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#POLB Poolbeg Pharma – Final Results

Poolbeg Pharma (AIM: POLB, ‘Poolbeg’ or the ‘Company’) announces its audited results for the period ended 31 December 2021. These results follow the Company’s spin-out from Open Orphan plc and the subsequent listing on the AIM market of the London Stock Exchange in July 2021.

 

Poolbeg Pharma is a clinical stage infectious disease pharmaceutical company with a capital light model which is looking to develop multiple products faster and more cost effectively than the conventional biotech model. Poolbeg is targeting the growing infectious disease market and, in the wake of the COVID-19 pandemic, infectious disease is becoming one of the fastest growing markets with an expected value of c. $250 billion by 2025.

 

The Company aims to bring innovative infectious disease products through to a value inflection point by generating early human efficacy data before rapidly monetising through partnerships and licensing deals with pharma and biotech. Poolbeg’s model aims to significantly reduce spend and risk compared to the conventional biotech model and allows multiple opportunities for monetisation through its broad portfolio. The model also enhances investor returns as the out-licensing revenues will be reinvested into the pipeline of additional assets which in turn, can be further monetised rapidly and as such, substantially extending the runway from the original £25m raised at IPO. 

 

Operational Highlights since IPO – significant strategic and operational progress

– POLB 001, a treatment for severe Influenza, remains on track to commence its bacterial lipopolysaccharide (LPS) human challenge trial in June 2022. Human data is expected before year end, at which point the Company aims to monetise by partnering or out licensing the product to pharma / biotech

–  Continued expansion and diversification of the portfolio, reducing risk due to having multiple shots on goal;

o  POLB 002 – in-licensed first-in-class, intranasally administered, RNA-based immunotherapy for respiratory virus infections

o  Option to licence and evaluate an intramuscular vaccine to prevent Melioidosis (POLB 003), a disease predominately found in tropical and sub-tropical regions, and five additional bacterial vaccine candidates

o  Oral Vaccine Delivery Platform – licensed access to use micro- and nanoencapsulation technology to develop oral vaccines for multiple disease indications

– In February 2022 the Company signed its first Artificial Intelligence (AI) deal with OneThree Biotech Inc. to identify new treatments for Respiratory Syncytial Virus (‘RSV’) through analysis of Poolbeg’s unique human challenge trial data and OneThree’s clinically validated biology driven platform

 

Financial & Corporate Highlights

–  Well capitalised with a strong cash balance of £20.9m at period end, following the IPO fundraise of £23.2m (after expenses)

–  Loss for the period amounted to £2.3m including the initial non-recurring costs of establishing the Group

– The Company has significant financial resources and will maintain its capital light approach to support its pipeline expansion and development

– Scientific Advisory Board strengthened with the appointment of Professor Daniel Hoft joining Professor Luke O’Neill and Dr Elaine Sullivan

 

2022 Pipeline

–  Intention to dual-list on the OTC market in the US in Q2 2022 to provide additional liquidity in the stock

–  Evaluating opportunities for non-dilutive grant funding to support the further development of existing pipeline

– Upon receipt of human data from POLB 001 study in H2 2022, the Company will look to commence monetisation to pharma and biotech companies via licensing or partnership agreements

–  Generation of value through advancement of portfolio assets POLB 002, POLB 003, and Oral Vaccine Delivery Platform

–  Preliminary outputs from the RSV Artificial Intelligence Discovery Programme are expected in H2 2022

–  Continuous engagement and discussion with pharma and biotech companies around the Company’s portfolio including out-licensing and product rights deals

– Continue to identify and conduct diligence on numerous new innovative infectious disease products to add to the pipeline, leveraging the expertise and network of our management team and scientific advisory board. In addition, we continue to evaluate further AI partnerships

– Continue to position the Company firmly at the cutting edge of global R&D as the infectious disease market grows to c. $250bn by 2025

 

 

Investor presentation

 

Poolbeg’s Chairman, Cathal Friel and CEO, Jeremy Skillington will provide a live presentation via the Investor Meet Company platform on 3 March 2022 at 6:00pm.

 

The presentation is open to all existing and potential shareholders. Investors can sign up to Investor Meet Company for free and add to meet Poolbeg Pharma plc via: www.investormeetcompany.com/poolbeg-pharma-plc/register-investor

 

 

Jeremy Skillington, PhD, CEO of Poolbeg Pharma said:

“This has been a period of great progress at Poolbeg. In less than six months we have grown and diversified our portfolio of products and platforms targeting a range of infectious diseases. POLB  001 is on track to commence its LPS human challenge trial, we have in-licensed an intranasal RNA-based immunotherapy POLB 002, as well as partnering to develop an oral vaccine delivery platform and agreeing an option to licence a late pre-clinical Melioidosis vaccine, POLB 003.

 

“In addition, we are now using cutting edge Artificial Intelligence technology to exploit our unique human challenge data, having signed up leading AI drug development experts OneThree Biotech to analyse and interrogate our RSV data to identify new drug targets and treatments. This is the first time that AI is being used to analyse RSV human challenge study data and initial results are expected in H2 2022.

 

“As well as growing our operational team since July, we’ve also added invaluable international academic expertise to our Scientific Advisory Board. Our capital-light business model is working well, leaving us with significant financial resources to invest in growing our pipeline further and developing our offering to pharma, without any need for further investment.”

 

 

Cathal Friel, Chairman of Poolbeg Pharma said:

“As the single largest shareholder of the Company, I will make it my duty to ensure that the share price starts performing again. I want to make it clear that none of us are happy with where the share price is currently given the drop since IPO. Market conditions have been and remain extremely challenging however, I want to reassure you that we are actively working on creating demonstrable value as we drive the business forward.

