Diffuse Astrocytoma

SOMERVILLE, Mass., Oct. 30, 2024 /PRNewswire/ -- Aitia, a biotech company pioneering the use of causal AI and Digital Twins in drug discovery and development, is expanding its collaboration with Servier, a global and independent pharmaceutical company, to tackle gliomas, a broad group of brain cancers. This collaboration aims to use Aitia's breakthrough technology which is powered by millions of data points from patient cancer tissues to find new treatments for this deadly disease. Under the terms of the collaboration, Aitia and Servier will work together to discover and, validate novel drug targets and develop novel drug candidates for glioma using Aitia's Gemini Digital Twins and Servier's therapeutic discovery and clinical development expertise in oncology. This collaboration will include exploration of the heterogeneous biology of these brain cancers, mechanisms of resistance, and drug response at the individual patient level. In a recent breakthrough in another form of glioma, specifically Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, sub-total resection, or gross total resection in adult and pediatric patients 12 years and older, Servier recently announced approval of the brain cancer drug, VORANIGO, the first approved drug for this disease area in almost 25 years. Gliomas, tumors that originate in the brain or spinal cord from glial cells, affects more than 190,000 people worldwide annually. The most aggressive form of glioma, glioblastoma, has an average survival time after diagnosis of approximately 15 months, with less than 7% of patients surviving beyond five years, according to the National Brain Tumor Society. Despite standard treatments like surgery, radiation and chemotherapy, glioblastoma has a high rate of recurrence and there are currently no curative therapies. "We are excited to expand our collaboration with Aitia into gliomas as we continue to prioritize brain cancer after our recent positive results and approval of VORANIGO in the US and in growing number of territories," said Fabien Schmidlin, Global Head of Translational Medicine at Servier. "At Servier, we are committed to advancing therapies for cancer patients with high unmet medical needs, and we believe that integrating Aitia's Gemini Digital Twins with our expertise in oncology, particularly in targeting molecular mutations, could open new avenues for more effective treatments." "Glioma is the among the deadliest forms of cancer, and the lack of broadly effective treatments highlights the urgent need for new approaches that leverage the growth of genetic and multi-omic patient data and breakthroughs in AI," said Colin Hill, CEO and co-founder of Aitia. "We believe that our Gemini Digital Twins, along with Servier's drug discovery and clinical development expertise in hard-to-treat cancers can lead to new breakthrough therapies for this disease." This collaboration represents the fourth area of research Aitia and Servier are collaborating on. The companies began their partnership in 2022, to advance drug discovery, translational, and clinical development efforts in Multiple Myeloma, then expanding in 2023 to include drug discovery and development for pancreatic cancer, and again in January 2024 to discover patient responders for Servier's LRRK2 inhibitor in Parkinson's disease. Aitia's approach centers on two key innovations: causal AI and Gemini Digital Twins. Causal AI goes beyond correlative associations to identify which genetic or molecular changes drive diseases and patient response to therapies. Gemini Digital Twins are virtual models that are reverse-engineered from huge quantities of genetic, multi-omic, and clinical data from patients that reveal how genes, proteins, and other molecules interact within cells and tissues to drive clinical outcomes. These Gemini Digital Twins of a specific disease allow researchers to rapidly test billions of experiments such as gene and protein knockdowns or application of a drug candidate in a human patient context versus animal models or cells in petri dishes. These high-throughput "virtual experiments" in patient-derived Gemini Digital Twins leads to discovering and selecting drug candidates that are more likely to succeed in clinical trials in specific patient populations. About Aitia Aitia is an AI-enabled biotechnology company deploying causal AI and creating Gemini Digital Twins to discover the next generation of breakthrough drugs in neurodegenerative diseases and oncology, including a lead program in Huntington's disease. By leveraging the convergence of multi-omic patient data, high-performance computing, and causal AI, Aitia's Gemini Digital Twins reveal the hidden biological mechanisms of disease to transform the discovery and development of new therapeutics. To date, Gemini Digital Twins have been used to accelerate R&D in oncology, neurodegeneration, cardiometabolic, and immunology. Media Contact: Isabelle Caffry Senior Director, Strategy & Corporate Development [email protected] +1-617-374-2300 Ryan Flinn In Like Flinn Communications [email protected] +1 510-207-7616 SOURCE Aitia WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Oncomine Dx Target Test to Identify Patients Eligible for Servier’s VORANIGO® (vorasidenib) tablet, the only FDA-approved treatment for Grade 2 IDH-mutant glioma CARLSBAD, Calif.