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(AVCT) Avacta Share Chat

Discussion in 'General Share Chat (AVCT)' started by Groucho, May 6, 2020.

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  1. Groucho

    Groucho Member

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    Researchers at the University of Oxford have today reported that the risk of the rare blood clotting known as cerebral venous thrombosis (CVT) following COVID-19 infection is around 100 times greater than normal, several times higher than it is post-vaccination or following influenza.

    The study authors, led by Professor Paul Harrison and Dr Maxime Taquet from Oxford University’s Department of Psychiatry and the NIHR Oxford Health Biomedical Research Centre, counted the number of CVT cases diagnosed in the two weeks following diagnosis of COVID-19, or after the first dose of a vaccine. The then compared these to calculated incidences of CVT following influenza, and the background level in the general population.

    They report that CVT is more common after COVID-19 than in any of the comparison groups, with 30% of these cases occurring in the under 30s. Compared to the current COVID-19 vaccines, this risk is between 8-10 times higher, and compared to the baseline, approximately 100 times higher.

    The breakdown comparison for reported cases of CVT in COVID-19 patients in comparison to CVT cases in those who received a COVID-19 vaccine is:
    • In this study of over 500,000 COVID-19 patients, CVT occurred in 39 in a million patients.
    • In over 480,000 people receiving a COVID-19 mRNA vaccine (Pfizer or Moderna), CVT occurred in 4 in a million.
    • CVT has been reported to occur in about 5 in a million people after first dose of the AZ-Oxford COVID-19 vaccine.
    • Compared to the mRNA vaccines, the risk of a CVT from COVID-19 is about 10 times greater.
    • Compared to the AZ-Oxford vaccine, the risk of a CVT from COVID-19 is about 8 times greater.
    However, all comparisons must be interpreted cautiously since data are still accruing.

    Paul Harrison, Professor of Psychiatry and Head of the Translational Neurobiology Group at the University of Oxford, said: ‘There are concerns about possible associations between vaccines, and CVT, causing governments and regulators to restrict the use of certain vaccines. Yet, one key question remained unknown: ‘What is the risk of CVT following a diagnosis of COVID-19?’.

    ‘We’ve reached two important conclusions. Firstly, COVID-19 markedly increases the risk of CVT, adding to the list of blood clotting problems this infection causes. Secondly, the COVID-19 risk is higher than we see with the current vaccines, even for those under 30; something that should be taken into account when considering the balances between risks and benefits for vaccination.’

    Dr Maxime Taquet, also from the Translational Neurobiology Group, said: ‘It’s important to note that this data should be interpreted cautiously, especially since the data on the Oxford-AstraZeneca vaccine come from EMA monitoring, whereas the other data uses the TriNetX electronic health records network. However, the signals that COVID-19 is linked to CVT, as well as portal vein thrombosis – a clotting disorder of the liver – is clear, and one we should take note of.’

    An important factor that requires further research is whether COVID-19 and vaccines lead to CVT by the same or different mechanisms. There may also be under-reporting or mis-coding of CVT in medical records, and therefore uncertainty as to the precision of the results.

    Full data are available from the OSF website.
    https://www.ox.ac.uk/news/2021-04-15-risk-rare-blood-clotting-higher-covid-19-vaccines
     
  2. Groucho

    Groucho Member

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    20 April 2021

    Avacta Group plc

    ("Avacta" or "the Group" or "the Company")


    Clinical validation of AffiDX® SARS-CoV-2 Antigen Lateral Flow Test

    98.0% clinical sensitivity for samples with PCR Ct values[1] up to 31


    Completing the technical data set for self-declaration of a CE mark for professional use in early May, followed immediately by commercial launch in Europe

    Avacta Group plc (AIM: AVCT), the developer of diagnostics and innovative cancer therapies based on its proprietary Affimer® and pre|CISION™ platforms, is pleased to announce positive data from the clinical validation of its AffiDX® SARS-CoV-2 antigen lateral flow test. Data from the clinical study conducted in Europe on 98 positive COVID-19 samples demonstrate excellent performance in identifying the SARS-CoV-2 virus across a broad range of viral loads. These data will now be combined with stability and other performance data from ongoing studies to finalise the technical file for CE marking the AffiDX® SARS-CoV-2 antigen lateral flow test for professional use, allowing the Company to begin commercial roll-out in Europe in May.

    The clinical evaluation of Avacta's lateral flow test was carried out at a single site in Europe with patient samples with viral loads confirmed by PCR. The study tested 98 positive samples (31 with Ct<26; 65 with Ct 26-30 and 2 with Ct 30-31). Avacta's rapid antigen test identified 96/98 of these correctly as positive with a 20 minutes read time resulting in a clinical sensitivity of 98.0% for samples within this broad range down to low viral loads. Out of a total of 102 negative samples tested with the lateral flow device, the test correctly identified 101 as negative, giving a clinical specificity of 99.0%.

