Mr. D’Orazio has extensive experience leading the development and commercialization of vaccines, drugs, radiopharmaceuticals, and biologics. His leadership experience has been in commercial planning, business development, marketing and partnership management roles. Mr. D’Orazio was formerly the CEO of ImmunoPrecise Antibodies (TSXV:IPA) where he led the transition from a private company to a public company. He co-founded and led Superna Life Sciences as CEO, a specialty-pharma company focusing on niche drugs for cancer patients in Canada where he successfully in-licensed two products and succeeded in getting Health Canada approval for both drugs in head & neck cancer and prostate cancer respectively. He has commercialization experience at all stages of drug development primarily in oncology, rare diseases and ophthalmology products respectively. He held roles in business development doing both in-licensing and out-licensing as well as managing partnerships between companies and sitting on their joint development teams. At QLT he was responsible for managing their $500M/year commercial partnership with Novartis. Prior to working for QLT, Mr. D’Orazio was at Pfizer (Pharmacia U.S.A.) and managed a $250M/year portfolio that included human growth hormone where he was involved in the strategic planning for label expansion for the Prader-Willi syndrome indication.
Mr. D’Orazio has an MBA from Vanderbilt University with an emphasis in both Finance and Marketing and a B.Sc. in chemistry from Loyola University of Chicago.
You have deep roots and years of experience in novel drug discovery, pharmaceuticals and biotech. What first drew you in to psychedelics and the potential they have as medicines?
This is a new frontier and a whole new world of opportunity using psychedelic compounds for therapeutic uses, as well as a lot of barriers to entry which for any scientist is exciting breaking new ground like that. The other thing that attracted me to this was the opportunity to work with this team again and the work they had already started on looking at psilocybin for Fibromyalgia.
From your perspective, how do you see the therapeutic potential of psychedelics and what kind of impact could that have on healthcare?
We’re just scratching the surface on the potential of these compounds. There is a lot to figure out, but there also is a lot of low-hanging fruit. If you look at the approved psychotropic drugs and pain management drugs on the market, we’re reaching the point of diminishing returns where incremental improvements are what differentiates new products. Psychedelic drugs have an opportunity to be the next big step forward in the area of treating certain mental health disorders, chronic pain disorders, and other diseases.
Can you share what made you want to be a part of Tryp Therapeutics and what you are focused on building?
I worked with the CEO, Jim Kuo before at Immuno Precise Antibodies and I heard very good things about Bill Garner from Jim and another CEO where Bill is a Board Member. I knew that Jim and Bill had a track record of success over the years on the various projects, and looking at the other members Bill and Jim had put together made the decision very easy. This is by far one of the best management teams I've seen in the entire sector and was drawn by the opportunity to drive this kind of innovation in such an exciting new area of research and potential.
What drug discovery does TRYP currently have on going and where are those clinical trials currently at?
We are developing plans to move forward in several areas with psilocybin. We are currently negotiating with more than one global centre of excellence and highly credible academic institution(s) where we expect to form development partnerships. We are also formulating our pre-clinical and regulatory strategy so we have the possibility to use the pre-existing pre-clinical data on psilocybin to move directly into Phase 2 clinical trials on our PFN Program.
Why did TRYP choose to focus on psilocybin?
There is considerable interest in the compound and lots of existing literature, studies and toxicity data in humans that allow for a fairly reliable baseline to start from. With the amount of innovation that has occurred in this space, and new regulations allowing for us to pick the ball back up in a number of promising areas of research, it's an exciting time to be working with unlocking the potential of psilocybin for therapeutic uses.
TRYP is targeting rare diseases and disorders without currently effective treatments. What gave you the confidence to pursue psilocybin and why do you think it could be a potential breakthrough for Fibromyalgia?
We have seen a reemergence of research in the area of psychedelics, specifically with psilocybin as a natural compound that’s starting to show promising early indications and effects on the brain’s neuroplasticity and neuro pathways. Fibromyalgia, a disease thought to be a neurosensory disorder, has the hallmarks of a perfect candidate for a new drug development pathway. If you consider the fact 30% of all patients are taking opiates as treatment and the balance of treatments have a checkered history of tolerability & efficacy, this disease, that affects more than 5 million people in the U.S alone, is clearly in need of a new approach to treatment.
You also have deep experience within oncology. TRYP currently has a oncology asset that is in Phase II. What are the plans for advancing that and what obstacles do you need to overcome to do so?
Razoxane is a fascinating compound and this asset really diversifies and we believe de-risks TRYP considerably next to our peers. We see a pathway to market for treating sarcomas. If you grew up in Canada, you undoubtedly know what a sarcoma is even if you don’t recognize the name— it’s the disease that Terry Fox fought heroically. He had a type of sarcoma that affected the bone. We are focused on a group of sarcomas that impact soft tissue. They are prone to spread to the bone and other organs. In the case of Terry Fox, he had a sarcoma of the bone and his leg had to be amputated. There have been few innovations in the treatment of soft tissue sarcomas and the front-line treatment still is amputation and radiation. Because there have been several trials with razoxane in soft tissue sarcoma patients that show great promise, we are more than hopeful that there is a place for this drug in the treatment of this difficult disease. We also know the toxicity profile and dose range, so we can advance the product quickly to late-stage trials once we get the green light from the FDA, EMEA and other regulatory bodies.
What can people expect to see from TRYP in the near future as a leading psychedelic focused biotechnology company?
We are trying very hard to bring a credible, rational, and efficient approach to clinical development which applies to all psychedelic drugs. We're very excited about our near term development pipeline and our PFN program focusing on Fibromyalgia and a range of eating disorders and are aligning with some of the leading academic centers of excellence around the world to continue innovating in the area of research and the development of potential therapeutic treatments.
Who else is doing important work within psychedelics you think more people should be aware of?
There are quite a few well-regarded groups, which validates the interest in using these products as a solution to certain diseases. We know Johns Hopkins University, Imperial College of London, University of Wisconsin, UCLA, UCSD, and University of Florida are all well-regarded in this area due to their commitment to high-quality research and access to funding.