Orion Corp has decided to concentrate future research on the development of new treatments for cancer and pain and discontinue work in neurodegeneration and rare diseases. The decision, announced on 24 March, comes as the Finnish company and its partner Bayer AG make regulatory applications in the US and EU for a new indication for Orion’s prostate cancer drug Nubeqa (darolutamide).
Germany-based ITM Isotope Technologies Munich SE has secured an equity investment of €33 million from two financial groups in order to advance a radiopharmaceutical for the treatment of gastroenteropancreatic neuroendocrine tumours, also known as islet cell tumours. The latest financing comes on top of an earlier €25 million investment, bringing the total sums raised by the company for product development up to €58 million.
The two newest investors are Indigenous Critical Infrastructure Fund Canada and a private equity group managed by Portland Investment Counsel Inc.
An allogeneic cell therapy has been successfully used to treat patients 10 years and older with Duchenne muscular dystrophy, a rare genetic disease that affects both skeletal and cardiac muscle. The therapy, CAP-1002, was tested in a Phase 2, placebo-controlled trial and effectively reduced the deterioration of upper limb function in the patients as well as improved cardiac function. The results of the study, called HOPE-2, were published in The Lancet on 12 March 2022.
The European Medicines Agency is studying the T cell immune response generated by the currently approved Covid-19 vaccines to find out whether anything can be learned for the future. In a briefing with journalists on 3 March, Marco Cavaleri, head of biological health threats and vaccines strategy, said the review covers all platforms represented by the currently approved vaccines. One of the objectives is to find out if the T cell component of immunity can offer protection against new variants of the virus.
The European Medicines Agency has proposed to extend the use of two messenger RNA (mRNA) vaccines for Covid-19 in order to give protection against the SARS-CoV-2 virus to younger people. In separate decisions, the agency is recommending that primary vaccination with Spikevax be approved for use in children from the ages of six to 11 years. Spikevax was developed by Moderna Inc. The agency is also proposing that Comirnaty, developed by BioNTech SE and Pfizer Inc, be authorised as a booster dose for adolescents from 12 years of age.
Data from a Phase 3 study of nirsevimab, a prospective treatment for respiratory syncytial virus (RSV) disease, showed an efficacy rate of 74.5% in infants entering their first season exposed to the virus, according to AstraZeneca Plc. The data were generated by the MELODY trial in which healthy late preterm and term infants were randomised to receive a single dose of nirsevimab or placebo. Altogether 1,490 infants were enrolled in the trial which was conducted across 21 countries. Nirsevimab is a long-acting antibody that is designed to protect infants with a single dose.
New data on a prospective vaccine for human papillomavirus type 16 (HPV-16)-induced cancers has demonstrated efficacy in combination with the checkpoint inhibitor nivolumab (Opdivo), ISA Pharmaceuticals BV announced on 1 March. The vaccine, ISA101b, consists of synthetic long peptides that are specific to the E6 and E7 proteins on the virus. These proteins play an important role in HPV-induced cancers.
Three Phase 3 studies in pregnant women of a candidate vaccine designed to prevent infection from the respiratory syncytial virus (RSV) have been stopped following a safety signal. The developer, GlaxoSmithKline Plc, announced a pause in the studies on 18 February and a halt 10 days later. The decision was based on an observation from the study’s independent data monitoring committee during a routine safety assessment. The safety observation wasn’t disclosed. Altogether, the three studies were scheduled to enrol 21,462 individuals, according to clinicaltrials.com.
A Phase 3 trial of Dupixent (dupilumab) in patients with chronic spontaneous urticaria has failed to meet its primary endpoints and is being stopped early, Sanofi SA announced on 18 February. Dupixent is a widely prescribed medicine for asthma and atopic dermatitis and is being investigated for a possible new indication in urticaria, a chronic inflammatory skin disease characterised by the sudden onset of hives.
Bayer AG has decided to discontinue development of the Phase 2 drug candidate, eliapixant, a P2X3 receptor antagonist that was being evaluated in endometriosis, refractory chronic cough, overactive bladder and diabetic neuropathic pain.
This is based on a review of data showing that the overall benefit no longer outweighs the risk in these indications. The drug was developed in collaboration with Evotec SE which will regain rights to the assets. Bayer announced its decision on 4 February 2022.
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