A new drug for endometrial cancer has been approved by the US Food and Drug Administration following a trial which showed an overall response rate of 42.3%. Jemperli (dostarlimab) was developed by GlaxoSmithKline Plc and is administered with a diagnostic developed by Roche. The diagnostic can recognise cancers which are deficient mismatch repair (dMMR), or cancers with a genetic feature that adversely affects the repair of DNA inside cells.
A new biotech company has been launched in the UK to develop medicines for cancer and inflammatory disease by targeting fibroblasts. Mestag Therapeutics Ltd was founded by a team of five fibroblast experts and has received seed financing of $11 million from SV Health Investors and Johnson & Johnson Innovation.
A German radiopharmaceutical company has raised €90 million to complete development and commercialise a radionuclide therapy for cancer as well as build its oncology pipeline. ITM Isotopen Technologien München AG is conducting a Phase 3 trial of Lu-Edotreotide in patients with gastroenteropancreatic neuroendocrine tumours, which are rare tumours of the pancreas and parts of the gastrointestinal tract.
Anavo Therapeutics BV, a new venture capital-backed company, has been launched in the Netherlands with seed capital of €20 million to investigate the development of drugs targeting phosphatases. Phosphatases are enzymes which, together with kinases, regulate the activity of signalling pathways in the body. But until recently, they have been largely unexplored as a target for therapeutics.
Roche reported a 1% decline in group sales, expressed in Swiss francs, in the first quarter as competition from biosimilar products eroded demand for the cancer drugs Avastin and Herceptin, and the rheumatoid arthritis drug Rituxan. By contrast, sales of diagnostic products, including tests for both Covid-19 and non-Covid-19 applications, were strong.
Forbion Capital Partners has announced the final close of a new fund which will invest in late-stage European assets developing therapies for high medical need. The Forbion Growth Opportunities Fund I closed at €360 million, having only been launched in July 2020. Investors included Pantheon Ventures, the European Investment Fund, and Eli Lilly and Co, amongst others.
Johnson & Johnson Inc is to resume the rollout of its single dose vaccine for Covid-19 in Europe following guidance from the European Medicines Agency that the vaccine’s benefits outweigh its risks. Eight cases of unusual blood clots associated with low levels of blood platelets have been identified in the US, one of which was fatal. But set against this, are the more than seven million people who have received the vaccine without serious incident, officials from the EMA said on 20 April, following a safety review.
Opdivo (nivolumab), one of the earliest checkpoint inhibitors, has been approved by the US Food and Drug Administration for the first-line treatment of gastric cancer – the first immunotherapy for this indication. The approval also covers gastroesophageal junction cancer and oesophageal adenocarcinoma.
Merck & Co Inc is to discontinue development of a recombinant fusion protein for Covid-19 because additional studies would be needed to qualify it for an emergency use authorisation. Merck announced the decision on 15 April following feedback from the US Food and Drug Administration.
GlaxoSmithKline Plc has stopped two Phase 2 studies of the IgG4 monoclonal antibody feladilimab that was being investigated in patients with metastatic head and neck squamous cell carcinoma. The company announced the discontinuation of the INDUCE-3 and INDUCE-4 trials on 14 April. This follows a recommendation by one of the trial’s independent data monitoring committees. The reasons were not given.