Enveric Biosciences Archives - Green Market Report

StaffApril 4, 2022
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Enveric Biosciences (NASDAQ: ENVB), a neuroscience company developing next-generation, psychedelic-inspired mental health medicines, announces yet another filing of a provisional patent application based on new discoveries by the Company. This adds to their”Psybrary”.

The application describes more than 100 novel individual molecules and, if the broadest claims are allowed, could protect more than 10,000 possible new drug development candidates.  The patent application and claimed drug candidates fall into the Company’s EVM201 second-generation, psychedelic-derived drug development program, with an initial target indication of cancer-related distress (CRD) and the potential to be expanded into additional mental health indications.

Dr. Peter Facchini, Ph.D., Chief Innovation Officer at Enveric, noted, “Our proprietary PsyAI artificial intelligence technology was used to design and provisionally rank a large and diverse collection of psychedelic-inspired molecules for further development. The majority of these new molecules, all of which are protected by this most recent provisional patent application, have already been synthesized in quantities sufficient to evaluate their safety and pharmacological properties, including receptor-binding profiles and behavioral analyses in animals. Based on our extensive in silico and experimental data, we are hopeful that we can nominate our lead candidates for entry into Enveric’s EVM201 preclinical development later this year.”


Dave HodesJanuary 24, 2022
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An emerging trend in some bioscience startups is the development of both cannabis and psychedelics products. One such company is Enveric Biosciences, headquartered in Naples, Florida, which hopes to leverage psychedelics-derived molecules for the mind and create synthetic cannabinoids for the body in the treatment of cancer.

Enveric Biosciences focuses on synthesizing novel, tailored and highly differentiated derivative molecules based on classic psychedelics such as psilocybin, N,N-dimethyltryptamine (DMT), mescaline and MDMA. 

Given that the company is working with both plant-based substances, could Enveric somehow combine psychedelics and cannabinoids for some sort of synergistic wellness effect, or some way of benefiting the patient through a shared entourage effect?

Joe Tucker, CEO and director of Enveric Biosciences, said that Enveric doesn’t have any near term aspirations of literally combining cannabinoids and psychedelics. “Enveric is a drug development company” he said. “So when you go down that path, it’s generally about a single molecule, what a single molecule is doing, a single indication that you’re going after. But you can see numerous applications where a patient could take a cannabinoid for their cancer, and a psychedelic separately approved for their mental health, and it could be the same patient benefit for both.”

The company is developing next-generation oncology palliative care treatments by advancing novel combinations of synthetic cannabidiol (CBD) with other therapeutic agents for the treatment of cancer-related conditions, such as glioblastoma multiforme (an aggressive and incurable cancer located in either the brain or spine) and chemotherapy-induced neuropathy. 

The company is also working on a topical treatment for radiodermatitis (RID), which is a side effect of radiotherapy that creates lesions on human skin. 

Approximately 95 percent of patients receiving radiotherapy will ultimately develop RID during or after the course of treatment, with major consequences on quality of life and treatment outcomes, according to a study. Treatment for RID represents a $1 billion global opportunity, according to an Enveric company presentation.

On the psychedelics side of the company, Enveric is exploring treatments for helping cancer patients with mental health. A report from the War on Cancer found that 71 percent of participants said their mental health declined during cancer treatment. 

Development of these treatments begin when Enveric’s scientists synthesized newer versions of classic psychedelics using a mixture of chemistry and synthetic biology along with their Psybrary, a library included in their September, 2021, purchase of MagicMed for $48 million, which contains a large, diverse portfolio of molecular derivatives.

Their Psybrary has been reported to contain 15 patent families, but Tucker said there are actually more that exist, and more coming, with over a million potential variations and hundreds of synthesized molecules. “It’s a major asset within the company,” Tucker said.

The initial focus of the Psybrary is on psilocybin and DMT derivatives, and it is expected to be expanded to other psychedelics. “We spend a lot of our time thinking about how to create new molecules,” Tucker said. “We are targeting molecules that are going to outperform the classic psychedelics.”

He said that they are not attempting to “own” psilocybin or any other psychedelic plants, which has been the pushback that so-called patent-centric bioscience companies like his are getting from industry purists. “We’re creating novel molecules,” he said. “These things that we’re making are not in these sacred psychedelic plants. They’ve never existed before. We’re actually creating something that’s new.”

Enveric’s artificial intelligence tool, PsyAI, which Tucker said they built from scratch, enables the company to narrow down the potential compound variations to best target specific mental or physical ailments. PsyAI can help researchers at the company target indications and accelerate the pathway to an Investigational New Drug (IND) designation from the U.S. Food and Drug Administration (FDA).

Tucker explained how their PsyAI works: “There’s not that much in the scientific literature about psychedelics that you can go and say if I modify psilocybin, for example, to look like this new compound, how’s it going to work? That information does not exist for psychedelics, because they’ve been essentially illegal,” he said. 

