georgejjl
4年前
John Dawson to retire from Oxford Biomedica
Oxford, UK – 17 January 2022: Oxford Biomedica plc (LSE:OXB) (“Oxford Biomedica” or “the Group” or “the Company”) a leading gene and cell therapy company, today announces that, after more than 13 years of service, John Dawson, Chief Executive Officer, has signalled to the Board his intention to retire from the Company. Accordingly, the Board has initiated a formal search for a successor.
Dr. Roch Doliveux, Chairman of Oxford Biomedica, commented: “John has provided more than 13 years of dedicated service and leadership to Oxford Biomedica and, on behalf of the Board and all of our staff, we thank him wholeheartedly. His successful career with the Company was underlined very recently by a much-deserved CBE awarded for services to UK Life Science. Under his leadership, together with the strong senior executive team, Oxford Biomedica has grown into an industry leader in lentiviral vectors, delivered multiple partnerships and successfully manufactured life-saving COVID-19 vaccine, all due to the expertise and robustness of the Company’s management team. We have commenced a formal process to appoint a successor who will lead the Group through its next phase of growth whilst also ensuring the Company remains fully focussed on the execution of its strategy of delivering life changing gene therapies to patients.”
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georgejjl
6年前
John Dawson named Executive of the Year for Companies <$10bn at the Annual Scrip Awards 2020
-Ends-
Oxford, UK – 3 December, 2020: Oxford Biomedica plc (LSE:OXB) (“Oxford Biomedica” or “the Group”), a leading gene and cell therapy group, is pleased to announce that, John Dawson, Chief Executive Officer of Oxford Biomedica, was named Executive of the Year in the category for Companies with a market cap <$10 billion at the 16th Annual Scrip Awards 2020.
This award recognises Oxford Biomedica’s achievements from June 2019 up to the end of May 2020, taking into account the Company’s efforts on the Lentivector® platform and subsequent partnership agreements, which more than doubled in the period from nine to nineteen, including a deal with Juno Therapeutics, a Bristol-Myers Squibb company, the extension of the commercial supply agreement with Novartis for a further five years to work on six programmes, and R&D collaboration with Santen to develop gene therapy products inherited retinal disease.
John Dawson, Chief Executive Officer of Oxford Biomedica, said: “It is a huge honour to accept this award on behalf of everyone at Oxford Biomedica and this is a true testament to the dedication and hard work demonstrated by everyone at the Company. We’ve collectively won this award for our efforts on our Lentivector® platform and deals including Juno Therapeutics, a Bristol-Myers Squibb company, and the Novartis extension. This award is by far the biggest recognition that Oxford Biomedica has received for its achievements in driving gene therapy forward for patients, and as a leader in the space. Congratulations to the other nominees on their work this year, and thank you to Scrip for recognising Oxford Biomedica.”
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georgejjl
6年前
Oxford Biomedica Signs Supply Agreement with AstraZeneca to Expand Manufacturing Support of COVID-19 Vaccine Candidate, AZD1222
The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulation (EU) No. 596/2014. Upon the publication of this announcement via the Regulatory Information Service, this inside information is now considered to be in the public domain.
Oxford, UK – 1 September, 2020: Oxford Biomedica plc (LSE:OXB) (“Oxford Biomedica” or “the Group”), a leading gene and cell therapy group, announced today that it has signed an 18 month supply agreement under a three year Master Supply and Development Agreement (“the Agreement”) with AstraZeneca UK Ltd (“AstraZeneca”) for large-scale commercial manufacture of the adenovirus vector-based COVID-19 vaccine candidate, AZD1222. The Parties may extend the supply period for AZD1222 by a further 18 months into 2022 and 2023 by mutual agreement.
Under the terms of the Agreement, AstraZeneca will pay Oxford Biomedica £15million upfront as a capacity reservation fee. Subject to satisfactory scale up of manufacturing capacity and continuation of the vaccine programme, Oxford Biomedica expects to receive additional revenue in excess of £35million plus certain materials costs for the manufacture of multiple large-scale batches of AZD1222 until the end of 2021.
As part of the Agreement, Oxford Biomedica will reserve capacity for AstraZeneca in up to three manufacturing suites in the Group’s new 7,800 m2 commercial manufacturing centre, Oxbox, for an initial 18 month period. This new GMP facility is suitable for manufacturing viral vectored vaccines and gene therapy vectors up to 1,000 litre scale. As part of Oxford Biomedica’s previously announced partnership with the UK’s Vaccine Manufacturing Innovation Centre (VMIC) two new manufacturing suites within Oxbox will become operational in the next two months, significantly earlier than originally planned by the Group.
