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British drugmaker AstraZeneca says it's confident that its new version of COVID-19 antibody treatment could protect immunocompromised patients against all known virus variants. Laboratory studies show the antibody, called AZD3152, neutralises all known variants of COVID-19 and AstraZeneca has support from regulators to make the treatment available by the end of this year, the company's vaccines head Iskra Reic said on Tuesday (April 18). AstraZeneca plans, pending more positive data and regulatory approval, to make the antibody available by the end of 2023. These types of therapies are most needed for people with compromised immune systems, either because of underlying conditions or because they are undergoing immune suppressing treatments. They account for nearly 2% of the global population. AstraZeneca's AZD3152, it new COVID-19 antibody, was acquired through a $157 million deal last year with British biotech start-up RQ Bio. The British drugmaker will likely make future investments like its current partnerships with RQ Bio but did not have any deals to announce, said Reic, a long-time AstraZeneca executive who has led the company's vaccines and immune therapies unit since it was formed in late 2021, during the pandemic.

American global healthcare company, Viatris, has launched a new rapid self-test for qualitative detection of antibodies developed after Covid-19 vaccinations. The firm is going to market the Covid-19 Neutralising IgG Serological self-test, manufactured by PRIMA Lab SA, in the UK market, which would check presence of neutralising antibodies after vaccination. The presence of antibodies indicates that a person has had an immune response to the Covid-19 vaccine, and not that protective immunity has been acquired. The self-test that can be performed easily at home with a small blood sample, delivers results in just 10 minutes and has a recommended retail price of sub £20. After two doses of the Covid-19 vaccine, the self-test has shown a seroconversion rate of 98.3 per cent for the Pfizer vaccine, 98.5 per cent for the AstraZeneca vaccine and 95.2 per cent for the Moderna vaccine. It recommended that the test be performed at least 14 days after completing the vaccination cycle.

Britain's biotech firm Avacta Group on Monday (January 10) announced halting sales of its Covid-19 rapid antigen lateral flow test AffiDX to replace antibodies in the device and increase its ability to diagnose the Omicron variant. The company stated that AffiDX is capable of detecting Omicron when the virus is present in high numbers in samples, but the sensitivity of the test reduces at lower viral loads. The performance of all rapid antigen tests came under scanner in wake of a large number of mutations in the Omicron variant. AffiDX contains both a proprietary Affimer reagent and a commercially available antibody. The Affimer reagent detects the Omicron variant with the same sensitivity as the Delta variant, and performance of the antibody is paired with the Affimer reagent in the test. This has been affected by the additional Omicron mutations, the firm said. Alastair Smith, chief executive of Avacta Group, said: "Our determination to only provide high quality, high performance diagnostic tests has led us to the correct decision to pause all marketing of the AffiDX® lateral flow antigen test. We have, of course, been unable to market the product in the UK since October 2021, as the product continues to await approval under the new CTDA regulatory process.

GlaxoSmithKline (GSK) says initial tests of the antibody-based Covid-19 therapy it is developing with US partner Vir suggest the drug is effective against the Omicron variant. A GSK statement on Thursday (December 2) said that lab tests and a study on hamsters have demonstrated the sotrovimab antibody cocktail to work against viruses that were bio-engineered to carry a number of hallmark mutations of the new variant. The tests are continuing to confirm the results against all of the Omicron mutations, with an update expected by the end of the year, it added. The antibody is designed to latch on to the spike protein on the surface of the coronavirus, but Omicron has been found to have an unusually high amount of mutations on that protein. "Sotrovimab was deliberately designed with a mutating virus in mind," said Vir chief executive George Scangos, adding that the drug was targeting a region of the spike protein that was highly unlikely to mutate.

British drugmaker GSK said on Tuesday (December 7) its antibody-based Covid-19 therapy with US partner Vir Biotechnology is effective against all mutations of the new Omicron coronavirus variant, citing new data from early-stage studies. The data, yet to be published in a peer-reviewed medical journal, shows that the companies' treatment, sotrovimab, is effective against all 37 identified mutations to date in the spike protein, GSK said in a statement. Last week, another pre-clinical data showed that the drug had worked against key mutations of the Omicron variant. Sotrovimab is designed to latch on to the spike protein on the surface of the coronavirus, but Omicron has been found to have an unusually high number of mutations on that protein. "These pre-clinical data demonstrate the potential for our monoclonal antibody to be effective against the latest variant, Omicron, plus all other variants of concern defined to date by the WHO," GSK chief scientific officer Hal Barron said.

CMS released payment allowances for two COVID-19 related billing codes. The codes account for the injection, infusion, and post-administration monitoring of the FDA- approved COVID-19 antibody drug.

