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#ORPH Open Orphan PLC – CAP accreditation
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 its clinical laboratories in Queen Mary’s Bioenterprise Centre and Plumbers Row (hLab) have been awarded accreditation by the College of American Pathologists (“CAP”). The Company sought the accreditation as part of its ongoing commitment to maintaining best in class quality systems.
The CAP is the world’s largest organisation of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programmes. The accreditation “supports laboratories performing testing on specimens from human, using methodologies and clinical application within the expertise of the program”. This further expands on the Company’s Good Clinical Practice for Laboratories (GCLP) accreditation from the Medicines and Healthcare products Regulatory Agency (MHRA) and provides additional quality assurances of its laboratory services for its clients, especially within the United States, thus ensuring the accuracy of test results and conforming to the requirements from the US Food and Drug Administration (FDA).
hLab is a highly specialised virology and immunology laboratory, offering a suite of services to support both pre-clinical and clinical respiratory drug and vaccine discovery and development. This includes assay development, transfer and optimisation across immunology, molecular and cell-based assays, including extensive options in sample matrix and stability testing and analysis. hLab is well equipped with Biosafety Level 2 and 3 facilities to provide high quality data outputs to enable clients to achieve early proof of concept, or to make a breakthrough discovery in the pathology and possible treatment of diseases with unmet medical needs. hLAB now provides services beyond supporting the Company’s in-house human challenge trials, offering lab services as a standalone service to s upport vaccine and drug development from pre-clinical studies through Phases I – III clinical trials.
Brandon Londt, Development Operations Director, hLab Development at hVIVO, said : “We are proud to have received the CAP accreditation, which is recognition of the quality of our laboratory and further demonstrates our commitment to maintaining the highest standards of excellence and ensuring that our work practices meet the rigorous CAP assessment standards. This accreditation will provide current and future clients a further degree of confidence in the quality of work performed in our laboratory and assurances of the results we produce.”
For further information please contact:
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Open Orphan plc |
+44 (0) 20 7756 1300 |
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Yamin Khan, Chief Executive Officer |
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Walbrook PR (Financial PR & IR) Stephanie Cuthbert / Phillip Marriage / |
+44 (0)20 7933 8780 or openorphan@walbrookpr.com +44 (0) 7796 794 663 / +44 (0) 7867 984 082 / |
#POLB Poolbeg Pharma – GMP manufacturing contract signed
Poolbeg Pharma (AIM: POLB, OTCQB: POLBF, ‘Poolbeg’ or the ‘Company’), a clinical stage infectious disease pharmaceutical company with a unique capital light clinical model, announces an update on its lead asset, POLB 001, a small molecule immunomodulator which aims to address a significant unmet need in severe influenza. The Company has signed a contract for GMP manufacturing, ensuring ample supply of GMP grade POLB 001 for use in its upcoming LPS human challenge clinical trial, due to commence in June 2022, and for use in investigating POLB 001 as a treatment for other disease indications.
POLB 001 has potential therapeutic applications beyond severe influenza, due to its mode of action of reducing hyperinflammation which is linked with many diseases. This is when harmful inflammation occurs in different areas of the body, such as the heart and lungs, causing organ damage. POLB 001 can block this from happening. The Company holds the worldwide rights to POLB 001 for all uses in humans and as such, is in a position to expand its IP around this asset to cover new disease areas which greatly increases the value of the program for partnering purposes. Following receipt of the results from the upcoming bacterial lipopolysaccharide (LPS) human challenge trial, the Company aims to rapidly monetise POLB 001 by partnering or out licensing the product to pharma / biotech for further development and commercialization.
The GMP manufacturing of the product began in late 2021 to ensure that sufficient grade and quantities of the product is available for use in the forthcoming human challenge trial which is due to commence in June 2022, with first results expected before the end of the year. The Company now has a validated manufacturing process for the development of the product for use in its clinical development for multiple disease areas.
The Company signed the Clinical Trial Agreement with the Centre for Human Drug Research (CHDR) in March 2022 for the upcoming LPS human challenge study. As part of the study, which is being completed in line with the Company’s capital light approach, researchers will stimulate healthy volunteers’ immune systems with LPS which triggers a robust immune response acting as a simulant for the hyperinflammatory effects associated with severe influenza infections, as well as other diseases. The study will provide key human data on the efficacy of POLB 001 in dampening the immune response in otherwise healthy volunteers.
Jeremy Skillington, PhD, CEO of Poolbeg Pharma said: “Preparations for the upcoming clinical trial of our lead asset, POLB 001, are progressing well and we are delighted to have executed a GMP manufacturing contract ensuring ample supply of POLB 001 for use in its clinical development for severe influenza and beyond.
With a mode of action which reduces the body’s hyperinflammatory response, POLB 001 has the potential to address several disease indications beyond severe influenza, and with our exclusive license for all human uses this could provide Poolbeg with the opportunity to greatly increase the value of the program for partnering and monetisation of POLB 001 to pharma or biotech companies.”
