GSK Halts Development of Multiple Cancer and Rare Disease Drug Candidates Amid Portfolio Review

Compiled by Fan Dongdong

GlaxoSmithKline Releases Q4 and Full-Year Financial Report, Including Drugs to Be Suspended from R&D in the New Quarter

Among these drugs is the OX40 agonist GSK3174998, a therapy that was suspended due to "insufficient clinical activity" in tumor treatment. GSK3174998 is a humanized IgG1 anti-OX40 monoclonal antibody. OX40 is a tumor necrosis factor receptor expressed on the surface of activated T cells. Previously, clinical trials of this drug as monotherapy were conducted. In 2015, GlaxoSmithKline and Merck & Co. announced the initiation of a Phase I clinical trial to evaluate GSK3174998 both as monotherapy and in combination with Merck’s Keytruda (pembrolizumab) for locally advanced, recurrent, or metastatic solid tumors that had progressed after standard therapy.

Other R&D products shelved alongside GSK3174998 include the anti-OSM drug GSK2330811 for the treatment of systemic sclerosis and Benlysta-Rituxan for Sjögren's syndrome, which were “terminated due to failure to meet efficacy endpoints.” Benlysta is the first B-lymphocyte stimulator (BLyS)-specific inhibitor and was previously approved by the FDA as the first medication for the treatment of lupus nephritis (LN). As a humanized monoclonal antibody, Benlysta specifically binds to the B-lymphocyte stimulator.

Furthermore, GlaxoSmithKline’s partner, Immutep, announced earlier this month that it would also suspend the Phase 2 trial of GSK2831781 (an anti-LAG-3 antibody) for ulcerative colitis. According to Immutep, the trial was halted following consultation with the Data Review Committee and an interim analysis of the trial data. GSK2831781 is a monoclonal antibody for the treatment of autoimmune diseases. It targets LAG-3–expressing activated T cells accumulated in diseased organs, depleting these activated T cells from the patient’s body through antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). Although the Phase 2 program for ulcerative colitis has been terminated by both companies, the collaboration between GlaxoSmithKline and Immutep remains in effect, and GlaxoSmithKline retains exclusive global rights to GSK2831781.

According to GlaxoSmithKline’s financial report for the fourth quarter and full year of 2020, the company’s sales in the fourth quarter amounted to £8.739 billion, a 2% year-on-year decrease, with earnings per share (EPS) of 13.6 pence, a 48% year-on-year decline. For the full year, GlaxoSmithKline reported total sales of £34.099 billion, a 1% year-on-year increase, and EPS of 115.5 pence, a 23% year-on-year rise. The company’s total operating profit for 2020 was £7.783 billion, up 12% year on year. GlaxoSmithKline maintained its 2022 earnings guidance unchanged for the full-year 2020 EPS.

In addition, GlaxoSmithKline (GSK) announced the latest updates on its collaboration with CureVac regarding the COVID-19 vaccine. Reportedly, the two companies have reached a partnership worth up to €150 million to jointly develop next-generation mRNA vaccines targeting SARS-CoV-2 variants, with an expected launch in 2022. GSK will also assist CureVac in producing up to 100 million doses of its first-generation COVID-19 vaccine, CVnCoV, this year; the vaccine is currently in Phase 2b/3 clinical trials.

Reference source: GSK culls cancer, rare disease meds amid Q4 clear-out