Category: antibody

  • FDA bans use of Lilly, Regeneron COVID drugs due to Omicron

    The FDA has limited the use of COVID-19 antibody therapies developed by Eli Lilly and Regeneron, on the back of data suggesting they have are “highly unlikely” to be effective against the now-dominant Omicron variant. The emergency use authorisations (EUAs) for Lilly’s bamlanivimab/etesevimab combination and Regeneron’s REGEN-COV (casirivimab and imdevimab) issued earlier on in the […]

  • AZ’s antibody first to be cleared by FDA for COVID prevention

    AstraZeneca’s antibody cocktail for COVID-19, now called Evushield, has become the first drug in the class to be authorised for prevention of infection by the US FDA. The long-acting antibody combination, formerly known as AZD7442 (tixagevimab and cilgavimab) has been cleared for pre-exposure prophylaxis (PrEP) of COVID-19 in adults and adolescents aged 12 and older […]

  • MHRA okays GSK’s Xevudy as data suggest it works against Omicron

    The UK medicines regulator has approved GlaxoSmithKline and Vir Biotech’s antibody for COVID-19, Xevudy, which has been shown to be effective against the new Omicron strain of SARS-CoV-2 in lab testing. Xevudy (sotrovimab) is the second COVID-19 antibody to be approved by the MHRA after Roche/Regeneron’s Ronapreve (casirivimab and imdevimab), which got a green light […]

  • US signs $1bn order for GSK, Vir’s COVID-19 antibody

    The US has made a sizeable order for GlaxoSmithKline and Vir Biotechnology’s antibody-based COVID-19 treatment sotrovimab said to be worth approximately $1 billion. The deal does not specify the number of doses of sotrovimab ordered by the federal government, but takes the total number to be supplied globally to around 750,000, according to a Reuters […]

  • COVID antibodies from Roche, Celltrion backed for approval in EU

    The EMA’s human medicines committee has recommended approval of Roche’s Ronapreve and Celltrion’s Regkirona for use in COVID-19, the first antibody-based therapies for coronavirus to be backed for full approval in the EU. Ronapreve (casirivimab and imdevimab) – developed and distributed by Regeneron as REGN-COV in the US – has been recommended by the CHMP […]

  • One dose of Regeneron’s COVID antibody protects for eight months

    A single dose of the COVID-19 monoclonal antibody therapy developing Regeneron reduced the risk of contracting the virus by around 82% for up to eight months, according to new trial data. The results suggest that the REGEN-COV (casirivimab/imdevimab) antibody could play a key role in protecting people who do not mount a sufficiently strong immune […]

  • GSK side-lines COVID drug otilimab to focus on Xevudy

    GlaxoSmithKline said today it would halt further development of its antibody for severe COVID-19 pneumonia – otilimab – in order to focus its resources on Xevudy for mild-to-moderate disease. The drugmaker said in its third-quarter results update this morning that it had decided to invest more in generating data on Vir BioTech-partnered anti-SARS-CoV-2 antibody Xevudy […]

  • AZ files for emergency use of COVID-19 antibody combo in US

    AstraZeneca has sought emergency use authorisation for its antibody combination AZD7442, following trial results indicating it can prevent symptomatic COVID-19 infection when given to healthy patients. AZD7442 (tixagevimab/cilgavimab) is the first long-acting antibody drug that has demonstrated it can be used in this way, reducing the risk of symptomatic COVID-19 by 77% compared to placebo […]

  • AbCellera Acquires TetraGenetics to Enhance its Capabilities for Developing Antibodies

    Shots: AbCellera acquires TetraGenetics in an all-cash transaction that includes up front, milestones based on the achievement of technical milestones related to the development of therapeutics The acquisition will combine TetraGenetics’ capabilities with AbCellera’s technology to provides an optimized protein source for AbCellera’s Abs discovery across a range of therapeutic areas. The technology has the […]

