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Just executed at 43.11p

Opened isa with ii , put in 19400 pounds and asked them to buy this amount in oo, that was 1 hour ago and still not executed

Open Orphan plc

("Open Orphan" or the "Company")

Potential demerger of certain non-core assets

Proposed Capital Reduction, Distribution in Specie and notice of General Meeting

Open Orphan plc (AIM: ORPH), a rapidly growing specialist pharmaceutical services clinical research organisation (CRO) and a world leader in vaccine and antiviral testing using human challenge clinical trials, announces that it is at an advanced stage in planning for a possible spin-out of certain non-core Development IP Assets. These Development IP Assets are a portfoilio of intellectual property and development assets, including HVO-001 which has potential application in the treatment of respiratory disease. These do not include the equity interests in Imutex Limited and PrEP Biopharm Limited.

The Board believes that to maximise shareholder value that the Development IP Assets are best developed separately from the core services business. Furthermore, such a spin-out transaction could provide the opportunity to secure separate financial resources for these assets, to enable accelerated development of these assets and achievement of commercial milestones. A spin-out transaction would also allow Shareholders to benefit from both the value of the development assets and the standalone value of the core services business, as they progress through their own key milestones.

To this end, a circular (a "Circular") is being sent to shareholders today providing background to, details of and reasons for, a proposed Reduction of Capital and Distribution in Specie, to facilitate the possible spin-out and admission to AIM of the Company's non-core Development IP Assets. The reduction in capital will also allow for the Company to pay dividends and distributions to shareholders should the Board deem it appropriate in the future.

The Board has decided to take the necessary preliminary steps in preparation for a potential spin-out, including incorporating a new subsidiary, further details of which are outlined in the Circular. The Company has decided to proceed in obtaining the approvals necessary for the Reduction of Capital and the Distribution in Specie which are required to implement the demerger. Notwithstanding that the Company is seeking the necessary approvals for the Reduction of Capital and the Distribution in Specie now, these considerations remain at an early stage, and there can be no guarantee that the Reduction of Capital and/or the Distribution in Specie will be completed. HMRC advance clearance for the Demerger has been successfully obtained so any distribution would be exempt for income tax purposes and have no capital gains implications for UK shareholders. Further announcements will be made at the appropriate time.

Open Orphan plc (AIM: ORPH), a rapidly growing specialist pharmaceutical services clinical research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials , announces that hVIVO , a subsidiary of Open Orphan, has entered into a contract with a biotechnology company to run a human viral challenge study for a r espiratory syncytial virus ("RSV") prophylactic and treatment.

This US biotechnology company is developing a product for the prevention and treatment of acute and chronic r espiratory syncytial virus infections. RSV is a contagious virus that affects the respiratory tract of children and at-risk older adults; in severe cases, it can cause pneumonia and other life-threatening breathing difficulties. RSV is a significant public health threat and is one of the leading causes of hospitalisation of young children across the world. It also poses a significant threat to at-risk older adults; in the current climate, RSV may also lower immunity and increase the risk of developing COVID-19, and where these infections occur together, it can worsen the severity of COVID-19 illness. There is currently no prophylactic or specific treatment on the market for RSV.

The total contract value is GBP7.5m and the study is due to commence in Q4 2021, with the majority of revenues being recognised in 2021. hVIVO will conduct this study on behalf of its client to demonstrate the efficacy of their lead candidate against RSV infection. The product is expected to have substantial advantages with respect to potency, safety, tolerability and convenience while fully maintaining efficacy when compared to other similar products.

Cathal Friel, Executive Chairman, said: "This is another substantial and significant contract win for hVIVO and Open Orphan. Through signing these deals, we continue to reinforce our position as the clear world leader in human challenge studies. Over the past year, Open Orphan has fully restructured, reorganised, and integrated our London, Paris and Breda operations to become a fast-growing, profitable provider of human challenge clinical trials in a manner required by the global pharmaceutical and biotechnology companies. We have expanded from one clinic to multiple clinics, and it is our stated objective to continue to invest and expand our global capability to ensure our position as the world leader in testing vaccines, antivirals, and monoclonal antibodies through the use of human challenge studies well into the future.

