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An inside look at GSK’s digital twin initiative

A GSK vaccine facility. Image courtesy of GSK.

Digital twins, functional computerized models of physical objects, are a staple of smart manufacturing. Their use in the pharmaceutical industry, however, is still in an early phase.

GlaxoSmithKline (LON:GSK) is one of the first pharmaceutical companies to announce a digital twin initiative. Partnering with Siemens (ETR:SIE) and Atos (EPA:ATO), GSK has created a real-time simulation of the entire vaccine manufacturing process.

A year in the making

The project, which launched a year ago, has already shown promise in reducing manufacturing timelines, optimizing product quality and other areas. The use of digital twins has enabled GSK to optimize vaccine-related experiments. “With digital twins, you’re able to do huge amounts of digital experiments and minimize the number of wet experiments that you do,” said Matt Harrison, head of sciences, digital innovati…

CureVac’s interim vaccine efficacy is 47% in Phase 2b/3 study

Germany-based CureVac (NSDQ:CVAC) announced that its mRNA vaccine was 47% effective against COVID-19 in a second interim analysis of a pivotal study involving approximately 40,000 participants in 10 countries.

The rise of COVID-19 variants played a role in the disappointing results. At least 13 COVID-19 variants were present in the study population who contracted the novel coronavirus. Some 57% of cases involved variants of concern.

FDA generally requires that a vaccine be at least 50% effective in a placebo-controlled trial to win emergency use authorization.

Get the full story from our sister site, Drug Discovery & Development.

CureVac’s interim vaccine efficacy is 47% in Phase 2b/3 study

Germany-based CureVac (NSDQ:CVAC) announced that its mRNA vaccine was 47% effective against COVID-19 in a second interim analysis of a pivotal study involving approximately 40,000 participants in 10 countries.

The rise of COVID-19 variants played a role in the disappointing results. At least 13 COVID-19 variants were present in the study population who contracted the novel coronavirus. Some 57% of cases involved variants of concern.

FDA generally requires that a vaccine be at least 50% effective in a placebo-controlled trial to win emergency use authorization.

CureVac’s stock dropped 3.47% to $94.79 per share after the company announced the news.

The company anticipates that a final analysis will be ready in a matter of weeks. Based on available data, the vaccine appears to have a favorable safety profile.

CureVac is partnering with GSK (NYSE:GSK) to develop a next-gen COVID-19 vaccine. That vaccine could potentially protect against multipl…

How lupus clinical trials are evolving

A high magnification micrograph of histomorphologic changes in a lymph node resulting from systemic lupus erythematosus (SLE). Image from Wikipedia.

In the past half-century, scores of investigational drugs for lupus have seemingly failed in clinical trials. GSK’s Benlysta (belimumab) is unique in winning approval from the FDA and European regulatory authorities.

Anifrolumab from AstraZeneca, which would be a first-in-class type I interferon inhibitor, is one of the most promising investigational drugs for treating systemic lupus erythematosus (SLE). SLE is the most common form of lupus. The PDUFA date for anifrolumab is September 30, 2021, according to the Antibody Society.

A fully human monoclonal antibody, anifrolumab binds to subunit 1 of the type I interferon receptor, potentially calming the impact of pro-inflammatory cytokines involved in lupus.

Anifrolumab has shown promise in SLE patie…

CureVac’s COVID-19 vaccine candidate inches forward to Phase 2b/3 efficacy readout

CureVac (NSDQ:CVAC) has announced that its first-generation COVID-19 vaccine has passed its first interim analysis but has chosen not to share efficacy data until a statistically significant efficacy analysis is ready.

The Tübingen, Germany–headquartered company is developing two mRNA-based vaccines. The mRNA vaccines from Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) are currently two of the most popular COVID-19 vaccines in the world.

The data and safety monitoring board also concluded that there were no safety concerns linked to the CVnCoV in the HERALD study.

The company’s second-generation vaccine is known as CV2CoV, which it is developing in collaboration with GSK.

Sanofi and GSK start Phase 3 trial of COVID-19 vaccine

Sanofi and GlaxoSmithKline announced today that they began enrollment in the Phase 3 clinical trial for their COVID-19 vaccine candidate.

The companies will evaluate the safety, efficacy and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate in a global, randomized, double-blind, placebo-controlled Phase 3 study of more than 35,000 participants aged 18 and older, according to a news release.

Prevention of symptomatic COVID-19 in SARS-CoV-2 naive adults constitutes the primary endpoint, while the prevention of severe COVID-19 disease and prevention of asymptomatic infection makes up the secondary endpoints.

Stage one of the study will investigate the efficacy of the vaccine formulation targeting the original D.614 virus (Wuhan) while a second stage will evaluate a second formulation targeting the South African (B.1.351) variant. The global study offers a chance to evaluate the vaccine candidate against a number of circulatin…

CureVac and GSK announce promising preclinical data for next-gen COVID-19 vaccine

As CureVac (NSDQ:CVAC) awaits European authorization for its mRNA COVID-19 vaccine, it is conducting preclinical research on a second-generation vaccine candidate known as CV2CoV, which it is developing with GSK.

