MEDTECH, INDUSTRIAL IMPACT
SOPHiA GENETICS | March 01, 2023
On February 28, 2023, SOPHiA GENETICS, a leading cloud-native software solutions provider in the healthcare space, announced that Synergy Oncology, a part of Synergy Laboratories based in Mobile, Alabama, will utilize SOPHiA DDM™ to develop a new cancer profiling solution. Synergy Oncology is a specialist in innovative platforms that improve patient care.
The use of SOPHiA DDM™ for Hereditary Cancers Solution in Synergy Oncology's state-of-the-art laboratory technologies will lead to the launch of Totality, a comprehensive end-to-end solution for tumor profiling that will assist clinical studies, cancer research and patient care.
Next-generation sequencing (NGS) is commonly used to detect biomarkers for hereditary cancers, but the resulting datasets are vast and complex, requiring sophisticated analysis. The SOPHiA DDM™ for Hereditary Cancers Solution leverages machine learning and Artificial Intelligence (AI) with patented technologies to evaluate raw NGS data, simplifying interpretation and expediting reporting. As Synergy Laboratories seeks to expand into other oncology offerings, the SOPHiA DDM™ platform could serve as a one-stop solution.
Synergy's new product, Totality, examines genes from solid tumor tissue and, by using SOPHiA DDM™ for Hereditary Cancers, provides physicians with a consolidated report that matches detected molecular alterations with clinical trials and FDA-approved therapies. By combining SOPHiA DDM™ for Hereditary Cancers with Synergy Oncology's technology, experts will be able to analyze and interpret findings from NGS data confidently, transforming high-quality data into valuable insights for researchers and care providers.
Synergy Oncology provides the most comprehensive NGS kit of its kind, including hereditary testing, liquid biopsy testing, and myeloid malignancies. The combination of Synergy Oncology and SOPHiA GENETICS technology will expand Synergy's oncology portfolio while helping to further the U.S. oncology market.
About SOPHiA GENETICS
SOPHiA GENETICS is a leading cloud-native software solutions provider in the healthcare space. It aims to establish data-driven medicine as the standard of care for life sciences research. The company combines expertise in life sciences, data computing and medical disciplines to bring data analytics solutions to market. SOPHiA GENETICS achieve its mission through the global adoption of SOPHiA AI, which uses pattern recognition, statistical inference and machine learning to provide equal benefits to all users. SOPHiA AI also encourages expert knowledge sharing for a sustainable impact on future patients. The company believes digital technologies are the key to unlocking the era of Data-Driven Medicine, where secure data pooling and knowledge sharing will be precious for patients. The company also focuses on combining the first two pillars of Data-Driven Medicine, Radiomics and Genomics, to ensure that the data used to help patients today will also benefit tomorrow's patients.
CELL AND GENE THERAPY, INDUSTRIAL IMPACT
Exelixis | February 14, 2023
On February 13, 2023, Exelixis, Inc., a leading global oncology firm innovating next-generation medicines and regimens at the forefront of cancer care and Sairopa B.V. (Sairopa), a renowned firm developing novel therapeutics for cancer by modulating the patient's immune system, announced that FDA has approved Sairopa's Investigational New Drug (IND) Application to assess the pharmacokinetics and safety of ADU-1805 in adults with advanced solid tumors.
ADU-1805, being a monoclonal antibody active against all human SIRPα alleles, has the potential to reach a broader patient population than existing SIRPα-directed therapeutics.
ADU-1805 has the potential to boost the immune system's ability to combat tumors by suppressing SIRPα, an important immuno-suppressive component of the tumor microenvironment. When compared to other SIRP family members, ADU-1805 has been designed to bind preferentially to SIRPα, which may improve its capacity to stimulate immune cells.
In accordance with the clinical development and option agreement announced in November 2022, Exelixis has the option to obtain an exclusive, global license to commercialize and develop ADU-1805 and other anti-SIRPα antibodies after reviewing data from predetermined phase 1 clinical studies of ADU-1805 to be conducted by Sairopa during the option period. This IND approval results in a $35 million milestone payment to Sairopa to be paid in the first quarter of 2023.
Founded in 1994, Exelixis is a leading global oncology firm at the vanguard of cancer care, developing next-generation drugs and regimens. Fueled by bicoastal centers of research and development expertise, its clinically distinct pipeline of small molecules, antibody-drug conjugates, and other biotherapeutics is quickly expanding its product portfolio to address a growing spectrum of tumor types and indications. In addition, the company has demonstrated an excellent track record of endurance in the face of adversity after working in the competitive biotech industry for over 25 years. Its main product's success has provided it with a robust commercial basis, allowing re-energizing research activities and team expansion in clinical development, drug discovery, and commercial areas.
CELL AND GENE THERAPY, MEDICAL
Be The Match BioTherapies® | January 18, 2023
On January 17, 2023, Be The Match BioTherapies, a company that provides solutions for organizations that develop and commercialize cell and gene therapies, introduced its offering of CIBMTR® clinical research organization services (CRO services), which significantly reduces the time needed to launch and execute high-impact clinical trials.
These CRO services are the outcome of a collaboration between Be The Match BioTherapies and CIBMTR, resulting in expertise and access to unmatched research, sites, donors, partnerships, scientific and operational knowledge, and other resources.
CIBMTR CRO services offer unique capabilities such as
Established relationships with over 225 clinical locations domestically
Nearly 20 years of expertise in transplant and cellular therapy trials and study management, as well as clinically-trained staff
On-staff transplant physicians provide direct contact with patients and donors for clinical and research insights.
A link to the CIBMTR outcomes database for over 575,000 patients
The new CRO services offer turn-key solutions, including protocol development and approval oversight, site selection, project management, site start-up, research sample/laboratory coordination, data management, study monitoring, patient-reported outcomes, statistical analysis, and financial administration. For certain services, such as data analysis, surveys, site selection and administration, and sample management, businesses may instead rely on the expertise of CIBMTR CRO services.
About Be The Match BioTherapies®
Be The Match BioTherapies is the sole supplier of cell and gene therapy solutions with fully configurable services to assist the cell therapy supply chain. It is committed to accelerating patient access to life-saving cell and gene treatments by delivering the best-quality cellular source material from Be The Match Registry®, the most-varied registry of prospective blood stem cell donors in the world, with over 7 million potential blood stem cell donors. Through global collaborations with apheresis, bone marrow collection, and transplant centers, the firm creates, onboards, trains, and maintains extensive collection networks to advance cell treatments.