While this Agreement means the Group has dedicated multiple new manufacturing suites to this critical project, importantly, Oxford Biomedica does not expect any impact to the Groups current partnerships or ability to secure and support additional new partnerships in the cell and gene therapy field.
This agreement builds on the supply agreement between the companies announced on 28th May, which related exclusively to manufacture of AZD1222 at 200L scale and associated process development.
John Dawson, Chief Executive Officer of Oxford Biomedica, said: “We have been working hard with AstraZeneca and other partners to establish GMP manufacturing of AZD1222 at scale, and we are therefore very pleased to extend our current partnership to include large-scale manufacturing of the vaccine candidate, AZD1222. Our previously announced partnership with the UK’s Vaccine Manufacturing Innovation Centre (VMIC) has supported our ability to make additional facilities available for this supply agreement. We look forward to continuing to work with AstraZeneca to rapidly contribute to the global effort to support the large-scale manufacturing of AZD1222 to ensure that the vaccine candidate is available if and when it is approved by Regulatory Authorities.”
https://www.oxfordbiomedica.co.uk/news-media/press-release/oxford-biomedica-signs-supply-agreement-astrazeneca-expand-manufacturing
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georgejjl
6年前
Safety and Immunogenicity of Novel 5T4 Viral Vectored Vaccination Regimens in Early Stage Prostate Cancer: A Phase I Clinical Trial
Federica Cappuccini 1, Richard Bryant 2 3, Emily Pollock 1, Lucy Carter 1, Clare Verrill 2 4, Julianne Hollidge 2, Ian Poulton 1, Megan Baker 1, Celia Mitton 1, Andrea Baines 1, Armin Meier 5, Guenter Schmidt 5, Richard Harrop 6, Andrew Protheroe 7, Ruth MacPherson 8, Steven Kennish 9, Susan Morgan 10, Selena Vigano 11, Pedro J Romero 11, Thomas Evans 12, James Catto 13, Freddie Hamdy 2 3, Adrian V S Hill # 1, Irina Redchenko # 14
Affiliations
1Nuffield Department of Medicine, The Jenner Institute, Oxford University, Oxford, UK.
2Nuffield Department of Surgical Sciences, Oxford University, Oxford, UK.
3Department of Urology, Churchill Hospital, Oxford, UK.
4Oxford NIHR Biomedical Research Centre, Oxford University, Oxford, UK.
5Definiens AG, Munchen, Bayern, Germany.
6Oxford Biomedica Plc, Oxford, UK.
7Department of Oncology, Oxford Cancer and Haematology Centre, Churchill Hospital, Oxford, UK.
8Department of Radiology, Churchill Hospital, Oxford, UK.
9Department of Radiology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
10Department of Pathology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
11Oncology, University Hospital of Lausanne, Lausanne, Switzerland.
12Vaccitech UK Limited, Oxford, UK.
13Academic Urology Unit, The University of Sheffield, Sheffield, UK.
14Nuffield Department of Medicine, The Jenner Institute, Oxford University, Oxford, UK irina.redchenko@ndm.ox.ac.uk.
#Contributed equally.
PMID: 32591433 PMCID: PMC7319775 DOI: 10.1136/jitc-2020-000928
Abstract
Background: Prostate cancer (PCa) has been under investigation as a target for antigen-specific immunotherapies in metastatic disease settings for the last two decades leading to a licensure of the first therapeutic cancer vaccine, Sipuleucel-T, in 2010. However, neither Sipuleucel-T nor other experimental PCa vaccines that emerged later induce strong T-cell immunity.
Methods: In this first-in-man study, VANCE, we evaluated a novel vaccination platform based on two replication-deficient viruses, chimpanzee adenovirus (ChAd) and MVA (Modified Vaccinia Ankara), targeting the oncofetal self-antigen 5T4 in early stage PCa. Forty patients, either newly diagnosed with early-stage PCa and scheduled for radical prostatectomy or patients with stable disease on an active surveillance protocol, were recruited to the study to assess the vaccine safety and T-cell immunogenicity. Secondary and exploratory endpoints included immune infiltration into the prostate, prostate-specific antigen (PSA) change, and assessment of phenotype and functionality of antigen-specific T cells.
Results: The vaccine had an excellent safety profile. Vaccination-induced 5T4-specific T-cell responses were measured in blood by ex vivo IFN-? ELISpot and were detected in the majority of patients with a mean level in responders of 198 spot-forming cells per million peripheral blood mononuclear cells. Flow cytometry analysis demonstrated the presence of both CD8+ and CD4+ polyfunctional 5T4-specific T cells in the circulation. 5T4-reactive tumor-infiltrating lymphocytes were isolated from post-treatment prostate tissue. Some of the patients had a transient PSA rise 2-8 weeks following vaccination, possibly indicating an inflammatory response in the target organ.