 

My personal belief is that one of the biggest reasons for the pressure on the share price is the perceived overhang from the forthcoming end to the lock-in of the shares received as part of the spin-out, by Open Orphan shareholders. Many shareholders are concerned that the release of these shares may damage the share price. I personally feel that this perception is wrong and that we won’t see a large sell-off of these dividend in specie shares. However, I would like to reassure shareholders that we are looking to put in place a series of actions that will reduce or eliminate the potential for these shares to impact the market. In addition to these specific actions, Poolbeg is also at an advanced stage of dual listing on the OTC market in the USA with plans to complete this within Q2. This should help provide additional liquidity in the Company.

 

Furthermore, the distribution in specie shares issued to shareholders as part of the demerger from Open Orphan are treated as a distribution for UK tax purposes, which could be taxable as dividend income. However, as advance clearance for a statutory demerger was obtained from HMRC, the distribution is exempt for UK income tax purposes, and hence there should be no UK income tax liabilities for UK resident shareholders. The only time that UK resident shareholder will be subject to tax on these dividend in specie shares, will be in the event that they sell them, and in that event there will be a capital gains tax payment due. This is a further reason why I don’t see shareholders looking to sell these dividend in specie shares immediately upon the end of the lock in.

 

In summary, I am very optimistic that in the months ahead our share price will perform and more importantly, that we will continue to progress our business model as outlined at IPO while we rapidly grow Poolbeg into a unique publicly listed company which will be a ‘one-stop-shop’ for pharma and biotechs seeking a range of infectious disease assets to develop in the months and years ahead.”

 

 

The Company’s Annual Report and Accounts for the period ended 31 December 2021 will be posted to shareholders in due course together with the notice of the 2022 Annual General Meeting, and will be available on the Company’s website: www.poolbegpharma.com/investors/documents/  

 

Footnote: c. $250bn infectious disease market made up of the: Diagnostics Market ( link ), Therapeutics Market ( link ), and Vaccines Market ( link ).

 

– Ends –

 

Enquiries

 

Poolbeg Pharma Plc

Jeremy Skillington, CEO

Ian O’Connell, CFO

 

 

+44 (0) 207 183 1499

finnCap Ltd (Nominated Adviser & Joint Broker)

Geoff Nash, James Thompson, Charlie Beeson,

Richard Chambers, Sunila de Silva (ECM)

 

 

+44 (0) 207 220 0500

Arden Partners PLC (Joint Broker)

John Lewellyn-Lloyd, Louisa Waddell

 

 

+44 (0) 207 614 5900

J&E Davy (Joint Broker)

Anthony Farrell, Niall Gilchrist

 

 

+353 (0) 1 679 6363

Instinctif Partners

Melanie Toyne Sewell, Rozi Morris, Tim Field

 

+44 (0) 20 7457 2020

poolbeg@instinctif.com

#POLB Poolbeg Pharma – Notice of Results

Poolbeg Pharma (AIM: POLB, ‘Poolbeg’ or the ‘Company’) a clinical stage infectious disease pharmaceutical company with a unique capital light clinical model will announce its results for the period ended 31 December 2021 on Thursday 3 March 2022.

The Company will be hosting an online presentation for investors on the same day, at 6:00pm GMT on the Investor Meet Company platform. 

The presentation is open to all existing and potential shareholders. Investors can register to attend here:

www.investormeetcompany.com/poolbeg-pharma-plc/register-investor  

– Ends –  Enquiries 

Poolbeg Pharma Plc

Jeremy Skillington, CEO

Ian O’Connell, CFO

 

+44 (0) 207 183 1499

finnCap Ltd (Nominated Adviser & Joint Broker)

Geoff Nash, James Thompson, Charlie Beeson,

Richard ChambersSunila de Silva (ECM)

 

+44 (0) 207 220 0500

Arden Partners PLC (Joint Broker)

John Lewellyn-Lloyd, Louisa Waddell

 

+44 (0) 207 614 5900

J&E Davy (Joint Broker)

Anthony Farrell, Niall Gilchrist

 

+353 (0) 1 679 6363

Instinctif Partners

Melanie Toyne Sewell, Rozi Morris, Tim Field

 

+44 (0) 20 7457 2020

poolbeg@instinctif.com

#POLB Poolbeg Pharma – Artificial Intelligence deal with OneThree Biotech

Poolbeg Pharma (AIM: POLB, ‘Poolbeg’ or the ‘Company’) a clinical stage infectious disease pharmaceutical company with a capital light clinical model, has signed an agreement with OneThree Biotech, Inc . a biology-driven artificial intelligence (‘AI’) company, to identify new drug targets and treatments for Respiratory Syncytial Virus (‘RSV’).

 

Under the terms of the transaction and as aligned with Poolbeg’s strategy, OneThree Biotech’s state-of-the-art AI analysis tools will identify drug assets which target immune-response pathways, have a higher probability of clinical success and have the potential to prevent and / or treat infectious diseases. The analysis will prioritise drugs with existing Phase I safety data, reducing spend and risk, which can feed into Poolbeg’s rapid, capital light clinical development strategy and its expanding pipeline of assets. The analysis is expected to commence in Q1 2022 with preliminary outputs from this work expected in H2 2022.

