Entheon Launches Psychedelics Pre-Screening Genetic Test

Gyroscope Therapeutics – Jessica Stitt was named chief financial officer of London-based Gyroscope Therapeutics Limited. Most recently, she served as the Vice President of Finance and Operations for MyoKardia, Inc., which was acquired by Bristol Myers Squibb in November 2020. Prior to MyoKardia, Stitt served as the Vice President of Finance and Investor Relations for Theravance Biopharma, Inc. She also previously held roles at Nektar Therapeutics, Alkermes and Blue Cross Blue Shield of Massachusetts.

Hansa Biopharma — Sweden-based Hansa Biopharma tapped Magnus Korsgren, as Vice President and Head of Research and Development. Korsgren will lead the efforts to advance Hansa Biopharma’s pipeline for rare immunologic diseases, including those for the treatment of anti-glomerular basement membrane antibody disease, Guillain-Barre Syndrome and antibody-mediated kidney transplant rejection post kidney transplantation. He brings more than 15 years’ experience from leadership positions in a variety of pharmaceutical and biotech companies, including Ferring, AstraZeneca, BioInvent and Novartis. Korsgren is board certified in Clinical Pharmacology and has published more than 30 original articles, reviews and book chapters.

ERS Genomics — Jon Kratochvil was named Vice-President for Business Development & Licensing for North America. Kratochvil joins the company from MilliporeSigma where he was Director of Business Development and Licensing. Prior to this he was a licensing manager and the competitive intelligence analyst for Abbott Laboratories diagnostics division.

9 Meters – Michael Rice was appointed to the board of directors of N.C.-based 9 Meters Biopharma. Rice is the president and co-founder of LifeSci Advisors, a life sciences investor relations consultancy, and the co-founder of LifeSci Capital, a research-driven investment bank. Previously, he was the co-head of health care investment banking at Canaccord Adams, where he was involved in debt and equity financing. Rice was also a Managing Director at ThinkEquity Partners. Before that, Rice served as a Managing Director at Bank of America and prior to that, he was a Managing Director at JPMorgan/Hambrecht & Quist.

Abivax — Sophie Biguenet was named chief medical officer of France-based Abivax. In her new role, she follows Jean-Marc Steens, M.D., who plans to retire after six years as Abivax’s CMO. Prior to joining Abivax, Biguenet served as CMO at Versantis, a Swiss clinical-stage biotech company. She started her biopharmaceutical career focusing on immunosuppression in solid organ transplantation at Roche. Prior to joining Versantis she held leadership positions in global drug development in France with Biogen Idec, and in the United States with Bristol-Myers Squibb and AbbVie.

Artizan Biosciences — Donnie McGrath and Seth Rudnick were appointed to the Artizan board of directors. McGrath has more than 20 years of pharmaceutical industry experience, and currently serves as Chief of Corporate Strategy and Business Development for Biohaven, and Executive Chairman of BioShin Ltd. He joined Biohaven in 2017 from BMS, where he was Vice President of Business Development and Head of Search & Evaluation. Rudnick has extensive expertise in drug discovery and development and healthcare investments. He currently serves on the boards of directors of G1 Therapeutics and Liquidia Technologies. Rudnick spent nearly 15 years building the biopharmaceutical investing capability for Canaan Partners. Prior to joining Canaan, he was the Chief Executive Officer and Chairman of CytoTherapeutics and served in leadership roles at Ortho Biotech and Biogen N.V.

Vaccitech – U.K.-based Vaccitech Ltd. appointed Anne Phillips and Karen A. Dawes to its board of directors. Phillips currently serves as Senior Vice President Clinical, Medical & Regulatory Affairs at Novo Nordisk. Prior to this, she served in multiple executive roles in drug development at GlaxoSmithKline including Vice President Medicine Development Leader of a leading prostate cancer therapeutic. Dawes has led a distinguished career as an executive at several biopharmaceutical companies including Bayer Corp., Wyeth Pharmaceuticals, Genetics Institute and Pfizer, where she held leadership roles in business, marketing and commercialization. More recently, Dawes has led her own successful consultancy company working with emerging companies on corporate strategy and commercial development.

SVB Leerink — Robert Minear will join SVB Leerink’s Healthcare Services and Technology Franchise team. Minear joins the firm as a Senior Managing Director focused on leading the firm’s financial sponsor origination efforts to further enhance the firm’s growing leveraged finance business. Minear joins SVB Leerink from Guggenheim Securities where he was a Senior Managing Director in Healthcare investment banking, with a focus on advising companies in the healthcare services sector. Prior to his work at Guggenheim Securities, Minear was a Managing Director and Head of Healthcare Services Mergers and Acquisitions in Jefferies Group’s Healthcare investment banking practice and a member of the M&A groups at UBS.

