Human Trials

ImmunityBio gets FDA authorisation to begin trial of novel Covid-19 vaccine candidate

ImmunityBio has secured authorisation from the US Food and Drug Administration (FDA) to commence a phase I clinical study of its novel Covid-19 vaccine candidate, called hAd5-Covid-19.

Seagen, Astellas report positive results from PADCEV phase 2 trial in advanced urothelial cancer

Seagen and Astellas Pharma announced positive topline results from the second cohort of patients in the pivotal phase 2 single-arm clinical trial known as EV-201.

J&J halts Covid-19 vaccine trials after unexplained illness in participant

Johnson & Johnson (J&J) has halted further dosing in all Janssen’s Covid-19 vaccine candidate clinical trials, as a result of unexplained illness in a study participant.

BMS presents positive data from phase 3 True North Trial of Zeposia in UC

Bristol Myers Squibb announced detailed results from True North, a pivotal, placebo-controlled Phase 3 trial evaluating oral Zeposia (ozanimod) as an induction and maintenance therapy in adult patients with moderate to severe ulcerative colitis (UC).

Pfizer’s Ibrance fails to meet primary endpoint in early breast cancer trial

The German Breast Group (GBG) and Pfizer announced that the Ibrance (palbociclib) has failed to meet the primary endpoint in phase 3 early breast cancer trial.

Pfizer, Sangamo dose first participant in phase 3 study of Hemophilia A gene therapy treatment

Pfizer and Sangamo Therapeutics, a genomic medicines company, today announced that the first participant has been dosed in the Phase 3 AFFINE study of giroctocogene fitelparvovec (SB-525), an investigational gene therapy for hemophilia A patients.

GSK, Vir Biotechnology to expand Covid-19 treatment study

GlaxoSmithKline (GSK) and Vir Biotechnology have announced that they will expand the study of a VIR-7831 (GSK4182136) monoclonal antibody to treat Covid-19.

Eureka initiates trial to evaluate ET140203 ARTEMIS T Cell Therapy in HCC

Eureka Therapeutics, Inc., a clinical stage biotechnology company developing novel T cell therapies to treat solid tumors, today announced the Company has initiated a Phase I/II clinical trial of its ET140203 ARTEMIS T cell therapy in adult patients with hepatocellular carcinoma (HCC), the predominant type of liver cancer. The Phase I portion of the ARYA-1 study is now open for enrollment.

Alnylam reports positive results from ILLUMINATE-B phase 3 study of Lumasiran

Alnylam Pharmaceuticals announced positive topline results from the ILLUMINATE-B pediatric Phase 3 study of lumasiran, an investigational RNAi therapeutic targeting hydroxyacid oxidase 1 (HAO1) – the gene encoding glycolate oxidase (GO) – in development for the treatment of primary hyperoxaluria type 1 (PH1).