AZD1222

Valneva Provides Clinical and Regulatory Updates for its COVID-19 Vaccine VLA2001

Retrieved on: 
Thursday, March 2, 2023
Vaccination, AZD1222, Seroconversion, Euronext Paris, VLA, COVID-19, Capsid, Valneva SE, Ageing, Saint-Herblain, Pharmaceutical industry, Vaccine, VLA2001

Saint-Herblain (France), March 2, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced additional data from remaining clinical studies and an update on regulatory submissions for its inactivated COVID-19 vaccine, VLA2001.

Key Points: 
  • Saint-Herblain (France), March 2, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced additional data from remaining clinical studies and an update on regulatory submissions for its inactivated COVID-19 vaccine, VLA2001.
  • As previously announced, Valneva will not invest in further development of the vaccine, in the absence of a new partnership1.
  • It is, however, completing remaining clinical studies and submissions as agreed with regulators.
  • The T-cell response against the spike protein elicited upon vaccination with VLA2001 was in the same range as for the active comparator.

Biopharmaceuticals Contract Manufacturing Market Analysis/Research Report 2022-2030: Merger & Acquisitions in CMO industry, Trading of CMOs at Strong EV/EBITDA Multiples, Current Trends - ResearchAndMarkets.com

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Wednesday, May 25, 2022
Health, Biotechnology, Coronavirus, Upstream, USD, COVID-19, AZD1222, Budget, Therapy, CMOS, CAGR, Growth, COVID, AstraZeneca, Fine chemical, Pharmaceutical industry, Generic drug, Service

The global biopharmaceuticals contract manufacturing market size is expected to reach USD 27.3 billion by 2030, growing at a CAGR of 5.2% from 2022 to 2030.

Key Points: 
  • The global biopharmaceuticals contract manufacturing market size is expected to reach USD 27.3 billion by 2030, growing at a CAGR of 5.2% from 2022 to 2030.
  • Contract manufacturers are engaged in broadening their service portfolio to meet the companies' demands with respect to regulatory standards and new services.
  • This is evident through growing investment in collaborations of companies with CMOs as well as continuous efforts taken up for expanding the service portfolio.
  • Pipeline analysis for biosimilar drugs, as of February 2018
    Number of drugs in a clinical development phase, 2015

Valneva Provides Regulatory Update on its inactivated COVID-19 Vaccine Candidate

Retrieved on: 
Monday, April 25, 2022
EMA, AZD1222, CHMP, UK, Vero, VLA, NHRA, Kingdom, Committee for Medicinal Products for Human Use, COVID-19, Conditional, Medication, Lyme disease, European Medicines Agency, Limiting factor, CpG, Chikungunya, European Directive on Traditional Herbal Medicinal Products, Infection, Vaccination, Bahraini, Technology, MHRA, Vaccine, Nasdaq, Company, United Kingdom, 1018, Euronext Paris, Safety, Health care, Committee, Severe acute respiratory syndrome coronavirus 2, VLA2001

VLA2001 is the only inactivated COVID-19 vaccine candidate in Europe, and we continue to receive messages every day from people who are looking for a more traditional vaccine approach.

Key Points: 
  • VLA2001 is the only inactivated COVID-19 vaccine candidate in Europe, and we continue to receive messages every day from people who are looking for a more traditional vaccine approach.
  • VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe.
  • Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need.
  • The Company takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these diseases.

Oxford Biomedica broadens its viral vector capabilities with the launch of Oxford Biomedica Solutions, a full scope AAV business in Boston, following closing of its deal with Homology

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Friday, March 11, 2022
Nasdaq, Novartis, Drug, Interim, OXB, Engineering, Transgene, Oxford BioMedica, 104th Street station (IND Fulton Street Line), AstraZeneca, CNS, Quality control, Intellectual property, Boehringer Ingelheim, AZD1222, Patient, Institute of Liver and Biliary Sciences, Group, Solution, COVID-19, Bristol Myers Squibb, AAV, Central nervous system disease, CEO, LSE, CGMP, Pharmaceutical industry, Fine chemical, Vaccine

High titre, high product quality, proven expertise, and speed are the foundation of the platform, and this differentiated new offering.

Key Points: 
  • High titre, high product quality, proven expertise, and speed are the foundation of the platform, and this differentiated new offering.
  • The unique platform and fully integrated end-to-end capabilities, including from vector design and process development through to clinical trials, are now available to customers.
  • Customers will also benefit from technical synergies brought in by the Companys extensive innovations and a world-leading position in viral vector manufacturing.
  • Dr. Roch Doliveux, Chair and Interim CEO of Oxford Biomedica, commented: We are delighted to have closed this transaction.

