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GSK finalizes Affinivax acquisition

GSK (LSE/NYSE:GSK) has wrapped up its acquisition of the privately-held biopharma Affinivax.

Cambridge, Massachusetts–based Affinivax has established a vaccine technology platform known as Multiple Antigen Presentation System (MAPS), designed to elicit a strong B-cell and T-cell immune response.

GSK was attracted to Affinivax, given its aim to bolster its portfolio of specialty medicines and vaccines.

AFX3772

Affinivax’s most advanced program is the AFX3772 vaccine candidate for streptococcus pneumoniae, which is currently in a Phase 2 trial. AFX3772 is a 24-valent vaccine candidate. In addition, the company is planning a Phase 3 study of AFX3772.

In July 2021, FDA awarded the AFX3772 Breakthrough Therapy designation to protect against S. pneumoniae invasive disease and pneumonia in adults 50 and older.

On a related note, Pfizer (NYSE:PFE) recently announced positive data related to a 20-valent pneumococcal conjugate vaccine candidate.…

Fall 2022 COVID-19 vaccine candidate tracker

[Photo from Pexels]

Approximately two-thirds of Americans have received at least one dose of a COVID-19 vaccine.

But COVID-19 cases remain elevated following the spread of a series of omicron sublineages, which pose a threat to those vaccinated and naturally infected with various lineages of the coronavirus.

A variety of companies are developing next-generation COVID-19 vaccines that could potentially optimize the strength and durability of immune protection compared to the first crop of vaccines.

Here, we round up notable COVID-19 vaccine candidates that, at least, could help pave the way for the fall 2022 booster drive.

BNT162b5

Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) are developing a bivalent COVID-19 vaccine candidate known as BNT162b5 based on the ancestral strain and a BA.1 Omicron variant. The vaccine has a modified spike protein design to optimize the immune response …

GSK finalizes $36B Haleon spin-off

GSK plc (LSE/NYSE: GSK) has demerged from its consumer healthcare division to create the publicly-traded company Haleon Group.

Haleon is now one of the world’s largest consumer healthcare companies, while GSK will focus on growing its prescription drug and vaccine businesses.

The company announced the “Haleon” name in February.

In hindsight, GSK would have fared better if it had accepted Unilever’s offer to buy GSK’s consumer healthcare division for £50 billion (about $68 billion). That sum also included £10 billion worth of debt.

In January, GSK rebuffed Unilever’s advances.

Haleon shares are now traded under the ticker HLN on the London Stock Exchange. On the day of opening, HLN shares dropped 3.18% to £316.60

GSK anticipates that Haleon shares will also commence trading on the New York Stock Exchange under the ticker HLN on July 22.

Dostarlimab drug trials: The science behind cancer and the therapy’s future

[Image courtesy of GSK]

Cancer treatment has been a critical point for clinical diagnostics. Over the years, various treatment approaches- from naked nucleic acid-based therapy, targeting microRNAs, oncolytic virotherapy, and suicide-gene-based therapy to CRISPR/Cas-9-based therapy. More recently, drug-based therapy has also emerged as a promising area for cancer therapeutics. Regarding drug administration, a major buzz has been created around dostarlimab, whose trials have yielded substantial results. Before this discovery, a series of gene therapeutics were initiated, with varying degrees of success.

Dostarlimab was first developed by AnaptysBio and later licensed to GSK (NYSE:GSK). The trade name for dostarlimab is Jemperli.

FDA approved dostarlimab for women with recurrent or advanced dMMR endometrial cancer in April 2021. In August of the same year, GSK won FDA accelerated approval for dostarlimab fo…

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 …

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…

Agenus and GSK tout positive Phase 3 data for RSV vaccine

Immuno-oncology firm Agenus (Nasdaq:AGEN) and its partner GSK (NYSE:GSK) have announced positive headline results from a pre-specified efficacy interim analysis of the AReSVi 006 Phase 3 trial of an experimental respiratory syncytial virus (RSV) vaccine.

RSV infects most children before the age of 2. Some 75,000 to 125,000 children are hospitalized as a result of the virus annually, according to data from the National Institute of Allergy and Infectious Diseases.

But RSV can also pose a risk to older adults, especially those with chronic conditions, as the CDC noted.

The Agenus and GSK study focused on adults at least 60 years of age.

The analysis of the Phase 3 trial was the first to show a statistically significant and clinically meaningful efficacy in older adults.

Agenus and GSK note that the AReSVi 006 study exceeded its primary endpoint without observing any unexpected safety concerns.

