Bristol-Myers Squibb, Bayer team up on Opdivo-Stivarga combo in colorectal cancer

Bristol-Myers Squibb is out to expand the pool of colorectal cancer patients it can treat with Opdivo and its bringing in Bayer to help. The two companies, along with Bristol partner Ono Pharmaceutical, have joined forces in a clinical pact to test the immuno-oncology star alongside Bayers Stivarga in patients with microsatellite stable metastatic colorectal cancer, which represents about 95% of cases. The companies stayed tight-lipped on the collaboration’s terms, but they did note that they’ll be plotting an indication-seeking trial for the drug duo. Right now, Opdivo bears a green light to treat a sliver of the colorectal cancer patient population. Nearly two years ago, the FDA gave the treatment a go-ahead in those with microsatellite instability-high (MSI-H) metastatic colorectal cancer, a rare tumor type that makes sufferers less likely to respond to conventional chemo. In the broader colorectal cancer group, though, “I-O monotherapy treatment approaches have shown limited activity,” Bristol noted, “thus, the need for additional treatment options including combination approaches remains high.” Meanwhile, while Stivarga already has an OK for previously treated colorectal cancer that has spread to other parts of the body, it too could benefit from another indication in the disease. While its sales grew overall in 2018, in the U.S., sales declined thanks to “a highly competitive market environment.” Its competition in colorectal cancer includes Otsuka’s Lonsurf, another drug for previously treated patients whose cancer has spread.

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Frontage Laboratories Acquires Accelera S.r.l.'s Bioanalytical and DMPK Businesses

PR Newswire | January 03, 2024

Frontage Laboratories, Inc. today announced that, through its wholly-owned subsidiary Frontage Europe S.r.l., it has completed the acquisition of the Bioanalytical and Drug Metabolism & Pharmacokinetics businesses of Accelera S.r.l (Accelera). Accelera is a premier Contract Research Organization located in Nerviano, within the Lombardy region of Italy, part of the well-established NMS Group S.p.A. which has positioned itself as a global niche player in delivering discovery & preclinical studies and clinical bioanalysis to pharma and biotechnology companies, academic institutions, and other healthcare stakeholders. "Today marks a very significant achievement in the 23-year history of Frontage Laboratories, as we establish a base of operations in continental Europe. Accelera has developed a tremendous reputation for high quality R&D services and we look forward to welcoming their Bioanalytical and Drug Metabolism & Pharmacokinetics teams to the Frontage family," said Dr. Abdul Mutlib, CEO of Frontage. "We envision this strategic acquisition as a first step in establishing Frontage's footprint in Europe, with the intent of adding other service areas in the continent. We believe both existing Frontage and Accelera clients stand to benefit greatly by leveraging Frontage's increasingly global platform. In addition, we are looking forward to partnering with the remaining Accelera business on exciting opportunities to service clients across our organizations." According to Dr. Song Li, Founder and Chairman of Frontage: "It has been a long-standing goal of Frontage to expand our operations in Europe. We consider ourselves fortunate to capitalize on our outstanding relationship with the Accelera team, which has enabled us to bring our plans to fruition. We are very enthusiastic about working together as we further develop the Frontage platform in Europe, starting from a footprint in the Biopark in Nerviano Lombardy, where Accelera and Nerviano Medical Sciences Srl have already established a long-standing and efficient value chain. As always, our ongoing focus will remain on delivering the highest levels of quality, technology and expertise to our clients." "We are thrilled to join forces with Frontage as part of this strategic acquisition that marks a significant milestone in Accelera's journey," said Luca Leone, CEO of Accelera. "Accelera has built a strong reputation for delivering high-quality R&D services through all phases of drug research and development with extensive experience in oncology. This unique occasion opens up new horizons for collaboration and growth. On one hand, we will further focus on offering top-notch In-vivo (end-to-end services) for multiple emerging modalities. At the same time, we look forward to exploring exciting opportunities to serve our clients across continents through our ongoing collaboration. This partnership reflects our commitment to advancing research and providing innovative solutions in the European market and beyond," said Luca Leone, CEO of Accelera S.r.l. "Having Frontage as part of the growing partners operating from our Biopark is a landmark moment for us. In addition to the endless potential of the Accelera-Frontage collaboration, Nerviano Medical Sciences can leverage Frontage's world-class capabilities to drive breakthrough advancements in our drug discovery and development process. By uniting our strengths, we believe we can accelerate the pace of innovation and make a lasting difference in the field where all companies of this strong alliance operate and thrive here in Nerviano," said Hugues Dolgos, CEO of NMS Group S.p.A and Nerviano Medical Sciences Srl. About Frontage Frontage Holdings Corp (1521.HK), together with its wholly owned subsidiary Frontage Laboratories, Inc., is a global Contract Research Organization (CRO) which provides integrated, science-driven, product development services from drug discovery to late phase clinical process to enable biopharmaceutical companies to achieve their development goals. Comprehensive services include drug metabolism and pharmacokinetics, analytical testing and formulation development, preclinical and clinical trial material manufacturing, bioanalysis, preclinical safety and toxicology assessment and early phase clinical studies. Frontage has enabled many biotechnology companies and leading pharmaceutical companies of varying sizes to advance a myriad of new molecules through development and to successfully file global regulatory submissions. About NMS Group NMS Group is the largest oncological R&D company in Italy with more than 400 employees, of whom more than half are highly educated individuals dedicated to innovative research, development and manufacturing. The NMS kinase inhibitor discovery platform as well as the antibody-conjugating payload platform are the driving forces of the group's innovation, securing global recognition of NMS in personalized therapy. Recently entrectinib, originally discovered by NMS, which is a targeted kinase inhibitor used to treat NTRK1/2/3 and ROS1 dependent solid tumors that was licensed to Ignyta, now a member of the Roche Group, gained approvals for commercialization in all major markets. This is further evidence of the competitiveness of the drug discovery platform of NMS Group. NMS Group has three subsidiaries. NMS S.r.l. is a FIC / BIC focused drug research and development company with a robust pipeline of more than a dozen anti-cancer projects, and three of the projects are currently in early clinical development.

