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
Mnemo Therapeutics | January 24, 2022
The journal Nature Medicine recently published a study in which researchers developed a novel receptor to enhance recognition of tumors by engineered T cells, addressing an underlying cause for relapsed tumors in patients after chimeric antigen receptor therapy. The study demonstrates high antigen sensitivity of HLA-independent T-cell receptors, created by editing the TCR Alpha Constant chain locus in human peripheralbio blood Tcells.
Low antigen expression
One major limitation of CARs is antigen escape, when a tumor no longer expresses the antigen detectable by the CARs or expresses them at a very low level; CARs with heightened sensitivity to low-expression level antigens boosts the efficacy of otherwise promising T-cell therapies.
In the study, conducted by researchers at New York's Memorial Sloan Kettering Cancer Center, researchers produced HIT T-cells and analyzed them in animal models
HIT T-cells were engineered from human peripheral blood T-cells by inserting variable region genes in the TRAC locus, endowing the cell with a single specificity for a target antigen such as CD19. Notably, this sensitivity was shown to be higher than traditional CARs for low levels of antigen expression resulting in superior cytotoxicity and cytokine secretion.
HIT Tcells outperformed traditional CAR T-cells in vivo in mouse models of B cell leukemia and acute myeloid leukemia, without costimulation. Coexpression of HIT with CD80 and 4-1BBL further augmented therapeutic activity and mouse survival.
HIT T-cells are a promising therapy for targeting cancer cell surface antigens with low abundance due to their sensitivity and persistence.
The team responsible for this important work includes MSKCC researcher and Mnemo Therapeutics scientific cofounder Michel Sadelain, M.D., Ph.D., MSKCC researcher and Mnemo scientific advisor Isabelle Rivière, Ph.D., as well as Justin Eyquem, Ph.D., University of California San Franciso and Mnemo scientific cofounder.
Mnemo's EnfiniT Platform
These findings support Mnemo's EnfiniT platform as the next-generation toolkit for CAR-T immunotherapies, which are founded on decades of breakthrough research from Institut Curie and MSKCC, and supported with best-in-class T-cell manufacturing. The EnfiniT platform brings together a suite of technologies to address the key challenges associated with CAR T therapies by both identifying a new class of antigens with greater tumor specificity and applying a range of technologies to significantly improve T-cell memory, persistence and sensitivity. The goal is to dramatically improve the body's ability to fight and overcome disease.
About Mnemo Therapeutics
Mnemo Therapeutics is a biotechnology company focused on the development of powerful new cell therapies. With its EnfiniT platform, Mnemo applies a novel, integrated approach to T-cell therapy to transform the body's immune response to overcome disease. Mnemo is headquartered in Paris with an office in New York City, and it maintains state of the art laboratories in Paris, New York, and Princeton, New Jersey. The company leverages an international talent pool and global resources in its quest to create accessible cures for all patients in need.
The Bracken Group | October 11, 2021
Three unique companies with shared origins have now united to better serve their clients in the life sciences industry. The new entity will be known as The Bracken Group (Bracken) with three divisions of the original three companies.
The combined companies' mission continues to be supporting the success of companies that improve health, using an integrated network of clients, consultants, and employees across the globe.
I am delighted to bring the companies together under the one outstanding leadership team which further improves the services we provide to our clients. The benefits of the synergy that comes from a closer inter-team relationship will be apparent as the cross communication will be immediate.
- Dr Colin G. Miller, CEO of The Bracken Group
Bracken has been specializing across the life sciences and digital health arenas since inception, This highly regulated life science industry includes high stakes and complex processes. We have created and continue to cultivate an integrated platform to help organizations in this industry succeed.
- Elliot Miller, Chief Growth Officer.
About Bracken Data
Bracken Data was founded in 2016 to improve how the industry can use public clinical trial data. Bracken Data offers a suite of clinical trial dashboard products, and custom data science and analytics services. For more information, please visit BrackenData.com.
About Bracken Marketing
Bracken Marketing was founded in 2017 to support the success of digital health and life science teams through marketing services, and custom marketing programs. Services include website design, content development, advertising, sales collateral production, and multi-media production.
About The Bracken Group
The Bracken Group, founded in 2018, provides highly experienced consultative support for the development of products that are designed to improve life, in an ethical manner, underpinned with integrity and quality. Bracken offers biopharmaceutical consulting in the development of drugs, biologics, and medical devices, as well as in the use of medical imaging in clinical trials. Clients leverage The Bracken Group's team of executive consultants across a range of specialties through Virtual C-Suite services and related offerings.