Borofalan (10B)

PAVIA, Italy--( BUSINESS WIRE )--TAE Life Sciences (TLS), a leading developer of Boron Neutron Capture Therapy (BNCT) systems and drugs, and the Italian National Center for Oncological Hadrontherapy (CNAO), a premier hadrontherapy center in Europe, today announced a definitive agreement to collaborate on groundbreaking global drug research and development initiatives for the implementation of BNCT. This strategic partnership will bring together the expertise of two innovative leaders in cancer treatment, with the purpose to revolutionize cancer care through BNCT, a targeted radiation therapy designed to improve outcomes for patients with complex and metastatic cancers. CNAO’s extensive experience in hadrontherapy, encompassing proton, carbon ions and other particles, complements TLS’s leadership in advancing cancer treatment with BNCT technology and drug development. BNCT is a type of combination cancer treatment that uses neutron radiation and a special boron compound to target and destroy cancer cells. The process involves two main steps. In the first one, a boron-rich compound is administered to the patient, typically via injection or infusion. This compound is designed to be selectively absorbed by cancer cells, with minimal uptake by normal tissues. In the second step, after the boron compound has been absorbed by the cancer cells, the patient is exposed to a beam of low-energy neutrons. These neutrons interact with the boron atoms within the cancer cells and destroy them. In late 2020, CNAO had already entered into an agreement with TLS to adopt the BNCT system and install an accelerator-based neutron source in Italy. Now, the new agreement completes the collaboration, including the drug development as well. Prof. Gianluca Vago , CNAO President, commented: “ Our mission has always been to leverage cutting-edge technologies to expand treatment opportunities for the benefit of cancer patients. Being chosen by TLS for such an important collaboration is a further recognition of CNAO's expertise in particle therapies, both in clinical and research activities. For this project, our center will work in close cooperation with University of Pavia, Polytechnic University of Milan, National Institute for Nuclear Physics and Fondazione IRCCS Policlinico San Matteo of Pavia. The partnership with TLS will enable us to open up new frontiers in BNCT and make CNAO a unique facility in the world to combine treatments with protons, heavy ions (carbon ions and other species) and neutrons.” Planned Milestones and Key Objectives: Installation and Clinical Trials: The installation of TLS’s Alphabeam ® BNCT system at CNAO is scheduled to begin in 2025, with clinical trials launching in 2026. The initial trials will leverage Steboronine ® (Boronophenylalanine, BPA)—an boron drug developed by Stella Pharma for BNCT and distributed by TLS in Europe and the US. Steboronine® selectively accumulates boron in cancer cells and is already approved in Japan for recurrent head and neck cancers, the focus of these first trials. Advancing Cancer Treatment: The collaboration is poised to expand the clinical applications of BNCT to address a wide range of cancers, including metastatic cancers, offering new hope for patients worldwide. CNAO NEXT Services: The partnership includes efforts to promote the range of services offered by CNAO NEXT, an independent company set up by CNAO, which operates in the field of precision therapies, providing technical and clinical consultancy and assisting other centers in implementing particle therapies. A significant aspect of the collaboration involves the clinical implementation and commercialization of new TLS BNCT drugs, such as Boronotyrosine (BTS), which has shown promising preclinical results in animal models. “ Our partnership with CNAO marks a transformative step in advancing BNCT as a next-generation cancer therapy,” said Rob Hill , CEO of TAE Life Sciences. “ Together, we aim to push the boundaries of cancer treatment and provide groundbreaking solutions to patients who need them most.” Additionally, prof. Lisa Licitra, Scientific Director of CNAO, Chief of Head and Neck Cancer Medical Oncology Dept at Fondazione IRCCS Istituto Nazionale dei Tumori, Associate Professor at the University of Milan, has joined the TLS Clinical Advisory Board as an internationally recognized leader in head and neck oncology. She will serve as leading oncologist for the BNCT clinical trials at CNAO focusing on head and neck cancer and will oversee the clinical trial at CNAO, further strengthening the collaboration’s scientific foundation. Prof. Lisa Licitra , Scientific Director of CNAO, affirmed: “ BNCT has demonstrated compelling responses for recurrent or refractory tumours, such as head and neck cancers. Therefore, working with