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CGI and Körber announce global partnership to enable pharmaceutical and life sciences clients to improve production operations

PR Newswire | January 23, 2024

CGI, one of the largest business and IT consulting companies in the world, today announced a partnership with Körber aimed at enabling pharmaceutical and life sciences companies to improve their production processes by combining CGI's end-to-end services with Körber's Werum PAS-X Manufacturing Execution System (MES) Suite. The global partnership is designed to help clients increase efficiency, accuracy, and safety in pharma products and enhance decision-making through access to real-time data. "CGI works side-by-side with clients to transform data into actionable insights to drive smart, sustainable and resilient operations," said Tim Hurlebaus President, U.S. Commercial & State Government operations and global executive sponsor for CGI's health and life sciences business. "This includes combining the benefits of MES and Industry 5.0 to gather rich insights to enable operational excellence. Our partnership with Körber complements our offerings portfolio, enabling us to deliver innovative new services and solutions to support the needs of our pharma and life sciences clients." Körber's platform serves as a digital, real-time process controller to shorten time-to-market, lower production costs and enable a more patient-centric approach, improving outcomes and leading to improved health. Compliant with Good Manufacturing Practices, PAS-X MES presents a comprehensive view of data from diverse integrated systems, enabling faster and more informed decisions, which can be a critical advantage in an industry where timing and accuracy are paramount. "Our PAS-X Products and Service Suites facilitate seamless digital transformation projects at our customers globally. By combining forces with CGI's global presence, expertise and complementary service portfolio in pharma and life sciences, we can offer a unique and compelling value proposition. CGI is one of the key partners to continue to expand our offering to our global customers" says Jan-Henrik Dieckert, COO Software, Körber Business Area Pharma. Embedding robust IT and operational technology (OT) security, CGI's business consulting and MES services expertise enables faster, more seamless, and operationally integrated implementation of the platform, including transformation through technical integration, data migration, and organizational change management and adoption. "In our global client insights research, pharma and life sciences executives said optimizing operations is their top business priority. CGI serves as a trusted advisor to help them achieve this priority through ROI-led digitization investments," said Maiken Lykke, Senior Vice-President, CGI Denmark. "We work collaboratively with clients to build solutions that tailor the right mix of services and technologies for their needs. We are pleased to partner with Körber to address the unique client challenges in this industry." CGI delivers clinical and IT solutions for 11 of the top 20 global biotech and pharmaceutical companies, including helping these organizations optimize their processes; launch new therapies for cancer and rare diseases; and drive digital transformation across their research & development, manufacturing and commercial functions globally. About CGI Founded in 1976, CGI is among the largest independent IT and business consulting services firms in the world. With 91,500 consultants and professionals across the globe, CGI delivers an end-to-end portfolio of capabilities, from strategic IT and business consulting to systems integration, managed IT and business process services and intellectual property solutions. CGI works with clients through a local relationship model complemented by a global delivery network that helps clients digitally transform their organizations and accelerate results. CGI Fiscal 2023 reported revenue is C$14.30 billion. About Körber We are Körber – an international technology group with more than 12,000 employees at over 100 locations worldwide and a common goal: We turn entrepreneurial thinking into customer success and shape the technological change. In the Business Areas Digital, Pharma, Supply Chain, and Technologies, we offer products, solutions and services that inspire. We act fast to customer needs, we execute ideas seamlessly, and with our innovations we create added value for our customers. In doing so, we are increasingly building on ecosystems that solve the challenges of today and tomorrow. Körber AG is the holding company of the Körber Group.

