-approved treatments for chemotherapy-induced peripheral neuropathy (CIPN). Artelo is on a mission to change that.

Transforming Pain Management

ART26.12 is a new chemical entity. Because ART26.12 is at the forefront of Artelo’s innovation, we asked Mr. Gorgas to elaborate on the science and strategy with this novel compound. He explained that ART26.12 is a selective fatty acid-binding protein 5 (FABP5) inhibitor. It inhibits a pathway that can raise endogenous levels of endocannabinoids, the body’s self-made cannabinoids. ART26.12 has the potential to stand out as a treatment due to its therapeutic value in preventing and treating CIPN, a common and often painfully debilitating complication of cancer therapies that often results in a reduction or interruption of cancer treatment. CIPN is frequently so painful that patients cannot progress on their anti-cancer therapy.

In preclinical models, inhibition of FABP5 using ART26.12 has shown activity in analgesia, reversing the effects of CIPN, a condition for which there are currently no approved treatments. Current pain management medications typically have significant side effects and/or addictive properties. To date, FABP5 inhibition has shown little to none of these effects while exhibiting good analgesic properties.

In addition to pain, inhibiting FABP5 may be useful in other areas of unmet need. Of recent note, landmark research in anxiety with another one of Artelo’s FABP5 inhibitors was selected as one of the top 50 (out of 12,000 research studies submitted) at the Society of Neuroscience annual meeting in November 2022. The preclinical results indicated that a novel FABP5 inhibitor from Artelo’s extensive library of FABP inhibitors significantly reduced anxiety behaviors without the abuse potential or cognition blunting of other treatments for anxiety disorders. There, it was concluded that modulation of the FABP5 system might serve as a promising target for the development of novel anxiolytics.

Key Development Programs

Artelo’s full-spectrum approach to modulating the ECS with lipid-modifying approaches include:

  • ART27.13, a cannabinoid (CB1 and CB2 ) receptor agonist, being investigated in the CAReS trial, currently enrolling patients with cancer anorexia.
  • ART26.12, a fatty acid binding protein 5 inhibitor, with regulatory-enabling studies well underway aiming to have the program in the clinic for chemotherapy-induced peripheral neuropathy within 18 months. A first for a FABP5 inhibitor.
  • ART12.11, a patented cocrystal composition of cannabidiol (CBD), in preclinical development for anxiety-related disorders including post-traumatic syndrome disorder (PTSD), as well as other potential indications.

If approved by the FDA, ART27.13 in cancer anorexia and ART26.12 in chemotherapy-induced peripheral neuropathy would be first-in-class treatments for people that have no currently approved treatment options. Artelo also believes its CBD cocrystal has the potential to be a best-in-class drug.

Wholistic Thinking- Treating the Whole Person

While several of Artelo’s programs may ultimately be useful as anti-cancer agents directly, Mr. Gorgas says the mission of Artelo today is to treat the whole person with cancer. While there have been many advancements in the treatment of tumors over the past two decades, cancer pain and cancer anorexia are still without FDA-approved treatments. Mr. Gorgas lamented that treatment of cancer anorexia has not advanced since he started his career in the pharmaceutical industry nearly 40 years ago, and the team at Artelo aims to change that. Using a mechanism-based approach modulating the ECS holds the therapeutic promise that may have eluded research to date.

Artelo’s priorities for 2023 are 1.) the rapid accrual in the CAReS Phase 2 with an expansion of clinical sites in the United Kingdom and Europe, 2.) gaining alignment with the FDA on the pathway and research to bring ART26.12 into the clinic for CIPN (a first for a FABP5 inhibitor), and 3.) advance and expand the understanding of differentiating properties of its patented CBD cocrystal.

Transformative Leadership—The Intersection of Experience and Innovation

Mr. Gorgas brings almost four decades of experience to his role in leading Artelo. Before founding Artelo, he served as Senior Vice President, Commercial and Corporate Officer at Mast Therapeutics, a publicly-held biotechnology company. There, he had commercial leadership accountability and business development responsibilities for the hematology, oncology, and cardiovascular franchises. Prior to that, he worked at Biogen, a publicly-held biotechnology company, as Senior Director, Global Marketing, with responsibility for the strategic vision and operational commercialization of the company’s worldwide cancer business.

Furthering his commitment to bringing healing to people living with cancer through innovative therapeutics, Mr. Gorgas became convinced that targeting the body’s endocannabinoid system with lipid-signaling drugs could lead to new solutions to old problems. This led Mr. Gorgas to establish Artleo Biosciences. Modulating the ECS with federally-compliant cannabinoid-based drug research has some added complexity and challenges, but the transformative potential of the programs at Artelo makes it worth the effort. And Artelo has a competitive advantage of having successfully navigated complex regulations to advance its programs across the globe.

Mr. Gorgas envisions benefiting millions of patients worldwide through product development at Artelo Biosciences. The company seeks to attain this vision through the application of innovative, next-generation science to real-world challenges for people living with cancer. Currently, alongside the business potential, Mr. Gorgas and the team at Artelo derive their motivation to solve pharmaceutical challenges that have eluded the industry for decades.

Words of Wisdom

Years ago, Mr. Gorgas read Peter Medawar’s “Advice to a Young Scientist,” who wrote, “In choosing topics for research…to enlist in, a young scientist must beware of following fashion.” Mr. Gorgas found it to be an essential suggestion.

Following fashion in science or on Wall Street often leads to dead ends. “When we started Artelo in 2017, federally-compliant research into the endocannabinoid system was very new and few dared to pursue the path, but that didn’t dissuade us. We were convinced that lipid-modulating drugs would ultimately prove their value in treating serious medical conditions like cancer pain and anorexia,” says Mr. Gorgas. “Decades of commitment and smart science pursued by pioneer researchers in the ECS like Artelo’s Chief Scientific Officer, Andy Yates, Ph.D., and Professor Saoirse O’Sullivan, Ph.D., now Artelo’s Vice President of Translational Research are beginning to pay dividends. We are excited to be a leading company with this innovation, and through our efforts, we hope people with cancer will live better in the decades to come than in decades past.”

Artelo Biosciences is traded on the Nasdaq Capital Markets exchange (Nasdaq: ARTL) and has analyst coverage with Ladenburg Thalmann & Co. Inc., H.C. Wainwright & Co., and Maxim Group.

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