  • Novartis’ transplant drug hope iscalimab flunks mid-stage trial

    Novartis hopes of improving on tacrolimus as the standard drug for preventing organ rejection in transplant patients have been dashed after its iscalimab candidate failed a mid-phase trial. An interim analysis of data from the CIRRUS-1 trial suggested that iscalimab (CFZ533) was less effective than tacrolimus at preventing rejection in kidney transplant patients when both […]

  • AC Immune claims half a win for tau drug in Alzheimer’s trial

    Shares in AC Immune leaped today after the company said its tau-targeting Alzheimer’s disease candidate semorinemab hit one of its objectives in a phase 2 trial, although it missed another. The Swiss biotech’s Nasdaq-listed shares were up around 66% shortly after the announcement of data from the LAURIET study in patients with mild-to-moderate Alzheimer’s disease, […]

  • PROVENT trial puts AZ COVID antibody combo back on track

    AstraZeneca’s AZD7442 has shown that it can prevent COVID-19 infection when given to healthy patients – the first time this has been demonstrated by a long-acting antibody-based drug. The results of the almost 5,200-patient PROVENT study show that pre-exposure prophylaxis using the antibody combination reduced the risk of developing symptomatic COVID-19 by 77% compared to […]

  • More malaria hope as antibody protects against infection

    A single dose of a monoclonal antibody developed by scientists at the US National Institutes of Health (NIH) has provided protection for people exposed to malaria parasites for up to nine months. The results of the phase 1 trial suggest that antibodies could be used to protect travellers, military personnel and health care workers traveling […]

  • Boehringer takes alteplase to phase 3 for COVID, but drops antibody

    Boehringer Ingelheim’s latecomer antibody therapy for COVID-19 has been side-lined, as the company focuses its attention on its thrombolytic drug alteplase, heading into a phase 3 programme later this year. The decision to discontinue development of BI 767551, an inhaled antibody, has been taken because of the “evolving landscape” in managing the pandemic including the […]

  • Biogen abandons tau antibody for Alzheimer’s after phase 2 miss

    Biogen has four other Alzheimer’s candidates in its clinical pipeline behind recently-approved Aduhelm, but one of them – anti-tau antibody gosuranemab – has just been canned. The decision comes on the back of the phase 2 TANGO study of gosuranemab (also known as BIIB092), which showed that the antibody was unable to show a benefit […]

  • Regeneron drug saves lives in severe COVID-19, but it’s not for all

    People who cannot generate an effective immune response against COVID-19 can be protected with an infusion of Regeneron’s antibody therapy REGN-COV, according to new data from the UK RECOVERY trial. The therapy significantly reduced the risk of death, the length of hospital stay and the need for a ventilator in the study, which involved around […]

  • AZ’s COVID jab tackles delta variant, but antibody fails clinical trial

    The delta variant of COVID-19 may be holding back the lifting of lockdown restrictions in the UK, but there is some good news – the AstraZeneca/Oxford University vaccine seems to offer a high level of protection against it. Real-world data from Public Health England (PHE) suggests that the vaccine prevents 92% of hospitalisations in patients […]

  • Antibody Purification: A Deeper Look into Service Providers Landscape

    Over time, several innovative technologies have been developed to support the designing and manufacturing of various types of antibody products; however, the aforementioned processes are characterized by high costs and technical complexities, especially during the production and downstream processing steps. Therefore, it is challenging for new entrants and companies with limited resources and capital, to […]

  • GSK, Sanofi eye Q4 approval as COVID jab starts phase 3

    GlaxoSmithKline’s COVID-19 drive has advanced on two fronts, with the start of phase 3 trials of its Sanofi-partnered vaccine candidate as well as an FDA emergency approval for antibody sotrovimab, developed with Vir Biotech. GSK and Sanofi think they could be on track for approval of the recombinant protein-based vaccine – delivered with GSK’s immune-response […]