 

OneThree Biotech is a clinically validated AI company with a proven technology platform which integrates chemical, biological, and clinical data with cutting-edge computational tools to answer complex questions surrounding disease biology and drug discovery. The team at OneThree will work closely with Poolbeg’s scientific team to build a tailored AI analysis model which can leverage the unique insights of human challenge trial data to identify disease-relevant cell signalling pathways which could lead to novel drug targets. OneThree will receive milestone payments based on candidate development and royalties on the sale of products derived from this partnership.

 

The Company believe that this partnership with OneThree Biotech is the first time that AI analysis has been undertaken on RSV human challenge trial data and samples to identify new drug targets. The unique nature of human challenge trials to produce disease progression data with high precision is expected to revolutionise the insights generated from this analysis. Poolbeg’s lead asset POLB 001, which is progressing towards its first human challenge trial in June 2022, was identified using such disease progression data. However, by utilising AI the Company aims to identify more targets, quicker and more cost efficiently than previously possible without this technology. 

 

Poolbeg entered a partnership with Eurofins Genomics in October 2021 to complete RNA sequencing of Poolbeg’s RSV disease progression samples from human challenge trials. This work was a key step in Poolbeg advancing its AI analysis programme. This RSV discovery dataset has been specifically designed for incorporation into OneThree’s AI platform. The data sets within this project will leverage up to 140Gb of biological data per subject spread over baseline healthy measurements and the course of infection which is expected to unveil unprecedented insights.

 

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 affecting an estimated 50-million people annually, leading to 4 million global hospitalisations and up to 74,500 in-hospital deaths in children under the age of 5 years. An estimated 45% of these cases and deaths occur in new-born infants under the age of 6 months.

 

Jeremy Skillington, PhD, CEO of Poolbeg Pharma, said:

“OneThree Biotech’s AI analysis tools will allow us to break new ground in data-driven drug discovery, by allowing us to evaluate and interrogate human challenge trial data like never before. This is a key part of our growth strategy, as we’ll be able to identify and develop drugs in a more time and cost effective manner, compared with the traditional biotech model. It will enable us to identify potential new treatments which have a higher probability of clinical success and which can feed into our rapidly expanding pipeline in-line with our capital light model.

 

This will be the first time that AI tools will be used to analyse RSV human challenge trial disease progression data, which illustrates the significance of this deal as well as Poolbeg’s innovative model. We look forward to updating the market on the outputs from this cutting-edge AI analysis in due course.”

 

Neel S. Madhukar, PhD, co-founder and CEO of OneThree Biotech , said:

“At OneThree our mission has always been to unlock new therapeutic opportunities by understanding biology on a deeper level. The ability to combine our AI platform with the data and expertise from Poolbeg Pharma will enable just that, and create an opportunity to make meaningful progress in the treatment of infectious diseases.”

 

Brad Pryde, co-founder and COO of OneThree Biotech , concluded:

 

“We have been impressed with Poolbeg Pharma’s clear dedication towards using technology and data to create efficiencies in drug discovery and development. We’re excited to demonstrate the strength of this partnership as future developments arise.”

 

Footnote: During a human challenge study, a number of healthy volunteers are exposed to an infectious agent in a safe and controlled quarantine setting to assess the efficacy of vaccines or treatments. Human challenge trial data is unique in the depth of longitudinal virology, health, biomarker and symptom data collected during the course of disease from pre-infection, onset, progression and resolution of an infection .

– Ends –

  Enquiries

 

Poolbeg Pharma Plc

Jeremy Skillington, CEO

Ian O’Connell, CFO

 

  +44 207 183 1499

finnCap Ltd (Nominated Adviser & Joint Broker)

Geoff Nash, James Thompson, Charlie Beeson,

Richard Chambers  Sunila de Silva  (ECM)

 

 

+44 (0) 20 7220 0500

Arden Partners PLC (Joint Broker)

John Lewellyn-Lloyd, Louisa Waddell

 

 

+44 (0) 207 614 5900

J&E Davy (Joint Broker)

Anthony Farrell, Niall Gilchrist

 

 

+353 (0) 1 679 6363

Instinctif Partners

Melanie Toyne Sewell, Rozi Morris, Tim Field

 

 

+44 (0) 20 7457 2020

poolbeg@instinctif.com

Little Dog Communications for OneThree   

Jessica Yingling, Ph.D.

 

+1 (858) 344-8091

jessica@litldog.com

#ORPH Open Orphan PLC – Positive results from RSV Human Challenge Study

Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, notes the announcement dated February 17 2022 from Enanta Pharmaceuticals, Inc . (NASDAQ: ENTA), a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, on positive results from a human challenge study assessing its respiratory syncytial virus (“RSV”) antiviral candidate, EDP-938. The results from this human challenge study have been published in TheNew England Journal of Medicine. hVIVO , a subsidiary of Open Orphan, conducted the Phase 2a, double-blind, placebo-controlled trial using its RSV Human Challenge Study Model.

 

The trial enrolled 178 healthy adult volunteers across two parts, 18-55 years of age, who were intranasally challenged with RSV-A Memphis 37b (“M37b”). Volunteers received either a dose of EDP-938 or placebo for five days after infection, with different dose levels of EDP-938 being assessed. The study demonstrated that both viral load and clinical symptoms were significantly lower in volunteers that received EDP-938 than those that received placebo, with similar safety profiles between placebo and the antiviral regimens. Importantly, no serious adverse events occurred.

RSV is a  contagious, common respiratory virus that usually causes mild, cold-like symptoms and 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 to at-risk older adults.

 

hVIVO has two decades of experience and expertise in safely conducting challenge studies across a range of respiratory and infectious disease viruses, including various strains of influenza, RSV, HRV, asthma and malaria, etc.