With the ongoing expansion of our clinical footprint, we can now provide any pharmaceutical company, anywhere in the world, rapid access to challenge study clinical trials to gather data on their product in a relatively short time period. In the past, human challenge studies suffered from the perception that it was difficult to find a provider and that it may take a long period of time to complete, however, Open Orphan is transforming this view. We are delighted to s

TIDMORPH

RNS Number : 5449R

Open Orphan PLC

09 March 2021

9 March 2021

Open Orphan plc

("Open Orphan" or the "Company")

New contract win with Oxford BioTherapeutics

Open Orphan plc (AIM: ORPH), a rapidly growing specialist pharmaceutical services CRO and a world leader in vaccine and antiviral testing using human challenge clinical trials, announces its subsidiary Venn Life Sciences ("Venn") has been awarded a contract for a study with Oxford BioTherapeutics, a clinical stage oncology company with a pipeline of immune-oncology and antibody-drug conjugate-based therapies.

This is a phase I, open-label, dose finding study which will be used to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of OBT076, a CD205-directed antibody-drug conjugate, in recurrent and/or metastatic CD205-positive solid tumours and in women with CD205-positive HER2-negative metastatic breast cancer.

For this study, the Venn Paris team will deliver high-quality data management and statistics services. Venn's team in Paris are highly regarded in the field as one of the leading providers in this area which is a perfect complement to the Company's London offering. The study is due to start immediately.

Cathal Friel, Executive Chairman, Open Orphan, commented: "We are delighted to be in a position to announce another contract win for the Paris team. This deal further demonstrates Open Orphan's ability to execute on its significant pipeline of contracts with important pharmaceutical businesses.

"Oxford BioTherapeutics is a clinical stage oncology company with a pipeline of first-in-class therapies aiming to fulfil major unmet patient needs by targeting difficult-to-treat cancers. The Venn team are looking forward to assisting with the study and providing the preliminary data required to advance this breast cancer trial."

Dr Rahim Fandi, MD, PhD Oxford BioTherapeutics CMO commented: "We are delighted to work with Venn and are sure that Oxford BioTherapeutics will benefit from their expertise."

For further information please contact:

The UK must prepare for a “hard winter” since the population could be less immune to other respiratory illnesses such as flu, a top medic has warned.

Speaking to the BBC’s Andrew Marr Show Sunday, Dr Susan Hopkins, Covid-19 strategic response director at Public Health England (PHE), said the country could see surges of other respiratory diseases, as well as coronavirus, come autumn.

It comes as the UK continues to roll out its vaccine program and starts to ease lockdown restrictions with summer approaching.

Asked if the country could be back in a difficult situation by autumn, Hopkins said: “I think it is really difficult to predict what is going to happen in the future and six months away is a long time."

9th feb

Sky news this morning.
The chancellor will also promise to invest a further £33m in vaccine testing and development to protect against future outbreaks and variants.

And there will be another £22m for what the government claims will be a "world-leading study" to test the effectiveness of combinations of different vaccines.

This research on the different use cases for lateral flow antibody tests is welcome,” said Chris Molloy, chair of the UK-RTC.

“The AbC-19 test is an important weapon in the global fight against Covid-19. It allows us to see the neutralising IgG antibodies produced in response to infection, or after vaccination.”

Shares in Omega closed more than 16% higher yesterday on the news, up 13p at 93p.

The results come after Prime Minister outlined the important role that lateral flow tests could play in reviving the UK economy. In his Covid-19 briefing on Monday evening, Boris Johnson said that he hopes people will be able to return to nightclubs and theatres through the use of rapid Covid-19 tests.

READ MORE: Omega confirms Covid testing contract

Last week, Omega confirmed that it has been chosen to help supply the UK Department of Health and Social Care (DHSC) with millions of lateral flow antigen tests for Covid-19. The intention is that once the DHSC has access to a test that has successfully passed a performance evaluation, it will be licensed to Omega for manufacture.

The company is ramping up capacity at its headquarters in Alva to produce approximately two million tests per week by the end of April. Omega’s house analyst, FinnCap, has said this could generate between £150 million and £200m of additional annual revenues for the Scottish company.

Staff headcount at Alva has increased from 60 to more than 120 people.

This research on the different use cases for lateral flow antibody tests is welcome,” said Chris Molloy, chair of the UK-RTC.

“The AbC-19 test is an important weapon in the global fight against Covid-19. It allows us to see the neutralising IgG antibodies produced in response to infection, or after vaccination.”