Indian pharmaceutical companies are gearing up to become global suppliers of repurposed Covid-19 drugs. With the launch of new innovative Covid-19 oral drugs, Indian companies are again expected to grab opportunities in the global supply of oral Covid-19 drugs, according to data and analytics company GlobalData. As several countries witness increasing cases of Covid-19 despite vaccination, they have started booking supply orders for innovative Covid-19 treatments like antibody cocktails, monoclonal antibodies and the latest addition such Merck's the oral Covid-19 drug 'molnupiravir'. Prashant Khadayate, pharma analyst at GlobalData, comments: "Oral treatment for Covid-19 would be the most convenient option for the patients ranging from mild to moderate Covid-19 and would not require a hospital setting. Currently, a majority of the Covid-19 treatments require a hospital setting." According to GlobalData's Pharma Intelligence Center, the UK is the first country to approve molnupiravir which is in pre-registration stage in the US, EU and Japan.

US-based developer of new immunotherapeutics, including a portfolio of checkpoint modulators, anti-cancer vaccines and adjuvants, Agenus has completed the acquisition of Switzerland-based biopharmaceutical firm 4-Antibody.

PBR Staff Writer Published 25 March 2014 US-based Goodwin Biotechnology has entered into an agreement with Aspyrian Therapeutics for the technology transfer, process development, scale-up, and cGMP manufacturing of a new Antibody Drug Conjugate (ADC) for use in Phase I clinical trials.

Prince Charles formally opened a new 1 billion pound AstraZeneca research and development (R&D) facility in Cambridge on Tuesday (November 23), as the company aims to fuel the growth of its drug pipeline. AstraZeneca has supplied two billion doses of its Covid-19 vaccine, developed at Oxford University, and is also looking to bring a preventative antibody cocktail against Covid-19 to market. Prince Charles, son of Queen Elizabeth and heir to the throne, saw an exhibit on the pandemic and a demonstration of how augmented reality headsets can help with lab work, before hearing about the company's net-zero targets. "The last two years have been some of the most difficult of a generation," Prince Charles said in a speech.

Covid-19 vaccines made by Pfizer and Moderna that use mRNA technology provide the biggest boost to antibody levels when given 10-12 weeks after the second dose, a new study has found. The "COV-Boost" study was cited by UK officials when they announced that Pfizer and Moderna were preferred for use in the country's booster campaign, but the data has only been made publicly available now. The study found that six out of the seven boosters examined enhanced immunity after initial vaccination with Pfizer-BioNTech's vaccine, while all seven increased immunity when given after two doses of AstraZeneca's vaccine. "A third dose will be effective for many of the vaccines we've tested and in many different combinations," Professor Saul Faust, an immunologist at the University of Southampton and the trial's lead, told the media.

The Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the marketing authorisation of Adtralza, a dermatological solution developed by Danish specialist LEO Pharma. This injectable solution contains 300 mg of tralokinumab in a 2 mL pre-filled pen and will be available for tralokinumab patients in the UK from early 2024. Tralokinumab is indicated for treating moderate-to-severe atopic dermatitis in adult and adolescent patients aged 12 and older who require systemic therapy, Leo Pharma said in a statement. It is a fully human monoclonal antibody developed to specifically bind to and inhibit the IL-13 cytokine. Previously, it was available in a 150 mg in 1 mL pre-filled syringe. According to Leo Pharma, the 300 mg tralokinumab in a 2 mL pre-filled pen offers a streamlined administration for both patients and prescribers. It begins with an initial 600 mg dose in two injections, followed by a single 300 mg maintenance dose administered every other week. "We're pleased that this simplified administration method for tralokinumab will soon benefit eligible atopic dermatitis patients in the UK. It aligns with our commitment to elevate the standard of care and support for individuals with skin conditions," said Leanne Walsh, Vice President and General Manager of UK and Ireland at LEO Pharma.

Japanese pharmaceutical firm Eisai Co plans to seek full approval of its experimental Alzheimer's drug lecanemab in the United States, Europe and Japan armed with data showing it can slow the brain-wasting disease for people with early symptoms, potentially getting the treatment to patients next year. It remains unclear how widely the drug developed with U.S. biotech Biogen Inc will be used due to uncertainty over insurance coverage, including the U.S. government's Medicare plan for people age 65 and over, potential side effects and cost. One Wall Street analyst told Reuters news agency that he is not counting on measurable sales until 2024. Several estimated lecanemab may be priced at around $20,000 per year. "Most people who this (drug) would apply to are on Medicare, and most private payers look to Medicare as they make their own (coverage) decisions. So there's a massive roadblock in the way of all who could benefit from this treatment," said Robert Egge, Alzheimer's Association chief public policy officer. Eisai confirmed on Tuesday (November 30) that lecanemab - an antibody designed to remove sticky deposits of a protein called amyloid beta from the brain - reduced the rate of cognitive decline on a clinical dementia scale by 27% compared to a placebo. It also gave new details on side effects including a dangerous type of brain swelling and brain bleeding.