Dr Andrew Catchpole, Chief Scientific Officer of hVIVO said: ” It’s pleasing to see another of our clients getting such positive results from a human challenge study that we conducted, and that the data has been published in The New England Journal of Medicine. EDP-938 is a potentially important medicine that could help reduce the global impact of RSV, and I look forward to following Enanta’s continued progression of the candidate through further clinical trials.”

 

Cathal Friel, Executive Chairman of Open Orphan, said :   “We are delighted to see that this important Phase 2a study of EDP-938 has yielded such positive results. We are a world leader in testing infectious and respiratory disease products using challenge studies such as this, and RSV is just one portion of our portfolio of challenge models, which also includes influenza, HRV, malaria, asthma, and now SARS-CoV-2. We look forward to continue offering our world class services to partners as we look to meet the growing demand from the infectious disease market.” 

 

Interested in becoming a volunteer?

 

hVIVO recruits many of its volunteers for its challenge study clinical trials through its dedicated  volunteer recruitment website,  www.flucamp.com . By volunteering to take part in one of our studies in a safe, controlled, clinical environment under expertly supervised conditions you are playing your part to further medical research and help increase the understanding of respiratory illnesses.

 

Individuals interested in taking part in  COVID-19 human challenge study  research can learn more at   www.UKCovidChallenge.com .

 

For further information please contact:

 

Open Orphan plc

+353 (0) 1 644 0007

Cathal Friel, Executive Chairman

Arden Partners plc (Nominated Adviser and Joint Broker)

  +44 (0) 20 7614 5900

John Llewellyn-Lloyd / Louisa Waddell

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson / Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

+44 (0)20 7933 8780 or openorphan@walbrookpr.com

Paul McManus/ Sam Allen / Louis Ashe-Jepson

+44 (0)7980 541 893 / +44 (0) 7502 558 258 / +44 (0) 7747 515393

 

#BVC BATM Advanced Comms – Trading Update and Notice of Results

BATM (LSE: BVC; TASE: BVC), a leading provider of real-time technologies for networking solutions and medical laboratory systems, gives notice that the Group will be announcing its results for the year ended 31 December 2021 on Monday 28 February 2022. 

The Group is delighted to announce that it expects to report full year revenue and EBITDA for 2021 slightly ahead of market expectations (which were raised during the year on 23 August 2021) reflecting strong growth from ongoing operations* with increased revenue in both divisions. In particular, this has been driven by significant growth in the Group’s Diagnostics unit of the Bio-Medical division.

Looking ahead, the Group entered the new year with a substantially higher backlog from ongoing operations than at the same point of the prior year and the strong momentum of 2021 has continued. Accordingly, the Group remains on track to deliver significant growth for full year 2022 in line with market expectations.  

Further detail will be provided in the Group’s full year results announcement on 28 February 2022.

Presentations to analysts and investors

Dr Zvi Marom, Chief Executive Officer, and Moti Nagar, Chief Financial Officer, will be holding presentations in London on the day of the results for:

· analysts at 9.00am GMT; and for

· private shareholders at 5.30pm GMT.

To register to attend either presentation, please contact laraapstein@luther.co.uk . 

* Excluding the contribution to 2021 and 2020 from NGSoft, a non-core subsidiary that the Group sold in March 2021, and the contribution to 2020 from a significant contract to supply critical care ventilators, which was exceptional in nature. 

Enquiries:

 

BATM Advanced Communications

Dr Zvi Marom, Chief Executive Officer

+972 9866 2525 

Moti Nagar, Chief Financial Officer

Shore Capital

Mark Percy, Anita Ghanekar, James Thomas (Corporate Advisory)

 

+44 20 7408 4050 

Luther Pendragon

Harry Chathli, Claire Norbury

+44 20 7618 9100

#ORPH Open Orphan – Launch of STRiVE project

Respiratory viral strains suitable for challenge agents being collected from consenting volunteers

 

Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that hVIVO, a subsidiary of Open Orphan plc, has recently launched the STRiVE project (Seasonal Transmissible Respiratory Virus SurvEy) to collect respiratory viral strains suitable for challenge agents from consenting hVIVO employees. Collection of new respiratory viral strains circulating in the community will allow hVIVO to continually update and broaden its world leading portfolio of human challenge study models.

 

As part of STRiVE, volunteers with cold or flu like symptoms can send nasal swabs to hVIVO for analysis. Since starting the project, hVIVO has identified over 180 promising virus candidates that could be used in the manufacture of novel challenge agents for its human challenge trials. Viruses isolated include several strains of coronavirus, adenovirus, human metapneumovirus (HMPV), human rhinovirus (HRV), parainfluenza virus (PIV), influenza, and respiratory syncytial virus (RSV).

 

STRiVE ensures hVIVO can regularly update its challenge agent portfolio with relevant strains as viruses mutate over time. Manufacturing antigenically relevant strains on demand broadens hVIVO’s repository of viral pathogens and could help extend the range of human challenge models it currently offers.

 

The average UK adult has an estimated 2-4 respiratory infections each year, resulting in billions of pounds of lost output due to illness. Despite familiarity with the negative impacts of cold and flu viruses, remarkably little is understood about the hundreds of viruses responsible that cause illness, including transmission and markers of protective immunity. Using human challenge modelling to better understand such issues could enable future public health benefits and savings.

hVIVO has two decades of experience and expertise in safely conducting challenge studies across a range of respiratory and infectious diseases, including various strains of influenza, RSV, human rhinovirus (HRV – common cold virus), malaria, and asthma. This portfolio has also expanded to include the SARS-CoV-2 virus.

