Company News

The US Food and Drug Administration has reported positive results from a clinical investigation of synthetic swaps that might be used at the front of the nose to test for the presence of the SARS-CoV-2 virus in the general population. The swabs have been tested by a collaboration that includes the FDA; the Bill & Melinda Gates Foundation, the insurer UnitedHealth Group; and the contract research organisation Quantigen LLC. The diagnostic is a polyester-based swab developed by US Cotton, which manufactures cotton swabs.

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.

Evotec SE has set up a gene therapy research and development site in Austria, broadening its drug discovery capabilities to include advanced therapies as well as small molecules and biologics. The company announced the new site on 6 April, while simultaneously disclosing a contract with Takeda Pharmaceutical Co Ltd to generate gene therapies for the Japanese company’s four therapeutic areas: oncology, rare diseases, neuroscience and gastroenterology.

The Danish antibody pioneer Symphogen A/S is to be acquired by Laboratoires Servier, culminating more than two years of close partnership between the two companies focused on oncology. The value of the transaction was not disclosed however the sums already committed by Servier for access to Symphogen’s portfolio are considerable. Potential milestone payments under the companies’ existing partnership amount to DKK 9 billion (€1.2 billion).

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.

The US Food and Drug Administration has approved a new therapy for adults and adolescents with haemophilia who do not respond to blood clotting factor replacement treatments because of neutralising antibodies.The new therapy, Sevenfact, is a recombinant factor VIIa treatment whose active ingredient has been obtained from genetically engineered rabbits. Factor VIIa is a recognised bypassing agent for patients with inhibitors to treatments for haemophilia A and B.

Netherlands-based AM-Pharma BV has raised new capital of €47 million, enabling it to start plans for a pivotal Phase 3 trial of its therapy for acute kidney injury, a disease with a high mortality rate and no approved pharmacological treatments. The newest financing, which involves a commitment from Cowen Healthcare Investments, brings total proceeds for the Phase 3 programme to €163 million, which will also support preparations for registration. The company intends to enrol 1,400 patients with sepsis-associated acute kidney injury in the trial with sites across 12 countries.

Switzerland-based AC Immune SA is expecting readouts this year from five clinical-stage products for neurological diseases which will give the first indication of how its multi-compound approach for treating Alzheimer’s disease is faring. Two of the trials are testing a vaccine targeting amyloid-beta in Alzheimer’s disease and Down syndrome. The other three include a vaccine, an antibody and a small molecule drug each directed against tau in Alzheimer’s disease. Tau is a protein found in neurons which, when it has become dysfunctional, drives cognitive decline and memory loss.

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.