    Lateral flow rapid antigen tests are intended to provide a low cost means of identifying individuals with a high viral load that means they are more likely to infect others. Many factors affect whether an individual will infect others or not, as well as viral load, such as the circumstances and length of exposure. However, there is a growing consensus that a viral load as measured by PCR of Ct<27 should be considered as infectious. The clinical data for Avacta's AffiDX® SARS-CoV-2 antigen lateral flow test demonstrated 100% sensitivity for identifying infectious individuals in this range.


    Dr Alastair Smith, Chief Executive Officer of Avacta Group, commented:

    "I am delighted with the clinical data from this larger clinical study, which has robustly evaluated the AffiDX® antigen test with lower viral loads of Ct>26 as well as with higher viral load samples. The results are very impressive and marks a major step in obtaining a CE mark for professional use.

    "As part of the study the same clinical samples were tested with two leading, commercially available lateral flow antigen tests, and the data show that the AffiDx® test had better clinical sensitivity across the range of Ct value and in particular at lower viral loads.

    "We are completing the necessary assessment of the product from our manufacturing partner Global Access Diagnostics, including stability testing that will complete the technical file for CE marking, which we expect will happen in early May.

    "We are very excited by the potential of this high quality SARS-CoV-2 rapid antigen test and we are looking forward to updating the market as we commercially roll-out the AffiDX® test in the coming months."

    This announcement contains information which, prior to its disclosure, was considered inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (MAR).

    Disclaimer: The AffiDX® SARS-Cov-2 rapid antigen test is not currently available for sale in the United States.
     
  3. Groucho

    Groucho Member

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    9BB9F00A-DA8F-4A60-BC41-B5E6D2A12A86.jpeg
    Yorkshire Post 21/04/21
     
  4. Groucho

    Groucho Member

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    22 April 2021

    Avacta Group plc

    ("Avacta", the "Group" or the "Company")


    Preliminary Results for the year ending 31 December 2020

    Significant progress in Diagnostics and Therapeutics Divisions


    Avacta Group plc (AIM: AVCT), the developer of diagnostics and innovative cancer therapies based on its proprietary Affimer® and pre|CISION™ platforms, is pleased to announce its preliminary results for the year ending 31 December 2020.


    Operating highlights


    Operating highlights - Diagnostics

    · Rapid generation of a range of Affimer® reagents that bind the SARS-CoV-2 coronavirus spike antigen for diagnostic testing applications.

    · Collaboration with several partners to develop a rapid test for the COVID-19 infection for mass population screening.

    · Appointed BBI Solutions, part of BBI Group ('BBI'), and Abingdon Health to manufacture the saliva-based rapid SARS-CoV-2 antigen test.

    · Entered a collaboration with the Liverpool School of Tropical Medicine ('LSTM') to provide analytical and clinical validation of the rapid coronavirus antigen test.

    · Announced launch of an ELISA laboratory test for the SARS-CoV-2 spike protein to support global research efforts into the coronavirus that causes COVID-19.

    · Collaboration with Adeptrix (Beverly, MA, USA) to develop a high throughput Affimer-based SARS-CoV-2 antigen bead-assisted mass spectrometry test ('BAMSTM' test) to be used on hospitals' existing installed base of mass spectrometers to diagnose COVID-19 infection. Initiated clinical evaluation of BAMS™ SARS-CoV-2 antigen test at a UK NHS hospital site.

    · Exclusive distribution agreement announced with Medusa19 Limited ('Medusa19') for direct-to-consumer sales of a rapid antigen self-test for Covid-19.

    · Major licensing agreement with Astrea Bioseparations Limited ('Astrea') for the use of the Affimer® platform in affinity purification applications.

    · Successfully passed first audit by the Group's Notified Body (BSI Group) of the Company's Quality Management System as first step in establishing ISO13485 accreditation, a critical quality assurance system for a developer and legal manufacturer of diagnostic products and medical devices. The final audit will take place in April 2021.

    · Strengthened and expanded diagnostics management team with the appointment of a Product Manager, Head of Product Development and Operations Director.



    Post-period highlights - Diagnostics

    · AffiDX® SARS-CoV-2 Antigen Lateral Flow Test shows excellent analytical sensitivity of 50 pg/ml of S1 spike protein with a read time of 20 minutes. As far as the Group is aware and on the basis of laboratory testing to date, this is currently the most sensitive S1 spike lateral flow test available. On 16 February 2021, we announced the initial clinical evaluation of this test using anterior (front) nasal swab samples (30 positive and 26 negative samples) which demonstrated a sensitivity of 96.7% for samples with an infectious viral load (PCR Ct value < 26) and a specificity of 100%. Subsequently, on 20 April we announced the completion of the clinical validation of the AffiDX® SARS-CoV-2 antigen lateral flow test with excellent performance data (clinical sensitivity of 98.0% for samples with Ct values up to 31 and clinical specificity of 99.0%).

