News

An experimental oncolytic virus therapy in clinical development by Targovax ASA has continued to show a survival benefit for patients with malignant pleural mesothelioma 21 months after treatment. At follow-up, half of the patients in the first-line treatment group were still alive and median overall survival had not been reached, the company announced on 23 February.

AstraZeneca Plc has voluntary withdrawn a bladder cancer indication for its checkpoint inhibitor Imfinzi (durvalumab) in the US, which was given an accelerated approval in 2017 but failed to show the required efficacy in a follow-up study. The Food and Drug Administration awards accelerated approvals to certain drugs, based on surrogate endpoints, but confirmation of clinical benefit needs to be verified in subsequent trials.

In just 12 years – the time it takes to develop a new chemical entity – argenx NV has grown from Dutch start-up into an internationally recognised biopharma enterprise. The company has a portfolio of wholly-owned and partnered antibody therapeutics, the first of which has been submitted for review to the US Food and Drug Administration. On 5 February, it announced gross proceeds of $1.15 billion from a global share offering, managed by J.P. Morgan and three other leading US financial institutions.

Less than a year after signing a lucrative licensing deal with Eli Lilly and Co, UK-based Evox Therapeutics Ltd has completed a Series C financing round to advance therapeutics based on exosomes into the clinic. The £69.2 million financing was led by Redmile Group, a US hedge fund, which was joined by the new investors OrbiMed Healthcare Fund Management and the Invus Group LLC.

Galapagos NV ended 2020 with a strong balance sheet but a reconfigured pipeline following its decision, together with partner Gilead Sciences Inc, to abandon plans to pursue a US marketing authorisation for Jyseleca (filgotinib), its small molecule drug for rheumatoid arthritis. The Food and Drug Administration turned back the application in August because of concerns about its benefit/risk profile at a dose of 200 mg. The two companies dropped plans for a US filing in December.

The Medicxi investment group has launched Centessa Pharmaceuticals Ltd, a new pharmaceutical company that brings together a group of diverse assets in order to develop them at scale with oversight from experts in the field. The launch marks a new stage in the Medicxi investment model that focuses on developing new drugs from single assets with a minimum of infrastructure in order to increase productivity and improve the return on investment.

Imcyse SA has raised an additional €21.3 million in Series B financing in order to advance its pipeline of immunotherapy compounds and simultaneously brought Pfizer Inc on board as a shareholder. Earlier, Imcyse announced a licensing deal with Pfizer to develop a preclinical asset for rheumatoid arthritis.

Novartis and the Bill & Melinda Gates Foundation have announced plans to work together to develop an in vivo gene therapy for sickle cell disease, one of the oldest known and most common genetic disorders. The project will pool the Swiss company’s drug discovery expertise with the Gates Foundation’s charitable healthcare mission. A therapy developed by the collaboration would be distributed to low and middle-income countries.

A small molecule drug being developed by Immunic Inc has shown evidence of clinical activity in hospitalised patients with moderate Covid-19 disease, the company announced on 17 February. The finding, from a Phase 2 trial, suggests that the drug, IMU-838, may have application in patients aged over 65 years, as well as preventing long-term Covid-19 symptoms such as fatigue.

Lynparza (olaparib) has passed an important threshold in a Phase 3 trial of patients with early breast cancer with the result that it will undergo a primary analysis for efficacy earlier than planned. This follows a recommendation by the trial’s independent data monitoring committee which concluded that the drug has the potential to achieve a sustainable and clinically relevant treatment effect in patients, according to the sponsors AstraZeneca Plc and Merck & Co Inc.