Brain Cancer

Phase 2b study evaluating diagnostic performance of 18F-RAD101 for suspected recurrent brain metastases from solid tumors of different origins Underscores Radiopharm’s commitment to developing transformative oncology radiopharmaceuticals April 28, 2025 -- Radiopharm Theranostics (ASX:RAD, Nasdaq: RADX, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced the dosing of the first patient in its U.S. Phase 2b imaging study of 18F-RAD101 in suspected recurrent brain metastasis. The U.S. multicenter, open-label, single arm Phase 2b clinical trial1 is evaluating the diagnostic performance of 18F-RAD101 in 30 individuals with confirmed recurrent brain metastases from solid tumors of different origins. The primary objective of the study is concordance between 18F-RAD101 positive lesions and those seen in conventional imaging (MRI with gadolinium) in participants with suspected recurrent brain metastases. RAD101 is a novel imaging small molecule that targets fatty acid synthase (FASN), a multi-enzyme protein that catalyses fatty acid synthesis and is overexpressed in many solid tumors, including cerebral metastasis. Disruption of FASN activity allows for the accurate detection of cancer cells, representing a strongly viable target for the imaging of brain metastasis. Positive data from the Imperial College of London’s Phase 2a imaging trial of 18F-RAD101 in patients with brain metastases showed significant tumor uptake that was consistent with and independent from the tumor of origin.2 “We are proud to pioneer the first U.S. clinical trial of RAD101,” said Harshad R. Kulkarni, MD, Chief Medical Advisor at BAMF Health and Principal Investigator of this Phase 2b study. “This marks an important step toward improving diagnostic precision and enabling more evidence-based, individualized treatment decisions for patients with brain metastases following stereotactic radiosurgery.” “This trial is an excellent illustration of BAMF Health’s clinical trials platform in action,” added BAMF Health’s Director of Clinical Trials. “Our Radiopharmacy is producing the imaging agent on-site, our clinic team is caring for the patient and providing the best image in the world, and our clinical trials team expertly coordinates it all. BAMF’s facility and team were built to do trials just like this.” “Current standard of care imaging is less sensitive in discriminating between tumor recurrence and radiation necrosis in patients with brain metastasis who have received anticancer treatments, including radiation,” said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics Ltd. “18F-RAD101 has the strong potential to improve diagnostic accuracy of brain metastases, and holds promise for discriminating between treatment effect and true progression in the more than 300,000 patients diagnosed with brain metastasis each year in the U.S. alone. We look forward to advancing this clinical trial and to reporting topline data in the second half of 2025.” 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 is listed on ASX (RAD) and on NASDAQ (RADX). The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer. The clinical program includes one Phase 2 and three Phase 1 trials in a variety of solid tumor cancers including lung, breast, and brain. Learn more at radiopharmtheranostics.com. BAMF Health is the world’s first vertically integrated platform for intelligence-based precision medicine. Headquartered in Grand Rapids, Michigan, BAMF Health employs the most advanced theranostic imaging technology to detect and treat cancer and other diseases and conduct advanced clinical trials. Our overriding mission is to empower patients to become people again. With a team of data scientists, researchers, software engineers, and clinicians —all working in lockstep—we’re making good on it. To learn more about BAMF Health, visit www.bamfhealth.com._______________________ 1 https://www.clinicaltrials.gov/study/NCT06777433 2 S. Islam et. Al., EJNMMI; 07 February 2025. https://doi-org.sutd.idm.oclc.org/10.1007/s00259-025-07118-0 The content above comes from the network. if any infringement, please contact us to modify.

