antibody

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 …

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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 …

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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, …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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Regeneron Reports Results of REGEN-COV Antibody Cocktail Used as Passive Vaccine to Prevent COVID-19

Shots: The ongoing P-III trial involves assessing REGEN-COV (casirivimab & imdevimab) in 2000+ participants used as a passive vaccine to prevent COVID-19. An exploratory analysis, conducted on the first ~400 individuals, randomized to receive passive vaccination with REGEN-COV (1200mg, SC) vs PBO Reduction in overall infections seen within 1st week with 100% prevention of symptomatic …

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Nirmidas Receives the US FDA’s EUA for its COVID-19 Rapid Antibody Fingerstick Test

Shots: The US FDA has granted EUA to Nirmidas’ COVID-19 rapid antibody IgG/IgM test for use in POC settings, delivering results in 15-20min Using a fingerstick serology test, the MidaSpot COVID-19 Ab combo detection kit checks for Ab against the RBD antigen and showed 100% sensitivity for IgG after 14 days post symptom onset and …

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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 …

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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% …

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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 …

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BASE10 Collaboration; Advaxis Public offerings; Takeda’s CABOMETYX Japan approval; TheraPharm Acquisition

BASE10 Collaborates with DNA Link for COVID-19 Antibody Test Research US-based BASE10 Genetics and Korean firm DNA Link announced a collaboration on a research project to appraise the usability of the DNA Link’s antibody test, AccuFind COVID-19 IgG, in a healthcare setting. Currently, most antibody tests available in the market need the samples to be …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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