Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.
Sweden-based Cyxone announced that topline results from its Phase II study of rabeximod in Covid-19 patients with moderate disease failed to demonstrate a statistical significance from placebo.
While the topline data analysis showed that almost all patients in the study were alive and free of respiratory failure after 28 days, there was no statistical significance observed at the time. As a result, the company was unable to assess whether or not Rabeximod provides additional benefits over standard of care in COVID-19 patients at day 28
The Phase II Covid-19 study included 92 patients. The intended inclusion criteria were patients diagnosed with Covid-19 who exhibited moderate symptoms. The patients were randomized to three arms, receiving a 15 mg or 30 mg dose of Rabeximod or placebo. The top line data analysis showed that 100% of the patients in the 30 mg arm were “alive and free of respiratory failure” 28 days following start of treatment. The corresponding proportions of patients in the 15 mg arm and in the placebo arms were 97% and 97%, respectively, the company said.
Secondary and exploratory endpoints will continue to be analyzed to assess benefit of Rabeximod in Covid-19. Notably, no serious adverse events connected to Rabeximod treatment were observed and the drug candidate was well-tolerated in infected patients. Cyxone continues its preparations for the phase IIb study of Rabeximod in the treatment of rheumatoid arthritis.
Elsewhere around the globe:
ITM – Germany’s Isotope Technologies Munich SE and Navigo Proteins GmbH, also of Germany, announced a research collaboration for the development of a fibroblast activation protein (FAP)-targeted radiopharmaceutical program for the treatment of solid tumors. FAP-Targeted Radionuclide Therapy is a promising new approach to treating cancer within the precision oncology field. Under the terms of the agreement, Navigo’s proprietary protein engineering platform will be used to develop and select a FAP-targeting Affilin molecule which will then be coupled with a therapeutic radioisotope provided by ITM. FAP is detectable in most epithelial cancers, including over 90% of breast, lung, colorectal and pancreatic carcinomas. The therapeutic candidate developed together by ITM and Navigo will enable a direct attack against tumor cells by irradiating them via crossfire effects in a highly precise manner, the companies said.
Sixfold Bioscience – Based in London, Sixfold announced it raised $10.5 million (£7.8 million) in seed funding. The funding will support the continued development of the Company’s Mergo RNA therapeutics delivery platform.
InteRNA Technologies – Netherlands-based InteRNA was cleared by the U.S. Food and Drug Administration to initiate a Phase I study assessing its lead miRNA candidate, INT-1B3, in patients with advanced solid tumors. INT-1B3 is a lipid nanoparticle (LNP) formulated, chemically modified mimic of the endogenous tumor suppressor, miR-193a-3p, and represents a promising novel therapeutic approach that is designed to simultaneously address multiple hallmarks of cancer. The open-label, multiple ascending dose Phase I/Ib trial will investigate the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of INT-1B3 in patients with advanced solid tumors. The study is expected to enroll a total of up to 80 patients at up to 15 clinical centers in the United States and Europe. Topline results from the Phase Ia part of the study are expected in the first half of 2022.
Principal Technologies – Investment firm Principal Technologies launched in Vancouver this week. The new firm is building a diverse portfolio of investments in global healthcare technology companies. The Company’s first investment saw it take a majority stake in E&E CRO Consulting, which is a specialized clinical research organization that supports healthcare technology companies with the planning and execution of clinical studies required for obtaining international distribution permits.
Pephexia Therapeutics – Based in Denmark, Pephexia secured €400,000 (about $450,000) to support research into the wasting disease cachexia. The financing is expected to enable the company to advance its innovative peptide projects for the treatment of cachexia. The company is on track to identify and characterize a lead candidate within a time frame of 12-18 months from now.
Mesoblast Limited – Australia-based Mesoblast announced new analyses from the landmark DREAM-HF Phase III trial showing that the greatest treatment benefit from rexlemestrocel-L is in HFrEF patients with diabetes and/or ischemia, who are at high-risk of cardiovascular mortality, heart attacks or strokes. Data showed that a single rexlemestrocel-L dose on top of maximal standard of care therapies reduced the composite 3-point MACE in all 537 patients by 33% over 30 months. Compared to control patients, rexlemestrocel-L reduced the incidence of 3-point MACE by 37% overall. In recent guidance to Mesoblast, the FDA confirmed that reduction in incidence of cardiovascular mortality or irreversible morbidity is a clinically meaningful endpoint in patients with chronic HFrEF. The agency encouraged Mesoblast to identify the highest-risk group with greatest likelihood of beneficial response to intervention with rexlemestrocel-L in trial.
Metrion Biosciences – Metrion, based in the U.K., has expanded its capabilities and expertise through the addition of automated low volume liquid handling capability and 384-well electrophysiology and fluorescence-based high throughput screening (HTS) assay systems. Metrion’s enhanced ion channel drug discovery service capabilities will include the introduction of additional automated low volume liquid handling capabilities, 384-well electrophysiology and fluorescence-based high HTS assay systems.
Vetter – Germany’s Vetter, a leading European contract development and manufacturing organization, was awarded the Frost & Sullivan’s 2021 Global Customer Value Leadership Award in the aseptic fill & finish market. Vetter was recognized for providing high customer value, in particular, the company’s best practices in collaboration with global customers. Additionally, the awarding committee further acknowledged the CDMO for the significant role it plays in the success of its clients by providing crucial support from the early development phase of drugs through regulatory approval and market supply worldwide.
Elypta – Sweden’s Elypta enrolled its first patient in the AURORAX-0093A study, which will assess Elypta’s metabolism-based liquid biopsy platform for the prognosis of muscle-invasive bladder cancer (MIBC) before neo-adjuvant chemotherapy. The first patient was enrolled at San Raffaele Hospital, Milan, Italy. AUR93A recruitment is ongoing and the study is slated for completion in 2023.
FUJIFILM Irvine Scientific – Fujifilm opened a new manufacturing facility in the Netherlands to increase global production of cell culture media products.
SOTIO Biotech – Switzerland-based SOTIO entered into a collaboration with Merck to assess the combination of SOT101, SOTIO’s IL-15 superagonist and Keytruda, a checkpoint inhibitor. The combination will be studied in a Phase II study in patients with selected advanced/refractory solid tumors. The study will enroll patients in the U.S. and selected European countries across six different indications, including second line non-small cell lung cancer, first and second line cutaneous squamous cell carcinoma, first line microsatellite instability-high colorectal cancer, second line hepatocellular carcinoma, first line metastatic castration-resistant prostate cancer, and second line ovarian cancer.
EEL Transcriptomics AB – Sweden’s EEL and its intellectual property for assay assets was acquired by Rebus Biosystems. Terms of the deal are not being disclosed.
