Business Wire

Adaptive Biotechnologies Announces a Collaboration with Sanofi to Use Adaptive’s clonoSEQ® Assay to Measure Minimal Residual Disease in Active and Future Isatuximab Multiple Myeloma Trials

Jaa

Adaptive Biotechnologies, the leader in combining Next Generation Sequencing (NGS) and expert bioinformatics to profile T- and B-cell receptors of the adaptive immune system, announced today that it entered into an agreement with Sanofi to utilize Adaptive’s NGS-based clonoSEQ® Assay to assess minimal residual disease (MRD) status in response to isatuximab. This investigational anti-CD38 monoclonal antibody is in clinical development for the treatment of newly diagnosed, relapsed and/or refractory multiple myeloma (MM).

Through this collaboration, the parties will work together to evaluate the clinical value of monitoring MRD negativity in isatuximab-treated MM patients. Adaptive will be responsible for seeking regulatory approvals for and commercialization of the clonoSEQ Assay in MM for select geographies. Adaptive will receive upfront payments and potential future milestone payments. Financial terms of the agreement were not disclosed.

“Adaptive is thrilled to apply its technology to help determine the depth and duration of response to isatuximab in MM-treated patients,” said Chad Robins, CEO and co-founder of Adaptive Biotechnologies. “We look forward to kicking off our collaboration and applying our validated, highly sensitive and quantitative clonoSEQ Assay to measure MRD status as a clinical endpoint in Sanofi’s clinical trials.”

The use of residual disease assessment to inform drug development has steadily increased in the past few years. Currently, there are three published meta-analyses1 , 2 , 3 describing the utility of incorporating a highly sensitive MRD measurement to evaluate a patient’s response to therapy. This collaboration is Adaptive’s fourth collaboration with leading biopharmaceutical companies.

“MRD status is being incorporated as an important clinical endpoint to assess response to therapy in patients with multiple myeloma and other lymphoid malignancies,” said Charles Sang, Adaptive’s Senior Vice President, Diagnostics. “We are excited to work with Sanofi on its late-stage MM trials to help demonstrate the clinical utility of achieving MRD negativity in isatuximab-treated patients.”

About Minimal/Measurable Residual Disease

Minimal/measurable residual disease (MRD) refers to cancer cells that remain in the body of a person with lymphoid cancer after treatment. These cells can be present at levels undetectable by traditional morphologic, microscopic examination of blood, bone marrow or a lymph node biopsy. Sensitive molecular technologies, such as next-generation sequencing utilized by the Adaptive Biotechnologies clonoSEQ Assay, are needed for reliable detection of MRD at levels below the limits of traditional assessment.

About the clonoSEQ ®  Assay

The Adaptive Biotechnologies clonoSEQ Assay enables physicians to utilize a molecular, NGS-based minimal/measureable residual disease (MRD) detection to inform clinical decisions in patients with lymphoid malignancies. The clonoSEQ Assay detects and quantifies DNA sequences found in malignant cells, which can be tracked in patients longitudinally on- and post-treatment. This robust assay provides consistent and accurate measurement of disease burden that allows physicians to assess response to therapy over time. Adaptive is seeking 510(K) marketing authorization from FDA for the clonoSEQ Assay. Currently clonoSEQ is not FDA cleared but is distributed as a CLIA certified service. Nothing in this release constitutes a recommendation to use clonoSEQ with respect to a particular drug therapy. This release may contain forward-looking statements that are subject to risks and uncertainties including but not limited to the risk that approval or commercialization of products or services will be delayed or not obtained, and the risk that future milestones will not be achieved.

About Adaptive Biotechnologies

Adaptive Biotechnologies is the pioneer and leader in combining NGS and expert bioinformatics to profile T-cell and B-cell receptors. Adaptive is bringing the accuracy and sensitivity of its immunosequencing platform to researchers and clinicians around the world to drive groundbreaking research in cancer and other immune-mediated diseases. Adaptive also translates immunosequencing discoveries into clinical diagnostics and therapeutic development to improve patient care. For more information, please visit adaptivebiotech.com.

1 Landgren O, et al. BMT. 2016.
2 Munshi NC, et al. JAMA Oncol. 2017.
3 Berry DA, et al. JAMA Oncol. 2017.

Contact information

Adaptive Biotechnologies
Beth Keshishian, 917-912-7195
media@adaptivebiotech.com

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Knopp Biosciences Presents Positive Preclinical Data for Lead Neonatal Epilepsy Drug Candidate at 2019 Antiepileptic Drug and Device Trials XV Conference24.5.2019 17:00:00 EESTTiedote

Knopp Biosciences LLC, a privately held drug discovery and development company focused on delivering breakthrough treatments for inflammatory and neurological diseases of high unmet need, today presented in vitro and in vivo data for the company’s lead molecule for the targeted treatment of KCNQ2-neonatal epileptic encephalopathy (KCNQ2-NEE) at the Antiepileptic Drug and Device Trials XV Conference in Miami, Florida. KCNQ2-NEE, a rare infant genetic epilepsy, results from mutations in genes encoding the Kv7.2/Kv7.3 ion channel, leading to frequent seizures and profound developmental delay. The preclinical data were presented by Steven Dworetzky, Ph.D., Knopp’s Chief Scientific Officer, a longtime Kv7 researcher who led the group that first cloned the Kv7.2 and Kv7.3 genes during his former tenure with the Bristol-Myers Squibb Co. Dr. Dworetzky presented results demonstrating the in vitro nanomolar activity of KB-3061 and its significant seizure protection in the maximal electroshock mo

