Université de Limoges

The LESS study will evaluate reduced endocrine therapy for HR+/HER2- patients with MammaPrint® Ultra Low tumors to improve quality of life without compromising outcomes Study strengthens Agendia’s growing global footprint in breast cancer to inform personalized treatment planning worldwide IRVINE, Calif. & AMSTERDAM--(BUSINESS WIRE)-- Agendia, Inc., a commercial-stage company focused on assessing an individual tumor’s risk of metastasis and the molecular subtyping reasons for its growth, today announced the first patient has enrolled in the LESS clinical trial, sponsored by Unicancer with the institutional support of Agendia. In an effort to improve outcomes while preserving quality of life for early breast cancer patients, the study is designed to safely discontinue adjuvant endocrine therapy after two years for tumors with a MammaPrint Ultra Low result in post-menopausal women with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer. The study aims to enroll 696 patients via 45 sites within the French breast cancer intergroup Unicancer (UCBG) by October 2024. “We are excited to identify early breast cancer tumors and further investigate the ability to reduce endocrine therapy duration, in an effort to minimize significant and varying side effects, while maintaining high survival rates,” said Fabrice André, MD, PhD, Professor in the Department of Medical Oncology, Institut Gustave Roussy, Villejuif, France and Co-coordinating Investigator of the study. Elise Deluche, MD, Deputy Head of Department at Centre Hospitalier Universitaire de Limoges and Co-coordinating Investigator of the study, added, “Enabling personalized treatments to prevent over- and undertreatment in breast cancer care could give women freedom from intensive long-term treatment regimens that may not increase their chance of cure.” Previous studies have shown patients with HR+/HER2- breast cancer with a MammaPrint Ultra Low result can have an excellent prognosis at 20 years with reduced endocrine therapy. “The LESS study is an important addition to Agendia leading the field in uncovering robust insights for patients and their providers to tailor treatments unique to every tumor,” said William Audeh, MD, Chief Medical Officer at Agendia. “Through our partnership with Unicancer, we are expanding knowledge on the complexity of breast cancer and enabling further personalized treatments in cancer care.” Agendia’s singular focus on breast cancer facilitates continued investment in global research to unravel the intricacies of precision medicine and drive personalized treatment planning for women with breast cancer. This study reinforces Agendia’s commitment to practice changing research that will aid decision-making, aimed at improving outcomes. About Agendia Agendia is a mission-driven, commercial stage company focused on enabling optimized decision-making by providing physicians with next-generation diagnostic and information solutions that can be used to help improve outcomes for breast cancer patients worldwide. The company currently offers two commercially-available genomic profiling tests that help surgeons, oncologists and pathologists to personalize treatment for women at critical intervention points throughout their patient journey. MammaPrint® is a 70-gene prognostic test that, along with other clinicopathologic factors, determines a specific patient’s breast cancer recurrence risk. BluePrint® is an 80-gene molecular subtyping test that identifies the underlying biology of an individual breast cancer to provide information about its behavior, long-term prognosis and potential response to systemic therapy. Together, MammaPrint® and BluePrint® provide a holistic view of the biology underlying an individual patient’s breast cancer, enabling physicians to objectively select the best treatment plan. For more information on Agendia’s assays and ongoing trials, please visit . About Unicancer Unicancer is the only French hospital network 100% dedicated to the fight against cancer and the only national hospital federation dedicated to cancer. It brings together the 18 French Cancer Comprehensive Centres (FCCCs), private not-profit health establishments, spread over 20 hospital sites in France, as well as 2 affiliated establishments. The FCCCs take care of nearly 540,000 patients per year (in short-stay, HAD and outpatient procedures). Unicancer is also the leading academic promoter of clinical trials in oncology, on a European scale, with 109 active clinical trials promoted, 20,000 patients included, 83,000 patients registered in the ESME database. Recognised as a leader in research in France, the Unicancer network enjoys a worldwide reputation with the production of one third of French publications of international importance in oncology (source: bibliometric study/Thomson Reuters). In total, more than 700 clinical trials (inclusions or follow-ups) are promoted in 2021 by the Unicancer network, more than 16% of CLCC patients are included in clinical trials and more than half of the PHRCs devolved to FCCCs. The 18 FCCCs and the Unicancer R&D department are ISO 9001 certified.

