Seven scientists drawn from six EU member states met for the first time on 18 March to advise the European Commission on how to respond to the multitude of issues facing public health authorities during the coronavirus pandemic. Among the topics discussed were managing hospital capacity, the conduct of new clinical trials, and the protection of vulnerable populations such as refugees.
A therapeutic cancer vaccine consisting of synthetic long peptides has delivered a meaningful survival benefit for cervical cancer patients when administered in combination with standard-of-care chemotherapy. The Phase 2 trial showed that the vaccine and carboplatin/paclitaxel chemotherapy were associated with prolonged survival.
A clinical study in which orally-delivered bacteria have been combined with the checkpoint inhibitor Keytruda has shown promising results in six patients with a variety of advanced cancers. The developer, 4D pharma Plc, said the data represent the first global confirmation that a live biotherapeutic product can initiate a response in cancer patients. It noted that a microbiome product combined with a checkpoint inhibitor might improve the efficacy of the checkpoint therapy.
Roche has announced plans to start a placebo-controlled Phase 3 trial of its rheumatoid arthritis drug Actemra (tocilizumab) in adults in hospital with pneumonia caused by the coronavirus. The trial is to be conducted in collaboration with the US Biomedical Advanced Research and Development Authority (BARDA). It will evaluate Actemra, plus a standard of care, compared with placebo plus a standard of care.
MorphoSys AG is preparing for the launch, pending US regulatory approval, of its first antibody therapeutic for cancer, marking its transition from a drug discovery company into a fully-integrated pharma enterprise. The product, tafasitamab, is being reviewed by the Food and Drug Administration with a decision expected in mid-August. It has been developed for diffuse large B cell lymphoma (DLBCL), an aggressive type of non-Hodgkin lymphoma.
UK-based Oxford Biomedica Plc has secured a new agreement to supply lentiviral vectors for gene therapies, this time with Juno Therapeutics, a member of the Bristol-Myers Squibb group. Announced on 18 March, the non-exclusive licence gives BMS access to the UK company’s lentiviral vector platform and is coupled with a five-year clinical supply agreement.
Italy-based MolMed SpA, which is recognised for its expertise in cell and gene therapy development and manufacturing, is to be bought by AGC Inc of Japan which is part of the Mitsubishi group. AGC is offering €0.518 per ordinary share of the Italian company for a total deal value of €240 million. The offer is being backed by MolMed’s largest shareholder Fininvest SpA.
The German biotech BioNTech SE has joined forces with Pfizer Inc to co-develop a candidate prophylactic vaccine against infection from the coronavirus 2019-nCoV which has affected 167,515 people globally as of 16 March and resulted in 6,606 deaths.
The agreement was announced by both companies on 17 March and aims to accelerate development of BioNTech’s vaccine for the disease, BNT162, which is a messenger RNA (mRNA) molecule. The candidate vaccine is expected to enter clinical testing by the end of April.
A Phase 3 trial of a new drug combination for ovarian cancer failed to meet its primary endpoint, AstraZeneca Plc announced on 12 March. The trial was investigating cediranib, an experimental vascular endothelial growth factor receptor (VEGFR) inhibitor, with Lynparza (olaparib), an approved cancer drug that targets DNA damage response in cells and tumours.
A saga involving CureVac AG, one of Europe’s most promising biotechs, entered a new phase on 16 March when the European Commission offered to provide up to €80 million in financial support to help the company scale up development and production of a vaccine against the coronavirus 2019-nCoV, also known as SARS-CoV-2.