Astellas Institute for Regenerative Medicine

The idea behind Astella's Cambridge, Massachusetts building is to foster statewide innovation among incubators, biotechs and academia. Astellas Pharma has cut the ribbon on a new life sciences center in Massachusetts that will house 400 team members and an incubator lab.The Astellas Life Sciences Center includes the drugmaker’s first U.S.-based SakuLab that will be shared with external partners. The labs are inspired by the Japanese word "saku," which means "to bloom," and are designed to be a place where bold and diverse ideas can grow, according to a Sept. 5 release. The idea behind the Cambridge building is to also foster a statewide innovation network, consisting of incubators, biotech startups and academia, according to Astellas.In addition, the location will house an engineered small molecules unit focused on targeted protein degradation research, an approach that offers the potential of unlocking "undruggable" targets.  About 400 Astellas employees, spanning medical, business development and research teams, will work in the new building.   "Our new Astellas Life Sciences Center and open innovation SakuLab will advance our efforts to deliver breakthrough therapies and novel modalities, with a focus on areas of high unmet need,” Astellas Chief Medical Officer Tadaaki Taniguchi, M.D., Ph.D., said in the company's release. “It will also strengthen our partnerships with local academic institutions and biotech innovators, underpinning our commitment to pursue transformative treatments in oncology, ophthalmology and rare diseases for patients in need.”The new center follows the 2020 unveiling of the Astellas Institute of Regenerative Medicine, built to develop regenerative and cell-based medicines, and located in nearby Westborough.The opening of the life sciences center also comes one day after word broke that the pharma’s gene therapy arm is shuttering a California production plant. That move is expected to affect around 100 employees, though it’s not immediately clear what that direct impact will be. That said, at least 17 employees are being let go from the biomanufacturing facility, according to a Worker Adjustment and Retraining Notification (WARN) alert. The pharma will be shifting all existing programs and projects from the plant over to the Astellas Gene Therapies’ site in Sanford, North Carolina, a spokesperson told Fierce Pharma. Astellas Gene Therapies—which Astellas Pharma formally launched in 2021—completed work on a new $100 million manufacturing facility in that state in 2022. “The consolidation of our operations is a planned step aimed at further improvements in our manufacturing capabilities,” an Astellas spokesperson told BioSpace. “We are confident this move will allow us to enhance efficiency and better serve our patients and partners’ needs.”Back in May, Astellas Pharma debuted a $90 million lab and office facility in South San Francisco. The 154,000-square-foot site is designed to create a “central location” for the Japanese pharma’s West Coast employees across research, technical operations, medical and development and commercial services, which were previously spread out across the Bay Area.The closure of the California manufacturing site is unrelated and won't affect any employees at the West Coast innovation center, Astellas' spokesperson confirmed.