    · On 28 January 2021, we entered a collaboration agreement with Bruker Corporation to evaluate the clinical utility and commercial potential of the BAMS™ SARS-CoV-2 Antigen Test.

    · On 8 February 2021, we established a commercial partnership with Mologic following several months' collaborative work to provide Avacta with a faster route to market for the lateral flow rapid antigen test by CE marking it for professional use under Mologic's existing ISO13485 quality system. The CE mark will then be transferred to Avacta after it receives ISO13485 accreditation, which is expected in April 2021.

    · The collaboration with Mologic also provides initial manufacturing capacity with the benefit of a short set-up time for the lateral flow test with Global Access Diagnostics ('GAD'), in addition to the agreements with BBI Group, Abingdon Health and others, that will provide manufacturing capabilities that can be scaled to several millions of tests per month.

    · On 9th March 2021, we announced a royalty bearing license agreement with Biokit, a Werfen Company, to develop and commercialise an Affimer-based in-vitro diagnostic test.



    Operating highlights - Therapeutics

    · Established a partnered programme ('AffyXell Therapeutics') in South Korea with Daewoong Pharmaceutical Co. Ltd., to develop the next generation of cell and gene therapies, incorporating Affimer® proteins to enhance the immune-modulatory effects. Programme subsequently expanded to provide access to the Affimer® platform for neutralising Affimer® therapies for the treatment of seriously ill patients with COVID-19 and to also prepare to rapidly develop similar therapies for future global pandemics.

    · Demonstrated initial proof-of-concept for its proprietary new class of drug conjugate, 'TMAC®', in a pre-clinical animal model of cancer.

    · Expanded the existing multi-target collaboration and development agreement with LG Chem Life Sciences ('LG Chem') to include new programmes incorporating Avacta's Affimer XT™ serum half-life extension system, deal worth up to $98.5 million plus royalties.

    · Appointment of Neil Bell as Chief Development Officer responsible for the late stage pre-clinical and early clinical development of Avacta's pipeline of pre|CISION™ pro-drugs and Affimer® immunotherapies.

    · Submitted the Clinical Trial Authorisation (CTA) to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for a phase I dose-escalation and expansion study of AVA6000 pro-doxorubicin, Avacta's first pre|CISION™ FAP-activated prodrug.

    · On schedule to select the next pre|CISION™ prodrug chemotherapy clinical development candidate from the pipeline by the end of 2021.

    · Significant progress with in-house Affimer® bispecific programmes towards selection of a clinical development candidate by the end of 2021. Two new programmes initiated, building on the AVA004 PD-L1 antagonist programme: AVA027, a PD-L1/TGfβ receptor trap combination, and AVA028, a PD-L1/IL2 bispecific.



    Post-period highlights - Therapeutics

    · On 7 January 2021, we announced the licensing agreement with Point Biopharma Inc to provide access to Avacta's pre|CISION™ technology for the development of tumour-activated radiopharmaceuticals.

    · Key appointments of Head of Chemistry, Manufacturing and Controls (CMC), Head of Clinical Operations and Head of Translational Sciences will together manage an extensive outsourced network of drug development service providers.

    · On 1 February 2021, AffyXell Therapeutics ('AffyXell'), the partnered programme with Daewoong Pharmaceuticals ('Daewoong'), closed a series A venture capital investment of $7.3m to further develop its pipeline of next generation cell and gene therapies.

    · On 18 February 2021, the Medicines and Healthcare products Regulatory Agency ('MHRA') approved the CTA for AVA6000 pro-doxorubicin for a phase I, first-in-human, open label, dose-escalation and expansion study in patients with locally advanced or metastatic selected solid tumours. The Group anticipates dosing first patients in mid-2021 subject to COVID-19 restrictions on hospital resources with first pharmacokinetics read-out possible before the year end.



    Financial and Corporate highlights

    · Fundraisings completed during the period raising £53.8 million to expand Diagnostics and Therapeutics programmes.

    · Cash and short-term deposit balances at 31 December 2020 of £47.9 million (31 December 2019: £8.8 million)

    · Revenues of £3.6 million for year ended 31 December 2020 (17-month period to 31 December 2019: £5.5 million)

    · Operating loss of £21.3 million for year ended 31 December 2020 (17-month period to 31 December 2019: £18.0 million)

    · Increased R&D investment across diagnostics and therapeutic programmes, leading to reported loss of £18.9 million (17-month period to 31 December 2019: £15.6 million)

    · Loss per ordinary share 8.4p (17-month period to 31 December 2019: 13.0p)

    · Paul Fry appointed as Non-executive Director. Paul is Chief Financial Officer of Vectura Group plc, an industry-leading inhaled drug delivery specialist listed on the FTSE Main Market.



