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GSK and Vir aim to ramp up sotrovimab supply during omicron surge

In early December 2021, GlaxoSmithKline (LON:GSK) and its partner Vir Biotechnology (NSDQ:VIR) announced that their COVID-19 antibody therapy sotrovimab appeared to retain efficacy against the omicron variant.

Now, demand for sotrovimab is eclipsing supplies of the drug as omicron has fueled a record number of infections in the U.S. and elsewhere.

According to the Wall Street Journal, Glaxo and Vir are moving to get another manufacturing plant on line to ramp up the production of the drug, which is currently produced in a single facility.

The U.S. has ordered 600,000 doses of the drug for $945.1 million for the first quarter of the year.

Other countries, including Australia and Canada, are also seeking to procure more of the drug.

GSK and Vir expect to sell 1.7 million doses internationally through binding agreements.

This week, WHO revised their COVID-19 therapeutics guidelines, adding sotrovimab to a list of “conditionally …

Unilever gives up hunt for GSK consumer unit

Unilever (LON:ULVR) recently offered to buy GlaxoSmithKline’s (GSK; NYSE:GSK) consumer healthcare unit for £50 billion (about $68 billion).

After facing pushback from analysts, investors and credit rating agencies about the deal, Unilever has abandoned the pursuit.

In an announcement, the company said it would not raise its offer above £50 billion, noting that it was committed to “strict financial discipline.”

The GSK consumer unit, of which Pfizer (NYSE:PFE) owns 32%, manufactures products ranging from toothpaste to Tylenol to vitamins.

GSK has said in the past that it was mulling spinning off the consumer division.

Pfizer and Johnson & Johnson (NYSE:JNJ) have made similar moves.

While GSK aims to focus on higher-margin drugs, Unilever is looking to rekindle growth after the pandemic has reduced demand for its products for hygiene and packaged food and refreshments.

Biotech Altos Labs emerges with $3B in funding to focus on ‘cellular rejuvenation programming’

The biotech Altos Labs has exited stealth mode with top-tier talent and $3 billion in funding with a broad mission of promoting homeostasis in cells to reverse disease, injury and disability.

In other words, the company aims to use biotechnology to fight aging and disease, as early media reports have suggested.

In a press release, Altos chief scientist and founder said the company sought to “decipher the pathways of cellular rejuvenation programming to create a completely new approach to medicine, one based on the emerging concepts of cellular health.”

Early investors in the company reportedly include the billionaires Yuri Milner and Jeff Bezos.

Altos Labs’ funding haul will likely free it from resorting to selling intellectual property to established biotech companies.

GSK’s current president of R&D and chief scientific officer, Dr. Hal Barron, will become the company’s CEO on August 1.

Barron also worked as the presiden…

GSK and Vir file for EUA for intramuscular administration of sotrovimab to treat COVID-19

GlaxoSmithKline (LSE/NYSE GSK) and Vir Biotechnology (NSDQ:VIR) are seeking to expand the use of the investigational monoclonal antibody sotrovimab.

Intravenous sotrovimab is currently authorized to treat mild-to-moderate COVID-19 in patients at least 12 years of age, weighing at least 40 kg (88 pounds). The authorization is constrained to patients who face a high risk of developing severe COVID-19.

Sotrovimab won emergency use authorization (EUA) in the U.S. in May 2021. In addition, it won EU marketing authorization as an early COVID-19 therapy in December 2021.

The companies note that data from the Phase 3 COMET-TAIL trial found that 500-mg intramuscular injection of the monoclonal antibody was non-inferior to intravenous injection.

Interim data from that trial was published in The New England Journal of Medicine last year. Final data were published as a pre-print on medRxiv. GSK and Vir Biotechnology anticipate that the full data will be publi…

7 potential applications of mRNA-based therapeutics

mRNA image courtesy of Wikimedia Commons.

Scientists have experimented with mRNA for decades, but the pandemic foisted the platform into the limelight. The Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) and Moderna (NSDQ:MRNA) COVID-19 vaccines have since emerged as two of the best-selling pharmaceutical products in recent memory.

Researchers are now exploring dozens of new possibilities for the mRNA platform.

Here, we summarize several areas where mRNA could find use in the coming years.

1. Cardiovascular applications

Image by Raman Oza from Pixabay

Researchers at the University of Pennsylvania recently shared positive data related to the use of mRNA and CAR-T cell therapy to treat cardiac fibrosis in a mouse model.

Last year, AstraZeneca (LON:AZN) announced positive results from a Phase…

Shingles vaccination may lower risk of severe COVID-19, study finds

Image courtesy of Pixabay

A large retrospective study found that a recombinant adjuvanted zoster vaccine was associated with a 32% reduced risk of COVID-19-associated hospitalization. The study, published in The Journal of Infectious Diseases, also found that individuals who received at least one dose of the Shingrix vaccine were 16% less likely to be diagnosed with COVID-19 during the trial period. The study authors concluded that the Shingrix vaccine offered a durable reduction in COVID-19 risk.

The study was conducted by GSK (NYSE:GSK) and Kaiser Permanente Southern California (KPSC). Recruiting individuals at least 50 from 1 March 2020 to 31 December 2020, the study followed 149,244 Shingrix zoster vaccine recipients and 298,488 unvaccinated individuals.

The study authors concede that the analysis had limitations related to variable health status and adherence to COVID-19 protocols such as mask-…

Sotrovimab wins EU marketing Authorization as an early COVID-19 therapy

GlaxoSmithKline (LSE/NYSE:GSK) and its partner Vir Biotechnology (NSDQ:VIR) have received marketing authorization from the European Commission for the dual-action monoclonal antibody Xevudy (sotrovimab).