--(BUSINESS WIRE)--Thermo Fisher Scientific, the world leader in serving science, has received approval from the U.S. Food and Drug Administration (FDA) for its Ion Torrent™ Oncomine™ Dx Target Test as a companion diagnostic (CDx) to identify patients eligible for treatment with Servier Pharmaceuticals, LLC’s VORANIGO® (vorasidenib) tablets. VORANIGO is an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, sub-total resection or gross total resection. As the first targeted therapy for Grade 2 IDH-mutant glioma, VORANIGO provides a new care path for patients with extremely limited treatment options. Gliomas are the most common malignant primary brain tumor in adults, representing approximately 81% of primary malignant brain tumors. Of those, approximately 20% harbor an IDH mutation and testing for these mutations is essential for accurate treatment decisions. Further, the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology recommend IDH mutation testing in all patients with a glioma, noting its impact on diagnosis and prognosis of gliomas. IDH mutation status has been a key factor in the NCCN treatment guidelines for years. With the FDA approval of VORANIGO, determining the IDH mutation status of patients with glioma will be even more critical. “VORANIGO is the first and only targeted therapy for patients living with grade 2 IDH mutant glioma, a relentless and incurable type of brain cancer that hasn’t seen treatment advances in nearly 25 years,” said David K. Lee, CEO of Servier Pharmaceuticals. “As more targeted therapies become available to patients, identifying key driver mutations is essential to help the right patients find the right treatment, at the right time.” In addition to the approval for IDH-mutant diffuse glioma, the Oncomine Dx Target Test, has also previously received approvals for indications in non-small cell lung cancer (NSCLC), cholangiocarcinoma (CCA), medullary thyroid cancer (MTC) and thyroid cancer (TC). As a distributable companion diagnostic, the test simultaneously delivers biomarker results for multiple targeted therapies from one sample, helping quickly match patients with the right targeted therapies. “As the healthcare system works to realize the impact of precision medicine, patients must have access to the proper testing that helps unlock targeted treatment options based on their unique genomic pro This access is the driving motivation behind the extensive work we do with pharma partners to help connect the right patients to new therapies as soon as they are approved,” said Kathy Davy, president, clinical next-generation sequencing at Thermo Fisher Scientific. “The work we do every day reflects our Mission, and combining our CDx technology with Servier’s breakthrough therapy will help dramatically impact care for patients with aggressive brain tumors.” Today’s approval expands clinical indications for the Oncomine Dx Target Test, which is currently approved and reimbursed by government and commercial insurers in 19 countries, including the U.S., Japan, South Korea and countries across Europe and the Middle East, covering more than 550 million lives globally. Following this approval, the two organizations will continue to collaborate on an additional companion diagnostics with the Ion Torrent™ Oncomine Dx Express Test.* Available on the Ion Torrent Genexus™ Dx System*, the Oncomine Dx Express Test can return results in as little as a single day, dramatically accelerating the pace with which patients can be matched with optimal treatments based on their genomic results. *The Oncomine Dx Express Test and the Genexus Dx System are currently available only in countries that accept the CE mark. About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit . Contacts Media Contact Information: Amanda Strickland Phone: (910) 622-8752 E-mail: amanda.strickland@thermofisher.com Jessika Parry Phone: 419-266-4016 Email: jparry@greenoughagency.com

LOUISVILLE, Ky., Aug. 12, 2024 (GLOBE NEWSWIRE) -- Onco360®, the nation’s leading independent Specialty Pharmacy, has been selected by Servier Pharmaceuticals, as a specialty pharmacy partner for VORANIGO® (vorasidenib). VORANIGO® is approved for the treatment of adults and pediatric patients 12 years of age and older with grade 2 astrocytoma or oligodendroglioma and a susceptible isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) mutation following surgery including biopsy, sub-total resection, or gross total resection1. This indication was approved based on the Phase III INDIGO (NCT04164901) trial, which showed vorasidenib significantly extended progression free survival (PFS) when compared to placebo. Vorasidenib is a small molecule inhibitor that targets IDH1 and IDH2 enzymes. “Onco360 is grateful for the opportunity to become a specialty pharmacy provider for VORANIGO®,” said Benito Fernandez, Chief Commercial Officer. “We are proud to add the first FDA approved targeted therapy for Grade 2 IDH-mutant glioma to our portfolio.” The FDA approval of vorasidenib is based on the results of the Phase III INDIGO clinical trial, which evaluated 331 patients with grade 2 astrocytoma or oligodendroglioma with IDH1 or IDH2 mutations. Patients received either vorasidenib 40mg daily or placebo until disease progression or unacceptable toxicity. The INDIGO trial met its primary endpoint of PFS and key secondary endpoint of time to next intervention (TTNI). The median PFS was 27.7 months in the vorasidenib group compared to 11.1 months in the placebo arm, HR = 0.39 (95% CI 0.27-0.56). Vorasidenib was well tolerated by patients as part of the INDIGO trial. The most common adverse reactions (≥15%) were fatigue, COVID-19, musculoskeletal pain, diarrhea, and seizure.2 Please see the full Prescribing Information for VORANIGO®. About Onco360 Oncology Pharmacy:Onco360 is the nation’s largest independent Oncology Pharmacy and clinical support services company. Onco360 was founded in 2003 to bring together the stakeholders involved in the cancer treatment process and serve the specialized needs of oncologists, patients, hospitals, cancer centers of excellence, manufacturers, health plans, and payers. It dispenses nationally through its network of URAC-, and ACHC-accredited Specialty Pharmacies. Onco360 is headquartered in Louisville, Kentucky, and is a flagship specialty pharmacy brand of PharMerica Corporation, a leading institutional pharmacy, specialty infusion, and hospital services company servicing healthcare facilities in the United States. For more information about Onco360, please visit Onco360.com. Media Contact: Benito Fernandez, Chief Commercial OfficerBenito.Fernandez@Onco360.com516-640-1332 References: VORANIGO (vorasidenib) Prescribing Information. Accessed August 2024. https://d11vmvycldsjdg.cloudfront.net/7fffe4c3-9746-4e82-9582-df9879a712d5/5939acdd-1c44-41f5-b2f6-260ab3860288/5939acdd-1c44-41f5-b2f6-260ab3860288_web_ready__c.pdfIngo K. Mellinghoff et al. INDIGO: Vorasidenib in IDH1 or IDH2 mutant low grade glioma. NEJM 2023; 389: 589-601. DOI: 10.1056/NEJMoa2304194.