Entheon Biomedical Corp. – Nancy Maher was named a Special Advisor of Data Science and Regulatory Affairs at Vancouver-based Entheon Biomedical. Maher has served as an executive and consultant for major pharmaceutical and information technology companies, including IBM, Gilead, Schering-Plough, Merck, Allergan, and Teva Pharmaceuticals. Maher is currently chief information officer of North America of Kyowa Kirin International plc. and joins Entheon as its Special Advisor of Data Science and Regulatory Affairs.

AavantiBio – Douglas J. Swirsky was named CFO of Boston-based AavantiBio. Swirsky will be responsible for building out the company’s financial, accounting, and facility functions to support AavantiBio’s growth and clinical development of its diversified pipeline of gene therapies. Swirsky most recently served as president and CEO of Rexahn Pharmaceuticals, Inc., where he led the company’s merger with Ocuphire Pharma, Inc. in 2020. Prior to Rexahn, he was president and CEO of GeneVec Inc. Swirsky currently serves as chairman of the Board of Directors of Cellectar Biosciences, Inc. and NeuroBo Pharmaceuticals, Inc.

Apnimed – David P. White joined the Apnimed team as Distinguished Scientist and Chair of Apnimed’s Scientific Advisory Board. White is a leader in sleep disorders having served as President of the American Academy of Sleep Medicine, and recently as the CMO for Philips Respironics. White is a Professor of Medicine, part-time, at Harvard Medical School in Boston, Mass.

Dyna Therapeutics – Wildon Farwell was named CMO of Dyne Therapeutics, Inc. Farwell joins Dyne from Biogen, Inc., where he was vice president, global head of neuromuscular diseases, medical affairs. During his 10 years at Biogen, Farwell led the development and life cycle management of Spinraza. Previously, Farwell was an Assistant Professor in Medicine at Harvard Medical School and a physician at Brigham and Women’s Hospital and the VA Boston Healthcare System.

Neurescue – Denmark-based Neurescue announced the appointment of medical device industry veteran Mette-Marie Harild to the company’s board of directors. Harild was most recently the regional vice president of Medtronic’s largest sub-region in Europe, Middle East and Africa. Prior to joining Medtronic, she held a number of leadership positions during her 16-year tenure with the Johnson & Johnson pharma company, Janssen, including sales director of Denmark and the Nordic sales director.

eTheRNA Immunotherapies – David Ricketts was appointed Consultant Director of Business Development for Manufacturing Services for Belgium-based eTheRNA Immunotherapies NV. He was previously CEO of PharmaDiagnostics NV and Link Technologies Ltd.

eGenesis – Gene-editing company eGenesis named Sapna Srivastava as its new CFO. Srivastava is a seasoned industry executive with experience leading finance and corporate strategy. Most recently, Srivastava served as the chief financial and strategy officer at Abide Therapeutics. She also held a similar role at Intellia Therapeutics.

Diaceutics — Nikita Lynn was named Vice President of Finance for Diaceutics. She has been promoted to this position following her tenure as Senior Director of Corporate Advancement. In this new role, she will work with the finance and executive management team to grow Diaceutics’ business. Before joining Diaceutics in August 2020, Nikita was a Senior Manager at PwC where she spent approximately six years in the Assurance Department.

Solid Biosciences – Erin Power Brennan was named chief legal officer and Joel Schneider was promoted to chief operating officer of Solid Biosciences. In her role at Solid Biosciences, Brennan will be responsible for all aspects of the Company’s legal and compliance affairs. Brennan was most recently SVP, General Counsel & Secretary at Covetrus Inc., where she was the lead legal executive for the animal health technology, pharmacy, and services business. In his previous roles at Solid, Schneider was responsible for sourcing and validating novel scientific approaches. Most recently, Schneider was responsible for overseeing the GMP implementation strategy of the company’s next-generation manufacturing process. His responsibilities will now grow to include corporate and technical operations, quality, patient advocacy, communications, corporate strategy, and human resources. The company also announced the appointment of Pfizer veteran Clare Kahn and Georgia Keresty, COO of Takeda Pharmaceuticals, to its board of directors.

CANNABIS CULTURE – Speakers from across North America connected at the first-ever Psychedelic Summit to provide education to the public on the new wave of modern consciousness-expanding medicine.

To begin the summit, which took place on February 25, 2021, Multidisciplinary Association of Psychedelic Studies (MAPS) Development Officer, Liana Gillooly, said her organization’s goal is to treat the root cause of trauma, which they believe is not being addressed by the pharmaceutical industry. “The vast majority of people who take psychedelics currently do so out of a clinical, therapeutic, or ceremonial environment.”

 

Gillooly on psychedelic use: “The vast majority of people who take psychedelics currently do so out of a clinical, therapeutic, or ceremonial environment.”

