BioSpace Global Roundup, Oct. 24


Sofinnova Partners – Life sciences-focused venture capital firm based in Paris, closed its latest fund, Sofinnova Capital IX, oversubscribed at €333 million. The firm now has more than €2B under management with more than €1B raised in the last four years across its platform of life sciences funds. Sofinnova Capital IX will invest in the healthcare industry and more specifically in the biopharmaceutical and medical device sectors. Sofinnova Partners will seek to invest as a founding and lead investor in start-ups and corporate spin-offs, and focus on therapeutic, paradigm-shifting technologies and products alongside visionary entrepreneurs, the company said. Sofinnova Capital IX will invest about two-thirds of its funds in European companies, and one-third outside of Europe, primarily in North America.

Hutchison China MediTech (Chi-Med) -- Hutchison China MediTech Limited, better known as Chi-Med, published results from its Phase II VIKTORY trial in Cancer Discovery. The research article titled “Tumor Genomic Profiling Guides Patients with Metastatic Gastric Cancer to Targeted Treatment: The VIKTORY Umbrella Trial” details the VIKTORY study, which was designed to classify patients with metastatic gastric cancer based on clinical sequencing and focused on eight different biomarker groups, including MET amplification, to assign patients to one of the 10 associated clinical trials in second-line treatment. The trial studied savolitinib as a potential treatment. Of the 10 associated clinical trials under the VIKTORY umbrella, the highest objective response rate (ORR) was observed in the MET amplification savolitinib monotherapy trial, which reported an ORR of 50%. The researchers concluded that the savolitinib monotherapy trial also met the pre-specified 6-week progression-free survival rate, indicating that it is worthy of further exploration in the MET amplification subset of patients with gastric cancer.

Ilya Pharma – Sweden-based Ilya announced the first cohort in the Phase I trial for its lead candidate ILP100 has been treated. LP100 represents both a novel drug delivery technology and a novel investigational new product. It is also classified as an advanced therapy medicinal product by the EMA and as a low-risk candidate under the gene therapy umbrella by the U.S. Food and Drug Administration, the company said. The Phase I trial contains two parts, a single ascending dose part and a multi ascending dose part in a total of 36 healthy volunteers to be included.

SurgiMab – France-based SurgiMab recruited its first U.S. patient in its pivotal Phase III trial evaluating SGM-101, a novel fluorescent tumor-specific antibody, for the improvement of surgical outcomes in colorectal cancer patients. The randomized Phase III trial aims to enroll 300 colorectal cancer patients in 10 clinical centers in Europe and the United States. The trial will assess the safety and clinical benefit of using fluorescence-guided surgery (FGS) with SGM-101 as an intraoperative imaging agent to better identify cancer lesions during the surgical procedure. Patients are injected with 10mg of SGM-101 four days prior to the scheduled CRC surgical procedure. SGM-101 is a tumor-specific antibody conjugated to a dye that fluoresces under near-infra-red light. It selectively targets a marker on the cancer cell surface known as carcinoembryonic antigen, which is overexpressed by more than 95% of colorectal cancer cells. Preliminary clinical data from the Phase III trial is expected in 2020.

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BD – Sweden’s BD, Becton, Dickinson and Company, a global medtech company, launched BD Intevia 1mL two-step disposable autoinjector. The autoinjector is a two-step push-on-skin device that is designed to effectively and safely inject a variety of drugs of different viscosities up to 35cP and different fill volumes up to 1mL. The unique design of BD Intevia 1 mL enables the pharmaceutical industry to adopt it for a variety of drugs without customizing the system components.

Follicum – Sweden-based Follicum completed the supplementary toxicology studies that will form the basis of the forthcoming clinical study with the topical formulation of FOL-005, a subcutaneous medication. Preparations for the clinical trial are ongoing and the completed toxicology studies mark the achievement of an important milestone for the company. The company expects to be ready for the start of the clinical study in patients with alopecia in early 2020. In additional news, the company also secured a Eurostars grant to develop a peptide-based treatment for diabetes. It is hoped that the research will lay the pre-clinical groundwork necessary for a new drug candidate.

SSB – Sartorius Stedim Biotech, based in Germany, announced the launch of its new Sartocheck 5 plus filter integrity tester. Designed for use in downstream processing, the Sartocheck 5 plus integrity tester is the latest development in the established Sartocheck line. Sartocheck 5 Plus features the most advanced functions for ensuring maximum data integrity and compliance with future requirements of quality risk management, such as the upcoming Annex 1 of the European Medicines Agency, the company said. The new filter tester greatly improves the detectability of operator errors, improper test set-ups and out-of-tolerance environmental conditions. It is also more reliable and easier to use than ever before. With the Sartocheck 5 Plus, false passed and false failed test results are therefore relegated to the past, SSB said.

EOS Imaging – Paris-based EOS Imaging, which specialized in 2D/3D orthopedic medical imaging and software solutions for 3D anatomical modeling and surgical planning, announced the first patient cases performed with its hipEOS 3.0 surgical planning software delivered intraoperatively by its smart navigation system, Intellijoint HIP. The system helps to select and position implants for the best anatomical fit and optimizes range of motion based on each patient’s 3D anatomy.

LabTwin – Germany-based LabTwin GmbH forged a partnership with ABI-LAB, a life science incubator and accelerator that supports biotech, medtech and medical data startups. This partnership gives ABI-LAB resident companies access to LabTwin’s voice and AI-powered digital lab assistant. LabTwin allows scientists to access, capture and structure data at the point of experimentation. Furthermore, the digital assistant provides guidance to scientists in real-time and automates mundane tasks such as setting timers or reminders, and managing supply lists.  For life science startups that are often budget and time-constrained, it is critical to use tools like LabTwin to reduce error, improve efficiency, sort valuable data and make research more reproducible, the company said.

Immunovia – Sweden’s Immunovia provided an update on its rheumatoid arthritis pipeline project, IMMray. Immunovia said IMMray showed an accuracy of higher than 90% when diagnosing CCP negative rheumatoid arthritis patients, compared to healthy controls. To support its RA program, Immunovia entered into a collaboration with Leiden University Medical Center’s Rheumatology Department, one of Europe’s leading research centers on rheumatoid arthritis. The university will provide biobank samples for a retrospective study that will be used for the next step in developing Immunovia’s proprietary IMMray RA-d assay, Immunovia said. The goal is to test whether or not the IMMrayplatform can differentiate between RA patients, independent of being seropositive or seronegative, and other conditions with similar symptoms. The current standard, CCP diagnosing tests, cannot diagnose the seronegative patients, missing approximately 30% of the RA cases, the company added.

Shuwen Biotech– China-based Shuwen Biotech has been designated as an International Cooperation Base for Novel Biomarkers and Innovative Diagnostic Technologies by authorities in Zhejiang Province, China. The designation was based on the recognition of Shuwen’s capabilities, infrastructures and accomplishments in the development and commercialization of innovative medical diagnostic products through licensing and international collaborations.

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