 

Cathal Friel, Executive Chairman of Open Orphan, said: Despite only commencing recently, STRIVE has already been a remarkable success, with over 180 viruses identified and 12 different strains, with potential to be used as challenge agents in hVIVO human challenge trials. I would like to thank all hVIVO employees who have thus far participated and encourage more to do so in order to continue to build up this important repository for cold and flu research.

 

“Importantly, the STRIVE clinical research project will play a significant role in the Company’s efforts to broaden its world leading portfolio of human challenge models.

 

Adrian Wildfire, Director of Scientific and Business Strategy at hVIVO, commented: Access to viable strains of circulating respiratory pathogens is extremely limited and this often presents a significant obstacle to anyone seeking to grow a new viral challenge agent. To grow a new viral strain a virus must be collected from a human host, processed and stored in an adequate manner to keep the virus alive.

 

“STRIVE will allow the Company to use its expertise to monitor the viral strains of cold and flu that are circulating in the community, and potentially lead to the discovery of new, wild type challenge agents and the development of new human challenge models with unparalleled translation into the field.

 

Interested in becoming a volunteer?

 

hVIVO recruits many of its volunteers for its challenge study clinical trials through its dedicated volunteer recruitment website, www.flucamp.com. By volunteering to take part in one of our studies in a safe, controlled, clinical environment under expertly supervised conditions you are playing your part to further medical research and help increase the understanding of respiratory illnesses.

 

Individuals interested in taking part in COVID-19 human challenge study research can learn more at www.UKCovidChallenge.com.

 

 

For further information please contact:

 

Open Orphan plc +353 (0) 1 644 0007
Cathal Friel, Executive Chairman
Arden Partners plc (Nominated Adviser and Joint Broker)    +44 (0) 20 7614 5900
John Llewellyn-Lloyd / Louisa Waddell
 
finnCap plc (Joint Broker) +44 (0) 20 7220 0500
Geoff Nash / James Thompson / Richard Chambers
 
Davy (Euronext Growth Adviser and Joint Broker) +353 (0) 1 679 6363
Anthony Farrell
 
Walbrook PR (Financial PR & IR) +44 (0)20 7933 8780 or openorphan@walbrookpr.com
Paul McManus/ Sam Allen / Louis Ashe-Jepson +44 (0)7980 541 893 / +44 (0) 7502 558 258 / +44 (0) 7747 515393

#POLB Poolbeg Pharma – Poolbeg Pharma licences first-in-class broad spectrum RNA-based immunotherapy for respiratory virus infections from the University of Warwick

17 January, 2022- Poolbeg Pharma (AIM: POLB, ‘Poolbeg’ or the ‘Company’), a clinical stage infectious disease pharmaceutical company with a capital light clinical model, has in-licenced a novel, first-in-class RNA-based immunotherapy for respiratory virus infections developed at the University of Warwick.

Poolbeg has secured an exclusive licence to this dual antiviral prophylactic and therapeutic candidate, which is at a late-pre-clinical development stage. In vivo data confirms that this immunotherapy asset targets pan-respiratory virus infections, which could include influenza, respiratory syncytial virus (RSV), SARS-CoV-2 and others.

The candidate, which will be developed by Poolbeg as POLB 002, was developed at the University of Warwick and derived from twenty years of research with world class virologists, Professor Andrew Easton and Professor Nigel Dimmock.

Administered intra-nasally, this RNA-based immunotherapy works by triggering nasal cells into an antiviral state to protect from the infecting virus. Simultaneously, it blocks the cells from making more virus by directly preventing its replication. Both modes of action combined can reduce infectious viral loads and improve disease symptoms. As a nasally administered and rapidly effective prophylactic antiviral candidate, it could potentially provide an effective solution for protecting at risk patient populations (e.g. the elderly, COPD patients, and asthmatics).

Respiratory virus infections are considered a top five global killer resulting in more than three million annual deaths worldwide. There is a significant unmet need for improved respiratory virus infection therapies and the current available treatments, vaccines and antiviral drugs, are typically pathogen specific. Consequently, 85% of illnesses caused by non-influenza viruses cannot be adequately treated and the emergence of resistance is also a major concern.

Jeremy Skillington, PhD, CEO of Poolbeg Pharma, said: “This dual action immunotherapy developed by the team at University of Warwick is a really exciting technology in the field of respiratory virus disease treatments. The data shows it to rapidly reduce viral load and also prevent the likelihood of virus resistance.

“It will be an excellent addition to our growing pipeline of assets and we plan to move rapidly towards human proof-of-concept studies using our capital light clinical model. We look forward to updating the market as POLB 002 progresses through the clinic with the ultimate aim of partnering it with Big Pharma.”

Professor Andrew Easton, from the School of Life Sciences at the University of Warwick, said: “Currently most respiratory virus infections cannot be treated despite being responsible for millions of deaths each year. This is a very exciting new approach with great potential. We are delighted to be developing it alongside the Poolbeg Pharma team, with their extensive knowledge and experience in the sector.”

– Ends –

Enquiries

 

Poolbeg Pharma Plc

Jeremy Skillington, CEO

Ian O’Connell, CFO

 

 

+353 (0) 1 644 0007
finnCap Ltd (Nominated Adviser & Joint Broker)

Geoff Nash, James Thompson, Charlie Beeson

 

+44 (0) 20 7220 0500
Arden Partners PLC (Joint Broker)

John Lewellyn-Lloyd, Louisa Waddell

 

+44 (0) 207 614 5900
J&E Davy (Joint Broker)

Anthony Farrell, Niall Gilchrist

 

+353 (0) 1 679 6363
Instinctif Partners

Melanie Toyne Sewell, Rozi Morris, Tim Field

+44 (0) 20 7457 2020

poolbeg@instinctif.com

 

University of Warwick
Alice Scott – Media Relations Manager

+44 (0) 7920 531 221

Alice.j.scott@warwick.ac.uk

 

#ANA Ananda Developments – Shareholders Update

ana

Ananda’s ambition is to be a leading UK grower and provider of consistent, high quality, carbon neutral medical cannabis for the UK and international markets.