Valneva Advances Booster Phase of Cov-Compare Trial of Its Inactivated COVID-19 Vaccine Candidate

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Tuesday, January 25, 2022
Nasdaq, Adult, Vaccine, COVID-19, 1018, Vaccination, National Institute for Health Research, Saint-Herblain, Lyme disease, Technology, Delta, Severe acute respiratory syndrome coronavirus 2, Chikungunya, AZD1222, National Institute, Company, CpG, Ageing, NIHR, Infection, EMA, Omicron, Vero, VLA2001

Saint-Herblain (France), January 25, 2022 Valneva SE , a specialty vaccine company, today announced the start of booster vaccinations in adult participants from its Phase 3 pivotal trial, Cov-Compare.

Key Points: 
  • Saint-Herblain (France), January 25, 2022 Valneva SE , a specialty vaccine company, today announced the start of booster vaccinations in adult participants from its Phase 3 pivotal trial, Cov-Compare.
  • This booster extension is intended to provide both homologous and first heterologous booster data to complement previous positive Phase 1/2 booster results.
  • The VLA2001 booster vaccination will be given at least seven months after completion of the primary vaccination series.
  • In addition, Valneva plans to initiate a further dedicated heterologous booster only trial of VLA2001 in the coming weeks.

Virica Biotech Announces R&D Partnership With Oxford Biomedica to Improve the Manufacturing of Lentiviral Vector Gene Therapies Using Viral Sensitizers

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Monday, January 24, 2022
Oncology, Health, Infectious Diseases, Genetics, Pharmaceutical, Biotechnology, Forward-looking statement, News, AZD1222, Vaccine, EMA, CNS, Group, VSE, COVID-19, Central nervous system disease, OXB, Growth, Novartis, Institute of Liver and Biliary Sciences, ACT Biotech Inc, Solution, Oxford, Boehringer Ingelheim, Industry, AstraZeneca, Efficiency, LSE, Bristol Myers Squibb, FDA

Virica Biotech Inc. , a leading developer of solutions for scaling of viral medicines, today announced it will collaborate with Oxford Biomedica plc (LSE:OXB), a leading gene and cell therapy company, to improve the yield and production efficiency of Oxford Biomedicas next generation lentiviral vector gene therapies using Viricas Viral Sensitizers ( VSEs ).

Key Points: 
  • Virica Biotech Inc. , a leading developer of solutions for scaling of viral medicines, today announced it will collaborate with Oxford Biomedica plc (LSE:OXB), a leading gene and cell therapy company, to improve the yield and production efficiency of Oxford Biomedicas next generation lentiviral vector gene therapies using Viricas Viral Sensitizers ( VSEs ).
  • Ella Korets-Smith, Chief Business Officer of Virica Biotech, said: There is growing demand from major industry players to use leading lentivirus technologies, like Oxford Biomedicas LentiVector platform, to develop cell and gene therapies.
  • Oxford Biomedica is a world-leading pioneer of cell and gene therapies.
  • Oxford Biomedica (LSE:OXB) is a leading, fully integrated, gene and cell therapy group focused on developing life changing treatments for serious diseases.

John Dawson to retire from Oxford Biomedica

Retrieved on: 
Monday, January 17, 2022
AZD1222, Intention, CNS, Group, COVID-19, Central nervous system disease, OXB, Growth, CBE, Novartis, Institute of Liver and Biliary Sciences, Leadership, Boehringer Ingelheim, Industry, AstraZeneca, Company, Oxford BioMedica, LSE, Workforce, Bristol Myers Squibb, Board, Pharmaceutical industry, Management

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.

Key Points: 
  • 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.
  • 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.
  • John Dawson, Chief Executive Officer of Oxford Biomedica, added: I am immensely proud of Oxford Biomedicas achievements, and will retire at the appropriate time.
  • Oxford Biomedica plc: T: +44 (0)1865 783 000 / E: [email protected]
    Oxford Biomedica (LSE:OXB) is a leading, fully integrated, gene and cell therapy group focused on developing life changing treatments for serious diseases.

Gritstone Announces Positive Clinical Results from First Cohort of a Phase 1 Study (CORAL-BOOST) Evaluating a T Cell-Enhanced Self-Amplifying mRNA (samRNA) Vaccine Against COVID-19

Retrieved on: 
Tuesday, January 4, 2022
COVID-19, U.S. Securities and Exchange Commission, NIAID, Severe acute respiratory syndrome coronavirus 2, Webcast, HIV, NIH, Immunity, SLATE, Cell, Infection, Antigen, AZD1222, Omicron, Cancer, Epidemic, NIHR, Hospital, National Institute, Program, Death, Epitope, Bill & Melinda Gates Foundation, University, National Institute for Health Research, AstraZeneca, Neoplasm, GLOBE, RNA transfection, Vaccine, ChAdOx1, COVID, Immunodeficiency, Security (finance), Gamma ray, Gilead Sciences, Safety, Entrepreneurship, Geometric mean, Lancet, CORAL, CEPI, Immune system, ELISpot, TCE, United Kingdom, Antibody, Virus, National Institute of Allergy and Infectious Diseases, Copper, Pharmaceutical industry, Gritstone, Delta

-- Webcast to be held today, January 4 at 8:30 a.m. ET --

Key Points: 
  • We designed our COVID-19 vaccines to drive broad CD8+ T cell immunity, an additional key layer of protection against viruses.
  • We are excited to expand the footprint of this trial and continue working with Gritstone in the clinical development of this promising, next generation, T cell-enhanced COVID-19 vaccine.
  • The CORAL-BOOST Phase 1 study is ongoing in the United Kingdom and has now dose escalated as planned to a 30 mg dose.
  • Gritstone will host a live webcast to discuss the results of this study today at 8:30 a.m.