Accelerate Your Business in South Korea Through 2019 K-Startup Grand Challenge24.5.2019 13:20:00 EESTTiedote

Entrepreneurs from across the globe should set their sights on participating in the 2019 K-Startup Grand Challenge. Supported by the Ministry of SMEs and Startups and National IT Industry Promotion Agency (NIPA) of South Korea, the initiative provides invaluable support and comprehensive resources to early age startups. Applications for the K-Startup Grand Challenge are currently being accepted through June 14, 2019. In order to advance in the program, teams must pass a regional audition. A judging panel of startup ecosystem experts and Korean accelerators will select 40 teams to participate in an enriching 3.5 month-long acceleration program in Korea. The selected teams will have exclusive access to free office space at the Startup Campus in Pangyo Techno Valley, one-on-one mentoring, information sessions, coaching on Korean and Asian business culture and the chance to attend insightful seminars on accounting regulations to tax laws, patents and more. Opportunities for networking with

New Investigational Clinical Data for Ipsen’s Oncology Products in 11 Solid Tumor Types to Be Presented at 2019 ASCO Annual Meeting24.5.2019 08:00:00 EESTTiedote

Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) today announced that new data from clinical studies on investigational uses of cancer medicines cabozantinib (Cabometyx®), liposomal irinotecan (Onivyde®), and lanreotide autogel (Somatuline®, marketed as Somatuline Depot® in the United States) will be presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting. The meeting takes place in Chicago, Illinois, U.S., 31 May–4 June 2019; data featuring Ipsen medicines includes: New data from the Phase 3 CELESTIAL trial on the association of adverse events with efficacy outcomes for cabozantinib in patients with advanced hepatocellular carcinoma Overview of the Phase 3 COSMIC-312 trial of cabozantinib in combination with atezolizumab vs sorafenib in patients with advanced hepatocellular carcinoma who have not received previous systemic anticancer therapy First Phase 2 data from the CaboGIST study (trial 1317) from the European Organization for Research and Treatment of

The Posiflex Group Showcases an Ecosystem of Connected Solution Endpoints with IoT Remote Monitoring at Computex 201924.5.2019 04:00:00 EESTTiedote

For the Computex 2019 show, The Posiflex Group is featuring leading solution technology from the family of brands as a fully Serviced IoT Ecosystem. Solution end points include: Connected Modular Kiosks, POS Terminals, and Digital Signage solutions from Posiflex and KIOSK Information Systems Smart Medical Displays with gesture controls from Portwell Connected Gaming Solutions with Player Tracking Technology from Portwell subsidiary, Ganlot The booth display is based on common field service endpoints represented in a European Manor Destination Resort setting. Field solutions for an array of vertical market applications include QSR ordering, cinema ticketing, fashion retail customer loyalty, interactive signage, hotel / medical center check-in and bill pay, as well as casino gaming technology. This year, in addition to their renowned POS product suite, Posiflex will be featuring newly introduced Modular Kiosk platforms (co-designed by KIOSK and Posiflex), which are configure-to-order sta

Audi China President Thomas Owsianski to Keynote at CES Asia 201923.5.2019 23:00:00 EESTTiedote

The Consumer Technology Association (CTA)TM today announced that Thomas Owsianski, president of Audi China, will deliver a keynote address at the upcoming CES Asia 2019. Now in its fifth year, CES Asia will run June 11-13, 2019 at the Shanghai New International Expo Centre (SNIEC) in Shanghai, China. Thomas Owsianski’s keynote is scheduled for 4 PM, Tuesday, June 11, where he will unveil Audi’s vision in transforming mobility from a driving experience to a digital adventure. Mr. Owsianski joined the top management team of Audi China in August 2018 and was named President in October 2018. “Audi has been at the forefront of driving global transformation in the automotive industry through their breakthrough advancements in technology,” said Karen Chupka, executive vice president, CES. “Innovation has revolutionized the transportation experience, and we welcome Mr. Owsianski to the CES Asia stage to share Audi’s vision for the future of global mobility.” Throughout Asia and beyond, technol

ITechLaw Publishes New Book and Opens Global Public Comment Period on Draft Principles for Responsible Artificial Intelligence23.5.2019 22:11:00 EESTTiedote

The International Technology Law Association (ITechLaw) has published Responsible AI: A Global Policy Framework, a new book that provides an in-depth review and eight discussion principles that address some of the hottest technology and moral issues of responsible development, deployment and use of artificial intelligence. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190523005752/en/ ITechLaw releases new book, Responsible AI: A Global Policy Framework, and opens public comment period. (Photo: Business Wire) Written by a multi-disciplinary group of 54 technology law experts, industry representatives and researchers from 16 countries, the book offers an actionable framework built on the following principles: Ethical Purpose and Societal Benefit, Accountability, Transparency and Explainability, Fairness and Non-discrimination, Safety and Reliability, Open Data and Fair Competition, Privacy, and AI and Intellectual Property.

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme