Clinical Research

Moderna Inc was set to raise gross proceeds of about $1.34 billion from a public share offering that was launched hours after the company reported positive interim data from a Phase 1 study of its messenger RNA (mRNA) vaccine for COVID-19. The company is issuing 17.6 million shares at a price of $76 per share. The offering is expected to close on 21 May. Proceeds will be used to finance the cost of manufacturing its COVID-19 vaccine which still has to complete clinical development and be approved by a regulator.

Netherlands-based Kiadis Pharma NV has raised €17 million in two private share placements enabling the cell therapy company to advance products for patients with both liquid and solid tumours. On 6 May, not long after the financing completed, the company received notice from US Food and Drug Administration that it could proceed with a Phase 2 study of its lead product – an adjunctive cell therapy for blood cancer patients undergoing a haploidentical haematopoietic stem cell transplant.

A Phase 3 trial of the small molecule drug elafibranor failed to meet its primary endpoint in adults with non-alcoholic steatohepatitis (NASH), the developer Genfit SA announced on 11 May. The trial was attempting to show a resolution of NASH without a worsening of fibrosis. The response rate among the 717 patients who were tested was 19.2% for those in the elafibranor group compared with 14.7% for patients on a placebo.

Early clinical data on a new cell therapy product to prevent organ rejection were reviewed in The Journal of Clinical Investigation on 1 May 2020 after a Phase 1b study showed the procedure to be safe and feasible. The therapy, MIC-Lx, is based on modified immune cells created from the white blood cells of a donor. It has been developed by the Heidelberg, Germany-based company TolerogenixX GmbH.

Newron Pharmaceuticals SpA has stopped development of sarizotan, a small molecule drug for Rett syndrome, after the Phase 3 STARS trial failed to meet its primary and secondary endpoints. Rett syndrome is a severe neurodevelopmental disorder, mainly affecting females, for which there are no approved treatments.

AstraZeneca Plc has partnered with the University of Oxford to develop, manufacture and distribute a candidate vaccine for COVID-19 that is based on technology originating from the university and its 2016 spin-out Vaccitech Ltd. The vaccine, ChAdOx1 nCoV-19, is in a Phase 1 clinical trial to test its safety and efficacy in healthy volunteers. Initial results from the study are expected to be reported in June.

A Phase 3 study of the antiviral remdesivir in patients with advanced COVID-19 has delivered positive results, the first indication that a treatment for the disease may be within reach. Preliminary data from the trial were disclosed on 29 April by the sponsor, the US National Institute of Allergy and Infectious Diseases.

A Phase 3 lung cancer trial of the checkpoint antibody Libtayo (cemiplimab) has been stopped early due to a significant improvement in overall survival, the developers Sanofi SA and Regeneron Pharmaceuticals Inc announced on 27 April. Libtayo is a programmed death receptor-1 (PD-1) blocking antibody that frees the immune system to fight cancer. The drug has already been approved in the US to treat advanced cutaneous squamous cell carcinoma.

Lynparza (olaparib) has demonstrated another benefit for patients with a specific genetic mutation – this time in a Phase 3 trial of men with metastatic castration-resistant prostate cancer. Lynparza is a poly ADP ribose polymerase (PARP) inhibitor that is already approved for ovarian, breast and pancreatic cancers.

A second pharma partnership is poised to start a human trial of a candidate vaccine for COVID-19 using messenger RNA (mRNA) technology. Germany-based BioNTech SE and Pfizer Inc will test BioNTech’s BNT162 programme in approximately 200 healthy subjects between the ages of 18 and 55. Permission to start the trial was granted by the German regulator, the Paul-Ehrlich-Institut, the companies announced on 22 April.