Clinical Research

The gene and cell therapy industry has significant potential. But this will only be realised if manufacturers share information about their technologies, enabling the advanced therapies to be produced at scale and marketed at affordable prices.

Semorinemab, an antibody directed against the tau protein, has failed to have an impact on patients with early Alzheimer’s disease despite earlier promise, the developer AC Immune SA announced on 23 September. Semorinemab is being developed with Genentech, a member of the Roche Group.  

AstraZeneca Plc and Oxford University have resumed clinical trials in the UK for their candidate Covid-19 vaccine following a pause earlier this month triggered by an adverse event. The event led to a voluntary stoppage of vaccination across all global trials to allow for a review of safety data by independent committees and international regulators.

On 12 September, AstraZeneca and Oxford announced that the UK regulator had ruled that it was safe to continue trials in the UK. Further details about the case were not disclosed.

Pfizer Inc and BioNTech SE are seeking regulatory approval to expand the enrolment of their Phase 3 Covid-19 vaccine trial to include 44,000 participants, up from 30,000 at present. An application to amend the trial protocol has been submitted to the US Food and Drug Administration, the companies announced on 12 September.

The prospective vaccine, BNT162b2, is a single nucleoside-modified messenger RNA that encodes an optimised SARS-CoV-2 full length spike glycoprotein which is the target of virus neutralising antibodies.

ABX464, a small molecule drug being investigated for ulcerative colitis, generated positive data in patients who completed a second year of treatment, the developer Abivax SA announced on 2 September. The Phase 2a maintenance study showed that 69% of patients were in clinical remission and 94% benefited from a clinical response at the end of the second year. Twenty-two patients were initially enrolled in the study in which ABX464 was administered once daily at a dose of 50 mg.

A Phase 3 trial of Farxiga (dapagliflozin) has shown a reduction in the risk of kidney failure and cardiovascular or renal death in patients with chronic kidney disease, according to the developer AstraZeneca Plc.  The trial results were presented on 30 August at a virtual meeting of the European Society of Cardiology. Farxiga is a sodium-glucose co-transporter 2 (SGLT2) inhibitor which has been approved to treat Type 2 diabetes and heart failure.

A Phase 3 trial of a prospective triple combination therapy for advanced melanoma failed to meet its primary endpoint of progression free survival, Novartis announced on 22 August. The trial was testing the experimental checkpoint antibody spartalizumab in combination with Tafinlar (dabrafenib) and Mekinist (trametinib), both approved products, in patients with melanoma with a BRAF V600 mutation.

A candidate antibody therapeutic for atopic dermatitis has met its primary endpoint in a Phase 2a study using a novel treatment strategy. The therapy, KY1005, targets the OX40-ligand, a key regulator of the immune system. In the study, the compound showed a clinically meaningful improvement in disease activity compared with placebo, according to the developer Kymab Ltd.

Data from two Phase 3 studies of the antibody therapeutic ofatumumab in relapsing multiple sclerosis have been published in the 6 August 2020 edition of The New England Journal of Medicine, illustrating the drug’s possible role as a first-choice option for patients with the disease, Novartis announced on 5 August. The data compared ofatumumab with teriflunomide (Aubagio), a marketed multiple sclerosis treatment.

Germany-based Medigene AG continued to progress its pipeline of cellular immunotherapies for cancer in the first half year of 2020 with the launch of a Phase 1 trial of a candidate product for patients suffering from relapsed blood cancers.