A research alliance between German BioNTech SE and Genmab A/S of Denmark has yielded its first product – a clinical stage bispecific antibody that is being investigated in patients with metastatic or unresectable malignant solid tumours. Called DuoBody-PD-L1x4-1BB, the jointly developed product started a Phase 1/2a study on 17 June. It has a dual mode of action that combines checkpoint blockade with the conditional stimulation of T cells.
It is estimated that up to 7% of patients with pancreatic cancer have a mutation in the tumour suppressor genes BRCA1 and BRCA2, impairing the body's ability to repair damaged DNA and allowing tumours to grow. BRCA mutations also drive ovarian and breast cancers, but they can be particularly lethal in pancreatic tumours because this cancer is difficult to detect at an early stage.
AstraZeneca Plc’s Bruton tyrosine kinase inhibitor Calquence, already approved in the US for mantle cell lymphoma, has delivered positive results in a Phase 3 trial of previously-treated patients with chronic lymphocytic leukaemia. The trial showed a statistically-significant and clinically-meaningful improvement in progression-free survival and will stop early, the company announced on 6 May. Calquence was administered as a monotherapy and compared with a combination of rituximab and a physician’s choice of either idelalisib or bendamustine.
MorphoSys AG has reported positive data from a single-arm Phase 2 study of its investigational monoclonal antibody tafasitamab with the cancer drug lenalidomide in patients with relapsed or refractory diffuse large B cell lymphoma. The drug, previously known as MOR208, is being prepared for a regulatory submission to the US Food and Drug Administration by the end of the year.
Another attempt to produce an effective therapy for glioblastoma multiforme (GBM), an aggressive brain cancer, has failed. This time it was a study testing the checkpoint antibody Opdivo (nivolumab) plus radiation in patients with newly diagnosed disease. The Phase 3 trial, known as CheckMate-498, did not meet its primary endpoint of overall survival at final analysis, according to the sponsor Bristol-Myers Squibb Co.
The US Food and Drug Administration has issued its first-ever draft guidance on the development of stimulant drugs to treat attention deficit hyperactivity disorder (ADHD), a condition whose symptoms include inattention and high levels of activity. While many of the recommendations are already in practice, the document gives clarification on the agency’s expectations for clinical trial design.
A Phase 3 trial investigating a new small molecule drug for advanced fibrosis failed to meet its primary endpoint, sending the developer Gilead Sciences Inc back to the drawing board. The drug, selonsertib, was being investigated in patients with stage 3 fibrosis due to non-alcoholic steatohepatitis (NASH), a progressive liver disease characterised by the accumulation of fat and inflammation in the liver.
A new player in the gamma delta T cell therapy arena has brought a cancer therapy to the clinic – this time for acute myeloid leukaemia. Glasgow, UK-based TC BioPharm Ltd has started a Phase 1 study of an allogeneic cell therapy consisting of activated and expanded gamma delta T cells.
Gamma delta T cells are a subset of lymphocytes which have both innate and adaptive immune properties. Besides TC BioPharm, at least two other companies are active in the field: GammaDelta Therapeutics Ltd of the UK and Gadeta BV of the Netherlands.
The Belgian cell therapy company Promethera Biosciences SA has reported a positive safety profile and early efficacy signals from a Phase 2a study of its lead therapy for liver disease, HepaStem. HepaStem is an allogeneic therapy derived from the stem cells of healthy donors.
The stem cells are administered by infusion into the bloodstream of patients where they circulate until reaching the liver, settle and support regeneration.
Gilead Sciences Inc and Novo Nordisk A/S of Denmark have decided to pool their resources to test a new combination therapy for the treatment of nonalcoholic steatohepatitis, a chronic and progressive liver disease characterised by the accumulation of fat and inflammation in the liver.