Latest news with #Astellas'
Yahoo
30-05-2025
- Business
- Yahoo
Astellas Enters Exclusive License Agreement with Evopoint Biosciences for XNW27011, a Novel Clinical-stage Antibody-Drug Conjugate Targeting CLDN18.2
- Agreement grants Astellas exclusive worldwide rights (excluding China's mainland, Hong Kong, Macao and Taiwan region) to develop and commercialize XNW27011 - - XNW27011 has demonstrated encouraging monotherapy efficacy in an ongoing Phase 1/2 study of patients with solid tumors, including gastric cancer, gastroesophageal cancer and pancreatic cancer - - Evopoint to receive a $130 million upfront payment and is eligible to receive up to $70 million near-term payments, and additional milestone payments associated with development, regulatory and commercialization milestones totaling up to $1.34 billion, as well as royalties on net sales of XNW27011, if approved - TOKYO and SUZHOU, China, May 29, 2025 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Evopoint Biosciences (Evopoint Biosciences Co., Ltd.) today announced they have entered into an exclusive license agreement for XNW27011, a novel investigational clinical-stage antibody-drug conjugate (ADC) targeting CLDN18.2. The agreement grants Astellas a worldwide (excluding China's mainland, Hong Kong, Macao and Taiwan region) exclusive license to develop and commercialize XNW27011. XNW27011 is currently being evaluated in a Phase 1/2 study in China in patients with CLDN18.2-expressing solid tumors, including gastric cancer, gastroesophageal cancer and pancreatic cancer. It uses a proprietary topoisomerase I inhibitor payload and linker technology, an approach that has demonstrated clinical success in other approved cancer therapies. Astellas has significant expertise in developing therapies that target CLDN18.2, including VYLOYTM, the first CLDN18.2-targeted therapy approved in the world. XNW27011 has the potential to address currently unmet patient need and will expand Astellas' oncology pipeline which currently contains CLDN-targeting therapies utilizing different approaches, as well as ADC's directed to other targets. Under the terms of the agreement, Evopoint will receive a $130 million upfront payment and is eligible to receive up to $70 million near-term payments, and additional milestone payments associated with development, regulatory and commercialization milestones totaling up to $1.34 billion, as well as royalties on net sales of XNW27011, if approved. Adam Pearson, Chief Strategy Officer, Astellas"Astellas is dedicated to advancing innovative therapies for some of the most challenging-to-treat cancers, such as gastric and pancreatic cancer. XNW27011 is a promising new asset that complements Astellas' pipeline and enhances our leading position in precision oncology. We look forward to harnessing our expertise in targeting CLDN18.2 and specialized knowledge in GI cancers to advance XNW27011 and deliver meaningful outcomes to patients." Arthur Qiang, Chairman, Evopoint"XNW27011 is a novel investigational antibody-drug conjugate that has shown great promise in the clinic. Astellas has a proven history of developing and commercializing a strong franchise of innovative cancer therapies. We are pleased to enter into this new license agreement to further our collective goals of bringing new treatment options for patients in need worldwide." About AstellasAstellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at About Evopoint BiosciencesEvopoint Biosciences is an innovative biopharmaceutical company with exceptional capabilities in R&D and commercialization. Since its inception, Evopoint has been committed to improving human health by discovering and developing cutting-edge pharmaceutical solutions that address significant unmet medical needs worldwide. Leveraging diverse discovery platforms in targeted therapy, ADC, and targeted protein degradation (TPD), the company has built a robust pipeline focused on oncology, infectious diseases and metabolic diseases. Learn more at Astellas Cautionary NotesIn this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. View original content to download multimedia: SOURCE Astellas Pharma Inc. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
23-05-2025
- Business
- Yahoo
Astellas and Pfizer's Xtandi combo reduces death risk in prostate cancer trial
Astellas and Pfizer have reported five-year follow-up outcomes from the open-label extension of the randomised Phase III ARCHES trial. The study indicated that Xtandi (enzalutamide), combined with androgen deprivation therapy (ADT), showed a 30% decrease in the mortality risk in men with metastatic hormone-sensitive prostate cancer (mHSPC). Patients treated with the combination therapy showed a reduction against those receiving placebo plus ADT. The findings offer a longer-term perspective on the overall survival (OS) benefits of the androgen receptor pathway inhibitor (ARPI), Xtandi. Subjects with high-volume disease experienced a 36-month improvement in median OS. The study also assessed various clinically relevant subgroups, including those with low-volume disease and those previously treated with docetaxel, all demonstrating consistent survival improvements. Additionally, the occurrence of treatment-emergent adverse events in the five-year follow-up aligned with previous analyses from the ARCHES trial, without any new safety concerns identified. The placebo-controlled, multinational, double-blind trial enrolled 1,150 participants across sites in South America, Canada, Europe, the Asia-Pacific region, and the US. Its primary endpoint was radiographic progression-free survival (rPFS), with OS as a key secondary endpoint. The post hoc five-year analysis aimed to provide a comprehensive view of long-term survival benefits. Astellas' medical affairs head and executive vice-president Shontelle Dodson said: 'The survival benefits of intervention with Xtandi in advanced prostate cancer are well-recognised. 