Prof. Ester Orlandi, Head of CNAO Clinical Department, we will initially focus on patients with this type of tumours. With the introduction of BNCT, we can reduce treatment to 1-2 sessions, expand therapeutic indications and potentially offer new hope to patients with metastatic tumours. Our goal will be to offer increasingly customized therapeutic options, by having at our disposal a wide range of particles: not only protons and carbon ions but also neutrons for BNCT, helium and oxygen.” About TAE Life Sciences: TAE Life Sciences is a privately held biotechnology company committed to developing a new biologically targeted radiation therapy based on Boron Neutron Capture Therapy (BNCT). TAE Life Sciences is the only company developing the next-generation targeted boron drugs and low-energy accelerator-based neutron system optimized for an in-hospital BNCT program that delivers cancer-killing radiation with cellular-level precision to treat patients with aggressive and refractory cancers. TAE Life Sciences’ Alphabeam™ BNCT system and proprietary boronated drugs are still in the investigational stage, and not available commercially. More information about TAE Life Sciences is available at taelifesciences.com . About CNAO: The National Center for Oncological Hadrontherapy (CNAO), located in Pavia, Italy, is one of the only six centers in the world able to perform hadrontherapy with both protons and carbon ions and has treated about 5,500 oncological patients, working in the particle therapy field for 15 years. CNAO mission is to be at the forefront of providing cutting-edge cancer therapies with the goal of offering highly targeted, precision treatments for patients with complex and rare cancers. CNAO is dedicated to advancing research and clinical applications of hadrontherapy, making a significant contribution to the improvement of cancer care, also through the establishment of a network of national and international collaborations. More information about CNAO is available at https://fondazionecnao.it/en/ .

IRVINE, Calif.--( BUSINESS WIRE )--TAE Life Sciences (TLS), a leader in developing boron neutron capture therapy (BNCT) technology and associated innovative boron target drugs, and Stella Pharma, the pioneering developer of boronophenylalanine (BPA) under the product name Steboronine® for BNCT, are pleased to announce a strategic collaboration focused on the development, commercialization and expansion of BNCT using BPA in the United States and European markets. Stella Pharma’s BPA drug is the world’s first and only clinically approved boron drug for BNCT, marking a breakthrough in cancer treatment. Japan became the first country to approve BNCT for the treatment of head and neck cancers, using Stella Pharma’s pioneering BPA drug. Now, Stella Pharma, as the leading producer and supplier of BPA, has joined forces with TAE Life Sciences to expand the adoption of BNCT worldwide. Supporting the Future of BNCT Therapy The collaboration objectives include extensive international cooperation in the development and commercialization of BNCT and BPA across the USA and Europe with clinical trials anticipated to begin in 2026. TLS will serve as the exclusive commercial partner for Stella Pharma’s BPA in these regions, representing a significant expansion of BNCT accessibility outside of Asia. “ Our partnership with Stella Pharma combines our shared commitment to advancing BNCT as a viable cancer treatment for patients worldwide,” said Rob Hill, CEO of TAE Life Sciences. “ We are excited to bring the proven benefits of BPA to U.S. and European healthcare institutions and to support BNCT globally with this powerful therapeutic solution.” Both companies have also committed to supporting BNCT equipment vendors across all markets in implementing BPA-based BNCT treatments. By fostering partnerships within the BNCT ecosystem, TLS and Stella Pharma aim to enhance the clinical reach of BNCT in treating recurrent head and neck cancers and advancing clinical studies for other cancers, including brain, skin, breast, esophagus, and lung cancers. “ Our alliance with TAE Life Sciences marks a significant step in expanding the reach of BPA-based BNCT treatments beyond Asia,” said Koki Uehara, President and Chief Operating Officer of Stella Pharma. “ We look forward to collaborating internationally to develop and commercialize BNCT and aim to deliver these advancing cancer treatments to patients and their families worldwide.” Exploring Future Opportunities Together Stella Pharma and TAE Life Sciences share a vision of advancing BNCT treatment for hard-to-treat cancers and pledge to explore additional areas for collaboration. Through this alliance, they seek to accelerate innovation, expand treatment options, and ultimately improve outcomes for cancer patients worldwide.