The companies hope to file regulatory sub…

GSK wins FDA approval for Priorix MMR vaccine

GSK plc (LSE/NYSE:GSK) has announced that the FDA has approved the Priorix measles, mumps and rubella (MMR) vaccine for individuals at least 12 months old.

Before the FDA approval, Merck & Co.’s M-M-R II was the only MMR vaccine currently FDA approved in the U.S. Merck also has a FDA-approved measles, mumps, rubella and varicella vaccine known as ProQuad.

Priorix is widely available throughout the world, having been licensed in more than 100 countries. More than 800 million doses have been distributed.

“We’re proud to make Priorix available in the U.S. for the first time, adding a choice for providers to help protect patients against these highly-contagious diseases and to further strengthen offerings in our pediatric vaccine portfolio,” said Judy Stewart, senior vice president and head of U.S. vaccines at GSK, in a news release.

Measles, mumps and rubella are highly contagious diseases.

In the U.S., measles surged in 2019, infecting at…

GlaxoSmithKline officially rebrands as GSK

GlaxoSmithKline (NYSE:GSK) has long gone by its acronym GSK. Now, the abbreviation is the company’s official name.

GlaxoSmithKline had announced its plan to change the name in an earnings announcement in April 27.

The London Stock Exchange and the New York Stock Exchange will update the company’s name in “due course,” as the company explained in a news release.

GlaxoSmithKline got its name from the 2000 merger of Glaxo Wellcome and SmithKline Beecham. In that deal, Glaxo Wellcome paid $75.7 billion to acquire its then competitor, creating what WSJ called in 2000 the “world’s No. 1 drugmaker.”

Now, GSK is in the process of creating a consumer health spinoff known as ‘Haleon.’

GSK’s consumer segment makes an array of products, including Centrum vitamins, Sensodyne toothpaste, and the pain-reliever brands Excedrin, Advil and Panadol.

The company’s decision to simplify its…

GSK to name Vishal Sikka to its board

GlaxoSmithKline plc (LSE/NYSE:GSK) has announced that the CEO of Vianai Systems, Vishal Sikka, will join its board as a non-executive director.

Vianai Systems is a Bay Area startup focused on ‘human-centered AI.’

Sikka will join after GSK spins off its consumer segment, which it will term ‘Haleon.’

At GSK, Sikka will provide perspective on AI, which GSK says is ‘central’ to its R&D.

Sikka has also worked as the CEO of Infosys, a management consulting firm and as a member of the board of German software giant SAP. Sikka also was named SAP’s first CTO in 2007. He decided to step down in 2014.

VishalSikka pictured in 2010. [Image courtesy of Wikimedia]

Sikka also serves on the board of directors of Oracle and BMW.

“I am delighted to welcome Vishal to GSK. He is an experienced board director and an outstanding technologist who has been at the forefront of advance…

SK Bioscience and GSK seek regulatory nod for COVID-19 vaccine in South Korea

SK Bioscience (KRX:302440) and GSK (NYSE:GSK) have filed a biologics license application with the Korean Ministry of Food and Drug Safety for their SKYCovione, a recombinant protein-based COVID-19 vaccine candidate.

The self-assembled nanoparticle vaccine candidate is adjuvanted with GSK’s pandemic adjuvant.

SKYCovione fared well in a Phase 3 study involving more than 4,000 adults in Thailand, Vietnam, New Zealand, Ukraine, the Philippines and South Korea.

In the study, the vaccine candidate performed better in terms of neutralizing antibody levels than AstraZeneca’s Vaxzevria COVID-19 vaccine. SKYCovione also had a good safety profile in the study. In particular, it generated neutralizing antibody titers almost three times more than the control vaccine two weeks after administering the second dose.

“At this point in time, when countries around the world are developing strategies to respond to the endemic phase of the COVID-19 gl…

CureVac and GSK announce positive preclinical data for bivalent next-gen mRNA vaccine candidate

Tübingen, Germany–based CureVac N.V. (Nasdaq:CVAC) and its partner GSK (NYSE:GSK) have announced positive preclinical data about their second-generation COVID-19 vaccine candidate that combines mRNAs for the beta and delta variants.

The companies conducted the preclinical research in conjunction with the Friedrich-Loeffler-Institut, Germany.

The research pitted the bivalent candidate against monovalent COVID-19 vaccine candidates.

The bivalent vaccine generated a robust immune response in animals, resulting in a significant reduction of viral load, high neutralizing antibody titers and strong T cell responses.

In a test focused on rats, the bivalent vaccine candidate resulted in a two-fold increase in neutralizing antibody titers against the omicron variant compared to the delta variant.

The researchers also tested the vaccine candidate in transgenic mice expressing the human ACE2 receptor.

The companies have published a manuscript o…