CELL AND GENE THERAPY
Sysmex Corporation | May 17, 2021
Sysmex Corporation and ThinkCyte, Inc. announced today the signing of joint development and investment agreements for the commercialization of an AI-based cell analysis technology in May 2021.
The development of novel testing and diagnostic technologies of high clinical utility is being pursued to improve the precision of diagnoses and maximize treatment as healthcare becomes more accurate and personalized at an increased pace - in combination with the advancement of technology. Meanwhile, telehealth, AI-powered medical imaging analysis, and automated testing of robots are all gaining traction in the healthcare industry.
Sysmex has been acquiring technologies for studying cells, genes, and proteins with high accuracy and sensitivity on a proactive basis. A cell analysis platform is one of the technologies that has been used in a variety of Sysmex products. In this field, Sysmex's current emphasis is on developing technologies that specifically analyze cells using different types of information such as cell function and responsiveness, as well as seeking faster cell analysis.
ThinkCyte has "Ghost Cytometry technology," which analyses morphological information of cells in a quick and simple process, while the information gathered by this technology is much richer than what can be collected using conventional flow cytometry (FCM) technique. This technology, in addition to counting and analyzing cells based on their basic morphological features, helps users to identify each cell based on its specific morphological details in terms of its characteristics and functions. This high-resolution analysis will allow for highly accurate clinical condition determination using body fluids such as blood, improve precision in a wide variety of cell-based diagnoses, and contribute to more personalized healthcare.
On March 31, 2021, Sysmex and ThinkCyte signed a memorandum of understanding to begin full-fledged joint development of the novel AI-based cell analysis technology as a result of ongoing collaborative research between the two companies to increase the viability of applying Ghost Cytometry technology to diagnostic techniques of high clinical value. In addition, on May 1, 2021, the two companies agreed to collaborate on joint development, with the aim of commercializing cell analyzers and testing techniques based on Ghost Cytometry technology for cell analysis (including research) in the field of in-vitro diagnostics (IVD). Meanwhile, on May 11, 2021, Sysmex agreed to make an equity investment in ThinkCyte, which will enable the two companies to enhance their strong partnership.
Sysmex and ThinkCyte have formed an alliance to develop novel cell analysis technology and research techniques by combining Sysmex's IVD capabilities with ThinkCyte's proprietary Ghost Cytometry technology, thereby contributing to the advancement and evolution of healthcare around the world.
About Sysmex Corporation
Sysmex works to contribute to the development of healthcare and people's healthy lives in accordance with its goal of "shaping the advancement of healthcare," as described in the Sysmex Group's corporate ideology, the "Sysmex Way." Sysmex performs integrated R&D, manufacturing, and sales, as well as providing support services for its in vitro blood, urine, and other bodily fluids testing instruments, reagents, and software. Sysmex's products are sold to medical institutions in over 190 countries and regions around the world.
Sysmex has been expanding its business in the life science domain in recent years, using proprietary technologies to develop new testing and diagnostic value, provide healthcare personalized to individual patients, and help patients minimize burdens and improve quality of life.
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.
Outcomes4Me | October 12, 2021
Outcomes4Me Inc., developer of a leading free mobile app and platform to navigate cancer treatment and care, today announced that it has partnered with Invitae Corporation (NYSE: NVTA), a leading medical genetics company, to expand education and access to genetic testing to breast cancer patients and survivors. The collaboration leverages the strengths of Invitae, which supplies clinical grade genetic testing, and Outcomes4Me’s 360-degree, validated and evidence-based cancer support and treatment options via its free and easy-to-use app. Initially and currently available in the United States, patients can now receive genetic counseling through Invitae’s partnership with Genome Medical, get testing, and upload their results within the Outcomes4Me app.There is a misconception that genetic testing is only useful as a preventative tool prior to a cancer diagnosis. According to Outcomes4Me patient data, almost half of users (46 percent) who qualified for testing (based on NCCN Guidelines®) did not receive testing or did not know if they had received testing. However, genetic testing can provide insights that can help inform and refine precision therapy use and clinical treatment trial enrollment. In addition, genetic testing results can be used to help prevent recurrence and reduce incidence of other inherited cancers.
A cancer diagnosis is often overwhelming for patients and their families. Outcomes4Me demystifies cancer by providing the most up-to-date and validated research, support, and treatment options, all grounded in science and data and curated according to the patient’s specific diagnosis. Outcomes4Me partners with the researchers, doctors, and academics that set the rigorous standards of cancer care for all treatment providers, including the National Comprehensive Care Network® (NCCN®), Vanderbilt-Ingram Cancer Center (VICC) and Massachusetts General Hospital (MGH). The collaboration with Invitae expands access to genetic testing, a vitally important tool in the patient’s cancer care arsenal.
“Outcomes4Me is an indispensable platform for patients with breast cancer, giving them the personalized knowledge and access to timely new trials and targeted therapies that could lead to better health outcomes. By providing access to our comprehensive genetic testing and counseling services, Outcomes4Me is adding a valuable resource that will empower patients to advance their knowledge, understanding, and therefore, self-advocacy during treatment and survivorship.”
Ed Esplin, M.D., Ph.D., FACMG, FACP, Clinical Geneticist at Invitae
Unlike popular direct-to-consumer genetic testing services, which test for a few specific genetic variants for certain genes, Invitae provides state-of-the-art clinical grade next-generation sequencing-based (NGS) genetic testing that comprehensively analyses more than 80 genes, including all known mutations of the important BRCA1/BRCA2 genes. This comprehensive approach, combined with associated genetic counseling, not only provides insights for cancer patients, but also for family members who may be at risk.
“Our collaboration with Invitae reinforces Outcomes4Me’s mission to give patients back control. Because of this work with Invitae, our valued community now has rare direct access to a much-needed testing service. Outcomes4Me will proudly continue to democratize the best in cancer treatment, research, and support by removing barriers and bias in information flow.”
Maya R. Said, Sc. D., Founder and CEO of Outcomes4Me
Invitae Corporation (NYSE: NVTA) is a leading medical genetics company whose mission is to bring comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Invitae's goal is to aggregate the world's genetic tests into a single service with higher quality, faster turnaround time, and lower prices.
Outcomes4Me is on a mission to improve health outcomes by empowering patients with understandable, relevant and evidence-based information. Outcomes4Me has developed a platform for shared decision-making between patients and providers. The platform harnesses regulatory-grade, real-world data and patient experiences generating deeper insights and better outcomes to improve care and accelerate research. The Outcomes4Me mobile app enables cancer patients to make decisions and take control of their care based on information that is personalized to their specific condition, including finding treatment options, matching to clinical trials, and tracking and managing symptoms. Based in Boston, Massachusetts, Outcomes4Me, a woman-led company, comprises seasoned healthcare, oncology, pharmaceutical, consumer and technology veterans.