In a medical setting, MAPS has been focusing on MDMA-assisted therapy to combat PTSD, which affects over 350 million people globally. However, two-thirds of these people do not adequately respond to available treatments.

Suicide rates in the United States have increased 24% since the year 1999 and psychiatric drug spending has increased in that same time from $13 billion to over $50 billion. “It is clear the way the pharmaceutical industry understands and treats mental disorders is deeply insufficient,” Gillooly said.

COVID-19 has amplified this challenge. The rate of depression and suicidal ideation have both tripled, and over half of Americans reported their mental health was negatively impacted by the pandemic.

Ketamine has been FDA approved since 1970 and holds promise for treating depression when paired with therapy sessions. However, Gillooly said the pharmaceutical company Janssen, thought that adding therapy to the treatment was an expensive barrier to market, “So instead we have a company charging upwards of $800 per dose for a drug that has been around for decades and costs providers under $3 per dose.”

 

Verbora on the drug enforcement: “The political regulation of these drugs does not reflect the reality of the harms to an individual and their families.”

Dr. Michael Verbora is Medical Director at Field Trip Health, an organization that is looking to move away from the current approach to mental illness that involves the daily use of medication, the passive “wait and see” attitude for results, and minimal psychotherapy.

Verbora said for every clinic doing ketamine-assisted psychotherapy there are 5 or 6 giving the drug without therapy, “I’m fairly confident that while we do see that does have anti-depressive effects, people are gonna rely on the drug more and more.”

Dr. Matthew Johnson, Professor of Psychiatry and Behavioral Sciences at Johns Hopkins University believes psychedelics work better than the average antidepressant because they bring about a dramatic experience to “dope-slap people out of their story,” allowing them to open “…a window of flexibility where they let go of the mental models we use to organize reality.”

In one psilocybin study, Johnson said there was an increase in the personality dimension of openness. “This is interesting because a personality dimension, by definition, is not supposed to change. It’s supposed to be a trait.”

This was the result of having a “mystical experience.” This idea was first reported, largely outside of drug use in the 1800s. It is described as one feeling a sense of unity, an overall positive mood, and seeming to transcend time and space.

Although historically demonized, the harms and risks of Ketamine, MDMA, and Psilocybin are not nearly as bad as tobacco and alcohol said Verbora. “The political regulation of these drugs does not reflect the reality of the harms to an individual and their families.”

 

Davis (Bottom Right) on psychedelic use: “Our parents used to always say to us when we were kids ‘don’t take these things, you’ll never come back the same.’ And of course, what they didn’t understand is that that, in some sense, was the entire bloody point.”

“It’s curious that the one ingredient that is constantly in that recipe of social change, which is consistently expunged from the record, is the fact that tens of millions of us lay prostrate before the gates of awe having taken some psychedelic,” said Wade Davis, Professor of Anthropology at the University of British Columbia.

Timothy Ko is the CEO of Entheon Biomedical, a company focused on using DMT for treating addiction. When Ko’s brother died in March of 2019 from a fentanyl overdose, despite his family spending hundreds of thousands of dollars to help his brother, Ko said the experience opened his eyes to the limitations to treating addiction in modern medicine.

 

CEO of Entheon Biomedical, a company focused on using DMT for treating addiction.

Ko’s said he sees the value of psychedelics. For it to be given to the people that need it the most, it needs to be validated in a clinical setting. That way, it can be presented to regulators and they have no choice but to view things objectively.

“When we talk about training and onboarding this type of new research, there’s a lot of work to be done for clinicians to get up to speed and to deploy this work in a really thoughtful and mindful way,” said Mind Cure CEO Kelsey Ramsden.

“One of the things that really excites me about this entire movement is it’s going to shift the entire conversation about how we think about humanity, how we think about health,” said Ronan Levy, Founder of Field Trip Health.

Levy thinks that the medicalization and the legalization of psychedelics complement each other. In a medical approach, people who are diagnosed as sick will have access to medical care, and in a legalization approach, there is plenty of benefits that people can get from psychedelic therapies in a controlled setting with professional supervision.

Speaking on the stigmas of the past regarding psychedelics, Davis said, “Our parents used to always say to us when we were kids don’t take these things, you’ll never come back the same.’ And of course, what they didn’t understand is that that, in some sense, was the entire bloody point.”

A double tragedy has sent a Western University graduate on a journey to research how states of consciousness can be combined with technology to treat trauma.

Londoner Heather Hargraves is the lead scientist on a project by Divergence NeuroTechnologies Inc. that will help clinicians make the best use of psychedelic medicine while treating patients for trauma.

Hargraves, who graduated from Western in 2017 with a master’s degree in psychology, returned to school in 2011 seeking answers as to why and how yoga and meditation helped her work through her own trauma.

