Clinical Research

GlaxoSmithKline Plc has reported positive Phase 2 data for an antibody-drug conjugate directed against multiple myeloma and announced plans to make regulatory filings later this year. The drug, belantamab mafodotin, showed a clinically meaningful overall response rate in patients with the disease, GSK announced on 23 August.

A proposed treatment for non-small cell lung cancer combining Imfinzi (durvalumab) with tremelimumab failed to improve overall survival in patients with late-stage disease, AstraZeneca reported on 21 August. The combination therapy was being tested against standard-of-care chemotherapy.

A trial of four experimental treatments for Ebola virus infection has been stopped early because two of the drugs were more effective in preventing deaths, than the others. The multi-drug trial is being carried out in the Democratic Republic of Congo where an outbreak of Ebola disease has been declared a public health emergency.

GlaxoSmithKline Plc has shifted three candidate vaccines targeting filoviruses to the US non-profit organisation, the Sabin Vaccine Institute, as it restructurings its portfolio to put a bigger emphasis on oncology, HIV and respiratory diseases. The products are prophylactic vaccines to prevent infection from the Ebola Zaire, Ebola Sudan and Marburg viruses. They entered GSK’s portfolio when the UK company acquired Okairos AG in 2013.

A candidate antibiotic designed to treat patients with serious infections passed the first of two Phase 3 hurdles after patients with acute bacterial skin and skin structure infections responded to treatment. The drug, ceftobiprole medocaril, is being studied in patients with acute bacterial skin and skin structure infections as well as in Staphylococcus aureus bloodstream infections. It is being developed by Basilea Pharmaceutica Ltd of Switzerland.

Verona Pharma Plc has reported positive Phase 2 results for a dry powder inhaler formulation of ensifentrine, its candidate product for chronic obstructive pulmonary disease (COPD). Ensifentrine is a dual inhibitor of the intracellular enzymes phosphodiesterase 3 and 4 for moderate to severe COPD. It has been shown to act as both a bronchodilator and an anti-inflammatory agent.

Roche said that its checkpoint antibody Tecentriq (atezolizumab) plus chemotherapy has shown positive results in a Phase 3 study of patients with previously untreated metastatic urothelial carcinoma compared with chemotherapy alone. The study, IMvigor130, is said to be the first positive outcome of an immunotherapy combination in this patient population.

France-based Transgene SA and its South Korean partner SillaJen Inc have stopped a Phase 3 study of the candidate oncolytic virus therapy Pexa-Vec for liver cancer early because it was considered unlikely to meet its primary endpoint of overall survival. There were no reported safety concerns, the companies said.

Novartis, Amgen Inc and the non-profit organisation Banner Alzheimer’s Institute have stopped two pivotal studies of umibecestat, a candidate Alzheimer’s drug, because a review identified a worsening in some measures of cognitive function among patients. The trial was intended to run until 2025.

MorphoSys AG has upgraded its financial guidance for 2019 following a decision by GlaxoSmithKline Plc to start Phase 3 trials of one of its antibodies. This triggers a €22 million milestone payment to MorphoSys. The German company now expects revenue this year will be between €65-72 million, up from €43-50 million previously, and its loss before interest and tax to narrow to €105-115 million from €127-137 million previously.