The antibody-drug conjugate Blenrep (belantamab mafodotin), which was given an accelerated approval in the US for multiple myeloma in 2020, has failed to show superiority against a competitor molecule in a follow-up Phase 3 study. Announcing the trial results on 7 November, GSK Plc said the ADC did not meet its primary endpoint of progression-free survival. Blenrep was being tested against pomalidomide in combination with low dose dexamethasone.
Two Phase 3 trials of an experimental antibiotic for uncomplicated urinary tract infections in female adults and adolescents have been stopped early for efficacy, according to the developer GSK Plc. The trials were testing gepotidacin which inhibits bacterial DNA replication and independently binds to two different type 2 topoisomerase enzymes. The trials were halted on the recommendation of the programme’s independent data monitoring committee. GSK said it plans to submit a new drug application for the antibiotic to the US Food and Drug Administration in the first half of 2023.
Immatics NV has raised $110 million in a public share offering to advance development of its T cell receptor T cell therapies for cancer. The financing coincides with the disclosure of interim clinical data for the company’s lead product IMA203 which is being studied in multiple solid cancers.
NMD Pharma A/S, a spin-out from Aarhus University in Denmark, has reported positive top-line data from a Phase 1/2a trial of a small molecule drug for myasthenia gravis, a chronic autoimmune disease. The drug, NMD670, recently received an orphan designation from the US Food and Drug Administration in light of the seriousness of the disease. Myasthenia gravis causes potentially life-threatening muscle weakness due to impaired neuromuscular transmission. NMD670 inhibits the skeletal muscle-specific chloride ion channel CIC-1.
Lecanemab, an antibody therapy targeting amyloid-beta protofibrils in patients with early Alzheimer’s disease, achieved positive results in a Phase 3 study, paving the way for regulatory reviews in the US, EU and Japan, the developer Eisai Inc announced on 28 September. The study, called Clarity AD, met the primary endpoint as well as key secondary targets, confirming that lecanemab’s mechanism of action is able to reduce cognitive clinical decline in Alzheimer's patients. Lecanemab works by binding to soluble amyloid-beta protofibrils.
Genfit SA of France is to acquire a small Swiss company that specialises in liver diseases in order to expand its clinical-stage portfolio for these complex disorders. The purchase of Versantis AG is expected to complete in the fourth quarter and give Genfit control of VS-01, a liposomal-based therapy for acute-on-chronic liver failure (ACLF), a condition for which no drugs have yet been approved. Genfit will also acquire a small molecule asset and a diagnostic.
A Phase 3 trial of a new monoclonal antibody for rheumatoid arthritis has been shown to be at least as effective as Humira (adalimumab) and methotrexate, the current standard of care, potentially increasing the treatment options for patients who haven’t been able to control their disease with methotrexate chemotherapy alone. The experimental drug, olokizumab, targets the interleukin-6 (IL-6) cytokine directly. This distinguishes it from Humira which targets tumour necrosis factor-alpha and three other antibody drugs that target the IL-6 receptor.
Sanofi SA announced the discontinuation on 17 August of its breast cancer programme AMEERA which was investigating amcenestrant, an oral estrogen receptor degrader, in several breast cancer indications. The decision follows the failure of a Phase 3 trial of the drug in patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer.
Verona Pharma Plc has raised $150 million from a public share offering on Nasdaq in order to support development of ensifentrine, its small molecule drug for chronic obstructive pulmonary disease. The UK company recently completed the first of two Phase 3 trials of ensifentrine in preparation for a possible regulatory submission to the US Food and Drug Administration in the first half of 2023.
A Phase 3 trial of canakinumab in patients with non-small cell lung cancer failed to meet its primary endpoint of disease-free survival compared with placebo despite earlier positive signals of the drug’s potential in the disease. The developer, Novartis, announced the results on 15 August. Canakinumab (Ilaris) is an approved treatment for arthritis and periodic fever syndromes and was being studied as an adjuvant treatment in patients with stages 2 to 3A and 3B lung cancer. The Phase 3 trial did not throw up any unexpected safety signals.