As part of its strategy to incorporate big data into regulatory decision-making, the European Medicines Agency is to invite pharma companies to apply for a pilot project under which they would submit patient data from clinical trials as part of their marketing authorisation applications. The project is expected to start in September and last up to two years. It would cover about 10 regulatory procedures.
A second booster dose of one of the two messenger RNA (mRNA) vaccines approved in the EU for Covid-19 is being recommended for adults between the ages of 60 and 79 years. This is to protect against a new wave of infections caused by a variant of the SARS-CoV-2 virus. The recommendation was issued on 11 July by the European Centre for Disease Prevention and Control and the European Medicines Agency.
It is often said that cell and gene therapies are a ‘process’ rather than typical drugs. This is based on the fact that their success depends on the quality of their starting materials and how they are manufactured. This could be an autologous chimeric antigen receptor (CAR) T cell-based gene therapy, or any one of the many allogeneic products in clinical development. Manufacturing is the key strategic issue for developers of these therapies, according to speakers at the On Helix annual meeting in Cambridge, UK on 7 July.
AstraZeneca Plc is to pay up to $1.27 billion to acquire the US company TeneoTwo Inc in a bid to strengthen its pipeline of medicines for haematologic malignancies. TeneoTwo’s portfolio features an early clinical stage T cell engager. These are bispecific antibody therapeutics which are engineered to redirect the immune system’s T cells to recognise and kill cancer cells.
NewAmsterdam Pharma BV has secured a licensing deal for its lead drug, a cholesterol lowering agent for patients who aren’t well controlled on statins. The partner is the Menarini Group of Italy which already has a cardiology portfolio of 18 products and is prepared to pay up to €1 billion for rights to the new product candidate.
Oncogeni Ltd, a company founded in 2019 by the British scientist and Nobel Laureate Martin Evans is to be acquired by Roquefort Therapeutics Plc in order to progress its preclinical assets for cancer. The all-share transaction, announced on 22 June, has been valued at around £4 million. Concurrently, the enlarged company will have two new investors: Daiichi Sankyo Co Ltd and the venture capital investor CH Health.
F-star Therapeutics Inc is to be acquired by a subsidiary of a large Chinese pharma group giving it a new setting in which to develop its bispecific antibodies for cancer. The acquirer is invoX Pharma, a subsidiary of Sino Biopharmaceutical Ltd which has a portfolio of small molecule drugs and biologics to treat cancer and other diseases.
Ipsen SA is to expand its oncology portfolio with the acquisition of Epizyme Inc, a US developer of epigenetic medicines. Epizyme’s lead product, Tazverik (tazemetostat) has been approved for two cancer indications in the US – diseases that are not covered by Ipsen’s current portfolio.
NOXXON Pharma NV has updated its drug development strategy in light of further positive data for its aptamer drug NOX-A12 in patients with glioblastoma. The company’s resources will now be fully deployed to advance NOX-A12 towards registration. Other research projects will be put on hold, the company announced on 23 June 2022.
Spain-based VIVEbiotech SL has received regulatory approval for an upgrade of its lentiviral vector manufacturing capacity that will significantly expand its ability to produce vectors for both in vivo and ex vivo gene therapies. The company currently has 40 programmes ongoing with four dedicated to in vivo administration.