Bio-Techne Corporation | April 13, 2022
Bio-Techne Corporation launched 3G assay for automated process impurity assessment on the EllaTM immunoassay platform ( NASDAQ: TECH ) and Cygnus Technologies, a division of Maravai LifeSciences ( NASDAQ: MRVI ).
In cell and gene therapy applications, the purification of viral particles to reduce host cell protein (HCP) contamination is an important part of the viral production workflow. To guarantee HCP impurity clearance is performed in compliance with regulatory criteria, accurate quantification throughout process phases is required.
The novel Simple Plex HEK 293 HCP 3G test uses a cartridge-based microfluidic design to deliver uniform and controlled assay conditions for HCP detection that is extremely accurate and reproducible. The test has a hands-free procedure and provides data in 90 minutes, providing pharmaceutical developers with a reliable and convenient tool for HCP impurity quantification. Simple Plex assays on the Ella platform, classic immunoassay methods, provide built-in calibration to reduce set-up time and user-dependent variability.
The gold standard in HEK 293 HCP impurity quantification is Cygnus Technologies' HEK 293 HCP ELISA Kit, 3G. With high-tech antibody affinity extraction and heavy spectrometry procedures, the kit's antibody was tested for reactivity to almost 3,000 distinct HCPs present in HEK 293 strains. The kit has been tested with various viral vector-based medicinal compounds and in-process samples, demonstrating that it possesses the specificity and sensitivity to detect HEK 293 HCP contaminants with the reproducibility needed to meet regulatory requirements. The Simple Plex HEK 293 HCP 3G assay uses the same HEK 293 HCP antibodies from market leader Cygnus Technologies, ensuring the Cygnus ELISA's extensive HCP detection coverage and industry-recognized specificity, as well as the automated Ella platform's workflow advantages.
We continue to enjoy the fruits of the Bio-Techne-Cygnus Technologies partnership as it provides the therapeutic development and manufacturing community an automated platform-based approach for HEK 293 host cell impurity testing, Fast and efficient process development and monitoring is crucial for biopharmaceutical companies providing a safe and efficacious product in a cost-effective manner."
Will Geist, President of Bio-Techne's Protein Sciences Segment.
Genelux Corporation | September 29, 2021
Genelux Corporation, a clinical-stage immunotherapy company, and Newsoara BioPharma Co., Ltd., announced a collaboration and exclusive license for the development and commercialization of Olvi-Vec and other oncolytic viruses.
According to the terms of the agreement, Newsoara shall have exclusive rights in Greater China (mainland China, Hong Kong, Macau and Taiwan) to Olvi-Vec for which Genelux currently is planning a U.S. based Phase 3 registration trial in platinum resistant/refractory ovarian cancer. Newsoara also shall have exclusive rights in Greater China to Genelux's proprietary oncolytic virus platform, and the parties will collaborate on the development of novel oncolytic immunotherapeutics.
Newsoara, at its cost and expense, will be responsible for development and commercialization and will have the future right to manufacture licensed products in Greater China. The parties also will collaborate on a Phase 2 clinical trial for the intravenous delivery of Olvi-Vec in a new indication using clinical sites in China and the U.S. Newsoara will be responsible for all trial costs.
Under terms of the agreement, Genelux will receive up-front and near-term payments totaling $11 million and will be eligible to receive additional per-product payments of up to $160.5 million, contingent on certain development, regulatory and commercial milestones, plus tiered royalties on net sales ranging from mid-single-digit to mid-double-digit percentages. Genelux shall have an exclusive license outside of Greater China to oncolytic virus products derived by Newsoara and will pay Newsoara milestones and royalties on sales of any such products which Genelux elects to develop.
We are delighted to be working with Newsoara on developing Olvi-Vec, as well as on our broader collaboration. It is a dynamic organization with a commitment to advancing cutting-edge therapeutics, whose strength in research, development and manufacturing in China is a perfect complement to our focus on the discovery and clinical development of novel virotherapies. Together we look forward to accelerating the development of Olvi-Vec and to strengthening and broadening our pipeline of next-generation oncolytic viral immunotherapies.
- Thomas Zindrick, J.D., President and CEO of Genelux.
About Olvimulogene Nanivacirepvec (Olvi-Vec)
Olvi-Vec is a proprietary, non-pathogenic oncolytic vaccinia virus, modified to increase its safety, tumor selectivity and therapeutic potential. Virus-mediated oncolysis results in immunogenic cell death and triggers immune activation and memory for long-term immunotherapy against cancer. Olvi-Vec has been administered to more than 150 patients in clinical studies. In these studies, Olvi-Vec was generally well tolerated and the data provided evidence of clinical benefit.
Newsoara is a clinical-stage biopharmaceutical company with the mission to develop and commercialize life changing medicines for the treatment of patients with cancer, autoimmune, metabolic and other major diseases in China and around the world. With fully integrated drug discovery, CMC and clinical development capabilities, Newsoara has built a robust and broad pipeline for treating major diseases with unmet needs. Newsoara has assembled a world-class management team with extensive experience in novel drug development that is motivated to improve and impact human health worldwide.
About Genelux Corporation
Genelux is a clinical-stage biopharmaceutical company focused on developing a pipeline of next-generation oncolytic immunotherapies for patients suffering from aggressive and/or difficult-to-treat solid tumor types. The Company's most advanced product candidate, Olvi-Vec (olvimulogene nanivacirepvec), is a proprietary, modified strain of the vaccinia virus (VACV), a stable DNA virus with a large engineering capacity. The core of Genelux's discovery and development efforts revolves around the company's proprietary CHOICE™ platform from which the Company has developed an extensive library of isolated and engineered oncolytic vaccinia virus immunotherapeutic product candidates, including Olvi-Vec.
CELL AND GENE THERAPY
Discovery Life Sciences | October 28, 2020
Discovery Life Sciences™ (Discovery), a global leader in biospecimen, genomic sequencing, cell, and immunohistochemistry (IHC) services, announces the launch of GMP-compliant Discovery Leukopaks™ and other cell-based products for use in human cell and gene therapy research, development and manufacturing programs. Cell and gene therapies have revolutionized treatment approaches to cancer and other complex diseases. Acceleration of the manufacturing and development of these novel therapies requires fast and reliable access to high quality, well-characterized human cellular raw materials. Discovery's reputation for speed and quality will be a boon to researchers around the globe. Discovery's launch of GMP-compliant Discovery Leukopaks and derivatives adds to Discovery's existing RUO (research-use-only) fresh and cryopreserved leukopaks and isolated immune cell populations. Discovery's next-generation short and long read sequencing and flow cytometry services can be incorporated to provide highly characterized, reliable human cellular materials for research, development, and GMP manufacturing.