UK pharmaceutical company Oxford Cannabinoid Technologies has secured two commercial agreements that will contribute to the development of its lead compound and other drug development programmes.
Focused on developing a portfolio of cannabinoid-based prescription medicines approved by medicines regulatory agencies which target the pain market, the company has secured agreements with life sciences consultancy Voisin Consulting SARL and Evotec SE subsidiary Aptuit (Verona) SRL.
The agreements follow its recent post-IPO review after its £16.5m fundraise and admission to the main market on the London Stock Exchange earlier in May this year.
Drug development programmes
Oxford Cannabinoid Technologies struck a deal with Voisin, which has over 200 professionals in the UK, US and India with expertise in medical devices, cannabinoids, neurological disorders and addictions, in June this year, which will support and advise the company on its regulatory strategy and roadmap for its drug development programmes in the US, UK and Europe.
This will include First Time in Human clinical trials for its lead compound OCT461201 – a selective cannabinoid receptor type 2 agonist which has initial indications in post-herpetic neuralgia and visceral pain caused by irritable bowel syndrome (IBS). The trials are expected to commence in 2022.
The deal with Aptuit (Verona) SRL, subsidiary of Evotec SE, a fully integrated drug discovery and development company based in Germany, with a market capitalisation of approximately €5.7bn, will provide access to Evotec’s technology platform to further accelerate the development of OCT461201 towards phase 1 clinical trials.
These trials will be aimed at demonstrating the compound’s safety and tolerability by utilising its INDiGO programme, which is an integrated drug development process for expediting early drug candidates to the clinical trial stage.
This is scheduled to run for approximately 12 months and will provide manufacturing, safety and toxicology packages for regulatory submissions to the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) and in the US, The Food & Drug Administration (FDA).
Dr John Lucas, Oxford Cannabinoid Technologies CEO, said: “I am delighted with the company’s progress across all fronts. The board agrees that we are off to a great operational start as a public company with the two partnership agreements signed recently, and we remain firmly on schedule to deliver the drug development timeline set out in our prospectus dated 17 May 2021.
“The Group will continue to develop its drug pipeline and its proprietary, unique library of cannabinoid derivative compounds. Furthermore, we have visibility over a number of exciting developments and a clear path to growth. By utilising a range of inputs, the Group is creating a drug development portfolio that is intended to maximise the therapeutic potential of cannabinoids, long-term market value and market exclusivity across its activities.”
CBD Science launches funding round to advance cancer pain treatments
CBD Science has announced the launch of a funding raise to help advance cannabis-based treatments for cancer pain.
UK-based CBD Science Group has launched an EIS-approved Series A funding round of £2m that will go toward research and development, ongoing clinical trials, working capital, as well as production and supply chain purposes.
The company, which recently received endorsement from the UK’s National Cancer Research Institute’s (NCRI) Living With and Beyond Cancer (LWBC) Executive for its Real World Evidence study into the role that cannabinoids can play in treating cancer-related pain.
The Real World Evidence study is a peer-reviewed clinical trial that seeks to quickly deliver approved therapies to patients in need.
CBD Science CEO, Dr Michael Raymont, commented: “Clinical Trial protocols have been written and peer-reviewed with highly sought-after endorsements from representative institutions, such as the National Cancer Research Institute (NCRI) as well as prominent patient groups.
“The company has consolidated partnerships with a number of leading oncology research centres across the UK, and intends to initiate patient enrolment in Q1 of 2022. Investments through this crowdfund will contribute to further R&D, ongoing clinical trial facilitation, working capital, and production/supply chain.
“Given the scale of suffering currently experienced by cancer patients, the opportunity to make an ongoing and very real difference to millions of people’s lives through this research is huge. Investment in CBD Science today provides the potential for synergistically rewarding outcomes for both investors and cancer patients.”
CBD Science has established a Clinical Advisory Board under the direction of its chief clinical advisor and former deputy medical director of NHS England, Professor Mike Bewick.
The company highlights there are an estimated three million patients suffering from cancer in the UK, with 367,000 new diagnoses per year, with pain affecting between 40 to 66 percent of those patients depending on the stage of their treatment. Alternative treatments for pain are usually opioid-based which often have harmful side effects such as dependence, addiction, and overdoses.
The negative impacts of opioids have led the National Institute for Health and Care Excellence (NICE) to recommend eliminating opioid use for people with chronic primary pain completely; however, without suitable alternatives, there are concerns of a continued UK Opioid epidemic.
Exclusive derivative library licence for Oxford Cannabinoid Technologies
Oxford Cannabinoid Technologies has signed a worldwide exclusive licence agreement with Canopy Growth Corporation.
Oxford Cannabinoid Technologies has signed a worldwide exclusive licence agreement with Canopy Growth Corporation to access Canopy’s cannabinoid derivative library.