On Dec. 31, 2000, Hargraves, then 21, barely survived a life-altering car crash that ultimately required six surgeries. After eight months off school, she returned to study philosophy.

A few weeks after she graduated in June 2004, her brother Stephen died in a car crash, spinning her into a state of deep trauma.

Hargraves used yoga, reflexology and meditation as part of her recovery strategy. She even lived in an ashram in India for three months. She eventually became a yoga and meditation instructor, but didn’t really understand the science behind how the experience helped people process trauma.

“When my brother passed away, it was a hard thing to recover from,” she said. “When I started doing yoga and meditation, I . . . was feeling better. It was really helping me. I became very curious about how it helped. I wanted to understand more about the neuro-anatomy changes that I was experiencing.”

Returning to Western in 2011to study psychology, Hargraves learned about the process of healing from trauma.

“They were looking at everything from meditation to disassociation to various altered states,” she said. “I felt like my grief had been rewired from the trauma. (At Western) it was the first time I heard someone say the brain can get rewired from stress and we can use technology to help rewire it back.”

Now a specialist in neuro- and biofeedback technologies for retraining the brain, Hargraves is interested in various states of consciousness caused by meditation and psychedelic medications such as DMT. ketamine and psilocybin..

Part of that work is developing an app that will track data from an EEG, a test that detects electrical activity in the brain. The app is expected to be released in the spring.

The software will use machine learning and artificial intelligence to guide drug dosages during psychedelic therapy sessions.

“It’s always been my platform that we can use technology to help access, support, prepare and integrate people around psychedelic experiences,” Hargraves said. The depth of someone’s psychedelic experience is “not something someone can easily share or tell,” she said.

The Londoner is partnering with Toronto-based Entheon Biomedical Corp., which has been working to develop psychedelic therapies to treat addiction.

When I started doing yoga and meditation, I . . . was feeling better. It was really helping me. I became very curious about how it helped. I wanted to understand more about the neuro-anatomy changes that I was experiencing.

HEATHER HARGRAVES

The new app will ultimately be used to guide dosages so that patients interested in psychedelic therapies won’t have to worry about having a negative experience, Hargraves said.

“This a clinical tool to enhance clinical assessment and feedback for clients,” she said.

hrivers@postmedia.com

The Canadian R&D company Entheon Biomedical has set out to investigate the therapeutic use of the psychedelic dimethyltryptamine (DMT) in treating addiction disorders. Specifically, the company has commissioned a clinical trial investigating the safety and efficacy of using intravenous DMT.

DMT is a hallucinogenic compound and is one of the main active ingredients in ayahuasca, a South American preparation used in shamanistic rituals, and can be extracted from several plants. Its effects are also more transient in contrast to those of other psychedelics, such as LSD and hallucinogenic mushrooms. In addition, DMT has already been shown to be safe to use.

Entheon Biomedical has made an agreement with the Centre for Human Drug Research (CHDR) located in Leiden, Netherlands, to carry out an early phase clinical trial with DMT on humans. According to Entheon’s CEO, Timothy Ko, the main objective of the study is to examine the safety of DMT in humans and, specifically, to evaluate the pharmacodynamics and pharmacokinetics of DMT when administered intravenously. Furthermore, the overarching goal of the clinical study would be to understand DMT’s potential as part of a therapeutic protocol to treat substance use disorders.

“Substance-use disorder is obviously a very complicated situation for both the individual grappling with it and for a society and public health system that is tasked with addressing and remedying the devastating effects and widespread damage that stems from unchecked substance-use disorder,” said Ko said in his interview with Technology Networks. “With no straightforward solution present, our belief is that a medicalized, psychedelic-assisted therapy model provides a powerful tool for substance-use sufferers to gain the clarity and support required to reclaim their lives.”

According to Ko, the fact that DMT is rapidly metabolized makes it well-suited to a shorter, more tailored therapy experience, which also decreases its costs and increases its scalability. Moreover, due to its rapid mode of action, DMT can provide the control necessary, which cannot be achieved with other longer-lasting psychedelics.

The clinical study will focus on target indications of nicotine addiction, alcohol-dependency and opioid use disorder. However, the study will examine whether DMT is effective in the context of mechanisms underlying drug-seeking and using behaviour, which could make it applicable when treating addictions for other drugs. “From this standpoint, our aim is to prove efficacy for the initial target indication and then expand to focus on additional indications and substance-use disorders,” said Ko.

The clinical trial is projected to start at the end of 2021. Despite the logistical challenges presented by the ongoing COVID-19 pandemic, the researchers are trying to make sure that the study stays on schedule. “But really, given the pressing need for effective treatments, paired with the growing loss of life from overdose, and the significant social and economic impact of substance-use disorders, an effective and scientifically validated solution cannot come quickly enough,” said Ko.