Clinical Research

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.

Bluebird bio Inc announced on 16 February the temporary suspension of two gene therapy trials following reports of two cases of cancer. The trials were being conducted in support of a prospective gene therapy for sickle cell disease. The company is investigating the cause of the cancers in order to determine if there is any relationship with the lentiviral vector used in the studies.

A vaccine developed by Russia to prevent coronavirus disease has been shown to be 91.6% effective, according to data from a Phase 3 trial published in The Lancet on 2 February 2021. The vaccine, Gam-COVID-Vac (Sputnik V), is a combined vector vaccine carrying the gene for the SARS-CoV-2 full length glycoprotein S. It is intended to elicit antibodies to the virus glycoprotein as well as antigen-specific cellular immunity.

A primary analysis of trial data from a vaccine being developed by AstraZeneca Plc and Oxford University shows that the product is safe and effective at preventing Covid-19 with no severe cases of the disease or hospitalisations more than 22 days after the first dose. The data were contained in a preprint edition of The Lancet which was issued on 3 February 2021.

Verona Pharma Plc has reported further positive data for its drug ensifentrine for patients with chronic obstructive pulmonary disease (COPD). In a Phase 2 trial of patients with moderate to severe disease, the drug achieved a statistically significant and clinically meaningful increase in lung function compared with a placebo. The trial was evaluating ensifentrine in a pressurised metered-dose inhaler formulation.

A Phase 3 trial designed to find out if adding ipilimumab (Yervoy) to Keytruda would improve the outlook for patients with non-small cell lung cancer has failed. As a result, Keytruda (pembrolizumab) monotherapy is still the better option for treating the disease, according to Merck & Co Inc.

Johnson & Johnson Inc said that its single-shot vaccine against Covid-19 was 66% effective in preventing moderate to severe disease following a Phase 3 trial that included participants from the US, South Africa and countries in Latin America.

Novavax Inc has reported that its protein-based Covid-19 vaccine achieved an efficacy rate of 89.3% in a Phase 3 trial conducted in the UK, even as a new strain of the virus was circulating in that country. Meanwhile, a separate Phase 2b study of the same vaccine achieved a 60% efficacy rate in South Africa in a study population that was HIV-negative. For the overall trial population, including those with and without HIV, the efficacy rate was 49.4%.

The German vaccine producer CureVac NV has announced the pricing of a follow-on share issue on Nasdaq giving total gross proceeds of $450 million. This comes five months after the company, which is developing a messenger RNA (mRNA) vaccine for Covid-19, raised $245.3 million in an initial public offering. In the latest financing, CureVac issued five million common shares at a price of $90 per share.

An oncology drug developed by PharmaMar SA of Spain has shown potent antiviral activity against SARS-CoV-2 in both laboratory and animal experiments, suggesting promise as a candidate for treating Covid-19, according to an article in Science on 25 January 2021. The drug, plitidepsin (Aplidin) is an anticancer agent of marine origin.

It was approved for the treatment of multiple myeloma in Australia in December 2018 and holds orphan drug designations in both the US and the EU.