Conclusions: An excellent safety profile and T-cell responses elicited in the circulation and also detected in the prostate gland support the evaluation of the ChAdOx1-MVA 5T4 vaccine in efficacy trials. It remains to be seen if this vaccination strategy generates immune responses of sufficient magnitude to mediate clinical efficacy and whether it can be effective in late-stage PCa settings, as a monotherapy in advanced disease or as part of multi-modality PCa therapy. To address these questions, the phase I/II trial, ADVANCE, is currently recruiting patients with intermediate-risk PCa, and patients with advanced metastatic castration-resistant PCa, to receive this vaccine in combination with nivolumab.
Trial registration: The trial was registered with the U.S. National Institutes of Health (NIH) Clinical Trials Registry (ClinicalTrials.gov identifier NCT02390063).
Read more at the following link
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7319775/
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georgejjl
6年前
Oxford Biomedica snags manufacturing equipment to ramp up production of COVID-19 vaccine
Oxford Biomedica and AstraZeneca reached a deal in late May to produce "multiple batches" of the university's vaccine. (Getty)
In the race for a COVID-19 vaccine, the University of Oxford has stormed to an early lead with the commercial manufacturing support of British drugmaker AstraZeneca. Now, in an effort to scale up capacity for global demand, one of AstraZeneca's manufacturing partners has struck a deal for new equipment.
Oxford Biomedica has inked a five-year deal with the U.K.'s Vaccines Manufacturing and Innovation Centre (VMIC) to build out the CDMO's Oxbox facility to help produce doses of the university's adenovirus-based COVID-19 vaccine.
As part of their deal, VMIC will supply manufacturing equipment for two suites at Oxford Biomedica's 84,000-square-foot Oxbox facility in Oxford, U.K., the CDMO said. The suites will be dedicated to producing Oxford's vaccine, AZD1222, but can also be used to manufacture other viral vector vaccines.
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In return, Oxford Biomedica will provide VMRI with "training and technical assistance" for its staff to scale up manufacturing of viral vector vaccines at its new facility at the Harwell Science and Innovation Campus at Oxford scheduled to open in mid-2021.
The manufacturing supply agreement will help Oxford Biomedica begin churning out doses of Oxford's vaccine candidate––which is currently in phase 2/3 trials in the U.K.––beginning this summer.
RELATED: AstraZeneca locks up COVID-19 vaccine supply with Oxford BioMedica production deal
Late last month, Oxford and British drugmaker AstraZeneca agreed to a one-year deal covering "multiple batches" of the university's vaccine as part of a consortium aimed at speeding production of the shot.
As part of the agreement, AstraZeneca received access to the OxBox facility with the goal of supplying clinical and commercial doses through 2020 with the possibility of expansion in the future.
AstraZeneca and the university agreed to tie up in April, with the drugmaker taking on commercialization and large-scale manufacturing of the school's vaccine, which was developed by Oxford’s Jenner Institute.
RELATED: AstraZeneca unveils massive $750M deal in effort to produce billions of COVID-19 shots
As Oxford Biomedica aims to ramp up its own manufacturing, AstraZeneca recently secured a massive tie-up to bring billions of doses of AZD1222 on the market in the coming years.
Last week, the British pharma inked a $750 million deal with the Coalition for Epidemic Preparedness Innovations and Gavi, the Vaccine Alliance to manufacture and distribute 300 million doses of Oxford's vaccine by the end of 2020, the drugmaker said Thursday.
AZ also agreed to a licensing deal with the Serum Institute of India to provide 1 billion doses of the vaccine to low- and middle-income countries, with the goal of 400 million produced by year's end. In total, the deals bring AstraZeneca's overall supply capacity for Oxford's vaccine to more than 2 billion doses per year, the drugmaker said.
https://www.fiercepharma.com/manufacturing/oxford-biomedica-reaches-manufacturing-equipment-deal-to-ramp-up-production-covid-19
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georgejjl
6年前
AstraZeneca agrees to make COVID-19 vaccine for Europe
European COVID-19 vaccine due by end of 2020
LONDON — Pharma giant AstraZeneca struck a deal Saturday with Europe’s Inclusive Vaccines Alliance to supply up to 400 million doses of an experimental COVID-19 vaccine, as efforts to boost manufacturing capacity continue at pace.