STOCKHOLM, May 3, 2025 /PRNewswire/ -- At this week's ESTRO conference in Vienna, RaySearch Laboratories AB (publ) and Vision RT proudly announces the next step in their collaboration: the full integration of MapRT with RayStation®* treatment planning system. This integration enables full access to the MapRT clearance map in RayStation to guide the user during treatment planning in choosing beam trajectories clear from collisions between the treatment unit, patient and couch. During CT simulation, MapRT cameras capture the entire surface of the patient, along with any immobilization accessories. The MapRT software then analyzes this data, alongside models of the treatment couch and machine, to identify safe gantry and couch angles which are represented by a clearance map that is immediately accessible in RayStation. The integration is designed to optimize beam options for better plans and minimize the need for dry runs. This is particularly important for treatment plans where the couch is rotated. Recent studies have demonstrated that non-coplanar treatments can significantly improve treatment plans for several cancers, including lung1,2,3,4, breast5,6,7,8, head and neck cancers9,10,11,12,13, lymphoma14,15, and high-grade glioma16. These treatments can offer clinically relevant benefits, such as improved organ-at-risk dose sparing. Helen Convery, Senior Dosimetrist (Development & Clinical Trials), who has tested the integration, says: "We have used MapRT at Raigmore Hospital since 2022 and have found it invaluable for checking for collision on all plans and optimizing non-coplanar plan angles. I think the integration into RayStation is of significant value and I can see it further streamlining and improving the efficiency of our workflow." Thomas Carter, VP of Marketing, Vision RT, adds: "We are already seeing clinics changing their planning techniques, allowing their patients to benefit from the extra beam options MapRT provides. This integration has the potential to streamline workflows, reduce errors, and free up resources, all while improving treatment predictability. It also opens the path for automated, collision-free planning." Björn Hårdemark, Deputy CEO, RaySearch: "Surface scanning is an excellent source of information about the most central aspect of radiation therapy – the patient. The tight integration between MapRT and RayStation makes this information available already during treatment planning, allowing the user to explore more creative beam configurations while maintaining clearance around the patient. It is a great example of how clinical benefit can be achieved through collaboration between radiation therapy technology vendors." MapRT is approved for CE marking and clinical distribution in the EU and UK. A version without the API is currently cleared for sale in the USA, with API version 510(k) pending. About Vision RT Vision RT is the inventor of Surface Guided Radiation Therapy (SGRT) which uses camera systems to track surface data, to offer more guidance across every step of the radiotherapy workflow: simulation, planning, treatment and dose visualization. We work tirelessly to improve the accuracy, efficiency, safety and comfort of radiation therapy. Vision RT is part of the William Demant Invest (WDI) family, a leading Danish Medtech investor with a long-term investment perspective. The companies in WDI employ more than 21,000 people. About RaySearch RaySearch Laboratories AB (publ) is a medical technology company that develops innovative software solutions for improved cancer treatment. RaySearch markets the RayStation®* treatment planning system (TPS) and the oncology information system (OIS) RayCare®*. The most recent additions to the RaySearch product line are RayIntelligence® and RayCommand®*. RayIntelligence is an oncology analytics system (OAS) which enables cancer clinics to collect, structure and analyze data. RayCommand, a treatment control system (TCS), is designed to link the treatment machine and the treatment planning and oncology information systems. RaySearch's software has been sold to over 1,100 clinics in 47 countries. The company was founded in 2000 as a spin-off from the Karolinska Institute in Stockholm and the share has been listed on Nasdaq Stockholm since 2003. More information is available at raysearchlabs.com. About RayStation RayStation®* is a flexible, innovative treatment