The marketing authorization covers individuals 12 and older who weigh at least 40 kg who do not need supplemental oxygen. It also requires that such individuals have a heightened risk of developing severe COVID-19.

This summer, GSK and VIR had reached a joint procurement agreement with the EC involving 220,000 doses of the drug.

“With today’s marketing authorization we are now able to expand access, and we are discussing with governments how we can bring sotrovimab to more patients,” said Dr. Hal Barron, chief scientific officer and president R&D of GSK, in a statement.

The two companies also have revealed that preclinical data suggest that sotrovimab retains activity against the Omicron variant, which threatens to become the dominant form of …

Ivy Brain Tumor Center partners with GSK and UCSF to test Zejula in brain cancer patients

The Ivy Brain Tumor Center (Phoenix) and University of California, San Francisco will partner on a Phase 0 clinical trial to test GSK’s (NYSE:GSK) Zejula (niraparib) in patients with newly diagnosed glioblastoma (GBM) and recurrent glioma (grades II–IV).

Zejula is a daily oral poly (ADP-ribose) polymerase (PARP) inhibitor.

FDA introduced Phase 0 clinical trials in 2004 to close the gap between initial drug testing and later-phase efficacy studies. If a drug shows promise in a Phase 0 trial, investigators can fast-track it to a Phase 2 study.

“Our mission is to do things differently from what has been done before,” said Shwetal Mehta, chief operating officer of the Ivy Brain Tumor Center, in an interview.

Many drugs tested for brain cancer have trouble crossing the blood-brain barrier, and yet conventional trials don’t tend to be nimble enough to measure near-term efficacy.

“We want to identify drugs that are effective, and we want to do thi…

Sanofi is banking on low-cost COVID-19 vaccine

Sanofi (NSE:SANOFI) and its partner GSK (NYSE:GSK) are hoping the low price of their experimental COVID-19 vaccine will stoke interest.

In a call with analysts, Thomas Triomphe, head of the Sanofi Pasteur vaccines division, said that its vaccine would cost less than $10 per dose.

The company is also upbeat about the vaccine’s prospects as a booster.

A Phase 2 trial is currently underway to evaluate its use as a booster. Sanofi has a Phase 3 trial in the works to test its overall safety and efficacy.

The investigational vaccine uses a recombinant protein platform.

Last month, the company scrapped its plans to pursue the development of an mRNA COVID-19 vaccine. Instead, it will continue researching mRNA vaccines that could “address future pandemics and other infectious diseases and therapeutics where there is a strong unmet need,” it announced.

In its Q3 earnings announcement, the company announced that vaccine sales grew 16.5% year ov…

Bayer abandons plans to produce first-generation CureVac vaccine

Bayer (ETR:BAYN) had planned to retool a facility in Wuppertal, Germany, to produce CureVac’s (NSDQ:CVAC) COVID-19 vaccine. But Leverkusen, Germany–headquartered Bayer has put those plans on ice, according to the German paper Leverkusener Anzeiger.

Bayer had planned on producing 160 million doses of the vaccine annually.

In June, CureVac reported that its COVID-19 vaccine was 48% efficacious in an international Phase 2b/3 study focused on various age groups. Despite having lower efficacy than the mRNA vaccines from rivals Moderna and Pfizer/BioNTech, CureVac had assumed in July that it would receive marketing authorization to distribute the vaccine in Europe.

The company announced it would withdraw its first-generation vaccine candidate, CVnCoV, from regulatory review at the European Medicines Agency. CureVac also canceled an existing advanced purchase agreement with the European Commission related to the CVnCoV vaccine.

Earlier this week, CureVac…

Caribou Biosciences adds Nancy Whiting to its board of directors

CRISPR genome-editing biopharma firm Caribou Biosciences (NSDQ:CRBU) has appointed Nancy Whiting to its board of directors.

Whiting had previously worked at Seagen (formerly known as Seattle Genetics) for 14 years and had three years of experience at GSK. At Seagen, she was involved in the development of several drugs, including Adcetris, Padcev, Tukysa, tisotumab vedotin and ladiratizumab vedotin.

Seagen has developed a chRDNA genome-editing platform that supports multiple genome edits. In addition, the company is working on a range of chRDNA-based cell therapies.

Whiting has “significant experience in all phases of drug development and commercialization with particular expertise in oncology, which is highly relevant to Caribou as we advance our pipeline of chRDNA-edited allogeneic cell therapies for the potential treatment of a variety of hematologic malignancies and solid tumors,” said Rachel Haurwitz, CEO of Caribou Biosciences, in a statement.

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NVIDIA debuts supercomputer for healthcare and AI research

Santa Clara, Calif.–based NVIDIA has launched the Cambridge-1, which it hails as “the United Kingdom’s most powerful supercomputer.”

Developed with healthcare applications in mind, NVIDIA invested some $100 million in the supercomputer.

Initial applications of the Cambridge-1 include using AI to improve drug development, explore the causes of dementia and identify genomic-based disease risk factors.

Early users of the Cambridge-1 include AstraZeneca (LON:AZN), GSK (NYSE:GSK), Oxford Nanopore, King’s College London, St. Thomas’ NHS Foundation Trust and Oxford Nanopore Technologies.

AstraZeneca’s focus of the computer will be on creating an open-source transformer-based generative AI model for chemical structures. The model can be used to predict chemical reactions, optimize molecules and generate de novo molecules.

AstraZeneca and NVIDIA are also teaming up to use Cambridge-1 to facilitate digital pathology to accelerate the process of annot…