Interim results from a Phase 3 trial of a respiratory syncytial virus (RSV) vaccine candidate for older adults have shown the treatment to be effective with no unexpected safety concerns, the developer GlaxoSmithKline Plc announced on 10 June. The vaccine contains a recombinant subunit prefusion RSV F glycoprotein antigen combined with an adjuvant. The adjuvant, AS01, is proprietary to GSK and is used with several of the company’s other products.
A Phase 2 trial of a small molecule treatment for ulcerative colitis failed to meet its primary endpoint of clinical remission in patients due to an apparent treatment interference from corticosteroids, according to the developer Immunic Inc. The treatment, vidofludimus calcium, was being compared with placebo in patients with moderate-to-severe disease.
A peptide vaccine intended to prevent disease progression in patients with prostate cancer failed to show efficacy in a Phase 2b study despite promising data earlier in its development. The vaccine, RV001 (onilcamotide) was developed by RhoVac AB of Sweden which announced the study results on 30 May.
Nektar Therapeutics Inc and Bristol Myers Squibb Co have stopped the global programme for a jointly developed cancer therapy following the failure of two clinical trials. The therapy combined bempegaldesleukin, an experimental interleukin-2 cytokine prodrug, with the checkpoint inhibitor Opdivo (nivolumab). A Phase 3 trial of the combination therapy in patients with previously untreated, metastatic renal cell carcinoma failed to reach statistical significance on the measure of objective response rate, according to the trial’s independent data monitoring committee.
A synthetic peptide being developed by Bicycle Therapeutics Plc of the UK has shown promising results in a Phase 1/2 study of patients with urothelial carcinoma. The drug, BT8009, is a synthetic short peptide which is being developed for advanced solid tumours associated with Nectin-4 expression. Results for eight out of 34 patients from the study were reported at the annual meeting of the American Association for Cancer Research in April.
An antibody construct developed by Affimed NV of Germany has generated objective responses from a small group of lymphoma patients – all of whom had exhausted all available treatment options. The Phase 1/2 investigator-led study is being conducted at the University of Texas MD Anderson Cancer Center in the US. Updated clinical data were presented at the annual meeting of the American Association for Cancer Research in April.
The Roche Group has disclosed data from a one-year analysis of an open-label Phase 3b trial of its multiple sclerosis treatment Ocrevus (ocrelizumab), a monoclonal antibody targeting CD20-positive B cells, a specific type of immune cell thought to contribute to myelin and nerve cell damage in the disease. The results showed that 75% of Ocrevus-treated patients with secondary progressive multiple sclerosis and primary progressive multiple sclerosis showed no evidence of disease progression. Moreover, 70% of these patients demonstrated stable or improved cognition after one year.
A Phase 3 trial of a potential first line therapy for a type of small cell lung cancer which has spread to other parts of the body, failed to meet its co-primary endpoint of progression free survival, the developer Roche announced on 30 March.
The trial was testing tiragolumab, an antibody targeting the immune checkpoint TIGIT, together with Tecentriq (atezolizumab) and chemotherapy. The combination therapy was compared with Tecentriq and chemotherapy alone in 490 people with extensive-stage small cell lung cancer.
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.