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.
The US Food and Drug Administration has asked for the immediate removal from the market of ranitidine medicines, some of which are sold under the trade name Zantac, owing to the presence of an impurity which may cause cancer. The FDA decision was announced on 1 April and follows an investigation that started in September 2019. The impurity is called N-Nitrosodimethylamine (NDMA) which is a known environmental contaminant found in water and foods. At low levels it is not considered dangerous.
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.
A Phase 3 trial of the Type 2 diabetes drug Farxiga (dapagliflozin), which was being in tested in patients with chronic kidney disease, is to be stopped early on efficacy grounds. This follows a recommendation by the trial’s independent data monitoring committee. Announcing the decision on 30 March, AstraZeneca Plc said the committee had concluded that patients in the trial experienced “overwhelming benefit” from the drug.
The Zolgensma gene therapy for spinal muscular atrophy, which was approved by the US Food and Drug Administration in May 2019, has now received a positive review by the European Medicines Agency. Pending approval by the European Commission, it is expected to be available to treat babies and young children across the EU soon. Spinal muscular atrophy is a rare and often fatal genetic disease that causes muscle weakness and progressive loss of movement.
Llft BioSciences Ltd of the UK has teamed up with King’s College London to create a new version of its cell therapy for cancer which uses a special type of neutrophil to attack solid tumours. The cell therapy is still in preclinical development, but the company will work with the university to develop a new version using induced pluripotent stem cells (iPSCs). It believes the iPSC version will be easier to manufacture and will deliver significant cost savings to patients. Clinical trials of the new therapy are expected to start in 2022.