The Directors of Ananda provide the following update to shareholders, which comprises Ananda’s responses to questions recently received from shareholders and other interested parties.

Melissa Sturgess, Ananda’s Chief Executive Officer, commented “We welcome these questions from shareholders and other interested parties.  We believe that the medical cannabis industry is not particularly well understood at the moment, and we appreciate the time taken to frame these questions and send them to the Company”.

Q1: 40 Hectares of Land were identified by JE Piccaver & Co (Gedney Marsh) Limited (“JEPCO”) for commercial growing. Is this already owned and is it the intention to use the whole area for the first growing season?

A: JEPCO* originally delineated a 40Ha area for the use of DJT Plants Limited (“DJT Plants”).  To comply with the Home Office’s desire for remote and secure locations to grow medical cannabis, a superior location was identified by JEPCO prior to DJT Plants submitting its application to the Home Office in October 2019.  The location and significant acreage around it is leased by JEPCO.  A sublease agreement between DJT Plants and JEPCO forms part of the acquisition package of the 50% of DJT Plants that is not already owned by Ananda.  The initial area DJT Plants will be subletting covers 10Ha of land which also includes some infrastructure in the form of large storage sheds.  The research facility is being built inside the storage sheds.   Also included within the sublease agreement is the option to sublet more land from JEPCO as demand for product grows (subject to commercial licencing from the Home Office). The earmarked land is currently being utilised for crops, including potatoes and wheat and will be made available to DJT Plants when it is required. There is no reason for DJT Plants to tie up further land now for which it would have to pay rent. It is conceivable that the total area for cannabis growing could be bigger than 40ha but that will depend on success and demand.

In summary, Ananda is able to tailor the size of its growing area to the demand for product.  To provide context, currently the UK market has around 10,000 patients who consume approximately 1 gram per day of cannabis.  A reasonable assumption for yield would be 300-400g per square metre (3 – 4 million grams per hectare).

In line with other markets for medical cannabis, such as Israel and Germany, the Directors expect that the growth of the UK market will accelerate over the coming years.  Ananda’s intention is to build capacity in line with market demand.  Ananda believes that the best result for patients is to deliver high quality, consistent medical cannabis products and the best result for shareholders is to focus on building a profitable business for the long term rather than building large production capacity in the first year.

Note:

* DJT Plants is the holder of the Home Office licence to grow >0.2% THC cannabis for research purposes. DJT Plants is 100% owned by DJT Group Limited, which in turn is 50% owned by Ananda and 50% owned by Anglia Salads Limited. Anglia Salads Limited is owned as to 68% by JEPCO and Stuart Piccaver, JEPCO’s principal shareholder. Shareholders of Ananda will shortly be asked to approve the acquisition of the 50% of DJT Group Limited that Ananda does not own. Anglia Salads Limited will become a significant shareholder of Ananda.

Q2: What stage is Ananda at with identifying potential customers and establishing relationships with them?

A: Ananda’s initial focus is the UK and we have commenced engagement with patient groups, prescribing groups and associated health care workers.  The Company has also commenced an initiative with the launch of the Medical Cannabis Research Roundup newsletters which comprise a regular summary of new scientific research in the medical cannabis space.  These summaries are collated into a regular newsletter which the Company sends to interested parties.  The Medical Cannabis Clinicians Society is to use Ananda’s updates to enhance its clinicians’ information database and will acknowledge Ananda’s contribution.  If you would like to receive copies of the newsletters, please go to the Company’s website at www.anandadevelopments.com  and sign up for the Medical Cannabis Research Roundup.

Q3: Is Ananda going down the same path as GW Pharmaceuticals Plc (“GW”) and becoming a pharmaceutical company?

A: No, Ananda is not a pharmaceutical company.  The key difference between Ananda and GW is that GW formulates licensed medicines and Ananda is focused on unlicensed medicines, at least in the initial stages.  Medical cannabis flower and oil (apart from the two GW products) currently prescribed in the UK are unlicensed.  These unlicensed medicines are prescribed to patients by specialist clinicians.

Q4: When does Ananda anticipate starting and finishing the test growing phase?

A:  The genetic stabilisation and field trial program, is expected to take around 18 months, provided there are no delays.  It will commence when the research facility construction is complete. There are two parts to the first phase. The first is to create stable genetics by ‘self-crossing’ for a number of generations (pollinating with a plant of the same genetics). Genetic stability is most easily explained by thinking about the similarity of the plants you grow when you buy a bag of tomato seeds.  It is currently difficult to obtain truly stable cannabis genetics without creating them yourself, and it is the Directors’ view that this is one of the causes of inconsistency of much medical cannabis flower. Inconsistent flower gives patients a different therapeutic experience from batch to batch, which is not ideal for the patient and does not generate confidence in the medicine for prescribing clinicians. The second part of the first phase is to take the best stable plants and grow them in the multi-chappelle greenhouses we have constructed at our research facility.  This is crucial, as all genetics respond differently in different conditions and some or many might not grow at all well.  We will take stable plants with the most ‘useful’ properties (combination of THC, CBD etc) and then find out which of those respond best to our growing conditions.