planning system, chosen by many leading cancer centers worldwide. It combines unique features such as unmatched adaptive therapy capabilities, multi-criteria optimization, market-leading algorithms for treatment plan optimization for HDR brachytherapy and external beam therapy with photons, electrons, and protons, as well as helium and carbon ions. RayStation supports a wide range of treatment machines, providing one control center for all treatment planning needs and ensuring centers get greater value from existing equipment. RayStation also seamlessly integrates with RayCare®*. By harmonizing the treatment planning, the care of cancer patients worldwide is improved. * Subject to regulatory clearance in some markets. For more information, please contact: Johan Löf, founder and CEO, RaySearch Laboratories AB (publ) Telephone: +46 (0) 8 510 530 00 [email protected]  Learn more about us on: LinkedIn YouTube [1] Ma M, Ren W, Li M, Niu C, Dai J. Dosimetric comparison of coplanar and non-coplanar beam arrangements for radiotherapy of patients with lung cancer: A meta-analysis. J Appl Clin Med Phys. 2021 Apr;22(4):34-43. doi: 10.1002/acm2.13197. Epub 2021 Feb 26. PMID: 33634946; PMCID: PMC8035566. [2] Kim ST, An HJ, Kim JI, Yoo JR, Kim HJ, Park JM. Non-coplanar VMAT plans for lung SABR to reduce dose to the heart: a planning study. Br J Radiol. 2020 Jan;93(1105):20190596. doi: 10.1259/bjr.20190596. Epub 2019 Oct 22. PMID: 31625759; PMCID: PMC6948076. [3] Lincoln JD, MacDonald RL, Syme A, Thomas CG. Static couch non-coplanar arc selection optimization for lung SBRT treatment planning. Phys Med Biol. 2023 Jul 21;68(15). doi: 10.1088/1361-6560/ace23f. PMID: 37369237. [4]Chapet O, Khodri M, Jalade P, N'guyen D, Flandin I, D'hombres A, Romestaing P, Mornex F. Potential benefits of using non-coplanar field and intensity modulated radiation therapy to preserve the heart in irradiation of lung tumors in the middle and lower lobes. Radiother Oncol. 2006 Sep;80(3):333-40. doi: 10.1016/j.radonc.2006.07.009. Epub 2006 Aug 24. PMID: 16934354. [5] J, F., et al. (2023). Locoregional breast radiotherapy including IMN: optimizing the dose distribution using an automated non-coplanar VMAT-technique. Acta oncologica (Stockholm, Sweden), [online] 62(10). doi:. [6] Xu, Y., Ma, P., Hu, Z., Tian, Y., Men, K., Wang, S., Xu, Y. and Dai, J. (2021). Non-coplanar volumetric modulated arc therapy for locoregional radiotherapy of left-sided breast cancer including internal mammary nodes. Radiology and Oncology, 55(4), pp.499–507. doi:. [7] A, B., et al. (2023). Dosimetric Comparision of Coplanar versus Non-coplanar Volumetric Modulated Arc Therapy for Treatment of Bilateral Breast Cancers. Journal of medical physics, [online] 48(3). doi:. [8] Biau J, Lopez L, Thivat E, Casile M, Millardet C, Saroul N, Pham-Dang N, Molnar I, Bourhis J, Lapeyre M. Postoperative SBRT in the treatment of early-stage oropharyngeal and oral cavity cancers with high-risk margins: A dosimetric comparison of volumetric modulated arc therapy with or without non-coplanar arcs and acute toxicity outcomes from the STEREOPOSTOP GORTEC 2017-03 phase 2 trial. Clin Transl Radiat Oncol. 2022 Nov 14;38:169-174. doi: 10.1016/j.ctro.2022.11.07. PMID: 36466746; PMCID: PMC9712819. [9]Woods KE, Ma TM, Cook KA, Morris ED, Gao Y, Sheng K, Kishan AU, Hegde JV, Felix C, Basehart V, Narahara K, Shen Z, Tenn S, Steinberg ML, Chin RK, Cao M. A Prospective Phase II Study of Automated Non-Coplanar VMAT for Recurrent Head and Neck Cancer: Initial Report of Feasibility, Safety, and Patient-Reported Outcomes. Cancers (Basel). 2022 Feb 14;14(4):939. doi: 10.3390/cancers14040939. PMID: 35205686; PMCID: PMC8870161. [10] Gayen S, Kombathula SH, Manna S, Varshney S, Pareek P. Dosimetric comparison of coplanar and non-coplanar volumetric-modulated arc therapy in head and neck cancer treated with radiotherapy. Radiat Oncol J. 2020 Jun;38(2):138-147. doi: 10.3857/roj.2020.00143. Epub 2020 May 26. PMID: 33012157; PMCID: PMC7533406. [11] Gayen S, Kombathula SH, Manna S, Varshney S, Pareek P. Dosimetric comparison of coplanar and non-coplanar volumetric-modulated arc therapy in head and neck cancer treated with radiotherapy. Radiat Oncol J. 2020 Jun;38(2):138-147. doi: 10.3857/roj.2020.00143. Epub 2020 May 26. PMID: 33012157; PMCID: PMC7533406. [12] Subramanian VS, Subramani V, Chilukuri S, Kathirvel M, Arun G, Swamy ST, Subramanian