The alliance, which was forged by Germany, France, Italy and the Netherlands to speed up production of a vaccine, is set to take delivery of the vaccine being tested by the University of Oxford by the end of 2020. The agreement with AstraZeneca also aims to make the vaccine available to other European countries that wish to take part.
The cost is expected to be offset by funding from the governments.
“This agreement will ensure that hundreds of millions of Europeans have access to Oxford University’s vaccine following approval,’’ AstraZeneca CEO Pascal Soriot said. “With our European supply chain due to begin production soon, we hope to make the vaccine available widely and rapidly.''
The agreement is the latest in a series to make the vaccine — even though it is not certain it will work. But so desperate is the need that scaling up of manufacturing continues despite the risk.
The Anglo-Swedish company recently completed similar agreements with Britain, the United States the Coalition for Epidemic Preparedness Innovations, and Gavi, the Vaccine Alliance for 700 million doses. A license also has been agreed with the Serum Institute of India for another 1 billion doses.
The vaccine was developed by Oxford University’s Jenner Institute, working with the Oxford Vaccine Group.
Testing of the experimental COVID-19 vaccine began in healthy volunteers in Britain in April with over 1,000 people aged 18 to 55. Another round with 10,000 volunteers began last month.
Other companies, including Moderna and Sanofi, are racing to develop and produce a vaccine against the new coronavirus, a step experts say will be crucial to allowing countries to ease their lockdowns and restrictions on public life.
https://www.foxbusiness.com/markets/astrazeneca-agrees-to-make-covid-19-vaccine-for-europe
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georgejjl
6年前
Oxford Biomedica Signs Clinical & Commercial Supply Agreement with AstraZeneca, for manufacture of COVID-19 vaccine candidate
The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulation (EU) No. 596/2014. Upon the publication of this announcement via the Regulatory Information Service, this inside information is now considered to be in the public domain.
Oxford, UK – 28 May, 2020: Oxford Biomedica plc (LSE:OXB) (“Oxford Biomedica” or “the Group”), a leading gene and cell therapy group, announced today that it has signed a one year Clinical & Commercial Supply Agreement with AstraZeneca UK Ltd (“AstraZeneca”). The Agreement relates to the GMP manufacture of the adenovirus vector based COVID-19 vaccine candidate, AZD1222, which recently entered clinical trials at multiple sites in the UK. Oxford Biomedica is working alongside AstraZeneca and other manufacturing organisations to provide large scale manufacturing capacity for this vaccine candidate.
As part of the Clinical & Commercial Supply Agreement, AstraZeneca will have access to Oxford Biomedica’s new 7,800 m2 commercial manufacturing centre Oxbox, located in Oxford, UK. In April 2020 Oxford Biomedica announced that it had joined a consortium including the Jenner Institute in relation to the potential for large scale manufacture of AZD1222. On 30 April 2020 AstraZeneca and Oxford University subsequently announced an agreement to enable global development, manufacturing and distribution of the vaccine.
The initial agreement requires Oxford Biomedica to provide AstraZeneca with multiple batches of vaccine, the majority of which are expected to be produced throughout 2020. The production will be from one of the Group’s recently approved GMP suites in Oxbox. The Commercial Supply agreement may be extended further depending on the progression of the programme.
John Dawson, Chief Executive Officer of Oxford Biomedica, said: “We are proud to be a part of the manufacturing consortium working with the Jenner Institute at University of Oxford, for the early manufacturing and scale up of this viral vector based candidate for COVID-19. Following the recent announcement of an agreement between the University of Oxford and AstraZeneca, we are very pleased to be one of AstraZeneca’s global network of manufacturing partners, and look forward to them being the third company to have rapid access to our specialised manufacturing capacity for this vaccine candidate at Oxbox”.
https://www.oxfordbiomedica.co.uk/news-media/press-release/oxford-biomedica-signs-clinical-commercial-supply-agreement-astrazeneca
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georgejjl
6年前
Oxford Biomedica joins Consortium to rapidly develop a COVID-19 vaccine candidate
Consortium led by Jenner Institute, University of Oxford
Fast-tracked clinical trial of ChAdOx1 nCOV-19 vaccine candidate starts this month
Oxford, UK – 8th April, 2020: Oxford Biomedica plc (LSE:OXB) (“Oxford Biomedica” or “the Group”), a leading gene and cell therapy group, announced today it has joined a Consortium led by the Jenner Institute, Oxford University, to rapidly develop, scale-up and manufacture a potential vaccine candidate for COVID-19, called ChAdOx1 nCov-19. This vaccine candidate is one of the leading vaccine candidates currently in development globally, and is expected to be the UK’s first COVID-19 vaccine in clinical trials later this month. The Consortium is led by the Jenner Institute, University of Oxford and also includes the Vaccines Manufacturing and Innovation Centre (VMIC), Pall Life Sciences, Cobra Biologics and Halix BV.
