News

Emily Whitehead celebrated her 14^th birthday in May, which was also the seventh year she has been free of cancer. The complete remission of her cancer - acute lymphoblastic leukaemia – is the first of many successes of the immunotherapy, chimeric antigen receptor (CAR) T cells, which are experiencing an expositive growth around the world.

The European Medicines Agency has issued a positive opinion for the personalised therapy Xospata (gilteritinib) to treat acute myeloid leukaemia (AML) following approvals for the same drug in both the US and Japan. The developer is Tokyo-based Astellas Pharma Inc.

Xospata is being recommended as a monotherapy for the treatment of adult patients with relapsed or refractory AML with a FLT3 gene mutation. The positive opinion will need to be adopted by the European Commission before Xospata can be marketed.

H. Lundbeck A/S is to acquire the US biopharmaceutical company Alder BioPharmaceuticals Inc in order to add migraine to its disease coverage and build expertise in monoclonal antibody technology. The transaction is valued at up to $1.95 billion net of cash.

Storm Therapeutics Ltd has disclosed data from an animal study of a new small molecule inhibitor of an RNA modifying enzyme which showed activity against cancer. The study results were announced on 18 September at a meeting in Cambridge, UK attended by scientists from Europe and the US who are at the forefront of the new science of RNA epigenetics.

Safety concerns once again triggered the stoppage of a late-stage Alzheimer’s disease trial with a BACE inhibitor, a small molecule drug intended to limit amyloid-beta production. Eisai Co Ltd and Biogen Inc announced the discontinuation of two studies with elenbecestat on 13 September following a review by the trials’ data safety monitoring board.

Crescendo Biologics Ltd has entered into collaborations with two UK universities to accelerate development of its lead product for tumours expressing prostate-specific membrane antigen (PSMA). The product, CB307, is due to enter the clinic in 2020.

Separately Crescendo appointed Steward Kay, formerly of GlaxoSmithKline Plc, as its chief business officer.

The European Investment Fund (EIF), together with institutions in Germany and Austria, has launched a new fund to support early-stage drug discovery projects sourced predominantly from academic institutions in both countries.

A French immunology company founded in 2013 has raised €39 million in a Series B financing round to advance the development of a drug candidate for patients with septic shock. Inotrem SA is being supported by Morningside Ventures, which led the round, along with the evergreen investor Invus. Existing investors Andera Partners, Sofinnova Partners and BiomedInvest, also participated in the round.

The Bill & Melinda Gates Foundation is to make a $55 million equity investment in BioNTech SE as part of a collaboration aimed at developing potential HIV and tuberculosis vaccine and immunotherapy candidate drugs. Total funding under the collaboration could reach $100 million through potential future grant funding from the Gates Foundation. The additional funds would be used to underwrite the evaluation of the candidate products in the clinic and to start new infectious disease projects.

The Italian gene therapy company Genenta Science SRL has raised €13.2 million in a new financing round to progress novel treatments for multiple myeloma and glioblastoma that deliver immunomodulatory molecules into the tumour environment. The company has received regulatory approval to start Phase 1/2 clinical trials in both cancer indications.

The new financing brings total capital raised by the company up to €30.2 million since its founding in 2014 as a spin-out from the San Raffaele Hospital in Milan.