To comply with academic institution guidelines, the founders' academic affiliations and roles are listed only at the end of the statement. BOSTON, Sept. 3, 2024 /PRNewswire/ -- Somite Therapeutics, a fully integrated TechBio company leveraging big data and AI to introduce novel cell replacement therapies, today announced a $4.8M extension of its pre-seed round, only 6 months after the initial raise, bringing total funds raised to over $10M. Continue Reading "With most of the funds still in the bank, we were not planning to fundraise until 2025," noted Dr. Micha Breakstone, Founder and CEO of Somite Therapeutics. "However, when Astellas Venture Management and Montage Ventures approached us, it was clear that they could add significant strategic value. Astellas Pharma and Astellas Institute for Regenerative Medicine (a wholly owned subsidiary of Astellas, "AIRM") focus on regenerative medicine and cell therapy research in ophthalmology and other therapeutic areas that have few or no available treatment options, while Montage Ventures has built a robust thesis and has deep insights into this space, so we decided to extend the round." Somite Announces Round Extension with Astellas Venture Management and Montage Ventures Joining as Board Observers Post this The additional funding will be used to expedite data generation to train Somite's AI platform, AlphaStem, advance SMT-M01 toward the clinic, start a second clinical program, SMT-B01, using brown adipocytes to treat metabolic disorders, and begin research with hypoimmune cell lines. "We are thrilled to partner with Somite and support their innovative approach to AI-driven cell therapies," said Dr. Nagisa Sakurai, Senior Investment Manager at Astellas Venture Management, who will be joining Somite as a Board Observer. "Somite's work in vertically integrated AI-driven cell therapy aligns perfectly with Astellas' focus. We see great potential for impactful synergies between our companies." "Among numerous companies in the TechBio space, Somite stood out as the most aligned with our vision of AI-driven novel therapeutic modalities," said Dr. Daphne Che, who will also be joining Somite as a Board Observer. "We firmly believe that Somite will emerge as a leader in fully integrated AI-driven cell therapy." Additional investors joining the round include Nachum Shamir, former Chairman and CEO of Luminex, and Paul and Dr. Kendra Harris, a renowned clinician with extensive experience in clinical trials, who will also be joining Somite's Scientific Advisory Board. About Somite Somite.ai is a venture-backed company aiming to become the OpenAI of stem cell biology, developing AI foundation models to produce human tissue for cell therapies at scale for diseases such as diabetes, obesity, and muscular dystrophies. Somite's AI platform, AlphaStem, fuels a virtuous cycle: It enables new cell therapies, generating massive data that further improve the platform, empowering even faster therapy creation with broader applications. The company's pipeline includes the promising SMT-M01 program for Duchenne muscular dystrophy (DMD) and the SMT-B01 program for metabolic disorders. Incorporated in Oct. 2023, Somite.ai has raised over $10m to date. Somite Management Team: Micha Breakstone, PhD: CEO and Co-founder - Repeat AI entrepreneur (Chorus.ai acq. for $575m) Jonathan Rosenfeld, PhD: CTO and Co-founder - Head of the Fundamental AI group at MIT FutureTech Carl Morris, PhD: Chief Scientific Officer Kristy Brown, PhD: SVP Translational Development Shai Kivity, VP Strategy & Operations Scientific Co-founders: Olivier Pourquie, PhD: Professor of Genetics and Pathology, Harvard Medical School and Brigham and Women's Hospital Allon Klein, PhD: Professor of Systems Biology at Harvard Medical School Cliff Tabin, PhD: Chair of the Department of Genetics at Harvard Medical School Jay Shendure, PhD: HHMI Professor of Genome Sciences at University of Washington Media Contact: [email protected] Website: SOURCE Somite Therapeutics

In the EV-301 trial, PADCEV was compared to physician’s chemotherapy choice in patients with advanced urothelial cancer. Credit: PeopleImages.com – Yuri A/Shutterstock. The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has approved Astellas’ PADCEV (enfortumab vedotin), a new antibody-drug conjugate (ADC) to treat locally advanced or metastatic urothelial cancer. The ADC is intended for adult patients with locally advanced or metastatic urothelial cancer after previous treatment with platinum-containing chemotherapy and PD-1/PD-L1 inhibitors. PADCEV targets Nectin-4, a protein highly expressed in bladder cancer. Its mechanism involves binding to cancer cells, internalising and then releasing a cytotoxic agent, leading to cell death. The latest approval is based on the results from the global EV-301 trial and the China-specific EV-203 trial, which served as a bridging study. EV-203 is a single-arm, open-label, multicentre Phase II trial of enfortumab vedotin in patients with la/mUC who previously received a PD-1/PD-L1 inhibitor and platinum-based chemotherapy. See Also: FDA approves updated mRNA vaccines for Covid-19 Verve Therapeutics gets grant for gene editing compositions to lower ldl cholesterol levels The EV-203 trial demonstrated a statistically significant objective response rate of 37.5% in patients treated with PADCEV, with the majority of adverse events being low-grade. The global EV-301 multicentre, open-label, randomised Phase II trial further supported these findings, showing improved overall survival and progression-free survival for patients treated with PADCEV compared to chemotherapy. As part of the EV-301 trial, PADCEV was compared to the physician’s choice of chemotherapy in 608 patients with advanced urothelial cancer. The results indicated a median overall survival advantage for the PADCEV group and a similar incidence of treatment-related adverse events between the two groups. Astellas oncology development head and senior vice-president Ahsan Arozullah stated: “We remain committed to driving scientific progress that leads to meaningful changes in the course of cancer across the globe. “The approval of enfortumab vedotin by the CDE provides patients in China with another treatment option for locally advanced or metastatic urothelial cancer, providing hope of better outcomes for those affected by this condition.” In July 2024, Astellas Pharma subsidiaries the Astellas Institute for Regenerative Medicine and Universal Cells signed a research partnership with the Graduate School of Medicine/Faculty of Medicine at Osaka University in Japan for the development of pluripotent stem cell-derived cartilage organoid cell therapy.