The Jenner Institute and the Oxford Vaccine Group have recruited individuals aged 18-55 from the Thames Valley area in the UK to study the vaccine’s safety and efficacy (see https://www.covid19vaccinetrial.co.uk/). Oxford Biomedica will provide access to its large scale GMP manufacturing facilities for viral vectors, including its new Oxbox facility, to the Consortium as required, which, along with other Consortium manufacturing partners in the UK and internationally, would allow for scaled manufacturing capacity should the safety and efficacy of the vaccine candidate be confirmed in clinical trials.
The Oxford vaccine candidate relies on adenoviral vector technology, ChAdOx1, developed at the Jenner Institute, in Oxford. It is seen as one of the most promising vaccine technologies for COVID-19 as ChAdOx1 has been shown to generate a strong immune response from one dose and it has demonstrated a good safety profile in pre-clinical and clinical trials conducted to date. No financial terms were disclosed.
John Dawson, Chief Executive Officer of Oxford Biomedica, said: “As an established clinical and commercial manufacturer of viral vectors, we are very pleased to be in a strong position in terms of capacity and capabilities to support the important and urgent efforts of the Consortium led by the Jenner Institute, University of Oxford, to develop and scale up manufacturing of this promising vaccine candidate for COVID-19.
“While our current activities on this vaccine candidate are just initiating, should the Consortium confirm there is promise for this candidate in the clinical trial initiating this month, we will play our role within the Consortium to scale up manufacturing as fast as possible. This will help to provide significant access to the vaccine candidate for further clinical trials and potentially, if approved for use, for many people in the UK and beyond.”
https://www.oxfordbiomedica.co.uk/news-media/press-release/oxford-biomedica-joins-consortium-rapidly-develop-covid-19-vaccine
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georgejjl
6年前
Gene Therapy for Parkinson's Disease: Preclinical Evaluation of Optimally Configured TH:CH1 Fusion for Maximal Dopamine Synthesis.
Badin RA1,2, Binley K3, Van Camp N1,2, Jan C1,2, Gourlay J1,2, Robert C1,2, Gipchtein P1,2, Fayard A1,2, Stewart H3, Ralph GS3, Lad Y3, Kelleher M3, Loader J3, Hosomi K4,5, Palfi S4,5, Mitrophanous KA3, Hantraye P1,2.
Author information
1
CEA, DRF, Institute of Biology François Jacob, Molecular Imaging Research Center (MIRCen), 92265 Fontenay-aux-Roses, France.
2
CNRS, CEA, Paris-Sud University, Université Paris-Saclay, Neurodegenerative Diseases Laboratory (UMR9199), 92265 Fontenay-aux-Roses, France.
3
Oxford Biomedica, Windrush Court, Transport Way, Oxford OX4 6LT, UK.
4
AP-HP, Groupe Hospitalier Henri-Mondor, DHU PePsy, Neurochirurgie, Créteil, 94010, France.
5
Université Paris 12, Faculté de Médecine, IMRB, INSERM U955, Team 14, Créteil 94010, France.
Abstract
A recent phase I-II, open-label trial of ProSavin, a lentiviral vector delivering the key enzymes in the dopamine biosynthetic pathway to non-dopaminergic striatal neurons, demonstrated safety and improved motor function in parkinsonian patients. However, the magnitude of the effect suggested that optimal levels of dopamine replacement may not have been achieved. OXB-102, a lentiviral vector with an optimized expression cassette for dopamine biosynthesis, has been shown to achieve a significantly higher dopamine yield than ProSavin. We assessed the efficacy of OXB-102 in the MPTP macaque model of Parkinson's disease (PD). At 6 months post-vector administration, all treated animals showed significant improvements in clinical scores and spontaneous locomotor activity compared to controls, with the highest recovery observed in the OXB-102 high-dose (HD) group. Positron emission tomography quantification of 6-[18F]-fluoro-L-m-tyrosine uptake showed a significant increase in amino acid decarboxylase activity for all treated animals, compared with controls, where the OXB-102 HD group showed the highest level of dopaminergic activity. A toxicology study in macaques demonstrated that the vector was safe and well tolerated, with no associated clinical or behavioral abnormalities and no immune response mounted against any transgene products. Overall, these data support the further clinical development of OXB-102 for the treatment of PD.
Full paper at the link below:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6685641/
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