'The collective – and growing – body of data for Xtandi continues to reinforce its long-term efficacy and patient impact in prostate cancer, including in the metastatic setting, and shows that Xtandi is changing the trajectory of those living with the disease.' Xtandi has been approved for use in more than 90 nations, including the European Union, Japan, and the US. Astellas is responsible for the global manufacturing and commercialisation outside the US while both companies jointly market the therapy within the US. Last October, Pfizer announced positive top-line data from the Phase III TALAPRO-2 study evaluating the combination of Talzenna (talazoparib) and Xtandi in patients with metastatic castration-resistant prostate cancer (mCRPC). "Astellas and Pfizer's Xtandi combo reduces death risk in prostate cancer trial" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Time of India
21-04-2025
- Business
- Time of India
PADCEV (enfortumab vedotin) Now Available in India for Locally Advanced or Metastatic Urothelial Cancer
Mumbai: Astellas Pharma India Pvt Ltd. today announced that PADCEVTM ( enfortumab vedotin ) is now available for prescription in India as monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer (LA/mUC) who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 or programmed death-ligand 1 inhibitor1 Enfortumab vedotin is a first-in-class antibody-drug conjugate that is directed against Nectin-4 , a protein located on the surface of cells and highly expressed in bladder cancer cells1Laboratory studies have shown that the anticancer activity occurs when it enters the cell and releases the cell-killing medicine that works to damage and kill the cell expressing nectin-4.1 In India, urothelial carcinoma patients who have progressed beyond platinum-containing chemotherapy and immunotherapy currently lack a standard of care. Treatment options for this population are limited and this launch will address a significant unmet need. The launch of PADCEVTM reinforces Astellas' commitment to expanding its oncology portfolio in India. Following the introduction of XospataTM (Gilteritinib) last April for relapsed or refractory FLT3+ acute myeloid leukemia (AML), PADCEVTM marks another step in the company's mission to deliver innovative cancer therapies to Indian patients. 'This launch marks a significant milestone for India. The approval of enfortumab vedotin provides a new treatment option for patients living with advanced urothelial cancer who have had limited treatment options thus far. It also further demonstrates our continued commitment to bringing global innovations to India and making a real impact on patient's lives,' said Sampada Gosavi, General Manager and Managing Director, Astellas India. About Urothelial Cancer Urothelial cancer is the most common type of bladder cancer (90 percent of cases) and can also be found in the renal pelvis (where urine collects inside the kidney), ureter (tube that connects the kidneys to the bladder) and urethra2. About the EV-301 Trial The EV-301 trial (NCT03474107) was a global, multicentre, open-label, randomised phase 3 trial designed to evaluate enfortumab vedotin versus physician's choice of chemotherapy (docetaxel, paclitaxel or vinflunine) in 608 patients with locally advanced or metastatic urothelial cancer who were previously treated with a PD-1/L1 inhibitor and platinum-containing therapies. The primary endpoint was overall survival and secondary endpoints included progression-free survival, overall response rate, duration of response and disease control rate, as well as assessment of safety/tolerability and quality-of-life parameters. Results were published in the New England Journal of Medicine. About PADCEV TM (enfortumab vedotin) PADCEV is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer1,4. Nonclinical data suggest the anticancer activity of PADCEV is due to its binding to Nectin-4 expressing cells followed by the internalisation and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).1 About Astellas Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at For Further Information, Please Contact: Astellas Pharma India Private Limited 301, 3rd Floor, C & B Square, 127, Andheri Kurla Road, Andheri (East), Mumbai 400069 India, Customer care no. +91-22-61557600 REFERENCES 1. PADCEV India Prescribing Information. 2. American Society of Clinical Oncology. Bladder cancer: introduction (5-2019). Accessed March 2022. 3. Powles T, Rosenberg JE, Sonpavde GP, et al. Enfortumab Vedotin in Previously Treated Advanced Urothelial Carcinoma. N Engl J Med. 2021; 10.1056/NEJMoa2035807. 4. Challita-Eid P, Satpayev D, Yang P, et al. Enfortumab Vedotin Antibody-Drug Conjugate Targeting Nectin-4 Is a Highly Potent Therapeutic Agent in Multiple Preclinical Cancer Models. Cancer Res 2016;76(10):3003-13. Disclaimer - The above content is non-editorial, and ET Healthworld hereby disclaims any and all warranties, expressed or implied, relating to it, and does not guarantee, vouch for or necessarily endorse any of the content.
