BioSpace Global Roundup, Sept. 19
Source BioScience – England-based Source BioScience, an international provider of integrated laboratory services and products, invested €585,000 in microbiology and sterility testing labs at its stability storage facility in Ireland. The investment expands the company’s current service offering at the site, adding a comprehensive suite of microbiology and sterility testing services with the aim of reducing turnaround times to allow more rapid feedback to customers and to minimize risk when storing samples. The new labs boast the latest equipment served by highly trained personnel combined with a robust compliance ethos. A full suite of competitively priced tests is offered including sample pick up, market-leading turnaround times and full reporting to meet customer’s requirements, the company said.
Versantis – Clinical-stage biotech company Versantis, based in Switzerland, announced the completion of an oversubscribed CHF (Swiss Franc) 16 million Series B financing round. The round was led by Swisscanto Invest by Zürcher Kantonalbank and was joined by Esperante Ventures. The proceeds from this new financing will be mainly used to assess the safety of VS-01, a multi-organ supporting therapy for liver cirrhosis, after multiple doses and establish its clinical proof of concept in the decompensated liver cirrhosis indication as well as in the rare Acute-on-Chronic Liver Failure patient population.
PPF – Czech Republic-based PPF snapped up a significant investment in Autolus Therapeutics plc, a company focused on T-cell therapies. PPF took a 19.2% stake in the company. The investment marked PPF’s second-largest investment in the healthcare sector, after PPF’s majority-owned biotechnology company SOTIO. Autolus Therapeutics is focused on the development of precisely targeted, controlled and highly active CAR-T cell products. The lead program AUTO1 is expected to enter a pivotal phase II study in patients with adult relapsed or refractory acute B lymphocytic leukemia later this year with an anticipated filing for marketing authorization in 2021.
Polyganics – Medtech company Polyganics, based in The Netherlands, announced positive data from its ENCASE I clinical trial, which was focused on evaluating the safety and performance of Liqoseal in reducing cerebrospinal fluid (CSF) leakage following elective cranial surgery. The three-month results of ENCASE I show the absence of CSF leakage as confirmed by MRI, no clinically significant swelling, and no device-related adverse events following surgeries that used Liqoseal for dural closure. Polyganics has submitted its filing for the CE Mark of Liqoseal based upon these positive data from the ENCASE I trial. Liqoseal is a dura sealant patch, developed using Polyganics’ proprietary bioresorbable polymer technology. The patch is indicated for use as an adjunct to standard methods of cranial dural repair to provide a watertight closure of the dura mater and reduce CSF leakage. In vivo studies show that Liqoseal also supports regeneration of the dura mater during the critical healing period, by acting as a scaffold for new fibrotic layer formation.
AlzProtect – France-based Alzprotect, a company focused on the treatment of Alzheimer’s disease, has been greenlit by French regulators to launch a phase IIa clinical trial with its drug candidate AZP2006 in Progressive Supranuclear Palsy (PSP), an orphan disease for which the company had already been granted the "orphan drug" status by the U.S. Food and Drug Administration and European Medicines Agency. The trial will aim to evaluate the tolerability of the product in PSP patients, to strengthen the pharmacokinetic data of the product in patients after three months of treatment and to evaluate the impact of the treatment on the disease's 20-plus biomarkers. This Phase IIa study should be completed by the end of 2020, and its first results will be published in 2021.
Poxel – France-based Poxel presented detailed Phase III results from its TIMES 1 program, which evaluated the efficacy, safety and tolerability of Imeglimin in Japanese patients with type 2 diabetes as well as data supporting the safety and efficacy of Imeglimin in various patient populations. The data was presented at the European Association for the Study of Diabetes meeting in Barcelona. Through improving mitochondrial function, Imeglimin has been observed to increase muscle insulin sensitivity and insulin secretion and decrease hepatic glucose production, all of which play a critical role in the treatment of type 2 diabetes. Full results of the Phase III trial are expected at the end of the year. Japan and all of Asia is considered an important area for diabetes treatments. A Japanese New Drug Application for Imeglimin is targeted for 2020, the company said.
Vetter – Germany-based Vetter, a contract development and manufacturing organization, announced that its U.S. clinical manufacturing facility located at the Illinois Science+Technology Park in Skokie has been named as one of “Chicago’s Best and Brightest Companies to Work For.” The award, sponsored by the National Association for Business Resources, recognizes companies that have distinguished themselves as having the most innovative and thoughtful human resources approach. The companies are evaluated on key measures in various categories, including compensation, benefits and employee solutions, work-life balance, diversity and inclusion and others.
OSE Immunotherapeutics – France-based OSE received a €5.4 million payment from Bpifrance that was triggered by the successful completion of development milestones related to its collaborative program EFFI-CLIN. This program is focused on evaluating BI 765063, a SIRPa-antagonist and myeloid checkpoint inhibitor. This first milestone of €5.4 million, as part of the EFFI-CLIN “Invest in the Future Program” was triggered by reaching several steps including initiation of studies characterizing the SIRPa/CD47 axis and determining preclinical efficacy, completion of regulatory preclinical toxicology studies, manufacturing of GMP compliant batches and development of a tool used to characterize the immune profile and biomarkers found in patients, the company said. BI 765063, previously known as OSE-172 is being developed in partnership with Boehringer Ingelheim. The asset is currently in Phase 1 testing in advanced solid tumors.