Immunogenicity refers to the capacity of a vaccine to provoke an immune response in the body. An effective immune response is characterized by the production of specific antibodies, activation of immune cells, and the development of immunological memory. The goal is to elicit a durable and robust response that can prevent or control infections. Leveraging Viral Vector Technology Viral vectors serve as essential vehicles for delivering antigenic proteins or genetic material into target cells, triggering an immune response. Biotechnology companies have been exploring advanced strategies to optimize viral vector design, aiming to enhance immunogenicity and improve vaccine effectiveness. Vector Selection: The choice of viral vector plays a crucial role in determining immunogenicity. Different viruses have unique properties and characteristics that can impact immune responses. Biotechnology companies meticulously select viral vectors that possess the desired attributes, such as the ability to infect target cells efficiently and induce strong immune responses. Genetic Engineering: Advanced genetic engineering techniques are employed to modify viral vectors, tailoring them to specific vaccine requirements. By introducing specific antigenic proteins or genetic material, researchers can stimulate the immune system to mount a targeted response. This precise manipulation enhances the vaccine's ability to elicit a robust immune reaction. Immunomodulatory Elements: Biotechnology companies are incorporating immunomodulatory elements into viral vector designs. These elements can enhance the immune response by stimulating various components of the immune system, such as antigen-presenting cells and T cells. By activating and priming these immune cells, the vaccine can generate a more potent and sustained immune response. Adjuvants: Adjuvants are substances added to vaccines to enhance their immunogenicity. They stimulate and amplify the immune response, improving the

AstraZeneca said on Thursday (June 30) that a combination of its cancer drug, Imfinzi, and chemotherapy showed promise in a late-stage trial in patients with an aggressive form of lung cancer, when given before surgery. Data showed the combination was more effective in removing cancer cells in tissue samples taken during surgery when compared with just chemotherapy in patients with non-small cell lung cancer, the drugmaker said. The interim result is a boost to the company's oncology efforts - a major area of focus - following disappointing data for Imfinzi earlier in the year in another area of therapy. AstraZeneca added the trial would continue as planned to assess the additional main goal of event-free survival, and the interim data would be shared with health authorities globally. Imfinzi belongs to the immunotherapy class of treatments, which boost the body's defences to fight cancer by using antibodies that block or bind to foreign substances in the body. The treatment generated $2.41 billion in 2021 sales.

British health agencies have secured funding to develop a standardised approach to test the performance of vaccines being used or in development against monkeypox, days after the World Health Organization labelled the growing outbreak a global health emergency. The Coalition for Epidemic Preparedness Innovations (CEPI) said it would give up to $375,000 to the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Security Agency (UKHSA) to develop standard tools to assess the strength and duration of immune responses generated by current vaccines, and for tests used to detect monkeypox antibody levels. Apart from administration fees, these tools will be made freely available to the global scientific community, paving the way for a common standardised assessment between countries documenting vaccine performance against monkeypox, CEPI said. Until this year, the viral disease has rarely spread outside Africa where it is endemic. But reports of a handful of cases in Britain in early May signalled that the outbreak had moved into Europe. So far, there have been more than 16,000 confirmed cases of monkeypox in more than 75 countries.

French drugmaker Sanofi said on Monday (June 13) an upgraded version of the Covid-19 vaccine candidate it is developing with GSK showed potential in two trials to protect against the virus's main variants of concern, including the Omicron BA.1 and BA.2 strains, when used as a booster shot. While the two companies' first experimental Covid shot is undergoing review by the European Medicines Agency, Sanofi and GSK have continued work on a vaccine that is moulded on the now-supplanted Beta variant, hoping still that it will confer broad protection against future viral mutations. Sanofi said this new vaccine candidate was shown to significantly boost antibody levels against a number of variants of concern, when given to trial participants who had an initial course of mRNA vaccines, a type made by BioNTech-Pfizer and Moderna. In a separate trial conducted by a French hospitals network, Sanofi's Beta-adapted booster shot triggered a higher immune response than Sanofi's first-generation shot or Pfizer-BioNTech's established vaccine in previously vaccinated volunteers.

Japanese drugmaker Eisai said on Tuesday (January 10) it had submitted a marketing application to the European health regulator for review of its Alzheimer's drug lecanemab, which was recently granted accelerated approval in the United States. The drug, developed in partnership with Biogen, is an antibody that has been shown to remove sticky deposits of a protein called amyloid beta from the brains of those in the early stages of the mind-wasting disease. Nearly all previous experimental drugs using the same approach have failed. The company's application to the European Medicines Agency is based on results from a late-stage study in which the drug was shown to slow down the rate of cognitive decline in patients with early Alzheimer's by 27 per cent, compared with a placebo. Eisai also reiterated its plans to apply for marketing authorization of the drug in Japan by the end of its business year on March 31.

Novartis has acquired CoStim Pharmaceuticals, an immuno-oncology company developing monoclonal antibody drugs that enable a patient's own immune system to better fight cancer.

The name coronavirus is derived from the Latin word corona meaning crown, Coronaviruses are a large family of viruses that infects the lungs