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Flagship Pioneering and Samsung Announce Collaboration to Advance Groundbreaking Technologies in Translational Science and Medicine

PR Newswire | January 09, 2024

Flagship Pioneering, the bioplatform innovation company, and Samsung today announced a collaboration aimed at fostering cutting-edge biopharmaceutical innovation poised to transform the world of healthcare through groundbreaking advancements in translational science and medicine. Through this collaboration, Samsung will work alongside Flagship-founded companies, leveraging Samsung's leading technologies and capabilities to accelerate first and best-in-class therapies. The newly formed strategic partnership is an expansion of the ongoing cooperation between Samsung and Flagship. The collaboration between Samsung and Flagship leverages the expertise of both organizations in the areas of life science technology, artificial intelligence, and CDMO services, and extends across Flagship's ecosystem of companies. Key Highlights of the Collaboration: Revolutionary Technology: The collaboration will leverage state-of-the-art technology including artificial intelligence, translational medicine, access to high quality clinical samples and Samsung's clinical trials infrastructure, and investment by Samsung in Flagship-founded companies. Shared Vision: Flagship Pioneering and Samsung share a common vision of transforming conventional drug discovery and development approaches to help bring new targeted therapeutic solutions to patients. The collaboration is driven by a commitment to pushing the boundaries of what is possible in the bio-pharmaceutical industry. "This collaboration represents a significant milestone in the pursuit of innovation and scientific excellence," said Stephen Berenson, Managing Partner, Flagship Pioneering. "As partners, we will bring together Flagship Pioneering's unparalleled expertise in inventing and developing revolutionary bioplatform companies with Samsung's strategic capabilities to reshape and empower the bio-pharmaceutical landscape, ultimately resulting in bigger leaps for patient care." "This newly formed collaboration is an important evolution of the ongoing relationship between two companies," said Jaywoo Kim, executive vice president, Samsung C&T. "We look forward to seeing the accelerating effect of Samsung's various technical expertise and extensive commercial capabilities on the future innovations Flagship and its ecosystem of companies will bring to market." About Flagship Pioneering: Flagship Pioneering is a biotechnology company that invents and builds platform companies, each with the potential for multiple products that transform human health or sustainability. Since its launch in 2000, Flagship has originated and fostered more than 100 scientific ventures, resulting in more than $70 billion in aggregate value. To date, Flagship has deployed over $3.6 billion in capital toward the founding and growth of its pioneering companies alongside more than $27 billion of follow-on investments from other institutions. About Samsung C&T: Samsung C&T Corporation, a dynamic player in industries ranging from construction, trading, fashion and resorts, is actively expanding its portfolio with strategic investments in the biopharmaceutical industry. Since its investing in Samsung Biologics and Bioepis, Samsung Biologics' CDMO production capacity has grown to over 600 kilo liters and contribute greatly to the stabilization of the biopharmaceutical supply chain. In addition, Samsung Bioepis has improved the accessibility of many patients around the world by successfully launching seven biosimilar products. Samsung C&T will continue investment in innovative technologies and businesses that contribute to 'improving quality of life' in various areas of bio & healthcare.

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