Shares in Omega closed more than 16% higher yesterday on the news, up 13p at 93p.

The results come after Prime Minister outlined the important role that lateral flow tests could play in reviving the UK economy. In his Covid-19 briefing on Monday evening, Boris Johnson said that he hopes people will be able to return to nightclubs and theatres through the use of rapid Covid-19 tests.

READ MORE: Omega confirms Covid testing contract

Last week, Omega confirmed that it has been chosen to help supply the UK Department of Health and Social Care (DHSC) with millions of lateral flow antigen tests for Covid-19. The intention is that once the DHSC has access to a test that has successfully passed a performance evaluation, it will be licensed to Omega for manufacture.

The company is ramping up capacity at its headquarters in Alva to produce approximately two million tests per week by the end of April. Omega’s house analyst, FinnCap, has said this could generate between £150 million and £200m of additional annual revenues for the Scottish company.

Staff headcount at Alva has increased from 60 to more than 120 people.

Provisional research has shown that the rapid Covid-19 test in which Scotland’s Omega Diagnostics is involved has an accuracy of more the 97 per cent, the highest of four such tests that were reviewed.

The study, performed by scientists at Public Health England (PHE), has yet to be evaluated by the medical community as part of the usual peer review process and could therefore contain errors in its assumptions and methods. However, it was welcomed by the chairman of the UK Rapid Test Consortium (UK-RTC), of which Omega is a member.

The consortium’s AbC-19 lateral flow test uses a small drop of blood from a finger prick to determine within 20 minutes whether a person has antibodies to fend off Covid-19. The study by PHE, in conjunction with the universities of Bristol, Warwick and Cambridge,

I believe that if he has price sensitive information, which is very likely considering all the contractors being negotiated he is not allowed to purchase shares because this would be considered insider dealing

RNS Number : 7839N

Open Orphan PLC

03 February 2021

Open Orphan plc

("Open Orphan" or the "Company")

New challenge study quarantine clinic

Open Orphan plc (AIM: ORPH), a rapidly growing specialist pharmaceutical services contract research organization (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials, announces that hVIVO, part of Open Orphan plc, has opened a new quarantine clinic in East London. The new site is based in Whitechapel, directly opposite the Queen Mary BioEnterprise Innovation Centre ("QMB") which houses hVIVO's 24 bedroom unique state-of-the-art FluCamp site and the recently opened new street-level volunteer screening centre. The Whitechapel Clinic will act as an extension of hVIVO`s current QMB site.

The converted 26-bedroom former boutique hotel, which will be known as the Whitechapel Clinic, has the capacity for up to 19 quarantine rooms and will be used as an additional unit for human challenge trials and volunteer recruitment screening. The quarantine rooms are located across three floors of the former hotel, with each level fully converted to include a nurses station on each floor.

The new site, like QMB, will follow the highest safety standards to deliver each clinical study and volunteer screening visit. Of the 19 rooms, 8 rooms on a single floor are flexible use clinic rooms, meaning they can be used as either quarantine bedrooms for challenge studies or for volunteer screening visits. Each room at the facility has been fully repurposed to the highest standard, with all volunteer rooms equipped with an en-suite bathroom, TV, wardrobe, and tea & coffee making facilities. This will provide a comfortable space for volunteers during studies. The Whitechapel Clinic, like QMB, is also equipped with a 24-hour security presence and a working hour reception desk.

Cathal Friel, Exexcutive Chairman of Open Orphan plc commented: "Our newest quarantine unit greatly increases our capacity to facilitate hVIVO's pipeline of upcoming studies. Our QMB clinic is now close to full capacity until December 2021, and as such, the newly renovated, state of the art Whitechapel Clinic will allow us to increase our study capacity substantially in the year ahead.

"We have leased the entire former Whitechapel Hotel and managed to convert the space on a very cost efficient basis which is now almost fully booked to capacity for H1 2021. This new facility will be run at the same high standard as our QMB site, and volunteers will be expertly supervised by our highly trained nurses and doctors in a safe and controlled clinical environment."

Interested in becoming a volunteer?