Note: Good Manufacturing Practice (GMP) is the regulatory code of standards that a medicine’s manufacturer must meet in its production processes to enable administration to humans.
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Enquiries
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Poolbeg Pharma Plc Jeremy Skillington, CEO Ian O’Connell, CFO
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+44 (0) 207 183 1499 |
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finnCap Ltd (Nominated Adviser & Joint Broker) Geoff Nash, James Thompson, Charlie Beeson
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+44 (0) 207 220 0500 |
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Arden Partners PLC (Joint Broker) John Llewellyn-Lloyd, Louisa Waddell
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+44 (0) 207 614 5900 |
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J&E Davy (Joint Broker) Anthony Farrell, Niall Gilchrist
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+353 (0) 1 679 6363 |
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Instinctif Partners Melanie Toyne Sewell, Rozi Morris, Tim Field
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+44 (0) 20 7457 2020 poolbeg@instinctif.com |
#ORPH Open Orphan – Imutex Vaccine Phase I Study Results
AGS-v PLUS mosquito vaccine candidate shows favourable safety, tolerability, and immunogenicity results
Results to be presented at the American Society of Tropical Medicine and Hygiene Annual Meeting
Open Orphan plc (AIM: ORPH) announces that data from the first-in-human Phase I clinical study evaluating the safety, immunogenicity, and in vitro efficacy of AGS-v PLUS, Imutex Limited’s (“Imutex’) mosquito saliva vaccine candidate against arboviral diseases, as well as data on the candidate’s effect on the reproductive capacity of mosquitoes that fed on vaccinated subjects will be presented on the 20th and 21st of November 2021. Imutex Limited (“Imutex”) is a joint venture with PepTcell Limited (“PepTcell”) (the legal name of SEEK Group) in which Open Orphan has a 49% shareholding.
The results will be presented in two virtual sessions at the American Society of Tropical Medicine and Hygiene (“ASTMH”) Annual Meeting, held from 17-21 November 2021. The titles and details of the two presentations are as follows:
· “Blood feeding on humans vaccinated with AGS-v PLUS, a mosquito salivary peptide vaccine, impairs the reproductive capacity of female Aedes albopictus mosquitoes” – Scientific Session 91: Mosquitoes-Vector Biology Epidemiology I, at 8.00 am (ET) on 20 November 2021. To be presented by Joshua Lacsina, M.D., Ph.D. of the Laboratory of Malaria and Vector Research at the National Institute of Allergy and Infectious Diseases.
· “Safety and immunogenicity of AGS-v PLUS, a mosquito saliva peptide vaccine against arboviral diseases” – Scientific Session 126: Clinical Tropical Medicine: Vector borne Disease, at 8.00 am (ET) on 21 November 2021. To be presented by DeAnna J. Friedman-Klabanoff, M.D. of the University of Maryland School of Medicine.
Following the presentations, Imutex expect to publish the results from the study in a scientific peer-reviewed journal.
Imutex was funded by the Department of Health and Social Care as part of the UK Vaccine Network (UKVN), a UK Aid programme to develop vaccines for diseases with epidemic potential in low and middle-income countries (LMICs) to carry out this study.
Data from this study, which was performed at the University of Maryland School of Medicine (Baltimore, Maryland, U.S.) and is related to a collaboration between PepTCell and The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), demonstrated that AGS-v PLUS was well tolerated with no serious adverse events experienced, and that it generated a strong immune response in participants. AGS-v PLUS showed a more robust immune response compared to AGS-v, a first-generation vaccine candidate developed by Imutex. The study evaluating the effect of AGS-v PLUS on the reproductive capacity of mosquitoes that fed on vaccinated subjects found that a regimen of the vaccine in combination with an adjuvant resulted in fewer eggs laid and adult progeny in the species Aedes albopictus.
Imutex’s AGS-v and AGS-v PLUS vaccine candidates are mosquito-borne disease vaccines with a novel proposed dual action mechanism of preventing infection in humans whilst controlling the mosquito population. AGS-v is composed of four synthetic peptides isolated from mosquito salivary glands. The AGS-v PLUS vaccine contains the same four peptides as AGS-v but adds a fifth synthetic peptide found in the saliva of many mosquitoes, increasing the potential breadth of protection.
Mosquito-borne diseases include Zika virus, West Nile virus, chikungunya virus, dengue, yellow fever, and malaria. There are around ~360 million cases of and more than 600,000 deaths from mosquito-borne diseases annually, although the true burden is likely underestimated. A vaccine efficacious against multiple mosquito-borne diseases could significantly impact public health.
