Oligometastatic Disease

Agreement will supply Tb-161 for RAD 402, a potential next generation radiopharmaceutical for treatment of advanced prostate cancerSYDNEY, Australia, Aug. 24, 2023 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a developer of radiopharmaceutical products for both diagnostic and therapeutic uses, is pleased to announce an expanded agreement with TerThera to supply the Company with Terbium-161 (Tb-161). The Tb-161 isotope will be linked to a proprietary monoclonal antibody (mAb) to form RAD 402, a radiotherapeutic that is being developed by Radiopharm to target KLK3 expression. KLK3 is highly expressed in prostate cancer cells but has limited expression in healthy tissue. Radiopharm will initiate a Phase I dose escalating trial evaluating the safety and efficacy of RAD 402 in patients with advanced prostate cancer, during the second half of 2024. “We are excited about bringing this highly differentiated technology (Tb161-RAD402) to patients with advanced prostate cancer. Until now, Prostate-Specific Membrane Antigen (PSMA) targeting agents represent the only theranostic option in the market or in development. RAD has decided to leverage a different mechanism of action by targeting KLK3, and the combination with Tb-161 is unique and highly promising,” said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. “Tb-161 has shown superior preclinical results in comparison with Lu-177, which may translate into higher absorbed doses in micrometastatic disease, with less kidney toxicity. This novel radiopharmaceutical has the potential to become the first KLK-based theranostic option for individuals with advanced prostate cancer. We signed a first agreement with TerThera in April 2023 for RAD 602 in brain cancer and now we have decided to amplify, developing a second molecule linked with Terbium-161. We are the first company that has access to Terbium-161 for the clinical development of two different molecules. This is a really exciting innovation!” Terbium-161 is a highly promising isotope for targeted cancer treatment due to its unique characteristics of radiation emitted, which includes both Auger electrons and short-range beta particles. The beta radiation travels only a few millimeters and Auger electron emission has a higher linear energy transfer that travels less than the width of a single cell. Tb‑161 has shown excellent bioequivalence presenting a biodistribution comparable to currently used radiolanthanides and is potentially superior to Lutetium-177 (Lu-177) due to Auger effect increasing potency and efficacy in selectively destroying tumor cells while leaving surrounding healthy tissue largely unaffected.1,2 “TerThera is positioned to meet the growing global demand for radioisotopes in oncology by providing a highly sustainable and uninterrupted supply of Terbium-161, a radionuclide that could potentially be positioned right in between conventional Beta- energy emitting therapeutic radionuclides and Alpha energy emitting therapeutic radionuclides. The properties of Tb-161 should make it one of the radionuclides of choice within the current and future theranostic landscape,” said Philippe van Overeem, CEO of TerThera. “We are proud to partner with Radiopharm Theranostics to supply their innovative radioligand pipeline and to help enable development of a new generation of therapeutic radiopharmaceuticals.” The costs associated with the purchase of Tb-161 are not material in relation to RAD’s annual budgeted expenditure and will be met from existing funds. The initial order with TerThera is expected to occur during Q4 2023. The effective date of the supply agreement is 28 August 2023 and there are no material preconditions. The supply agreement is for an initial period of 3 years and may be extended for additional two years, unless agreed otherwise by either party. Cancellation provisions are at industry standard rates. Radiopharm will own all data generated and all inventions and discoveries made or conceived from its clinical trials. About TerThera BV TerThera is a radionuclide production focussed company based in The Netherlands. The founders and staff of TerThera have decades of experience in the nuclear medicine industry and are giving their full focus on the production of the innovative radionuclide Terbium-161 (Tb-161). TerThera is building a global platform to meet the growing demand for radionuclides in oncology and nuclear medicine. About Radiopharm Theranostics Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm has been listed on ASX (RAD) since November 2021. The company has a pipeline of six distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer, in pre-clinical and clinical stages of development from some of the world’s leading universities and institutes. The pipeline has been built based on the potential to be first to market or best in class. The clinical program includes one Phase II and three Phase I trials in a variety of solid tumour cancers including breast, kidney and brain. Learn more at RadiopharmTheranostics.com. Authorised on behalf of the Radiopharm Theranostics board of directors by Executive Chairman Paul Hopper. For more information: Riccardo CanevariCEO & Managing DirectorP: +1 862 309 0293E: rc@radiopharmtheranostics.com Timothy McCarthyLifeSci Advisors, LLCP: +1 917 679 9282E: tim@lifesciadvisors.com Paul Hopper Executive Chairman P: +61 406 671 515 E: paulhopper@lifescienceportfolio.com MediaMatt WrightNWR CommunicationsP: +61 451 896 420E: matt@nwrcommunications.com.au Follow Radiopharm Theranostics: Website – https://radiopharmtheranostics.com/ Twitter – https://twitter.com/TeamRadiopharm Linked In – https://www.linkedin.com/company/radiopharm-theranostics/ References———————————————————1 McNeil, S.W., Van de Voorde, M., Zhang, C. et al. EJNMMI radiopharm. chem. 7, 31 (2022).2 Müller C, Umbricht C, Gracheva N, Tschan V, Pellegrini G, Bernhardt P, et al. Eur J Nucl Med Mol Imaging. 2019;46(9):1919–30.