TIDMORPH

RNS Number : 4290N

Open Orphan PLC

01 February 2021

Open Orphan plc

("Open Orphan" or the "Company")

Contract extension with Carna Biosciences

Open Orphan plc (AIM: ORPH), a rapidly growing specialist pharmaceutical services clinical research organisation (CRO) and a world leader in vaccine and antiviral testing using human challenge clinical trials, announces a further contract renewal with Carna Biosciences, Inc. ("Carna"), extending its integrated drug development consultancy services with Venn Life Sciences ("Venn"), part of Open Orphan plc .

Carna Biosciences is a clinical-stage biopharmaceutical company which focuses on the discovery and development of innovative therapies to treat serious unmet medical needs, focusing on small molecule drugs. The renewal of this contract is expected to deliver significant revenue for Venn over the next twelve months.

The Venn team in the Breda office in the Netherlands, will provide Chemistry, Manufacturing & Control (CMC), Non-Clinical, Clinical and Regulatory consultancy services to this client for two of the client's leading development programmes. This successful collaboration has been extended until the end of December 2021.

Cathal Friel, Executive Chairman of Open Orphan, said: "The extension of this contract further demonstrates our ability to collaborate successfully with our clients and provide a service that results in repeat business. Venn and Carna have built up a good working relationship over a period of s everal years where both parties closely collaborated on drug development planning and its execution through consultancy services contracts. We look forward to delivering this contract for Carna in the year ahead."

Masaaki Sawa, Ph.D., Chief Scientific Officer and Head of Research and Development at Carna Biosciences, said: "The partnership with Venn Life Sciences complements our clinical development team and underlines our commitment to become a clinical stage company. By continuing the collaboration with the Venn team, we will accelerate our drug development."

RNS Number : 2335M

Open Orphan PLC

20 January 2021

Open Orphan plc

("Open Orphan" or the "Company")

Expansion of volunteer recruitment centres for human challenge trials

Open Orphan plc (AIM: ORPH), a rapidly growing specialist pharmaceutical services clinical research organisation (CRO) and the world leader in vaccine and antiviral testing using human challenge clinical trials, has opened two new volunteer recruitment centres to screen potential trial volunteers, the first in East London and a second in central Manchester. These new locations are part of the Company's expansion of its human challenge study trials launching in 2021.

The first new site is a repurposed former coffee shop at the street level of Queen Mary BioEnterprise Innovation Centre ("QMB"), which houses hVIVO's current 24-bedroom state-of-the-art quarantine clinic in Whitechapel, East London. This is the first time a branded volunteer recruitment centre has been situated at street level whereby volunteers can walk straight in for screening. The large, multi-use space has the capacity to provide substantially more volunteer medical screening and processing with dedicated private physical exam and consenting rooms, ample hot-desking space and a refreshment area, as well as a dedicated reception area. Importantly, this means the facility can now offer 520 volunteer recruitment visit slots per week, with the intention that this will increase over time. This new centre has processed its first volunteers in recent weeks. Learn more about the screening process at www.flucamp.com/what-is-screening/ .

The Company has opened another similar volunteer recruitment facility in central Manchester, broadening its reach and reducing travel time required by potential volunteers to attend the initial visit at our London clinic. It will have an initial capacity for more than 100 visits per week, but this will increase substantially in the weeks that follow. The clinic is due to process its first volunteers on 27 January.

Cathal Friel, Executive Chairman of Open Orphan plc commented: "We are delighted to have had the opportunity to get access to these new volunteer recruitment screening centres and to have them fully operational so quickly. The current pandemic has forced many businesses to close and we are able to provide another use for these spaces not currently in use. These spaces presented an opportunity for us to open street level volunteer recruitment centres quickly and efficiently. The number of volunteers required by hVIVO is increasing rapidly in line with the number of studies the company is running, and these two additional centres will allow us to increase our capacity substantially in the year ahead. Given our extensive pipeline of upcoming contracted studies, we are also continuing to explore additional quarantine facilities.