Imutex is focused on developing broad-spectrum vaccines against influenza (flu) and mosquito borne diseases. To find out more about the product developments, both in influenza vaccine development (FLU-v) and in Zika vaccine development (AGS-v), please visit the Imutex website: www.imutex.com
Cathal Friel, Executive Chairman of Open Orphan, said: “The Company has been eagerly anticipating the results from Imutex’s first-in-human Phase 1 clinical trial for its AGS-v PLUS mosquito vaccine candidate, and we now look forward to the data being presented at the upcoming ASTMH Annual Meeting.
“The positive data for the AGS-v PLUS mosquito vaccine candidate is encouraging; data showed AGS-v PLUS was well tolerated and generated a strong immune response in participants against mosquito-borne diseases, with an increased immune response compared to the four peptide AGS-v candidate. Imutex’s AGS-v and AGS-v PLUS vaccine candidates both employ a novel proposed dual action mechanism that prevents infection in humans whilst controlling mosquito population by limiting transmission.
“There are more than 600,000 deaths worldwide per year from mosquito borne diseases, as such, if these positive Phase I results translate into clinical efficacy, the potential number of lives saved will be significant.”
Dr Olga Pleguezuelos, Chief Science Officer at PepTcell, commented: “We are very excited about the study results. AGS-v PLUS was demonstrated to be safe and immunogenic, and not only impacted the pathogenicity of the Zika virus as seen in an in vitro assay, but also reduced the number of eggs and adult progeny of mosquitoes that fed on vaccinated subjects. The next step is to evaluate clinical efficacy in a controlled human challenge study or in a study in endemic areas. Many mosquito-borne diseases lack effective preventative and therapeutic treatments, so AGS-v PLUS could potentially save many lives.”
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.
For further information please contact:
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Open Orphan plc |
+353 (0) 1 644 0007 |
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Cathal Friel, Executive Chairman |
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Arden Partners plc (Nominated Adviser and Joint Broker) |
+44 (0) 20 7614 5900 |
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John Llewellyn-Lloyd / Louisa Waddell |
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finnCap plc (Joint Broker) |
+44 (0) 20 7220 0500 |
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Geoff Nash / James Thompson/ Richard Chambers |
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Davy (Euronext Growth Adviser and Joint Broker) |
+353 (0) 1 679 6363 |
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Anthony Farrell |
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Walbrook PR (Financial PR & IR) Paul McManus/ Sam Allen/ Louis Ashe-Jepson |
+44 (0)20 7933 8780 or openorphan@walbrookpr.com +44 (0)7980 541 893 / +44 (0) 7502 558 258 / +44 (0) 7747 515393 |
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#POLB Poolbeg Pharma – Update on POLB 001 Clinical Development
18 November 2021 – Poolbeg Pharma (AIM: POLB, ‘Poolbeg’ or the ‘Company’) a clinical stage infectious disease pharmaceutical company with a capital light clinical model, is pleased to provide an update on the clinical development progress of its lead asset, POLB 001, a small molecule immunomodulator for the treatment of severe influenza.
The Company intends to commence the Phase Ib human challenge study of POLB 001 in June 2022 which will be a key step in the molecule’s development. To enable this study, the Company has signed a Letter of Intent to retain the Centre for Human Drug Research (CHDR) to run the challenge study and signed an agreement with SEDA Pharmaceutical Development Services for drug formulation services. A vendor has also been selected for GMP* manufacturing of POLB 001.
In this study, clinical researchers from CHDR will stimulate a healthy volunteer’s immune system with bacterial lipopolysaccharide (LPS) in a safe and controlled clinical environment. The study will provide key human data on the efficacy of POLB 001 in dampening the immune response in otherwise healthy volunteers. It will use LPS to simulate the effects of treating severe influenza in the volunteers without the virus itself being present. In cases of severe influenza, the body produces an over-heightened immune response that can cause more damage to the body than the virus itself. POLB 001’s mode of action is to reduce this hyper-immune response. The design of the study (the study protocol) is expected to be finalised by the end of Q1 2022.
In advance of the Phase Ib study commencing, the Company has completed the manufacturing of a non-GMP* batch of POLB 001 which is on hand for any non-clinical (not administered to humans) requirements, such as formulation. This is also an important step in validating the manufacturing process. On this basis, manufacturing can now be scaled up as required as the clinical development phase progresses. The Company will now move towards manufacturing GMP* grade POLB 001 material needed for the LPS challenge study and has similarly selected a vendor for this work.
Jeremy Skillington, PhD, CEO of Poolbeg Pharma said:
“We are delighted to be progressing our POLB 001 asset as planned, with preparatory steps in motion in advance of the LPS human challenge study clinical trial. We have selected experienced partners in SEDA to formulate the product, and CHDR to run our LPS human challenge study. The clinical study is expected to commence in June 2022, as detailed at IPO. With our capital light and early monetisation model, we are actively developing infectious disease assets with modest investment where they can be monetised / licenced to Big Pharma. We will continue to provide updates as we progress the programme.”
*Good Manufacturing Practice (GMP) is the regulatory code of standards that a medicine’s manufacturer must meet in its production processes to enable administration to humans.
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 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 |