The Directors believe this will provide the best platform for the start of commercial growing (subject to licence) and enable the creation of a library of strains which will be proprietary to DJT Plants.

Q5: When will Ananda start its first production growing and first harvest? 

A: It is not possible for the Directors to provide a time for this, because it depends on many factors, including Ananda’s ability to secure a number of licences and approvals, including a commercial growing licence from the Home Office, a manufacturing licence from the MHRA (including GMP certification of our manufacturing facility) and a few other minor licenses.  Ananda is obviously focused on becoming a profitable company as quickly as possible and commercial growing is key to this.

Q6: What does Ananda intend to do to educate the medical profession regarding medical cannabis?

A: We have commenced the Medical Cannabis Research Roundup initiative as described above. In addition to our work, there are specialised groups focused on education, such as the Medical Cannabis Clinicians Society (www.ukmccs.org).  That Society is currently training specialists in medical cannabis and providing education to other health care groups.   Stuart Piccaver, Chief Executive Officer of JEPCO, and Melissa Sturgess presented to over 100 members of the Medical Cannabis Clinicians Society on 8 September 2021

Claims as to efficacy and healing properties cannot be made about unlicensed medicines.  This is the case for all manufacturers of medical cannabis and all unlicenced medicines in the UK.  We can only provide specialists with factual information, known as ‘detailing’.  If the Company is able to commence commercial production, we intend to provide, amongst other things, certificates showing the CBD, THC, terpene etc content of the flower being prescribed and to show the full supply chain, so that prescribers can get comfort about UK quality and provenance.

Q7: There are reports that vegetable growers are struggling to obtain and retain resources for vegetable  production. Is the growing of cannabis plant resource intensive, and does the Company envisage any issues in attracting the right resources to be able to grow the target volume of plants? 

A: One of the reasons Ananda partnered with JEPCO is that they deal with human resourcing every year for their salad leaf business.  To provide perspective, they have around 70 full time employees and we are able to draw on skills from that pool, on an as needs basis, as per the Service Agreement between DJT Plants and JEPCO.  Stuart Piccaver has been dealing with the requirements for seasonal labour for many years and has developed a focus on automation where possible, in order to reduce labour requirements and human handling of high care plant material.  One of the reasons for a managed expansion of the cannabis growing business, rather than immediate large scale, is to ensure we are able to manage labour requirements effectively and securely.  All labour will have to be trained in cannabis growing, harvesting etc.  We must also consider issues such as site security and numbers of people moving around high care areas.

Q8: How far down the supply chain is Ananda looking to serve or is the target to be a vertically integrated company? 

We are focused on the UK initially, and this requires us to grow medical cannabis to GACP (Good Agricultural Collection Practices), manufacture it under MHRA certified GMP (Good Manufacturing Processes) and distribute under GDP (Good Distribution Practices). Initially, we propose producing flower-based products and will add extract products as the business grows.  We do not want to take on aspects of the supply chain that we feel are not part of our remit (for example it is unlikely we will buy a specials pharmacy (pharmacy that handles unlicensed medicines)).  We want to remain focused on growing and providing high quality medical cannabis to UK patients and build the business from that base.

-Ends-

The Directors of the Company accept responsibility for the contents of this announcement.

ANANDA DEVELOPMENTS PLC
Chief Executive Officer
Melissa Sturgess

Investor Relations
Jeremy Sturgess-Smith

+44 (0)7463 686 497
ir@anandadevelopments.com
PETERHOUSE CAPITAL LIMITED
Corporate Finance
Mark Anwyl

Corporate Broking
Lucy Williams
Duncan Vasey

+44 (0)20 7469 0930

#ORPH Open Orphan Plc – $13.4m Influenza HCS contract win

(AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials , announces that hVIVO , a subsidiary of Open Orphan plc, has signed a $13.4m contract with a US-based biotechnology company to test its novel antiviral candidate using the hVIVO Influenza Human Challenge Study Model.

 

The study is expected to commence in H2 2022 and will be conducted at hVIVO’s state-of-the-art quarantine facilities in London. The Company expect the majority of revenues to be recognised in 2022.

 

The Company expects to sign an increasing number of contracts in this area as the global pandemic has highlighted the increased investment needed from governments and Big Pharma to develop effective, novel treatments for a range of infectious diseases that have potential to cause the next pandemic. Influenza is one such disease, with emergences of flu pandemics impossible to predict. Symptoms of influenza may be mild or cause severe disease, or in certain cases, death. Influenza is a serious global health threat with an estimated 1 billion cases per year, 3-5 million severe cases and 290,000 – 650,000 deaths per year.

 

hVIVO has two decades of experience and expertise in safely conducting challenge studies across a range of respiratory viruses, including various strains of influenza, respiratory syncytial virus (RSV), human rhinovirus (HRV – common cold virus), malaria, and asthma. In October 2020, this expanded to include the SARS-CoV-2 virus.

 

Cathal Friel, Executive Chairman of Open Orphan, said : ” We are delighted to announce this significant challenge study contract valued at over £10m, with a US-based biotechnology client testing its highly promising influenza antiviral candidate. This contract demonstrates the Company’s continued ability to convert its leading portfolio of challenge study models into substantial contracts, with signed contracts across a number of our challenge study models including RSV, asthma, hRV, and flu in the clinic next year. This underlines our market position as the world leader in the testing of vaccines, antivirals and respiratory products using human challenge trials.