We are proud of our hard working and dedicated team for transforming both of these sites in record time into volunteer recruitm

Press release is dated 19/1/21

RNS Number : 1421L

Open Orphan PLC

11 January 2021

11 January 2021

Open Orphan plc

("Open Orphan" or the "Company")

First volunteer dosed in intran asal COVID-19 vaccine clinical trial

Open Orphan plc (AIM: ORPH), a rapidly growing specialist pharmaceutical services CRO and a world leader in vaccine and antiviral testing using human challenge clinical trials, announces that the first volunteer has been dosed with the Codagenix Inc. ("Codagenix") needle free, intranasal COVID-19 vaccine, COVI-VAC. Conducted by hVIVO, part of Open Orphan plc, the Phase I clinical trial of COVI-VAC is being carried out at their facility in the UK. COVI-VAC is a single-dose, intranasal, live attenuated (the entire virus in a weakened form) vaccine against SARS-CoV-2, the virus that causes COVID-19.

Further to the Company's announcement on 28 July 2020, hVIVO is working in collaboration with US biotech Codagenix to conduct a Phase I study of COVI-VAC. This is a randomised, double-blinded, placebo-controlled dose-escalation study, and will evaluate the safety and tolerability of the single-dose intranasal vaccine candidate in 48 healthy young adult volunteers at hVIVO's state-of-the-art Quarantine Facility in Whitechapel, London.

The study will also evaluate the vaccine's ability to provoke an immune response - measuring neutralising antibodies, mucosal immunity in the airway and cellular immunity. COVI-VAC has the potential to address several key logistical challenges to immunisation against SARS-CoV-2 at a global scale. As a single-dose, intranasally-delivered vaccine, COVI-VAC will not require a needle and syringe to be administered, nor ultra-low temperature freezers for storage. COVI-VAC can be manufactured on a large scale and supports ease of administration in a mass vaccination campaign. Codagenix expects to report initial data from the study by mid-2021.

Cathal Friel, Executive Chairman, Open Orphan, commented: "We are delighted to have been chosen by the New York based Codagenix to run this very important COVID-19 vaccine study in our quarantine clinic in London. This vaccine is one of the first of the next generation COVID-19 vaccines, it is a single dose, needle free, intranasal, live attenuated COVID-19 virus vaccine. Thus, in our opinion, because it is a live attenuated virus vaccine, COVI-VAC has the potential to give much longer-lasting cellular immunity against COVID-19 than many of the first-generation vaccines.

"Codagenix sought an inpatient facility for the first in human evaluation of COVI-VAC to allow for thorough evaluation of product safety and real-time volunteer monitoring, and our unique state-of-the-art quarantine facility in East London is one of the few facilities in the world suitable to conduct this trial safely and successfully. hVIVO are providing a full-service trial as part of this contract with Codagenix and the team at FluCamp have been responsible for all aspects of trial recruitment for this study

Open Orphan PLC Contract renewal with top-3 pharmaceutical client

06/01/2021 7:00am
UK Regulatory (RNS & others)

Open Orphan (LSE:ORPH)
Intraday Stock Chart

Wednesday 6 January 2021
Click Here for more Open Orphan Charts.
TIDMORPH

RNS Number : 6842K

Open Orphan PLC

06 January 2021

6 January 2021

Open Orphan plc

("Open Orphan" or the "Company")

Contract renewal with top-3 global pharmaceutical client

Open Orphan plc (AIM: ORPH), a rapidly growing specialist pharmaceutical services CRO and a world leader in vaccine and antiviral testing using human challenge clinical trials, announces a further contract renewal with a major top-3 global pharmaceutical client extending its consultancy services to end of December 2021. This follows on from the announcement made on 22 December 2020 regarding the same client and demonstrates the repeat business that Venn Life Sciences ("Venn") continues to win from its long-term clients.

The Venn team in the Breda office in the Netherlands, will provide Chemistry, Manufacturing & Control ("CMC") consultancy services to this leading global pharmaceutical client for one of the client's vaccine development programmes and follows the recently announced contract renewal for work on two of the client's vaccine development programmes. This successful collaboration has been extended until end of December 2021.

Cathal Friel, Executive Chairman of Open Orphan, said: "We are delighted to enter 2021 with another contract signed by the Venn team in Breda with this top-3 global pharmaceutical client. Venn have been providing CMC support to this top tier company since 2012 and are pleased to be continuing to work with this client in their vaccine development programme.

"This contract demonstrates the depth of vaccine development knowledge across the Company and, in addition to being the world leader in vaccine and antiviral testing using human challenge clinical trials, reinforces our position as the go-to clinical research organisation for many other services required by both large pharma and vaccine developers at all stages of development."

Full text of Times article on ADVFN

And in The Times newspaper on line