Clinical Research

Bristol Myers Squibb Co has launched its second preclinical collaboration with Immatics NV in order to explore the potential of an antibody-like bispecific molecule as a treatment for solid tumours. The newest agreement, announced on 14 December, gives BMS exclusive rights to an engineered bispecific molecule consisting of a receptor that binds to a cancer target and a region that recruits T cells to the tumour site to become activated. The upfront payment is $150 million.

The US Food and Drug Administration has placed clinical holds on six trials of the HIV medicine islatravir after some trial participants showed a decrease in total lymphocyte and CD4+ T cell counts – a sign of weakened immune systems. Developed by Merck & Co Inc, islatravir is being studied for both the treatment and prevention of HIV-1 infection. “With the FDA’s clinical hold, no new studies may be initiated,” the company announced on 13 December.

The New England Journal of Medicine has published data from a Phase 3 trial of Dupixent (dupilumab), a widely prescribed anti-inflammatory drug which was recently approved by the US Food and Drug Administration for children with uncontrolled moderate-to-severe asthma. Data from the trial formed the basis of a US approval and have been included in a regulatory filing with the European Medicines Agency.

Merck & Co Inc paused enrolment on 6 December for two Phase 3 trials of its lead investigational treatment for HIV – a little more than two weeks after stopping dosing in a Phase 2 study of an HIV combination therapy. The measures were taken on the recommendation of the trials’ respective data monitoring committees. They affect MK-8507, a non-nucleoside reverse transcriptase inhibitor, and islatravir, a nucleoside reverse transcriptase translocation inhibitor. In both cases, the actions were taken in relation to total lymphocyte and CD4+ T cell counts in patients.

A stem cell-derived therapy has restored the function of pancreatic islet cells in a patient with Type 1 diabetes in what is being described as the first demonstration of a potentially curative treatment for the disease. The therapy is being developed by Vertex Pharmaceuticals Inc on the basis of research conducted by Douglas Melton, a professor at Harvard University and co-director of the Harvard Stem Cell Institute in Cambridge, US.

Vifor Pharma Group has expanded its presence in nephrology with the acquisition of two companies with therapies addressing specific aspects of vascular calcification. The companies are Sanifit Therapeutics SA of Spain and Inositec AG of Switzerland.

Merck & Co Inc and its partner Ridgeback Biotherapeutics LP published new efficacy data for their Covid-19 treatment on 26 November showing that the anti-viral drug reduced the risk of hospitalisation or death by 30%, compared with a placebo, instead of the earlier reported 50%. The updated efficacy figure is based on additional data presented to the US Food and Drug Administration. The FDA’s Antimicrobial Drugs Advisory Committee was scheduled to meet on 30 November to evaluate the latest information.

Daprodustat, a candidate drug for the treatment of anaemia due to chronic kidney disease, has generated positive data in five Phase 3 trials – the first oral inhibitor of an enzyme linked to a protein complex to show efficacy without an increased cardiovascular risk. Data from two of the trials were published in The New England Journal of Medicine on 5 November 2021.

A candidate antiviral for the treatment of Covid-19 has delivered an 89% reduction in the risk of Covid-19 related hospitalisation or death compared with placebo in a Phase 2/3 clinical study, the developer Pfizer Inc, announced on 5 November. On the recommendation of the trial’s independent data monitoring committee, the study was stopped and data will be sent to the US Food and Drug Administration to support an emergency use authorisation.

An experimental breast cancer treatment for patients with estrogen receptor positive and HER2 negative breast cancer has met the primary endpoint in a Phase 3 trial paving the way for regulatory submissions in the US and Europe in 2022, the developers Menarini Group and Radius Health Inc, announced on 20 October.