BioSpace Global Roundup, Feb. 27
Sartorius – Germany-based Sartorius introduced BioPAT Spectro, a tool to be used with its ambr automated micro and mini bioreactor systems and with the single-use production bioreactors BIOSTAT STR. The new tool offers access to Raman spectroscopy analysis in high throughput process development, supporting faster Raman model building and accelerating scale-up into commercial manufacturing, the company said. Raman spectroscopy is non-invasive and can measure multiple analytes, making it suitable as a Process Analytical Technologies (PAT) method for process control and monitoring of cell cultures.
Shuwen Biotech – China’s Shuwen Biotech Co. Ltd. announced that PerkinElmer, Inc. will distribute Shuwen’s breakthrough diagnostic test for preeclampsia in over 100 countries around the globe, accounting for over 120 million pregnancies annually. Preeclampsia affects 2–8% of pregnancies worldwide and in places such as Latin America, it represents the number one cause of maternal death. Unfortunately, in the majority of cases, symptoms of preeclampsia are not noticeable until it has progressed. Shuwen's preeclampsia detection kit is a highly accurate, urine-based, non-invasive point-of-care test. Clinical testing has shown the test to be over 95% accurate in diagnosing preeclampsia in women who are admitted to hospitals, regardless of reason for admission, the company said.
ProBioGen AG – ProBioGen, based in Berlin, teamed up with ImmunOs Therapeutics AG in a manufacturing agreement for that company’s novel platform of multitasking biologics. ProBioGen will support ImmunOs in the development of their biologics using its recently launched DirectedLuck Transposase technology and conducting large scale GMP manufacturing. ImmunOs has a pipeline of novel agents in development.
Stilla Technologies -- Stilla Technologies, a provider of pioneering digital PCR (dPCR) solutions for high-precision genetic analyses that is based in Paris, announced it will be joining an initiative led by Yuzi Holdings and TusPark Science & Technology Service Group to donate two Naica Systems to City of Zhengzhou and City of Xinyang in China, to help them better detect the coronavirus and monitor its mutations. As part of the initiative, Cycloud/Apexbio, Stilla's distributors and business partners in China, will offer technical support, reagents and kits. Digital PCR is an alternative detection method known for its higher sensitivity, accuracy, resolution and tolerance, compared to standard quantitative PCR. The Naica System, the latest generation of digital PCR platforms developed by Stilla Technologies, combined with Cycloud/Apexbio's Covid-2019 detection kits, can provide fast, accurate and reliable DNA/RNA detection of the virus and its mutations, the company said.
Securecell – Switzerland-based Securecell announced a number of partnership deals to bolster its presence across Asia and the Middle East. The company partnered with Alit Life Science, Biofors Global and Danyel Biotech to build its market presence in China, Korea and Israel as a major step to further penetrate new markets. The company said its partners were selected based on their “strong connection and network” in those pharma markets. Initially, the new partners will focus on distributing Lucullus PIMS software solution which has been Securecell’s flagship product for many years, as well as Numera auto sampling and sample processing machine. In a second step, they will enrich their portfolio by adding Securecell’s new products tailored to improving perfusion cultures at the benchtop scale.
Mologic – The U.K.’s Mologic Ltd., a developer of lateral flow and rapid diagnostic technologies, launched an accelerated program with the Institut Pasteur de Dakar, Senegal to develop a low-cost, high-performance rapid diagnostic test for the Ebola virus. Mologic will apply ultra-sensitive lateral flow technology to lead product development and manufacture, with the Institut Pasteur de Dakar leading validation of the test in collaboration with the Institut National de Recherche en Biologie in Kinshasa. The test will be manufactured both in the U.K. and in Senegal. The new Ebola diagnostic test will detect the infection early in blood by embedding monoclonal antibodies against surface glycoproteins (GP) - one of the first detectable biomarkers of infection. By developing a simple test deployed at the point of need, the project aims to overcome the obstacles in case identification, logistics and sample transportation to a central qualified lab. This has potential to significantly improve response times and control of the epidemic through time critical contact tracing, community engagement, immunization and safe and dignified burial.
Abivax – Paris-based Abivax dosed its first patient in a U.S. Phase I/II clinical trial of ABX196 to treat patients with hepatocellular carcinoma (HCC), the most common form of liver cancer. The trial is assessing ABX196, an invariant Natural Killer T cell (iNKT) agonist combined with Bristol-Myers Squibb’s checkpoint inhibitor Opdivo (nivolumab). The objective of the trial is to generate initial data about the safety and tolerability of this novel combination treatment as well as data on its preliminary efficacy. Thus far, ABX196, both alone and in combination with a checkpoint inhibitor, showed a statistically highly significant therapeutic effect in reducing tumor growth as measured by MRI and increasing survival in mice with HCC, Abivax said. ABX196 is Abivax’s second promising drug candidate in clinical development. The company’s other asset, ABX464, is being developed in a Phase IIb trial in ulcerative colitis and a Phase IIa trial in rheumatoid arthritis. A Phase IIb study is also planned in Crohn’s disease for ABX464.