First cancer center in Oklahoma and fourth VA medical center to offer advanced MRI-guided radiation therapy to treat cancer. DENVER, June 13, 2023 /PRNewswire/ -- ViewRay, Inc. (Nasdaq: VRAY) announced today that the VA Oklahoma City Healthcare System has selected MRIdian MRI-guided radiation therapy system to expand radiation therapy services at the Oklahoma City VA Medical Center. This will be the first cancer center in Oklahoma and the fourth VA medical center offering Veterans access to MRIdian's advanced MRI-guided radiation therapy to treat cancer. The MRIdian system will enable the Oklahoma City VA Medical Center to provide precision MRI-guided radiation therapy technology to Veterans seeking personalized treatment for a broad range of cancer, including pancreas, prostate, lung, liver, breast, and oligometastatic disease. Other VA medical centers that will be offering MRIdian MRI-guided radiation therapy include Louis Stokes Cleveland Medical Center (VA Northeast Ohio Healthcare System), Lt. Colonel Charles S. Kettles VA Medical Center (VA Ann Arbor Healthcare System), and Michael E. DeBakey Medical Center (VA Houston Healthcare system). The Veterans Health Administration is America's largest integrated healthcare system, providing care at 1,298 healthcare facilities, including 171 medical centers. The VA is leading the fight against cancer through precision oncology by developing and applying new technologies, tools, research knowledge, and best-practice therapies. Their scientific and medical breakthroughs are shared inside and outside their healthcare system to benefit Veterans and all Americans. "ViewRay is proud to be working with VA Oklahoma City Healthcare System, a talented group of clinicians committed to bringing patients the benefit of precise and personalized radiation therapy," said Paul Ziegler, ViewRay Executive Vice President and CCO. "We are excited to see another VA healthcare system join the growing MRIdian community. Expanding the availability of MRIdian's short-course non-invasive therapy with fewer side effects and better quality of life is an important advancement for our Veterans." The MRIdian system provides oncologists with outstanding anatomical visualization through diagnostic-quality MR images and the ability to adapt a radiation therapy plan to the targeted cancer with the patient on the table. This combination allows physicians to define tight treatment margins to avoid unnecessary radiation exposure of vulnerable organs-at-risk and healthy tissue and allows the delivery of ablative radiation doses in five or fewer treatment sessions without relying on implanted markers. MRIdian enables automatic gating of the radiation beam if the target moves outside the user-defined margins by providing continuous real-time tracking of the target and organs at risk. This allows for delivering the prescribed dose to the target while sparing surrounding healthy tissue and critical structures. This results in minimizing toxicities typically associated with conventional radiation therapy. To date, over 31,000 patients have been treated with MRIdian. Currently, 62 MRIdian systems are installed at hospitals around the world, where they are used to treat a wide variety of solid tumors and are the focus of numerous ongoing research efforts. MRIdian has been the subject of hundreds of peer-reviewed publications, scientific meeting abstracts, and presentations. For a list of treatment centers, please visit: Disclaimer: Nothing in this material is intended to provide specific medical advice or to take the place of written law or regulations. Safety Statement The MRIdian Linac System is not appropriate for all patients, including those who are not candidates for magnetic resonance imaging. Radiation treatments may cause side effects that can vary depending on the part of the body being treated. The most frequent ones are typically temporary and may include, but are not limited to, irritation to the respiratory, digestive, urinary, or reproductive systems; fatigue; nausea; skin irritation; and hair loss. In some patients, side effects can be severe. Treatment sessions may vary in complexity and duration. Radiation treatment is not appropriate for all cancers. You should discuss the potential for side effects and their severity as well as the benefits of radiation and magnetic resonance imaging with your doctor to make sure radiation treatment