LINKÖPING, Sweden, Oct. 26, 2022 /PRNewswire/ -- International medical imaging IT and cybersecurity company Sectra (STO: SECT B) has received an order for its digital pathology solution from three university hospitals in southwestern France. The hospitals will complement their use of microscopes with a joint digital solution allowing the pathologists to review and collaborate around cases in a way that has not been possible before. Digital access to cases, tools for reviewing, diagnosing and collaborating, and efficient resource sharing create new ways to improve the treatment of complex diseases, such as cancer care. "Remote access to pathology cases will enable us to share and leverage resources between our hospitals and to facilitate the management of complex cases requiring special expertise, but also to foster teaching and research activities. It will also allow us to offer our pathologists, if they wish, a more flexible life thanks to remote work," explains Dr. O. Renaud, pathologist at the Poitiers University Hospital. The University Hospitals of Bordeaux, Poitiers and Limoges are part of the Nouvelle-Aquitaine region in France. Together they conduct about 100,000 pathology cases every year. By moving to a digital workflow, the pathologists will have instant and, if needed, remote access to digital images of tissue samples instead of relying on physical glass slides reviewed in microscopes. They will be able to easily access and share current and historical images and information between departments and hospitals. With digital images and workflows in place, the intention is to also leverage the opportunities created by AI. The Sectra solution includes an AI platform that makes it easy for healthcare providers to add applications from various AI vendors to the workflow and clinical use. "Access to resources, particularly specialists, is a challenge for many healthcare providers. We're excited to have the opportunity to put our experience of implementing regional imaging solutions to use for these three university hospitals. Their joint quest to improve cancer care, combined with modern technology, has the potential to truly impact patients in this area, and we are proud to be able to contribute," says Fabien Lozach, President of Sectra in France. The contract was signed in September 2022 and is the first order under the four-year framework agreement for pathology that was signed earlier this year. It is part of the regional project eNovA-Path that aims to make all techniques and organ specialists available across the region, regardless of geographic location, through a shared diagnostic network. Sectra's pathology solution provides pathologists with assistance at critical decision points, such as grading or performing more precise measurements. It also enables image analysis, which in turn reduces variation and improves the precision of tasks such as cell counting. Digital access further facilitates second opinions and external reading resources as well as enabling integrated diagnostics. The pathology solution is part of Sectra's enterprise imaging solution, which provides a unified strategy for all imaging needs while lowering operational costs. The scalable and modular solution, with a VNA at its core, allows healthcare providers to grow from ology to ology and from enterprise to enterprise. Visit Sectra's website to read more about Sectra and why it's top-ranked in "Best in KLAS". About Sectra Sectra contributes to a healthier and safer society by assisting health systems throughout the world to enhance the efficiency of care, and authorities and defense forces in Europe to protect society's most sensitive information. The company, founded in 1978, is headquartered in Linköping, Sweden, with direct sales in 19 countries, and distribution partners worldwide. Sales in the 2021/2022 fiscal year totaled SEK 1,949 million. The Sectra share is quoted on the Nasdaq Stockholm exchange. For more information, visit Sectra's website. CONTACT: Dr. Torbjörn Kronander, CEO and President Sectra AB, +46 (0)705 23 52 27 Marie Ekström Trägårdh, Executive Vice President Sectra AB and President Sectra Imaging IT Solutions, +46 (0)708 23 56 10 The following files are available for download: SOURCE Sectra

Inotrem's phase 2b trial found that TREM-1 modulation with nangibotide improved respiratory, cardiovascular and renal function in septic shock patients. Rates of septic shock, a serious complication of sepsis, are on the rise. With only antibiotics and symptomatic treatment available, biotech Inotrem hopes its investigational asset could be the first mechanism-based treatment for the life-threatening condition. The French biotech released data from its phase 2b clinical trial in septic shock patients, dubbed Astonish, today at the International Sepsis Forum in Barcelona. The company’s lead compound nangibotide hit the trial’s main goal, improving patient scores on an organ failure assessment scale, as well as confirming that excessive TREM-1 activity is associated with severe immune dysregulation. “The Astonish trial was designed as a phase 3 enabling trial; it generated positive and important insights about nangibotide’s therapeutic activity and our precision medicine approach in septic shock,” Jean-Jacques Garaud, Inotrem’s senior VP and head of scientific and medical affairs, said in an Oct. 13 release. Garaud co-founded the immunotherapy biotech in 2013 after leaving his role as head of research and early development at Roche. He hasn’t gone far, though, as Inotrem remains closely tied to the big pharma. In 2020, Inotrem and Roche’s diagnostics division upgraded a years-long collaboration on a plasma test for septic shock with a worldwide licensing agreement.  The diagnostic aims to help sort out a mixed population of patients with activated TREM-1 pathways that may respond to nangibotide, Inotrem’s targeted treatment for sepsis and septic shock. In 2019, nangibotide received fast-track designation from the FDA, which can potentially help speed up the approval process, and holds a similar status from the European Medical Association.   Inotrem designed the peptide to inhibit TREM-1, which are receptors on certain white blood cells, to improve inflammatory response, vascular function and post-septic shock survival chances. In Astonish, the biotech measured nangibotide’s therapeutic effect in patients with high levels of the TREM-1 pathway activation marker sTREM-1. The double-blind study, held in six European countries and the U.S., evaluated nangibotide among 355 patients with septic shock. The study confirmed that excessive TREM-1 activity is associated with severe immune dysregulation, organ dysfunction and ultimately death, according to the company. “We observed that the TREM-1 pathway was activated in severe infections leading to septic shock,” Bruno François, professor and specialist affiliated with Limoges University Hospital and coordinating investigator for Astonish, said in the release. “Nangibotide is the first TREM-1 inhibitor and Astonish confirms its potential as a new therapeutic option for the septic shock patient population.” With the tie between TREM-1 activity and immune dysregulation confirmed, Inotrem’s TREM-1 inhibitor also hit the trial’s main goal—improving morbidity scores related to organ function and patient clinical evolution over five days of treatment. The change of this score in the nangibotide-treated arms was compared to patients receiving a higher dosage as well as those receiving a place. The benefit of nangibotide high-dose treatment compared to placebo was clinically and statistically significant at higher concentrations of sTREM-1, representing about 50% of the patients. Overall, the trial showed that TREM-1 modulation with nangibotide improved respiratory, cardiovascular and renal function, according to Inotrem. “We are looking forward to bringing definitive evidence in a phase 3 clinical study that nangibotide can reduce mortality in these critically ill patients,” François said. Nangibotide is also being assessed in several other indications, including severe forms of COVID-19 and acute heart attacks. A readout for an ongoing phase 2 trial in patients with severe COVID-19 is expected Oct. 25. at the European Society of Intensive Care Medicine meeting in Paris.