  • EU starts rolling review of GSK’s antibody for COVID-19

    The EMA has begun a rolling review of a COVID-19 antibody developed by GlaxoSmithKline and Vir BioTech which could become the fourth drug of its type cleared for early use in the EU.  Sotrovimab (VIR-7831) – also known as GSK4182136 – is being assessed as a treatment for patients with SARS-CoV-2 infection aged 12 and […]

  • EMA starts review of GSK/Vir COVID-19 antibody

    The EMA has started reviewing the emergency use application for GlaxoSmithKline and Vir Biotech’s COVID-19 antibody VIR-7831, which could become the fourth drug of its type cleared for early use in the EU.  The monoclonal antibody – also known as GSK4182136 – is being evaluated for the treatment of people with mild or moderate COVID-19 […]

  • Provention faces delay in FDA review of diabetes prevention antibody

    The FDA says it has uncovered “deficiencies” in the marketing application for Provention Bio’s much-anticipated drug teplizumab for the prevention of type 1 diabetes (T1D) that could delay its review. The issues are holding up discussions between the agency and company about labeling and post-marketing requirements for teplizumab, and are concentrated around the pharmacokinetics data […]

  • Lilly and GSK/Vir antibody pairing offers resistant COVID-19 hope

    Two antibodies targeting different parts of the COVID-19 virus spike protein, from Eli Lilly and GlaxoSmithKline/Vir Biotech, can cut viral load dramatically within a week.  The BLAZE-4 trial found that co-administration of Lilly’s bamlanivimab – already granted emergency approval as a COVID-19 treatment – and GSK/Vir’s experimental antibody VIR-7831 reduced virus levels by 70% after […]

  • COVID-19 drives Boehringer’s R&D spend to record level in 2020

    Boehringer Ingelheim invested €3.7 billion on R&D last year, the highest spend in its history, as it mobilised its scientists to seek out new therapies for COVID-19. Not all those efforts have been successful. Boehringer abandoned BI 764198, an inhibitor of TRPC6 in phase 2 for acute respiratory distress syndrome (ARDS) in patients hospitalised for […]

  • Lilly Collaborates with Biolojic to Discover and Develop Antibody Therapies for Diabetes

    Shots: Biolojic to receive ~$121M including development and commercialization milestones and a promissory note that may be convertible into Biolojic equity in future Additionally, Biolojic is eligible to receive royalties on sales of therapies that emerges during the collaboration The collaboration will leverage Biolojic’s AI-based multibody platform to discover and develop a potential novel Ab-based […]

  • Regeneron’s REGEN-COV Antibody Cocktail Confirms its Effectiveness Against UK and South Africa SARS-CoV-2 Variants

    Shots: REGEN-COV neutralizes the SARS-CoV-2 B.1.1.7 variants, identified in the UK & SA. The data was included in a bioRxiv paper and submitted for peer-reviewed publication on the changing resistance of SARS-CoV-2 variants to Ab neutralization REGEN-COV retained its neutralizing capability against the B.1.1.7 variant. The Ab cocktails also retained its potency against the B.1.351 […]

  • AZ deploys mobile sites to test COVID-19 antibody AZD7442

    AstraZeneca is playing catch up with Eli Lilly and Regeneron with its antibody therapy for COVID-19, but aims to narrow the gap with the help of decentralised clinical trial specialist Care Access Research. AZ started its STORM CHASER trial of AZD7442 – actually a pair of antibodies – in December, and will now tap into […]

  • Regeneron’s Antibody Cocktail Demonstrate Promising Results in Hospitalized Patients on Low-Flow Oxygen

    Shots: The company reported encouraging initial data from an ongoing P-I/II/III trial of its casirivimab + imdevimab (8,000/2,400mg) in hospitalized COVID-19 patients requiring low-flow oxygen. The results passed the futility analysis as seronegative patients treated with the Ab cocktail had a lower risk of death or receiving mechanical ventilation In seronegative patients, the cocktail reduced […]