Adagio Therapeutics Provides Update for ADG20 COVID-19 Antibody Program and Reports Third Quarter 2021 Financial Results

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Monday, November 15, 2021
Population, Safety, AES, Drug, PK, Adolescence, General Administration of Sport of China, Private Securities Litigation Reform Act, Therapy, Immunodeficiency, Infection, Disease, Research and development, Food, AZD1222, Severe acute respiratory syndrome coronavirus 2, Treatment, Serum, Research, IV, Forward-looking statement, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Epitope, Human, Vaccine, GLOBE, Half-life, Antibody, SEC, Supervised injection site, EUA, United States Patent and Trademark Office, Patent, Nasdaq, Patient, FDA, Adult, Pharmaceutical industry, Lithium

WALTHAM, Mass., Nov. 15, 2021 (GLOBE NEWSWIRE) -- Adagio Therapeutics, Inc., (Nasdaq: ADGI) a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential, today provided an update on its lead COVID-19 antibody program, ADG20, and reported third quarter 2021 financial results. ADG20 is an investigational monoclonal antibody product candidate designed to provide broad and potent neutralizing activity against SARS-CoV-2, including variants of concern, for the prevention and treatment of COVID-19.

Key Points: 
  • ADG20 is an investigational monoclonal antibody product candidate designed to provide broad and potent neutralizing activity against SARS-CoV-2, including variants of concern, for the prevention and treatment of COVID-19.
  • Further, our single injection delivery avoids the inconveniences associated with IV administration or multiple injections, said Lynn Connolly, M.D., Ph.D., chief medical officer of Adagio.
  • Certain patient populations may not be ideal candidates for emerging oral treatment options due to adherence concerns, comorbidities or possible drug interactions.
  • Research & development expenses including in-process research and development for the third quarter of 2021 were $49.4 million.

Gritstone Announces Positive Preclinical Data in Non-Human Primate Challenge Study with Second-Generation COVID-19 Vaccine Against SARS-CoV-2

Retrieved on: 
Wednesday, November 10, 2021
National Institute of Allergy and Infectious Diseases, NIAID, Immunity, SAM, Cancer, Foundation for the National Institutes of Health, CORAL, Manuscript, ChAdOx1, RNA transfection, Neoplasm, Coalition, Clinical trial, Immunodeficiency, Infection, Antigen, Security (finance), CEPI, Immune system, HIV, Epidemic, National, Immunization, Coronavirus, Coalition for Epidemic Preparedness Innovations, AZD1222, Severe acute respiratory syndrome coronavirus 2, Mutation, COVID-19, Bill & Melinda Gates Foundation, Forward-looking statement, Program, GMT, National Institute, Epitope, SLATE, Vaccine, U.S. Securities and Exchange Commission, GLOBE, EDGE, Mouse, Vaccination, BioRxiv, Cell, Patient, Head, NIH, AstraZeneca, La Jolla Institute for Immunology, Gilead Sciences, Bill

EMERYVILLE, Calif., Nov. 10, 2021 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing next generation cancer and infectious disease immunotherapies, today published positive preclinical data in non-human primate models from the CORAL next-generation COVID-19 vaccine program against SARS-CoV-2, the coronavirus that causes COVID-19 disease. In a non-human primate challenge study, immunization with a self-amplifying mRNA (SAM) vaccine protected rhesus macaques against SARS-CoV-2 infection as either a homologous prime-boost regimen (2 doses) or as a single boost following an optimized chimpanzee adenoviral (ChAd) vector prime. The manuscript describing these data is available on a preprint server on bioRxiv at https://www.biorxiv.org/content/10.1101/2021.11.08.467773v1 and is concurrently undergoing scientific peer-review for potential publication.

Key Points: 
  • The manuscript describing these data is available on a preprint server on bioRxiv at https://www.biorxiv.org/content/10.1101/2021.11.08.467773v1 and is concurrently undergoing scientific peer-review for potential publication.
  • Advancing new vaccine strategies, like our SAM platform, may help avoid further propagation and mutation of SARS-CoV-2 and potentially address delays in global vaccination.
  • We look forward to sharing preliminary data from our first CORAL trial early in the first quarter of 2022.
  • The self-amplification capability may extend the duration and magnitude of antigen expression, potentially enabling lower vaccine doses or need for frequent repeat administrations.