Sanofi-GSK COVID-19 vaccine effective against omicron

GSK plc (LSE/NYSE:GSK) and Sanofi (NYSE:GSK) have announced that their adjuvanted bivalent vaccine candidate had 72% efficacy against omicron in adults in stage 2 of a Phase 3 study.

For those with SARS-CoV-2 seropositivity, the vaccine was 93.2% effective against omicron.

The vaccine is based on the original D614 virus and the beta (B.1.351) strain.

Across variants, the vaccine was 64.7% efficacious against symptomatic infection in adults. For those previously infected with COVID-19, the vaccine was 75.1% efficacious overall.

GSK and Sanofi noted that the vaccine candidate appeared to be well-tolerated.

Moderna (Nasdaq:MRNA) is developing a bivalent omicron booster vaccine candidate known as mRNA-1273.214.

Pfizer Inc. (NYSE:PFE) and its partner BioNTech SE (Nasdaq:BNTX) have released minimal data to date on their next-generation COVID-19 vaccine.

Sanofi’s and GSK’s Phase 3 COVID-19 clinical trial, dubbed VAT08, enrolled more …

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Sanofi-GSK next-generation COVID-19 booster could go head-to-head against revised Moderna and Pfizer offerings

Sanofi (Nasdaq:SNY) and GSK (NYSE:GSK) have announced that their next-generation COVID-19 booster vaccine candidate based on the beta variant yielded a substantial immune boost in adults previously primed with mRNA vaccines.

The novel vaccine yielded a strong increase in antibody titers above baseline against various variants of concern, including a 40-fold increase against the BA.1 omicron subvariant 15 days after vaccination. The same vaccine also yielded a 15-fold increase against the original D614 virus and a 30-fold increase against the beta strain.

The results were from two studies, the VAT02 Cohort 2 and COVIBOOST VAT013.

The new vaccine candidate elicited a more robust immune response than the Pfizer-BioNTech booster vaccine or the first-generation Sanofi-GSK vaccine candidate.

Last week, Moderna (Nasdaq:MRNA) also announced that its bivalent omicron booster vaccine candidate, mRNA-1273.214 yielded 1.75 times more neutralizing antibodies t…

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Sanofi unveils new campus in Massachusetts

Sanofi announced today that it is officially opening its new 900,000-square-foot campus at Cambridge Crossing in Cambridge, Massachusetts.

The new campus brings together 2,500 Sanofi Massachusetts-based employees in a shared space. The goal is to improve collaboration between R&D, Medical, and the Specialty Care business unit — and grow a science-centered, patient-focused culture. The Paris-based pharmaceutical company has a Play to Win strategy that focuses on growth, innovation, efficiency and reinvention.

Get the full story on our sister site Pharmaceutical Processing World. 

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Sanofi unveils new campus in Massachusetts

Sanofi announced today that it is officially opening its new 900,000-square-foot campus at Cambridge Crossing in Cambridge, Massachusetts.

The new campus brings together 2,500 Sanofi Massachusetts-based employees in a shared space. The goal is to improve collaboration between R&D, Medical, and the Specialty Care business unit — and grow a science-centered, patient-focused culture. The Paris-based pharmaceutical company has a Play to Win strategy that focuses on growth, innovation, efficiency and reinvention.

“Cambridge has been our home for many years. Opening our new facility in Cambridge Crossing is allowing us to bring together our employees across Massachusetts under one roof — which is an important step in facilitating the kind of collaboration needed to fulfill our purpose of chasing the miracles of science to improve people’s lives,” Bill Sibold, EVP and head of Global Specialty Care at Sanofi.

Dr. John Reed, EVP and global h…

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Regeneron purchases exclusive rights to Libtayo from Sanofi for $900M 

Sanofi (Nasdaq:SNY) has agreed to sell Regeneron (Nasdaq:REGN) exclusive international rights of Libtayo (cemiplimab) for $900 million. Sanofi will also receive an 11% royalty on global sales of the drug.

Libtayo is a monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells.

Sanofi could also receive $100 million if the drug hits regulatory milestones in the next two years. The Paris-headquartered company could get an additional $100 million for meeting sales-related milestones in the same time window.

FDA approved the drug for advanced cutaneous squamous cell carcinoma in 2018. In 2021, Libtayo picked up indications for advanced basal cell carcinoma and first-line advanced non-small cell lung cancer with PD-L1 expression of at least 50%.

Sanofi and Regeneron entered into an international immuno-oncology alliance in 2015, agreeing then to split operating profits for Libtayo in the U.S. Sanofi agreed then to commercialize the dr…

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Digital therapeutics open up new opportunities in medicine

Pear Therapeutics designed the reSET prescription digital therapeutic for the treatment of substance abuse disorder. [Image courtesy of Pear Therapeutics]A wide range of companies are aiming to make waves through digital therapeutic offerings, and each is doing things differently.

“We are seeing tremendous momentum for the DTx industry, with more and more products coming to market and gaining commercial coverage and recent signals from the White House and Congress demonstrating their interest and recognition of DTx products as an important way to expand access to quality treatments for populations with public coverage, especially underserved communities,” Digital Therapeutics Alliance CEO Andy Molnar said via email. “While we are riding a massive swell, the wave hasn’t even begun to crest. The community is expanding and convening this broad coalition of stakeholders is critical to really scale the industry and drive DTx adoption and integration to truly transform healthc…

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Digital therapeutics open up new opportunities in medical design

A wide range of companies are aiming to make waves through digital therapeutic offerings and each is doing things differently.