The agreement will give Oxford Cannabinoid Technologies Holdings plc (OCTP), the holding company of Oxford Cannabinoid Technologies Ltd (OCT), access to Canopy Growth’s entire cannabinoid derivative library, including 335 derivatives of CBD, THC and CBG, intellectual property rights including 14 patent families and associated product research and development.
The agreement will see OCT develop and commercialise at least one CBD derivative; at least one CBG derivative; and at least one THC derivative, as pharmaceutical drug products, and will also give the company responsibility for the manufacture and supply of the compounds for development and commercialisation.
OCTP Chief Executive, Dr John Lucas, commented: “Acquiring an exclusive licence to Canopy Growth’s pharmaceutical cannabinoid derivative library is a significant achievement for the Group and speaks volumes about our international reputation within our market.
“Not only does the Canopy Library provide us with over 330 “new” compounds that we can put to immediate use in our screens, we will also have an exclusive license to 14 patent families covering a wide-range of cannabinoid derivatives.
“We believe this will increase the probability of a favourable outcome from Programmes 3 and 4 and accelerate the timeframe to clinical trials. Importantly, the library offers the opportunity to develop additional drug development programmes that should expand our drug development pipeline.”
The Oxford Cannabinoid Group currently has four drug development programmes running in parallel, with its first and most advanced programme OCT461201, initially targeting indications in neuropathic and visceral pain. For this programme, Phase 1 clinical trials are scheduled for Q3 2022 with Phase 2 trials expected in Q2 2023.
The second programme uses inhaled phytocannabinoids to target an undisclosed orphan pain condition, with Phase 1 trials also scheduled for Q3 2022 and Phase 2 expected in Q2 2023.
Canopy Growth and OCT will establish a Development Steering Committee (“DSC”) to monitor the progress of the development and commercialisation activities OCT is undertaking in relation to the Canopy Library. The principal objective of Programme 3 is to identify drug candidates for neuropathic pain conditions, and for Programme 4 to develop a “first-in-class” drug candidate that is expected to have use across multiple therapeutic areas including pain, neurology, immuno-inflammation and oncology.
Grow Group and Sanoid Isolates: a cannabis pan-European logistics hub
Grow and Sanoid aim to supply high quality cannabis products at an affordable price point for patients.
Grow Group and Sanoid Isolates will establish a pan-European logistics hub for medical cannabis, says Harry Wildschut, CEO and co-founder at Sanoid.
London-based biopharmaceutical company Grow Group recently acquired Spain-based premium medical cannabis producer Sanoid Isolates in a move that will help establish an entire supply chain for medical cannabis products.
Grow Group, which aims to bring medical cannabis products to patients at an affordable price, made the acquisition as part of its expansion strategy into international markets.
Sanoid Isolates is currently working on a high-tech greenhouse near Sevilla, Andalusia, with an ambition to grow and produce high-quality cannabinoid extracts and purified isolates, having received a production license by the Spanish authorities to grow a validation crop in 2019 to certify the extraction facility, which aims to be finished by 2022.
A budding relationship
With a background in marketing, sales and general management in manufacturing companies internationally, Wildschut joined Sanoid in 2018 – which was born out of sister company, Córdoba-based Phytoplant Research – one of the first companies to conduct research on medicinal cannabis in Spain.
“In 2018 I visited Córdoba for the first time to understand what was happening here and what kind of research they were doing – the year which was also a famous year for the cannabis industry when Canada legalised cannabis. Prior to that, in early 2018 I picked up on the idea of creating a commercial company, and so, presented the business plan to my shareholders.
“Together with the Phytoplant team we presented our licence application to the Spanish health authorities, and immediately – as confident as we were to get the licence – I started building the cultivation facilities near Seville. We got a licence in June and we did our first trial crop in the second half of 2019, and we were about to start building the extraction facility.
“Up until the point of time where we had cultivation facilities up and running, the total investment was around five million, but in order to build the extraction facility, we would need another 10 million to get operational.
“We decided we needed investors or potentially even new owners who could take Sanoid forward in its next step into GMP manufacturing. Altogether, it took about nine months for Grow to close a final deal two months ago – so, I’m extremely pleased with Grow as my new shareholders, and with Grow being in a position to actually fund the build of our GMP facilities.”
A unique position for cannabis cultivation
Wildschut says that Sanoid is in a unique position for its cannabis cultivation activities thanks to the ideal growing climate in Andalusia, and with Sanoid being one of a handful of companies to receive a licence from the Spanish Drug and Healthcare Products Agency (AEMPS).
“We are in a very unique position because, in Spain, only three operational licences are in place. There are two or three runners up if you like, including Sanoid, which gives us a fairly unique position, given the fact that we have one of the most ideal growing climates here in Andalusia.
“Supporters of indoor growing will tell you it allows for four or five crops in a year and allows control of all the elements to a maximum because it is in a closed building using artificial lights. However, the single biggest downside of that, is that it is incredibly expensive and unsustainable, given the huge amount of electricity you need.