  • Abbott’s COVID-19 IgG Quantitative Antibody Blood Test Receives CE Mark

    Shots: Abbott received CE Mark for its new quantitative SARS-CoV-2 IgG lab-based serology test. The test measures levels of IgG Abs to help in the evaluation of a person’s immune response The study to determines the clinical performance of Abbott’s SARS-CoV-2 IgG II Quant test on its Alinity i instrument showed that it had 99.60% […]

  • Roche Highlights its Bispecific Antibody Portfolio Across a Range of Blood Cancers at ASH 2020

    Shots: The company presented the new data of its T-cell engaging bispecific Abs, mosunetuzumab, glofitamab and cevostamab at ASH 2020, demonstrating encouraging activity across multiple types of blood cancer Roche divulges that its mosunetuzumab & glofitamab showed promising responses across multiple types of NHL, including R/R FL & DLBCL, reinforcing from the P-I/Ib GO29781 study […]

  • BASE10 Collaborates with DNA Link to Support Authorization of COVID-19 IgG Antibody Test at the Point of Care

    Shots: The companies collaborated to evaluate the usability of DNA Link’s AccuFind COVID-19 IgG antibody test in a healthcare setting The study intends to expand access to antibody testing outside of laboratory settings The companies plan to launch the study in Dec’2020 Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Base 10 genetics The post […]

  • Y-mAbs claims FDA OK for neuroblastoma drug Danyelza

    Y-mAbs Therapeutics has claimed its first product approval, getting a green light from the FDA for Danyelza for the rare cancer neuroblastoma. Danyelza (naxitamab) is an antibody that targets GD2, a protein found on the surface of some tumour cells, and it has been cleared by the US regulator for use alongside GM-CSF – a […]

  • Lilly to ship COVID-19 drug straight away after FDA green light

    Eli Lilly has said it will start shipping supplies of its COVID-19 drug bamlanivimab immediately, after claiming emergency-use authorisation (EUA) for the antibody. The AbCellera-partnered drug, previously known as LY-CoV555 or LY3819253, can be used to treat mild-to-moderate COVID-19 in patients 12 years and older, who are at high risk for progressing to severe disease […]

  • Regeneron’s COVID-19 antibody cocktail therapy hits safety problem

    Regeneron’s coronavirus antibody cocktail therapy against COVID-19, famously used to treat president Donald Trump, has hit a safety issue after independent safety experts recommended it should not be given to high-risk patients in a late-stage clinical trial. It’s the latest blow for antibody therapies against COVID-19 after Eli Lilly last week announced it won’t resume […]

  • NIAID drops Lilly antibody from ACTIV-3 COVID-19 trial

    Eli Lilly says no more patients will be treated with its COVID-19 therapy bamlanivimab in a trial run by the US National Institute of Allergy and Infectious Diseases (NIAID), as results to date suggest it is unlikely to  be effective. The ACTIV-3 study was comparing bamlanivimab (also known as LY-CoV555 or LY3819253) and placebo when […]

  • Regeneron joins Lilly in seeking emergency OK for COVID-19 antibody

    Regeneron has followed Eli Lilly in asking the FDA for emergency approval of its COVID-19 antibody therapy, shortly after the drug was thrust into the spotlight by being used to treat President Trump. The request for emergency use authorization (EUA) for REGN-COV2 comes amid a spike in interest about antibodies against the SARS-CoV-2 coronavirus, driven […]

  • Chasing Regeneron, AZ starts trials of its COVID-19 antibody cocktail

    The first patients have been dosed in a trial of two AstraZeneca antibodies, collectively known as AZD7442, that are being developed to both treat and prevent coronavirus infections. The phase 1 trial – funded by the US government – will take place in the UK and will test the safety of AZD7442 and its pharmacokinetic […]

  • Regeneron recruits Roche to make COVID-19 antibody drug REGN-COV2

    Roche has agreed to help Regeneron manufacture its COVID-19 antibody cocktail REGN-COV2, which started late-stage clinical testing a few weeks ago, in a deal that could more than triple supplies of the drug if it gets approved. Regeneron is already working on ramping up manufacturing capacity for REGN-COV2, with the help of $450 million in […]