“We are seeing tremendous momentum for the DTx industry, with more and more products coming to market and gaining commercial coverage and recent signals from the White House and Congress demonstrating their interest and recognition of DTx products as an important way to expand access to quality treatments for populations with public coverage, especially underserved communities,” Digital Therapeutics Alliance CEO Andy Molnar told Medical Design & Outsourcing. “While we are riding a massive swell, the wave hasn’t even begun to crest. The community is expanding and convening this broad coalition of stakeholders is critical to really scale the industry and drive DTx adoption and integration to truly transform healthcare.” 

Read: How DeepWell is developing video games as tools for treating me…

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Sanofi announces publication of early study of rilzabrutinib for immune thrombocytopenia

Sanofi (Nasdaq:SNY) has announced that the New England Journal of Medicine (NEJM) has published positive data from the Phase 1/2 dose-finding study testing the safety, pharmacokinetics and clinical activity of rilzabrutinib for immune thrombocytopenia.

Immune thrombocytopenia is associated with bruising and bleeding. Fewer than 200,000 Americans are diagnosed with the condition each year.

Rilzabrutinib is an experimental oral Bruton’s tyrosine kinase (BTK) inhibitor. The drug candidate has been the focus of about 20 clinical trials to date, with indications ranging from asthma to urticaria.

The study, published in NEJM, focused on adults with heavily pre-treated immune thrombocytopenia (ITP), concluded that rilzabrutinib therapy led to a rapid and durable increase in platelet count. Rilzabrutinib also appeared to have a good safety profile.

The drug candidate may increase platelet counts in patients with immune thrombocytopenia. As the NEJM articl…

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Sanofi oncology drug candidate hits roadblock

Amcenestrant, a once-promising investigational optimized oral selective estrogen receptor degrader (SERD) from Sanofi (Nasdaq: SNY), did not meet the primary endpoint in a recent Phase 2 trial focused on advanced or metastatic breast cancer.

Sanofi had previously referred to amcenestrant as a “potentially transformative” product.

Investigators did not identify any new safety signals for the drug candidate in the Phase 2 AMEERA-3 trial.

SNY initially dipped after the news was announced but had stabilized by the middle of the day — up 1.60% to $50.94.

Some 367 patients participated in the open-label study.

Sanofi plans to study amcenestrant in the upcoming AMEERA-5 and AMEERA-6 studies.

“This Phase 2 trial evaluated amcenestrant as a monotherapy in a patient population with advanced disease where limited treatment options remain,” said Dr. John Reed, head of research and development at Sanofi. “While we are disappointed with the AMEERA…

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Sanofi details €2B plan to make France an mRNA leader

French drugmaker Sanofi (Nasdaq:SNY) said it would spend €935 million (about $1.1 billion) between 2022 and 2026 to produce mRNA-based vaccines.

That funding is part of a larger €2 billion (about $2.4 billion) initiative to accelerate its mRNA development capability, Sanofi explained on its French-language website.

The company plans to use the funds to ramp up its lipid nanoparticle production capability and identify six candidate mRNA vaccines.

Get the full story from our sister site, Pharmaceutical Processing World. 

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Sanofi details €2B plan to make France an mRNA leader

French drugmaker Sanofi (Nasdaq:SNY) said it would spend €935 million between 2022 and 2026 to produce mRNA-based vaccines.

That funding is part of a larger €2 billion initiative to accelerate its mRNA development capability, Sanofi explained on its French-language website.

The company plans to use the funds to ramp up its lipid nanoparticle production capability and identify six candidate mRNA vaccines.

To commemorate the investment, French Prime Minister Jean Castex and Sanofi CEO Paul Hudson arrived at the company’s planned Evolutive Vaccines Facility plant in Neuville, France, on March 7.

The Neuville site will ultimately house equipment for multiple vaccine and biological platforms.

To date, Sanofi has been left on the sidelines as Pfizer (NYSE:PFE), BioNTech (Nasdaq:BNTX) and Moderna (Nasdaq:MRNA) have raked in billions of dollars of mRNA-based vaccine sales.

Last year, Pfizer raked in $36.8 billion in COVID-19 vaccine sales al…

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Nirsevimab offers significant protection against RSV in infants in Phase 3 trial

AstraZeneca’s (LON:AZN) and Sanofi’s (Nasdaq:SNY) nirsevimab had 75% efficacy against lower respiratory tract infections resulting from rr (RSV) in a Phase 3 study.

There are currently few treatment options for lower respiratory tract infections stemming from RSV. Two antivirals, palivizumab and ribavirin, are available, while new vaccines are currently authorized.

RSV is the most common cause of lower respiratory tract infections in infants.

AstraZeneca has announced that the immunostimulant nirsevimab is the first potential therapy that could offer sustained protection for an entire RSV season with a single dose.

In the placebo-controlled MELODY Phase 3 trial, nirsevimab had 74.5% efficacy against medically-attended lower respiratory tract infections from RSV in healthy infants.

The Phase 3 study was recently featured in NEJM. Another article in the same journal focused on nirsevimab’s safety profile in the MEDLEY Phase 2/3 study, c…

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