“When I started Sanoid, my view was that, first of all, we are going to grow to extract, because, in my view, patients are not going to continue to consume plant material. Doctors are not going to be comfortable prescribing plant material as a medicine, given its inconsistency. So, sooner rather than later, there will be products available based on cannabis that will be drinks or pills or creams – which will be much more comfortable for doctors to prescribe – so that is how I started Sanoid.
“And, that’s why we grow with the natural sun, predominantly for extraction. If you grow for extraction, the size of the bud and the smell and flavour is not that important, and we already see that trend growing very quickly already in Germany, which is one of the biggest medical markets. The good thing about our setup in Andalusia, is that the typical cost of one gramme of indoor material is around one euro and, for that one gramme of material here in Seville, it is 10 cents.
“I’m a very strong believer that we are now in a position with Grow Group to reduce the end price for patients, make it a lot more affordable and reach a much larger audience of people who will benefit from cannabis medicines.”
Cost-effective medicines for European patients
Grow’s relationship with Sanoid gives the company the ability to control its own supply chain, and, Wildschut highlights, once further markets open up across Europe, the pair will be able to move into those markets at a fast pace, with the confidence of supplying high quality products at an affordable price point for patients.
“Hopefully, we will be one of those few, inspiring examples of cannabis companies serving patients European or globally,” says Wildschut.
“The reason why we have this unique licensing in Spain is because of, first of all, our Phytoplant legacy – the fact that we have European registered varieties – which is mandatory to get a licence in the first place. But secondly, a cultivation licence as such, is not being granted in Spain – there are allegedly over 100 applications here in Spain for people who want to grow, legitimately, but the Spanish government only allows cultivation for GMP processing. So you need to have GMP processing facilities in order to cultivate. But we have this tremendous ideal climate here in Andalusia where we can grow very cost efficiently.
“Our next step is to actually get those GMP facilities. We’re going to take a two-step approach. The first one is that we’re currently applying for a cultivation licence to grow validation material for a GMP flower facility – we are going to build our extraction factory, but also a dedicated GMP drying processing and packaging area for flower.
“Seeing how there is still an urgent need for good GMP flower, we do believe it’s worth the investment to be able to deliver that. That’s something we are looking to put in place in the first quarter next year, so that from next year onwards, we will be in a position to provide smaller quantities of GMP flower for the German and UK markets.
“At the same time, we will start a phase two, which is the build out of our extraction and purification facility, which involves heavy equipment and machinery. By the end of next year we will be in a position to certify our extraction facility and that means that in 2023 we should be in a position to grow our first commercial crop in our greenhouses and start producing our first products from our factory to go to markets, whether it be GMP flower or extracts for products with the famous entourage effect, or whether it be isolates as API’s to be used in producing pills or lotions, for example.
“There are two further steps we are now seriously looking into. The first step, is to actually produce those pills and creams ourselves, and the other part is that Grow is now considering putting all of their logistic manufacturing facilities here in the south of Spain where we will turn out to be the pan-European logistics hub to supply all the future Grow companies – in Germany, the UK, and France, for example.
“So, that is already where our strategic model is emerging on how we could serve the whole of Europe, with sales offices all around Europe by Grow with our logistic manufacturing down here in Spain, in a very very cost effective manner.
“What we are of course hoping for is a continuous momentum, or perhaps even acceleration of legislation around Europe. What we see now is the inconsistency of legislation – in the UK for instance they allow to some extent sales to patients, but they don’t allow manufacturing or cultivation. In Spain it’s the other way around – we don’t have legislation to consume cannabis in Spain legally, medicinally or recreationally, but, there are a few companies who are allowed to produce an export only.
“I believe that Grow now is in a very privileged position, because I don’t believe cultivation in Germany or in Holland, or in Denmark or in Canada, is not sustainable. So I believe that, apart from politics, economics will drive to the model Grow actually incorporated today, with cultivation production in cost efficient locations and patient access locally.
“The whole regulatory environment is very important to further increase the acceptance and the availability of cannabis medicines.
“I have a hard time finding insurance for my cultivation facilities because cannabis is not recognised as an official crop yet. So insurance companies are reluctant to step into this, but also banks – although luckily we see some movement with banks that are willing to give credit lines to cannabis companies. The UK has now allowed cannabis companies to be listed as is the case in Canada, so, legislation, once that opens up, there will be much more ancillary businesses supporting our industry and ultimately with surprises coming down that really open the market to the many hundreds of thousands or even millions of patients will benefit from using medicinal cannabis.”
- CBD pet product market expected to reach $4.7bn by 2028
- How the carbon capture of hemp can help reduce emissions
- World anti-doping agency to carry out scientific cannabis review in 2022
- CBD Science launches funding round to advance cancer pain treatments
- World’s first medical-grade vapouriser now available in the UK