Harvard Business Review
07-04-2025
- Health
- Harvard Business Review
Building Effective Partnerships to Power Life Sciences Innovation - SPONSOR CONTENT FROM ASTELLAS
By Tadaaki Taniguchi For people living with serious diseases, science has the potential to change everything. Twenty-five years into what many have called 'biology's century,' rapid advancements in our understanding of molecular biology, genetics, and biotechnology are unlocking the extraordinary properties of living systems to improve lives and redefine what is possible in medicine. Exciting advances in immuno-oncology, targeted protein degradation (TPD), and cell and gene therapy, along with precision medicine, hold tremendous promise to transform outcomes for people living with cancer, vision loss, and rare diseases. Realizing the full potential of these exciting new modalities requires collaboration and coordination across the life-science ecosystem—from the bench to the bedside—starting at the earliest stages of drug discovery. As a trained surgeon who transitioned into a career in the pharmaceutical industry, I've witnessed first-hand the vital importance of collaboration between academia, biotech, and the broader pharmaceutical sector in answering one simple question: How can we better help the next patient? This is especially true in Massachusetts and the Greater Boston area, where collaboration has played a significant role in driving some of the most important advances in modern medicine. By partnering with leading institutions like Mass General Brigham, LabCentral, and UMASS Chan Medical School, we can accelerate progress and expand research frontiers by merging drug discovery expertise with academic leadership. Our partnerships extend beyond academic walls, to organizations such as MassBio and the Longwood Fund, which enable us to connect and collaborate with leading innovators doing cutting-edge research. Successful collaborations are built on open communication and a shared commitment to both risks and rewards. These partnerships thrive when there is a balance between academic freedom and commercial objectives, empowering researchers to drive groundbreaking science within a culture of continuous learning, all while ensuring real-world impact. This spirit of collaboration is a driving force behind the Astellas Life Sciences Center (ALSC) in Cambridge, Mass., allowing us to tap into the rich insights and experience of the vibrant local life-science community. With 400 employees, ALSC houses such key functions as medical and development, translational medicine, drug discovery, and business development. The ALSC is also home to Astellas' first U.S.-based SakuLab: an open innovation space designed to help us engage with external partners. It joins SakuLab-Tsukuba, the company's first incubator space, located at our flagship research campus in Japan. By collaborating with biotech companies at the forefront of adeno-associated virus gene therapy research and sharing lab communities such as LabCentral 238 in Boston's Kendall Square, Astellas' strategy is to push the boundaries of science in complex novel areas like cell and gene therapy, oncology, and ophthalmology. Our work in these complex areas is fueled by our nearby Astellas Institute for Regenerative Medicine, our global hub for pioneering the development and manufacturing of regenerative medicine and cell-based therapies. These are all key components of our effort to build an innovation network across Massachusetts, connecting biotechnology leaders, academia, and other local partners. By working together, we can drive progress for patients in an ecosystem that is truly greater than the sum of its parts. Chris Coburn, Chief Innovation Officer at Mass General Brigham, notes the importance of collaboration. 'Innovative partnerships, like ours with Astellas, are pivotal in bridging scientific discovery and real-world patient impact,' he says. 'By uniting academic excellence with industry expertise, we are accelerating advancements in oncology, rare diseases, and cell and gene therapy, creating new opportunities to address unmet medical needs.' So, how can we better help the next patient? By forging powerful partnerships, we will broaden our pipeline, unlock new treatments, and shape the next generation of life-changing medicines. Tadaaki Taniguchi is the Chief Research & Development Officer at Astellas Pharma, where he leads the company's global R&D efforts to drive innovation and advance transformative therapies.
