AstraZeneca Plc has partnered with the University of Oxford to develop, manufacture and distribute a candidate vaccine for COVID-19 that is based on technology originating from the university and its 2016 spin-out Vaccitech Ltd. The vaccine, ChAdOx1 nCoV-19, is in a Phase 1 clinical trial to test its safety and efficacy in healthy volunteers. Initial results from the study are expected to be reported in June.
A Phase 3 study of the antiviral remdesivir in patients with advanced COVID-19 has delivered positive results, the first indication that a treatment for the disease may be within reach. Preliminary data from the trial were disclosed on 29 April by the sponsor, the US National Institute of Allergy and Infectious Diseases.
A Phase 3 lung cancer trial of the checkpoint antibody Libtayo (cemiplimab) has been stopped early due to a significant improvement in overall survival, the developers Sanofi SA and Regeneron Pharmaceuticals Inc announced on 27 April. Libtayo is a programmed death receptor-1 (PD-1) blocking antibody that frees the immune system to fight cancer. The drug has already been approved in the US to treat advanced cutaneous squamous cell carcinoma.
Lynparza (olaparib) has demonstrated another benefit for patients with a specific genetic mutation – this time in a Phase 3 trial of men with metastatic castration-resistant prostate cancer. Lynparza is a poly ADP ribose polymerase (PARP) inhibitor that is already approved for ovarian, breast and pancreatic cancers.
A second pharma partnership is poised to start a human trial of a candidate vaccine for COVID-19 using messenger RNA (mRNA) technology. Germany-based BioNTech SE and Pfizer Inc will test BioNTech’s BNT162 programme in approximately 200 healthy subjects between the ages of 18 and 55. Permission to start the trial was granted by the German regulator, the Paul-Ehrlich-Institut, the companies announced on 22 April.
A partnership that brings together industry, pharmaceutical regulators and the US National Institutes of Health (NIH) is being created to speed up the development of therapies and vaccines for COVID-19. The planned alliance is the work of the NIH and its sister foundation, the Foundation for the NIH.
The German biotech BioNTech SE has joined forces with Pfizer Inc to co-develop a candidate vaccine against infection from the coronavirus SARS-CoV-2 which had affected 1.7 million people globally as of 12 April and resulted in 105,952 deaths.
A Phase 3 trial of the lung cancer drug Tagrisso (osimertinib) will be unblinded early on the recommendation of the data monitoring committee on evidence of overwhelming efficacy, the developer AstraZeneca Plc announced on 10 April. Tagrisso, a tyrosine kinase inhibitor targeting the epidermal growth factor receptor (EGFR), has already been approved for first and second-line use in patients with advanced non-small lung cancer. The Phase 3 trial, called ADAURA, was treating patients with early-stage disease. The primary endpoint of the trial is disease-free survival.
Oncology developer iTeos Therapeutics Inc has raised $100 million in an oversubscribed fundraising led by RA Capital Management and Boxer Capital LLC bringing total monies generated under its B financing round up to $175 million. The funds will enable the company to progress two early clinical-stage compounds for treating solid tumours which target mechanisms of immunosuppression.
Johnson & Johnson Inc has announced the selection of a lead vaccine candidate to test against COVID-19, the disease caused by the coronavirus SARS-CoV-2. It intends to start clinical studies by September at the latest. The first batches of the vaccine could be available for emergency use authorisation by early 2021, the company announced on 30 March.