PsyAI is used essentially to make up for that missing information, using computer modeling and programming based on the three-dimensional structure of the molecules and three-dimensional structure of the receptors that are being targeted, among other factors. 

“We look at our Psybrary of so many possible molecules, and say which of these are likely to, at the most basic level, bind to and switch on, activate or inactivate the receptors that we want to,” Tucker said. “What that really means is if you know enough about the indication, the mental health challenge you’re trying to treat, you can say turn these receptors on and turn these receptors off,” he said.

With PsyAI, you can look at a large potential list of drug candidates, and say which are the ones that are far more likely than a randomly selected molecule to give you exactly the outcome you want for the patient. “So it’s really a very powerful screening tool,” Tucker said.

The company has experienced some financial hiccups since its inception in 2021, according to SEC documents, and has been using available cash to fund their operations as the company geared up its research and development efforts—not unusual for a capital-intensive drug development company.

Research and development expense for the nine months ended September 30, 2021, was $2,295,826, compared to $134,259 for the comparable period in 2020, an increase of 1,610%. 

But the company also raised $25 million in 2021, in what Tucker called a “foundational year.” 

“The entire drug development industry took a nosedive, and psychedelics took an even harder nosedive than everyone else this past year,” Tucker said. “This year going forward is when I think the rubber is going to meet the road. The long-term investors are going to be the ones that look through the companies and see that there are a lot of companies out there. But which ones of these really have the legs, really have the technology, the intellectual property to actually see this drug development through and develop a winning, hopefully billion dollar, molecule?,” he said. “Those sophisticated, long-term fundamental investors are the ones that are going to be making sure certain companies are adequately funded and make it through the challenges ahead. So (2022) is going to be a turning point year for the industry, where the companies that have a lot of real pharmaceutical fundamentals behind them, in my opinion, are going to be supported.”


StaffDecember 15, 2021
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Psychedelic biotech company Enveric Biosciences (NASDAQ: ENVB) announced the appointment of Bob Dagher, MD, as Chief Medical Officer, effective immediately. Robert Wilkins, MD, stepped down from his role of Chief Medical Officer on November 29th, 2021.

Prior to joining Enveric, Dr. Dagher served as the Chief Medical Officer at WCG MedAvante-ProPhase where he led the clinical science organization to help forge and develop compelling scientific solutions to match industry challenges. Before joining WCG, Dr. Dagher served as the Chief Medical Officer at Cadent Therapeutics, where he led and advanced the company’s pipeline of small molecules, coupled with the implementation of precision biomarkers, for the development of innovative programs in rare diseases and common indications targeting movement and cognitive disorders.  Following his early experience treating patients in academic and private practice settings, Dr. Dagher started his career in the pharmaceutical industry at GlaxoSmithKline, followed by Sanofi/Genzyme working on neurology, psychiatry, and urology indications. 

“As a trailblazing company working to discover and develop the next-generation treatments through the use of both psychedelic-derived molecules for the mind and synthetic cannabinoids for the body, Enveric has major potential to make a real difference for mental health and cancer patients in need,” said Dr. Dagher. “As Chief Medical Officer, I look forward to working with the leadership and clinical teams to harness the power of these groundbreaking technologies to truly help bring solutions to various indications ranging from cancer-related distress to a whole host of other mental health disorders.” 

Dr. Dagher brings over 20 years of experience working in clinical development in the pharmaceutical industry for both small and large pharmaceutical companies and as a board-certified physician from the American Board of neurology and psychiatry. He has an extensive therapeutic background concentrated in the neuroscience space which includes a focus on psychotic, affective and anxiety disorders, as well as neuroimmunology, neurodegeneration and movement disorders. Furthermore, Dr. Dagher has supported and driven successful drug development programs from preclinical stages through Phase 4 clinical trials.

“Dr. Dagher joins our team at a crucial time where we are continuing to build momentum and drive development of our key psychedelic molecules for the mind and cannabinoids for the body,” said Dr. Joseph Tucker, Chief Executive Officer, Enveric Biosciences. “Dr. Dagher brings extensive experience working in the pharmaceutical industry with a focus and passion for drug development for neurological and mental health indications. His experience is expected to be very valuable as he will lead Enveric alongside our clinical team in continuing to advance our pipeline. Dr. Dagher’s addition to Enveric is key addition as we continue our focus on building a world-class management team.”

 

 

 


Video StaffNovember 16, 2021

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Green Market Report recently spoke with Enveric Biosciences (NASDAQ: ENVB) CEO Dr. Joseph Tucker at the Microdose Wonderland conference in Miami. Dr. Tucker sees room for both cannabinoids and psychedelics within the company. He also believes there are several areas for patients with needs that are currently unmet and Enveric looks to address those conditions.


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