In a study involving rats, the new mRNA vaccine candidate yielded high levels of antigen and strong neutralizing antibody titers after the first vaccination.

Tübingen, Germany–based CureVac also said the vaccine candidate led to high levels of antibodies against several variants of concern, including B.1.1.298, B.1.1.7 and B.1.351.

“To successfully fight the COVID-19 pandemic in the long term, we will need different vaccines, and we need to be able to respond effectively to emerging variants,” GSK Global Vaccines President Roger Connor said in a statement.

CV2CoV uses a new mRNA platform than CureVac’s first COVID-19 vaccine candidate known as CVnCoV. The new platform intends to bolster intracellular mRNA stability and translation to y…

GSK and Vir Biotechnology seek EUA for COVID-19 monoclonal antibody

GlaxoSmithKline and Vir Biotechnology have filed for emergency use authorization (EUA) for VIR-7831 (GSK4182136), a dual-action SARS-CoV-2 monoclonal antibody.

VIR-7831 is designed to stop SARS-CoV-2 viral entry into cells and accelerate the clearing of infected cells.

VIR-7831 would have a similar indication to other monoclonal antibodies that have won an EUA. It is intended for patients 12 or older who weigh at least 40 kg who have a high risk of hospitalization or death from COVID-19.

One notable example of a monoclonal antibody that has won such an EUA from the FDA is Lilly’s bamlanivimab, which is intended to be used soon after a positive COVID-19 test result is obtained but is contraindicated for patients who are hospitalized COVID-19 infections.

Compared with bamlanivimab, VIR-7831 may offer more resistance to SARS-CoV-2 variants based on preclinical data and a preprint study published in BioRxiv.

The U.S. government recently stopped…

Former head of Operation Warp Speed leaves two more drug companies

Following allegations of sexual harassment, former head of Operation Warp Speed Moncef Slaoui has left roles at two more companies.

Yesterday, Slaoui was terminated as the chair of the Galvani board of directors, GlaxoSmithKline’s board of directors announced. The same day, Vaxcyte confirmed in an SEC filing that it had axed Slaoui as its chairman of the board. Today, Centessa Pharmaceuticals announced that he stepped down as the company’s chief scientific officer.

Get the full story at our sister site, Drug Discovery & Development.

Former head of Operation Warp Speed leaves two more drug companies

Following allegations of sexual harassment, former head of Operation Warp Speed Moncef Slaoui has left roles at two more companies.

Yesterday, Slaoui was terminated as the chair of the Galvani board of directors, GlaxoSmithKline’s board of directors announced. The same day, Vaxcyte confirmed in an SEC filing that it had axed Slaoui as its chairman of the board. Today, Centessa Pharmaceuticals announced that he stepped down as the company’s chief scientific officer.

Slaoui, who served as the head of Operation Warp Speed — the Trump administration’s program to accelerate COVID-19 vaccine development — had his termination made effective immediately by all three companies.

Termination of Slaoui follows the receipt of a letter by GlaxoSmithKline alleging against him sexual harassment and inappropriate conduct towards a GSK employee. The allegations refer to incidents that occurred several years ago when he was a GSK employee.

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How COVID-19 sidelined top vaccine manufacturers

Pfizer, with its partner BioNTech, and Moderna were the first to win emergency use authorization from FDA for COVID-19 vaccines. Johnson & Johnson recently got permission to distribute its vaccine.

But other Big Pharma companies have struggled to get vaccines to the finish line, including GlaxoSmithKline, Merck and Sanofi — among the largest vaccine manufacturers in the world.

While the pandemic offers pharmaceutical companies a unique opportunity to curry favor with the public and politicians, the current dearth of vaccines is partly a result of Big Pharma companies being “missing in action,” according to Zain Rizvi, a pharma-focused researcher at Public Citizen researcher, quoted in Financial Times.

COVID-19 vaccines could be a cash cow for Pfizer and Moderna. The former expects to rake in $15 billion worth of vaccines this year, while Moderna has forecasted $18.4 billion in sales.

Smaller va…

GSK, Sanofi launch new COVID-19 vaccine study for protein-based vaccine

Sanofi (NYSE:SNY) and Glaxo Smith Kline (NYSE:GSK) are moving forward with their development plans of a COVID-19 vaccine.

In December, the two companies announced that their vaccine development efforts had been delayed after the product failed to mount a robust immune response in older adults.

The two companies believe the setback resulted from an insufficient amount of the antigen in the vaccine. They have since revised the formulation and have launched a Phase 2 study to test the adjuvanted recombinant protein-based COVID-19 vaccine candidate.

If the study meets its primary endpoints, the companies will launch a Phase 3 trial in the second quarter of the year with authorization potentially following in the fourth quarter of the year.

“We are confident that our vaccine candidate has strong potential and we are very encouraged by the latest preclinical data,’ said Thomas Triomphe, executive vice president and head of Sanofi Pasteur, in a statement…