K, Fogliata A, Cozzi L. Multi-isocentric 4π volumetric-modulated arc therapy approach for head and neck cancer. J Appl Clin Med Phys. 2017 Sep;18(5):293-300. doi: 10.1002/acm2.12164. Epub 2017 Aug 20. PMID: 28834021; PMCID: PMC5874945. [13] Wild, E., Bangert, M., Nill, S. and Oelfke, U. (2015). Non-coplanar VMAT for nasopharyngeal tumors: Plan quality versus treatment time. Medical Physics, 42(5), pp.2157–2168. doi:. [14] Rossi L, Cambraia Lopes P, Marques Leitão J, Janus C, van de Pol M, Breedveld S, Penninkhof J, Heijmen BJM. On the Importance of Individualized, Non-Coplanar Beam Configurations in Mediastinal Lymphoma Radiotherapy, Optimized With Automated Planning. Front Oncol. 2021 Apr 15;11:619929. doi: 10.3389/fonc.2021.619929. PMID: 33937025; PMCID: PMC8082440. [15] Chen X, Jin D, Wang S, Li M, Huang P, Dai J. Non-coplanar intensity-modulated radiation therapy for young female patients with mediastinal lymphoma. J Appl Clin Med Phys. 2012 Nov 8;13(6):3769. doi: 10.1120/jacmp.v13i6.3769. PMID: 23149772; PMCID: PMC5718536. [16] Yu VY, Landers A, Woods K, Nguyen D, Cao M, Du D, Chin RK, Sheng K, Kaprealian TB. A Prospective 4π Radiation Therapy Clinical Study in Recurrent High-Grade Glioma Patients. Int J Radiat Oncol Biol Phys. 2018 May 1;101(1):144-151. doi: 10.1016/j.ijrobp.2018.01.048. Epub 2018 Jan 31. PMID: 29619962. This information was brought to you by Cision The following files are available for download: SOURCE RaySearch Laboratories WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

TARRYTOWN, N.Y., May 1, 2025 /PRNewswire/ -- Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address oncogenic and immune dysregulation that drive cancer, today announced that data from its Phase 2 clinical trial of lucicebtide (formerly known as ST101), a first-in-class antagonist of C/EBPβ, in patients with glioblastoma will be featured during an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30-June 3, 2025, in Chicago and online. Presentation Details: Title: "Use of lucicebtide (ST101) in glioblastoma patients by antagonism of C/EBPβ-dependent mesenchymal cell transition and immunosuppressive M2 macrophage polarization" Abstract Number: 2016 Session Type and Title: Rapid Oral Abstract – Central Nervous System Tumors Session Date and Time: Saturday, May 31, 2025, 3:00 pm – 4:30 pm CDT Presenting Author: Fabio M. Iwamoto, MD, Division of Neuro-Oncology, New York-Presbyterian/Columbia University Irving Medical Center More information can be found on the 2025 ASCO Annual Meeting website. About Lucicebtide (formerly known as ST101) Lucicebtide, a first-in-class antagonist of C/EBPβ, has completed the main portion of a Phase 2 dose expansion study in recurrent glioblastoma (rGBM) (NCT04478279). An ongoing window-of-opportunity sub-study is evaluating lucicebtide in combination with radiation and temozolomide in patients with newly diagnosed GBM (ndGBM) and as a monotherapy in patients with rGBM, with patients receiving ST101 before and after surgical resection in both cohorts. ST101 has been granted Fast Track designation for rGBM from the U.S. Food and Drug Administration (U.S. FDA) and orphan designations for glioma from the U.S. FDA and the European Commission. About Sapience Therapeutics Sapience Therapeutics, Inc. is a privately held, clinical-stage biotechnology company focused on discovering and developing peptide therapeutics to address oncogenic and immune dysregulation that drive cancer. With in-house discovery capabilities, Sapience has built a pipeline of therapeutic candidates called SPEARs™ (Stabilized Peptides Engineered Against Regulation) that disrupt intracellular protein-protein interactions, enabling targeting of transcription factors which have traditionally been considered undruggable. Sapience can also direct cargo to cell surface targets with their new class of molecule called SPARCs™ (Stabilized Peptides Against Receptors on Cancer), enabling delivery of radioisotope payloads such as α-particles to cancer cells. Sapience is advancing its lead programs, lucicebtide (formerly known as ST101), a first-in-class antagonist of C/EBPβ, and ST316, a first-in-class antagonist of β-catenin, through Phase 2 clinical trials. For more information on Sapience Therapeutics, please visit and engage with us on LinkedIn. SOURCE Sapience Therapeutics, Inc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED