News

Trial of Galderma skin treatment in NEJM

Country
Switzerland

Results from a Phase 2 study of a new treatment for the chronic skin condition, prurigo nodularis, showed that the antibody performed better on a pruritus rating scale than placebo and also delivered clear or nearly clear skin for over one third of participants. Results of the trial were published in the New England Journal of Medicine on 20 February.

Cancer vaccine passes futility analysis

Country
Denmark

An experimental therapeutic cancer vaccine with a dual mode of action has passed its first clinical hurdle and will continue to be investigated as a first-line therapy in patients with metastatic non-small cell lung cancer (NSCLC). The vaccine, IO102 is being developed by IO Biotech ApS of Denmark in combination with Keytruda. An interim Phase 2 analysis, designed as a futility analysis, showed that the vaccine delivered an objective response rate that was substantially higher than Keytruda monotherapy had done in patients with a similar profile.

Thermo Fisher to acquire Qiagen

Country
United States

Thermo Fisher Scientific Inc is to acquire Qiagen NV of the Netherlands, significantly expanding its service offering to the global life sciences industry. The transaction values Qiagen at approximately $11.5 billion, which includes the assumption of Qiagen’s $1.4 billion in net debt. The offer price of €39 per share represents a premium of about 23% to the closing price of Qiagen’s shares on the Frankfurt Stock Exchange on 2 March.

Venclexta misses endpoint in AML trial

Country
United States

A Phase 3 trial designed to generate a new cancer indication for Venclexta (venetoclax) failed to meet its primary endpoint of a statistically significant improvement in overall survival in acute myeloid leukaemia, AbbVie Inc announced on 28 February. Venclexta is being jointly developed with Roche and already has been approved in four cancer indications. The newest trial compared Venclexta in combination with the chemotherapy cytarabine against a combination of cytarabine and placebo. Patients in the trial had AML and were ineligible for intensive chemotherapy.

Gilead starts trials of candidate antiviral for COVID-19

Country
United States

Gilead Sciences Inc has launched two Phase 3 studies of an experimental nucleotide analog to treat adults diagnosed with infection from the COVID-19 coronavirus. The studies will assess two dosing durations of the drug remdesivir, administered intravenously. They follow the US Food and Drug Administration decision to accept Gilead’s clinical trial application.

Remdesivir has been tested in humans with Ebola virus disease and in animal models for Middle East respiratory syndrome and severe acute respiratory syndrome, which are caused by other coronaviruses.

EU risk assessment for the coronavirus

Country
Belgium

Public health and border control officials at the European Commission currently believe that the risk of imminent transmission of the COVID-19 coronavirus across the EU is low to moderate – even as the virus continues to infect increasing numbers of people in Italy.

According to the BBC, the number of cases in Italy reached 400 on 26 February, up by 25% in just 24 hours. To date, there have been 12 fatalities.

Bicycle runs with Genentech

Country
United Kingdom

Bicycle Therapeutics Plc has entered into a collaboration with Genentech, a member of the Roche Group, to develop new therapies for cancer using its short peptide technology. The deal is potentially valued at up to $1.7 billion, giving the 11-year old company significant new resources to develop its technology. The company’s scientific founders are Gregory Winter, who invented a technique for humanising mouse monoclonal antibodies, and Christian Heinis, a researcher in the field of peptide therapeutics.

New indication for Trulicity

Country
United States

The Type 2 diabetes medicine Trulicity (dulaglutide) has been approved in the US to treat adults with diabetes who have cardiovascular disease or are at risk of the disease. The makes Trulicity, first approved in 2014, the only Type 2 diabetes medicine that can also be used to reduce the risk of major adverse cardiovascular events.

Positive data in cell therapy trial

Country
United Kingdom

Positive long-term data have been reported for a cell therapy being tested in patients with retinitis pigmentosa, a group of hereditary diseases of the eye that can lead to a progressive loss of vision and blindness. Results from the ongoing US Phase 1/2a study of the human retinal progenitor cell therapy showed a meaningful clinical effect at all points in time out to 12 months after treatment.

Mode of action of septic shock treatment confirmed

Country
Germany

The mode of action of an experimental treatment for septic shock has been confirmed in a Phase 2 study, paving the way for further development of the therapy in patients with an early stage of the disease. Septic shock is a life-threatening organ dysfunction caused by the body’s response to infection. The trial, AdrenOSS-2, enrolled 301 patients who were identified by a novel biomarker as having early septic shock and elevated blood levels of the peptide hormone adrenomedullin. They were treated with the monoclonal antibody adrecizumab.