The OCT ‘Meet the Team’ series is intended to give you a snapshot of the people behind the business, providing more of an insight into what we do, and why we are so passionate about our work.
To kick things off, we sat down with our Chief Scientific Officer, Dr Valentino Paravicini
Interviewer: Valentino, thank you for chatting with us today.
Valentino: My pleasure!
Interviewer: As you are a relatively recent addition to the OCT leadership team, why don’t we start with you telling us about your decision to join the business – what drew you to the company?
Valentino: It’s quite simple: I was drawn to OCT because it is looking to uncover cannabinoids’ ability to treat a variety of indications, and that’s an area I’ve wanted to explore for quite some time.
Having worked in the fields of oncology, inflammation and immunology for over twenty-five years, in both big pharma and biotech on both sides of the Atlantic, as well as with national research organisations, including the National Institutes for Health in the US, and what is now the Francis Crick Institute here in the UK, I’ve spent a lot of time looking for innovative ways of approaching problems with inflammation and autoimmunity. More specifically, I’ve been looking at their associated symptoms, and believe cannabinoids could unlock some new treatments that are transformative for patients.
I observed that the early signs showed that the research conducted at that point had been promising. Then, when I met the rest of the team for the first time, it really became a no-brainer. It was instantly apparent that there is a unique blend of passion and experience at OCT which fuels excitement in the work the business is doing, and I wanted to be part of that. So, when I was offered the chance to delve deeper into that kind of research with the team at OCT, I jumped!
Interviewer: That’s fascinating! What’s been the most exciting moment for you in the development of the business since you joined?
Valentino: Where do I start
I think first and foremost, we’ve spent a great deal of time developing a creative and studious strategy for progressing our own proprietary cannabinoid derivative library, which has been great fun. For example, we’ve not only been bouncing around ideas of general concepts and potential drugs, but also identifying novel approaches to the route of administration, which in itself provides a number of exciting opportunities. I am thrilled with the results of the process and believe we are well positioned to build on the exciting research already underway.
We’ve already had some significant successes in our research. Our lead compound, OCT461201, is making great strides. And we’ve also been able to run successful tests on an experimental cellular model (based on human stem cells) that recreates nerves in vitro. A number of our compounds have shown efficacy in blocking the “firing” of abnormal impulses in the newly generated human neurons (which can form the basis of pathologies like neuralgias, migraines and even epilepsy), suggesting we can develop treatments with the potential to treat pain in a number of indications. It’s very exciting!
Interviewer: It’s great to hear the business is continuing to progress with its research. Has the Covid-19 pandemic created any challenges for you?
Valentino: Naturally, the various lockdowns that have occurred since the pandemic started have resulted in some delays, as laboratories have had to reduce their activities to essential maintenance; but we’ve actually been able to continue progressing in a number of areas – for example, in developing the manufacturing process for OCT461201 – which I’m really pleased about. It is a real testament to the quality and hard work of our academic and business partners. We’ve worked hard to develop the highest quality relationships, and it’s stood us in really good stead as we’ve had to navigate the complexities of the pandemic.
Interviewer: You’ve mentioned a few times that OCT461201 is progressing well – could you tell us more about that progress?
Valentino: Of course
We’ve made significant progress in two key areas: we’ve been able to conduct additional in vitro work, which has confirmed the excellent safety profile of the molecule, with no cytotoxicity observed in any of the cells tested. And from a manufacturing perspective, we’ve successfully internalised the synthetic pathway technology and scaled up the process to produce a medium-size batch of the desired polymorph (the purified and crystalised format of the compound).
There’s more work to be done to develop large-scale manufacturing capabilities – for example, in reagent sourcing – but we are very much on track to bring drugs to market that have potential to help millions of patients suffering from acute and chronic pain, and that’s why we do the job!
Interviewer: And I’m right in saying that, in particular, OCT461201 aims to provide a treatment for irritable bowel syndrome (‘IBS’)
Valentino: That’s correct. In animal models, the compound has proved effective in reducing pain and discomfort, as well as other symptoms associated with IBS. However, that is not all. OCT461201 attributes point towards other forms of pain, notably neuropathic pain orphan diseases, such as postherpetic neuralgia (‘PHN’), an extremely painful condition caused by shingles, which is basically chickenpox reloaded. The excruciating pain remains even when shingles disappears. PHN and other disorders affecting less than 200,000 people are often overlooked by the major pharmaceutical companies, so it is not surprise they are called “orphan diseases”. OCT is very much in pursuit of this avenue and the efficacy showed by OCT461201 in the in vivo models makes me very optimistic. OCT wants to help patients so far neglected by big pharma, because it is the right thing to do from the scientific, ethical and, not least, business point of view. In fact, regulatory exclusivity is granted to companies who develop drugs for these diseases, clinical trials are usually smaller, faster, and less expensive, and, because patient populations are typically more homogeneous in terms of causes of the diseases, means that clinical trials have an increased significance and, thus, chance of success.
Interviewer: And from a safety point of view, OCT461201 will be safe to administer?
Valentino: Absolutely! OCT461201 has excellent pharmaco-toxicological profiles, which means it can be turned into a drug that can be easily and safely delivered to patients. A selectivity panel has shown that the compound is unlikely to have any effect on the central nervous system and the heart, and we have not found any genetic liability or issues with drug-drug interaction. Not only is OCT461201 safe in vitro, but it is also well tolerated following multiple dosage in vivo (both in rodents and dogs). In fact, when tested for efficacy in the rat model, OCT461201 was tolerated 400-fold over the efficacious dose, giving us a solid therapeutic window.
Put simply, I we do not foresee any complications in the transition to the next stage of preclinical development. In fact, we have already developed a plan for large scale GMP-grade materials in preparation for the clinical batch and post approval phase, where large amounts are going to be needed for therapy.
And moreover, OCT461201 safety profile (and of course efficacy) means it can be developed into drugs that treat other indications and therapeutic areas as well – for example, neuralgias – which, with our academic partnerships, we are well positioned to do.
Interviewer: That’s extremely exciting. Thank you for taking the time to speak with us, and we look forward to further updates soon.