GSK Has High Hopes For COPD Vaccine

By combining its expertise in respiratory and vaccines, the UK drugs giant could have a potential blockbuster for chronic obstructive pulmonary disease, which is expected to become the third leading cause of death worldwide by the end of the decade.

Source: Shutterstock

16 million people in the US suffer from COPD

While GlaxoSmithKline PLC's renewed efforts on oncology R&D are well documented, the drug giant's established strength in respiratory and vaccines has resulted in an intriguing program for a potentially game-changing vaccine for chronic obstructive pulmonary disease (COPD).

Giving a brief pipeline update as GSK unveiled its financials for the full year and fourth quarter and plans to split into two (pharma and consumer healthcare) on 5 February, R&D head Hal Barron highlighted a Phase II study assessing GSK3277511A, an investigational vaccine. The trial is evaluating the reduction of the frequency of moderate and severe acute exacerbations in COPD patients by targeting two bacteria, Haemophilus influenzae and Moraxella catarrhalis.

Barron said, "We know Haemophilus influenzae and Moraxella catarrhalis are associated with COPD exacerbation, so we extracted the functional antigens from these two bacteria and combined them with our ASO1 adjuvant." The same adjuvant, which was designed to enhance the body’s immune response, is used for Shingrix, GSK's blockbuster shingles vaccine, which had fourth quarter sales of £532m.   (Also see "Pharma Is Priority As GSK Confirms Split With Consumer" - Scrip, 5 Feb, 2020.)

He added that initial studies show "the vaccine is safe, highly immunogenic and induces very high functional antibodies against these bacteria. GSK is the only company moving ahead with a vaccine for COPD patients and we should see proof-of-concept data by the end of this year."

The World Health Organization has estimated that COPD would become the third leading cause of death worldwide by 2030, "so we think the opportunity is definitely there," claimed Roger Connor, president of GSK Vaccines. "In the US alone, we estimate there’s around 16 million people suffering from COPD."

He added that the vaccines unit was “working very closely with our respiratory colleagues in pharmaceuticals, because obviously the huge experience that we have as well there will be key." Connor said, "We’re expecting to see efficacy data linked to that reduction in moderate to severe exacerbation, and we’re studying a population of 40- to 80-year olds. So, let’s see, but we’re excited about the opportunity." Some 30-45% of COPD exacerbations are associated with Haemophilus influenzae and Moraxella catarrhalis.

GSK's respiratory franchise performed well in the fourth quarter with sales up 9% to £892m. There were impressive showings for Trelegy (fluticasone/vilanterol/umeclidinium), the only triple therapy approved in the US for COPD, which brought in £172m, and the interleukin-5 inhibitor biologic Nucala (mepolizumab) for severe eosinophilic asthma, sales of which were up 28% to £218m.

Barron said that Nucala had a growing number of additional indications beyond severe eosinophilic asthma, having also been approved for eosinophilic granulomatosis with polyangiitis at the end of 2017. He added that GSK now had positive data in patients with hypereosinophilic syndrome, which it expects to file in the first half of this year, and data from a pivotal study in patients with nasal polyps are scheduled for the first half of 2020.  (Also see "HES Flare: GSK's Nucala Edges Forward" - Scrip, 14 Nov, 2019.)

In September 2018, the US Food and Drug Administration rejected Nucala as an add-on to inhaled corticosteroid-based maintenance treatment to reduce exacerbations in COPD patients with elevated eosinophil levels, saying more data were required. GSK has not given up and Barron noted that the first patient was dosed at the end of December in the pivotal MATINEE COPD study. (Also see "US FDA Rejection Stings Nucala In COPD; New Study May Be Needed" - Pink Sheet, 10 Sep, 2018.)

Oncology Is Priority

In the near-term, however, two oncology launches will be the focus for GSK. The first is its PARP inhibitor Zejula (niraparib) which is approved for ovarian cancer patients in the second-line maintenance setting but sales have been disappointing, with fourth-quarter sales of £66bn.

However, Zejula was submitted to the FDA for first-line maintenance in ovarian cancer at the end of 2019 for all-comers, not just in patients with BRCA mutations. It is expected to be approved in 2020 when it will go up against AstraZeneca PLC and Merck & Co. Inc.'s class-leading Lynparza (olaparib).  (Also see "New Front Opens in First-Line Ovarian Cancer Market: GSK’s Zejula Vs. AZ’s Lynparza " - Scrip, 29 Sep, 2019.)

GSK's other big hope for this year is its multiple myeloma candidate belantamab mafodotin. The anti-B-cell maturation antigen (BCMA) antibody-drug conjugate, backed by data from the pivotal Phase II DREAMM-2 study, was granted a priority review by the FDA in January and an accelerated assessment by the European Medicines Agency's Committee for Human Medicinal Products earlier this month.  (Also see "GSK Files Its BCMA Drug In Multiple Myeloma" - Scrip, 17 Dec, 2019.) (Also see "GSK: Please, EMA, Can We Have Some More? " - Pink Sheet, 30 Jan, 2020.)

Barron noted that the Phase III DREAMM-9 trial had been initiated, which tests belantamab in combination with Velcade (bortezomib), Revlimid (lenalidomide) and dexamethasone in newly diagnosed multiple myeloma patients who are ineligible for transplant. He added that to address the main side effect of keratopathy, the eye disorder associated with the therapy, "we have developed educational materials and programs to help ensure that upon launch, patients treated with belantamab are managed optimally."

900 Vaccines Jobs To Go

The pipeline updates came as GSK began its two-year program to split into two and despite its commercial success (Q4 sales rose 21% to £1.74bn), the firm's vaccines unit in Belgium will be the first to suffer significant job losses as part of the restructuring.

GSK is cutting its headcount in the vaccines division in Belgium by up to 720 posts in R&D, manufacturing, quality control and global support functions, while 215 temporary contracts will not be renewed. The company, which employs 9,000 people in Belgium and is the country's largest pharmaceutical employer, said the restructuring "aims to strengthen a common approach to R&D between the pharmaceutical and vaccine divisions by improving the allocated funding and decision making on which vaccines or drugs to develop."

Despite the job cuts, GSK stressed that it plans to invest €500m in Belgium over the next three years to make the vaccines division more agile.