    Dr Alastair Smith, Chief Executive Officer of Avacta Group, commented:

    "There is no doubt that 2020 was a momentous year for Avacta. I am enormously proud of the entire team who have been instrumental in delivering this transformational growth and creating substantial commercial and clinical opportunities for the Group for 2021 and beyond, despite the difficult working conditions imposed on laboratory working by the COVID-19 pandemic.

    We are now very close to self-declaration of the CE mark of the AffiDX® rapid antigen test for professional use and commercial launch in early May. We have made very good commercial progress with potential distributors, licensing partners and large-scale end users and demand is strong. We also expect to see the first pharmacokinetic data for AVA6000 before the end of the year which will give us the first indication of the effectiveness of the pre|CISION™ chemistry in humans so I am very much looking forward to updating the market on these events and other progress across the Group during the coming months."

    Avacta Group PLC - Final Results #AVCT @Avacta https://www.voxmarkets.co.uk/rns/announcement/4639bc33-39ad-403b-baf9-86c2e5ff4ab4 #voxmarkets
     
  5. Groucho

    Groucho Member

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    New vaccine candidate to be tested against AstraZeneca
    Henry Bodkin HEALTH CORRESPONDENT

    A NEW vaccine trial is being launched that will gauge whether an “old-fashioned” technology works better than the AstraZeneca jab.

    Scientists are calling for 4,000 volunteers to take part in a study of the Valneva vaccine, made in Scotland.

    Apart from those aged under 30, they will be randomly given either the candidate drug or the AstraZeneca vaccine, allowing scientists directly to compare safety and efficacy.

    By contrast, previous trials have compared the effect of a single vaccine against a placebo. It follows the news last week that the number of extremely rare but serious blood clotting events potentially linked to the AstraZeneca jab had roughly doubled.

    Similar potentially linked clots in people who have taken the Johnson and Johnson vaccine have led scientists to speculate that adenoviral vector platform technology – used by both jabs – might be the causal factor.

    Valneva uses an inactivated vaccine technology, a format which has been deployed over the last 100 years to vaccinate billions for diseases such as seasonal flu, hepatitis A, polio and rabies.

    The jab has now completed phase one and two safety and immunogenicity trials, where doses were “well tolerated with no safety concerns identified”. Recruitment for the final stage will start this week, with scientists hoping to have the results available for a submission to the regulator in the autumn.

    Up to 100 million doses of the vaccine have been secured. Prof Adam Finn, chief investigator for the Valneva study, said: “We definitely need more vaccines to help us out of this pandemic and this one is a very promising candidate.”

    Daily Telegraph 26/04/2021
     
  6. Groucho

    Groucho Member

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    10 May 2021

    Avacta Group plc

    ("Avacta" or "the Group")


    AffiDX® SARS-CoV-2 Antigen Lateral Flow Test Update


    Submission of Declaration of Conformity for CE mark for Avacta's rapid antigen test

    Avacta Group plc (AIM: AVCT), the developer of innovative cancer therapies and diagnostics based on its proprietary Affimer® and pre|CISION™ platforms, is pleased to announce that the Declaration of Conformity for CE mark of its AffiDX® SARS-CoV-2 antigen rapid test for professional use has been submitted to the Medicines and Healthcare products Regulatory Agency ("MHRA") through the Group's partner Mologic Limited.

    The Group has developed a SARS-CoV-2 antigen lateral flow test using its Affimer® platform to detect the coronavirus spike antigen and recently announced data from a clinical study on 98 positive COVID-19 samples that demonstrate excellent performance in identifying the SARS-CoV-2 virus across a broad range of viral loads.

    These data have now been combined with stability and other performance data and a submission of the Declaration of Conformity for CE marking of the AffiDX® SARS-CoV-2 antigen lateral flow test for professional use has now been made to the MHRA.

    The Group expects to receive confirmation of the registration of the AffiDX® in-vitro diagnostic device in the coming days, which will allow the Group to immediately place the test on the market.


    Dr Alastair Smith, Chief Executive of Avacta Group commented:

    "I am absolutely delighted to have reached this significant milestone for the Diagnostics Division and Avacta Group.

    "I am very proud of the quality and performance of Avacta's AffiDX® antigen test. As part of the recent clinical study the same clinical samples were tested with two leading, commercially available lateral flow antigen tests, and the data show that the AffiDX® test had better clinical sensitivity across the range of Ct values tested and, in particular, at lower viral loads.

    "We are very excited by the potential of this high quality SARS-CoV-2 rapid antigen test and the interest that we have received for it from potential commercial partners, distributors and end users. We are looking forward to receiving confirmation of the registration from MHRA in the coming days allowing the Group to immediately place the test on the market."
     

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