BioSpace Global Roundup, Dec. 26


Sartorius – Germany-based Sartorius and the German Research Center (DFKI) for Artificial Intelligence established the Sartorius AI Lab (SAIL) research laboratory to further develop products and platform solutions. SAIL is assigned to the DFKI research department of Smart Data & Knowledge Services and uses DFKI's deep learning hardware and expertise, which is unique throughout Europe. As a protected data room and independent data laboratory, SAIL is also open to Sartorius partners and customers as part of cooperation agreements, and the first projects have already been initiated. In addition, Sartorius and DFKI will use SAIL for training purposes, and DFKI employees will also be able to further their education in life science applications at Sartorius research sites. Sartorius and DFKI intend to develop and employ machine learning and image and pattern recognition processes, among other technologies, for life science applications. For example, their researchers are working on new deep learning algorithms and methods for image recognition of cells and organoids, analysis and modeling of biological systems and for simulation and optimization of biopharmaceutical production processes. Sartorius provides extensive data for this purpose and sends specialists from its Corporate Research and Product Development units to SAIL.

Gedea Biotech – Sweden’s Gedea announced that all patients have been successfully recruited for the multi-center study evaluating the clinical performance of an antibiotic-free treatment for vaginal infections. Topline results are expected in the second quarter of 2020. This pilot study marks the start of a clinical development program of a treatment with dual effect, targeting both vaginal bacterial and fungal infections. The study will be followed by a proof of concept study to be initiated next year. The open-label single-armed, multi-center study has been designed to evaluate clinical performance, tolerability, and safety of the local treatment in 24 adult women with vulvovaginal candidiasis (VVC). Gedea has in addition a treatment for bacterial vaginosis in late product development stage.

Immunovia – Diagnostic company Immunovia, which is based in Sweden, announced its Commercial Test Model study was successful, showing a 95% accuracy, and the company is on track for commercialization of the IMMray PanCan-d commercial biomarker signature. The study was performed in order to finalize the IMMray PanCan-d commercial biomarker signature and to validate its accuracy in differentiating PDAC (pancreatic ductal adenocarcinoma) stages I through IV vs. controls that best mirror the clinical, commercial setting situation i.e patients with non-specific but concerning symptoms, including type II diabetics as well as healthy individuals.

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Aglai Oncology Funds – Netherlands-based Aglaia, a life sciences investors, launched its “Life Sciences Impact Suite,” a groundbreaking tool enabling measurement and reporting of the social impact realized by investments, alongside financial performance. The suite was developed as a means to accelerate the impact movement and to challenge the Fund industry to demonstrate value beyond financial profits.

Thirona – Holland-based Thirona developed innovative software to screen people for tuberculosis even in the most remote of areas. CAD4TB is the most validated and widely used artificial intelligence solution for TB-detection worldwide. Every day, it is used to screen 7.000 people for this disease that kills 1.6 million people a year – that is more than die from AIDS and malaria combined.

SiSaf – London-based SiSaf Ltd. entered into a strategic collaboration with Avellino Labs USA, Inc., a leader in precision medicine, to co-develop topical gene therapies for Corneal Dystrophies resulting from mutations in the TGFβI gene. The collaboration brings together Avellino’s expertise in gene-based diagnostics and therapeutics for eye diseases and SiSaf’s groundbreaking non-viral delivery technology. Under the terms of the agreement, SiSaf Ltd and Avellino Labs USA, Inc., will co-develop topical non-viral gene therapies that deliver small interfering RNA (siRNA) molecules to the cornea to periodically block the production of mutant TGFβI protein, as well as gene therapies that utilize CRISPR gene editing technologies to permanently correct mutations in the TGFβI gene at the DNA level.

Poxel – France’s POXEL SA and its development partner, Sumitomo Dainippon Pharma Co., Ltd. of Japan, announced positive topline results from TIMES 2, a Phase III trial evaluating Imeglimin in combination with approved hypoglycemic therapies, and as a monotherapy, for the treatment of type 2 diabetes in Japan.

Pioneer Project -- The Pioneer Project, a major international Hospital-University Research (RHU) project that addresses the critical challenge of resistance to PD1(L1) inhibitors, today announced that a first patient has been included in its umbrella clinical trial designed to evaluate efficacy and safety of four original ICI combinations in patients with PD1(L1) inhibitor-resistant advanced non-small-cell lung cancer. Checkpoint inhibitors have led to a significant lengthening of life expectancy in about 20% of NSCLC patients, and yet, lung cancer remains the leading cause of cancer deaths worldwide as most patients are or become resistant to these treatments. The Pioneer Project has designed an unprecedented multiparametric approach that should allow to better understand, predict and obviously overcome these resistances.

Isofol Medical AB – Sweden’s Isofol announced approval of a patent in Japan covering the Active Pharmaceutical Ingredient (API), arfolitixorin hemisulfate. The patent is valid until 2034. Arfolitixorin is currently being studied in the ongoing global Phase III study AGENT in patients with metastatic colorectal cancer, including sites in Japan.

Hutchison China MediTech (Chi-Med) -- Hutchison China MediTech Limited, better known as London’s Chi-Med, received priority review from China’s National Medical Products Administration for surufatinib for the treatment of patients with advanced non-pancreatic neuroendocrine tumors (NET). In November, the NDA for surufatinib for the treatment of non-pancreatic NET was accepted for review by the NMPA, and the U.S. Food and Drug Administration granted Orphan Drug designation to surufatinib for the treatment of pancreatic NET.

Juvisé Pharmaceuticals – France-based Juvisé acquired two oncology products from AstraZeneca. The products are Arimidex (anastrozole) and Casodex (bicalutamide) and can be marketed in 40 European, African and other countries. With this acquisition, Juvisé Pharmaceuticals enters the oncology therapeutic area, in which the company wants to further expand and consolidates its fast-growing ambition.

CELLINK -- To meet rising demand and incorporate its expanding product portfolio in the production line, Germany-based CELLINK has signed an agreement to extend its business operations into new premises where all production efforts will take place. The new space is located in Gothenburg close to the CELLINK headquarters. Beginning in January 2020, the size of the company’s space will increase from 300 to 1900 square meters. This significant expansion will enable the company to increase its production capacity.

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