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GSK announces plans for new headquarters in London

GSK plc (LSE/NYSE:GSK) has announced its plans to move to its global headquarters to a new building in central London in 2024.

The company is currently based in Brentford, a suburban town in West London.

GSK isn’t the only Big Pharma company to announce a headquarters change. In late November, Sanofi (Nasdaq:SNY) moved its home base to Paris’s 17th arrondissement neighborhood.

The company terms its new six-storied headquarters as the ‘Earnshaw.’

Approximately 3,000 employees will be based at the site. It will have offices for the company’s C-suite. It will also have space for the company’s R&D team, and employees focused on the supply chain, operations, corporate functions and HIV-focused ViiV Healthcare, a joint venture with Pfizer and Shionogi.

The headquarters will be a hybrid working environment.

Construction of the Earnshaw building is slated for completion in 2023.

GSK spun out its consumer division, which it branded…

Europe approves GSK and Sanofi’s next-gen COVID-19 booster vaccine VidPrevtyn Beta

The European Commission has approved the VidPrevtyn Beta COVID-19 vaccine as a booster for individuals who are at least 18.

The vaccine is the first next-gen protein-based adjuvanted COVID-19 booster to win European approval.

Sanofi (Nasdaq:SNY) developed the vaccine based on the beta variant using GSK’s (NYSE:GSK) pandemic adjuvant.

After announcing the news, Sanofi shares were up 1.45% to $43.97 in early afternoon trading. GSK shares were up 2.42% to $33.21.

VidPrevtyn Beta is a monovalent, recombinant-protein vaccine developed by Sanofi, modeled on the Beta variant and including GSK’s pandemic adjuvant. The vaccine uses recombinant-protein technology found in Sanofi’s seasonal flu vaccines.

In July, GSK and Sanofi announced that their adjuvanted bivalent version of its vaccine was 72% efficacious against omicron in adults in a Phase 3 study.

GSK and Sanofi noted that the vaccine performed well in registrational trials when the omi…

GSK stops two Phase 3 studies for novel antibiotic gepotidacin stopped early

GSK (LSE/NYSE:GSK) has announced that it would stop enrolling the pivotal EAGLE-2 and EAGLE-3 studies of the antibiotic gepotidacin based on advice from the independent data monitoring committee.

Gepotidacin is a topoisomerase type II inhibitor.

The EAGLE-2 and EAGLE-3 trials met the primary efficacy endpoint related to combined clinical and microbiological resolution. The EAGLE-2 and EAGLE-3 studies, involving data from more than 3,000 patients, sought to establish non-inferiority to nitrofurantoin for uncomplicated urinary tract infections (uUTIs).

EAGLE-2 and EAGLE-3 provided a test-of-cure (TOC) visit for gepotidacin compared with the traditional antibiotic nitrofurantoin in patients with a uUTI. Patients in the study were confirmed to have a uropathogen sensitive to nitrofurantoin. The data monitoring committee did not note any safety concerns.

GSK is gearing up a New Drug Application for gepotidacin, which it intends to file in the first hal…

GSK’s RSV vaccine candidate for older adults wins priority review from FDA

On the heels of winning an EU nod for its RSV vaccine marketing authorization application, GSK (LSE/NYSE:GSK) has announced that FDA has accepted a Biologics License Application for its RSV vaccine candidate for older adults.

The agency also granted priority review to the vaccine, which will clip four months off the vaccine candidate’s biologics license application (BLA) review time.

The PDUFA date for the vaccine candidate is May 3, 2023.

Several other companies are also developing RSV vaccines, including Pfizer (NYSE:PFE), Icosavax (Nasdaq:ICVX) and Moderna (Nasdaq:MRNA).

GSK said that its RSV vaccine, if approved, would be the first to protect adults 60 and over from RSV infections, which can lead to pneumonia, hospitalization and death.

While researchers have sought to develop RSV vaccines since the 1960s, no vaccine against the virus is currently available.

In granting the BLA, FDA reviewed data from a prespecified interim analy…

GSK shares positive headline results from Phase 2 study of dostarlimab with chemotherapy in non-small cell lung cancer

[Image courtesy of GSK]

GSK (LSE/NYSE:GSK) said that the PERLA Phase 2 study of dostarlimab met its endpoint of objective response rate in non-small cell lung cancer patients.

The study used Response Evaluation Criteria in Solid Tumors (RECIST) criteria to compare dostarlimab against Merck’s Keytruda (pembrolizumab) in patients with metastatic non-squamous non-small cell lung cancer who also received chemotherapy. A blinded independent central review evaluated the study’s results with RECIST v1.1 criteria.

AnaptysBio (Nasdaq:ANAB), a clinical-stage biotech, originally developed dostarlimab, which it later licensed to Tesaro, which GSK acquired in early 2019.

The randomized, double-blind PERLA study enrolled 243 patients.

GSK notes that the trial is the most extensive global head-to-head study of programmed death receptor-1 (PD-1) inhibitors in patients with metastatic non-squamou…

Niraparib promoted long-term progression-free survival benefit in Phase 3 advanced ovarian cancer study

Brentford, UK–headquartered GSK (LSE/NYSE:GSK) reported long-term data from the phase 3 PRIMA study indicating that the PARP inhibitor Zejula (niraparib) promoted a sustained and clinically meaningful progression-free survival (PFS) benefit in ovarian cancer patients.

The survival benefit was evident across biomarker subgroups, including BRCAm, HRd and HRp.

Patients in the HRd subgroup had a 48% reduction of progression or death compared to placebo.

The estimated probability of no progressive disease or death at four years in the broader population was 24% for niraparib compared to 14% for placebo.

GSK plans to present the updated efficacy analysis data on September 11 at the (European Society for Medical Oncology) ESMO Annual Meeting in Paris.

GSK noted in a news release that the overall survival data are “not yet mature based on the prespecified analysis plan.”

The study tested niraparib as maintenance therapy in first-line ovarian…

WHO decision clears path for GSK’s Mosquirix malaria vaccine

The World Health Organization (WHO) has awarded prequalification to GSK’s (LSE/NYSE:GSK) Mosquirix.

The move marks the first time that a malaria vaccine has won prequalification.

The WHO decision regarding the Mosquirix malaria vaccine is a prerequisite for United Nations (UN) agencies like UNICEF to procure the vaccine in regions with moderate to high P. falciparum malaria transmission.

Malaria was associated with 409,000 deaths in 2019, according to WHO.

GSK shares fell 1.19% in afternoon trading to $31.47.

The Mosquirix malaria vaccine is also referred to as RTS and S/AS01.

Mosquirix has a long developmental history. GSK began developing the vaccine, then known as RTS,S, in 1987.

In 2001, GSK and PATH’s Malaria Vaccine Initiative entered into a public-private partnership to develop the vaccine for infants and young children in malaria-prone countries.

To win the WHO prequalification, GSK shared detailed c…

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 …