is right for you. About ViewRay ViewRay, Inc. (Nasdaq: VRAY) designs, manufactures, and markets the MRIdian® MRI-Guided Radiation Therapy System. MRIdian is built upon a proprietary high-definition MR imaging system designed from the ground up to address the unique challenges and clinical workflow for advanced radiation oncology. Unlike MR systems used in diagnostic radiology, MRIdian's high-definition MR was purpose-built to address specific challenges, including beam distortion, skin toxicity, and other concerns that potentially may arise when high magnetic fields interact with radiation beams. ViewRay and MRIdian are registered trademarks of ViewRay, Inc. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Private Securities Litigation Reform Act. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, ViewRay's financial guidance for the full year 2023, anticipated future orders, anticipated future operating and financial performance, treatment results, therapy adoption, innovation, and the performance of the MRIdian systems. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to commercialize the MRIdian Linac System, demand for ViewRay's products, the ability to convert backlog into revenue, the timing of delivery of ViewRay's products, the timing, length, and severity of the COVID-19 pandemic, including its impacts across our businesses on demand, our operations and global supply chains, the results and other uncertainties associated with clinical trials, the ability to raise the additional funding needed to continue to pursue ViewRay's business and product development plans, the inherent uncertainties associated with developing new products or technologies, competition in the industry in which ViewRay operates, and overall market conditions. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to ViewRay's business in general, see ViewRay's current and future reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2022 and its Quarterly Reports on Form 10-Q, as updated periodically with the Company's other filings with the SEC. These forward-looking statements are made as of the date of this press release, and ViewRay assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. SOURCE ViewRay, Inc.

TUESDAY, May 2, 2023 -- A patient-centered, multidisciplinary approach is strongly recommended for decision-making regarding treatment for oligometastatic non-small cell lung cancer (NSCLC), according to a clinical practice guideline issued jointly by the American Society for Radiation Oncology and European Society for Radiotherapy and Oncology and published online April 25 in Practical Radiation Oncology . Puneeth Iyengar, M.D., Ph.D., from UT Southwestern in Dallas, and colleagues addressed five key questions relating to use of local and systematic therapy in the management of oligometastatic NSCLC. Recommendations were based on a systematic literature review. The authors note that a patient-centered, multidisciplinary approach is strongly recommended for all decision-making regarding potential treatment based on a lack of significant randomized phase 3 trials. Definitive local therapy integration is relevant if technically feasible and clinically safe to all disease sites (five or fewer). Definitive local therapies are conditionally recommended in synchronous, metachronous, oligopersistent, and oligoprogressive conditions for extracranial disease. The only primary definitive local therapy modalities recommended for use in management of oligometastatic disease are radiation and surgery ; indications are provided for choosing one over the other. For systemic and local therapy integration, sequencing recommendations are provided. Recommendations are also provided for optimal technical use of hypofractionated radiation or stereotactic body radiation therapy as definitive local therapy. "Despite the widespread enthusiasm in the field of oligometastatic disease, the quality of evidence supporting the integration of definitive local therapy into a multimodality treatment strategy is still lower as compared to indications such as locally advanced NSCLC," a coauthor said in a statement. "To compensate for this lack of highest-quality evidence, recommendations of this guideline were established by a broad consensus." Several authors disclosed financial ties to the pharmaceutical industry. Abstract/Full Text (subscription or payment may be required) Posted May 2023