 

“The recent emergence of the Omicron variant has illustrated the threat of pandemic infectious diseases, and as a result, pharma companies globally are looking to address the next cohort of infectious diseases which have potential to reach pandemic level, and are developing new therapeutics to help tackle them. Influenza is high on this list, and we expect to sign more contracts of this type as the infectious disease market grows exponentially in the coming years to be worth $250 billion by 2025. “

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 (as implemented into English law) (“MAR”). With the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain.

 

Interested in becoming a volunteer?

 

hVIVO recruits many of its volunteers for its challenge study clinical trials through its dedicated  volunteer recruitment website,  www.flucamp.com . By volunteering to take part in one of our studies in a safe, controlled, clinical environment under expertly supervised conditions you are playing your part to further medical research and help increase the understanding of respiratory illnesses.

 

Individuals interested in taking part in  COVID-19 human challenge study  research can learn more at   www.UKCovidChallenge.com .

 

 

For further information please contact:

 

Open Orphan plc

+353 (0) 1 644 0007

Cathal Friel, Executive Chairman

Arden Partners plc (Nominated Adviser and Joint Broker)

  +44 (0) 20 7614 5900

John Llewellyn-Lloyd / Louisa Waddell

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson/ Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

+44 (0)20 7933 8780 or openorphan@walbrookpr.com

Paul McManus/ Sam Allen/ Louis Ashe-Jepson

+44 (0)7980 541 893 / +44 (0) 7502 558 258 / +44 (0) 7747 515393 

#POLB Poolbeg Pharma – Poolbeg signs option for new vaccine candidate

6 December 2021 – Poolbeg Pharma (AIM: POLB), ‘Poolbeg’ or the ‘Company’, a clinical stage infectious disease pharmaceutical company with a capital light clinical model, has signed an Option Agreement to licence MelioVac, a vaccine for melioidosis, with University College Dublin (‘UCD’) and its inventor, Associate Professor Siobhán McClean , through NovaUCD, the university’s knowledge transfer office.  

The Company will continue its due diligence on MelioVac, a preclinical asset and recipient of a Wellcome Trust Award to aid its development, as well as 5 of other potential vaccine candidates discovered by Associate Professor McClean and her team, for the duration of the Option Agreement, prior to signing a ‘Licence Agreement’.

Dr McClean is Associate Professor and Head of Biochemistry at the UCD School of Biomolecular and Biomedical Science.   Dr McClean completed her BSc in Biochemistry in UCD and received her PhD from Imperial College London. Her research focuses on lung infections which led her to develop a platform technology to identify proteins that bacteria use to attach to human cells. These proteins have proved to be excellent vaccine candidates. Dr McClean completed some of the original research to identify the antigens associated with the Melioidosis Vaccine at TU Dublin.

Poolbeg Pharma has identified melioidosis as an infectious disease of interest due to its rising incidence around the world and because there is currently no approved vaccine available. Concerns are growing about global warming contributing to the spread of the disease to traditionally non-tropical areas.

Melioidosis, also known as Whitmore’s disease, is an infectious disease caused by the bacterium Burkholderia pseudomallei, commonly found in the soil and surface groundwater of many tropical and subtropical regions, with diverse clinical presentations including pneumonia and severe sepsis with multiple organ abscesses. Incidence of the disease is widespread in South-East Asia, Northern Australia and India, with climate change having a substantial impact on the spread of the disease to new areas such as Brazil. There are an estimated 165,000 cases of melioidosis each year, of which as many as 89,000 (54%) are estimated to be fatal.

Other potential vaccine candidates that the Company is evaluating include those for Klebsiella pneumoniae,Escherichia coli (O157), Burkholderia cepacia complex, Pseudomonas aeruginosa and Acinetobacter baumannii.

 

Jeremy Skillington, PhD, CEO of Poolbeg Pharma, said:

“Melioidosis offers Poolbeg an opportunity to expand our portfolio of infectious disease assets, as promised at IPO. This is a disease which presents a dangerous and underappreciated threat to human health which currently has no approved vaccine and a very high mortality rate. If we can take MelioVac through clinical development to Phase II ready, it has the potential to generate significant returns for investors in the short-term while contributing to the global response to the threat of infectious diseases with an unmet medical need. We are excited by the potential of the MelioVac opportunity along with the other vaccine candidates in the UCD portfolio.”

 

Siobhán McClean, Associate Professor at the UCD School of Biomolecular and Biomedical Science and inventor of MelioVac , said:

“We are passionate about developing a vaccine against Melioidosis. Poolbeg Pharma is a great potential partner to work with, bringing its experience of vaccine development and industry connections to our innovative science. On the basis that a license is taken, it would be a great to see the development of MelioVac and other candidates, and contribute significantly to the world’s renewed fight against infectious diseases.”

– Ends –

 

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 (as implemented into English law) (“MAR”). With the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain.

 

  Enquiries

 

Poolbeg Pharma Plc

Jeremy Skillington, CEO

Ian O’Connell, CFO

 

+353 (0) 1 644 0007

finnCap Ltd (Nominated Adviser & Joint Broker)

Geoff Nash, James Thompson, Charlie Beeson,

Richard ChambersSunila de Silva (ECM)

 

+44 (0) 20 7220 0500

Arden Partners PLC (Joint Broker)

John Lewellyn-Lloyd, Louisa Waddell

 

+44 (0) 207 614 5900

J&E Davy (Joint Broker)

Anthony Farrell, Niall Gilchrist

+353 (0) 1 679 6363

Instinctif Partners

Melanie Toyne Sewell, Rozi Morris, Tim Field

+44 (0) 20 7457 2020

poolbeg@instinctif.com

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