Ankündigung • Apr 20
Radiopharm Theranostics Presents Initial Findings from Phase 1 First-In-Human HEAT Clinical Trial for 177Lu-RAD202 in HER2+ Solid Tumors at American Association for Cancer Research 2026 Radiopharm Theranostics announced that new data from the ongoing Phase 0/1 HEAT trial (NCT06824155), evaluating 177Lu-RAD202, a first-in-class HER2-targeted radiopharmaceutical therapy, will be presented as a poster at the American Association for Cancer Research Annual Meeting 2026, being held April 17–22, 2026 in San Diego, California. 177Lu-RAD202 demonstrated encouraging tumor uptake and a favorable safety profile in the lowest dose cohort. The Data Safety and Monitoring Committee recently approved advancing 177Lu-RAD202 to the next highest dose at 130 mCi. The AACR poster highlights first-in-human safety, biodistribution, dosimetry and tumor uptake clinical findings from the initial lowest dose cohort of three patients with advanced HER2-positive breast and urothelial cancers who had received multiple prior metastatic therapies and were dosed at 30 mCi. Meaningful tumor uptake of 177Lu-RAD202 was observed at the initial and lowest dose level of 30 mCi, particularly in breast cancer lesions. 177Lu-RAD202 was generally well tolerated in the first three treated patients, with predominantly Grade 1–2 treatment-emergent adverse events. No dose-limiting toxicities or treatment discontinuations due to adverse events were observed. Organ-level absorbed radiation doses were within expected and clinically acceptable ranges, supporting continued dose escalation. On April 8, 2026, Radiopharm Theranostics announced the positive recommendation from the Data Safety and Monitoring Committee to advance 177Lu-RAD202 to the third cohort at a dose level of 130 mCi in the Phase 1 ‘HEAT’ clinical trial in patients with HER2-positive advanced solid tumors. 177Lu-RAD202 is a Lutetium-177–labeled single-domain antibody (sdAb) designed to target HER2-expressing tumors. The sdAb format enables deep tumor penetration and rapid systemic clearance, while the beta-emitting isotope 177Lu delivers cytotoxic radiation with potential bystander effects independent of HER2 receptor density. The HEAT trial (HER2-Antibody Therapy with Lutetium-177; (NCT06824155)) is a first-in-human, open-label, multicenter integrated Phase 0/1 study evaluating 177Lu-RAD202 in patients with HER2-positive locally-advanced or metastatic solid tumors. Phase 0 evaluates biodistribution, pharmacokinetics, and radiation dosimetry using an imaging dose. Phase 1 consists of multiple-dose escalation to assess safety, tolerability, tumor targeting, and to determine the recommended Phase 2 dose. RAD202 is a proprietary single-domain monoclonal antibody (sdAb) that targets the Human Epidermal Growth Factor Receptor 2 (HER2)-positive expression in advanced solid tumors. HER2 is overexpressed in breast cancer and several other solid tumors and represents a validated target in oncology. In a previous diagnostic study of ten HER2-positive breast cancer patients, RAD202 demonstrated clinical proof-of-concept and had positive safety and biodistribution. Ankündigung • Apr 08
Radiopharm Theranostics Advances 177Lu-Rad202 to Next Dose Level in Phase 1 Clinical Trial Radiopharm Theranostics announced that it has received a positive recommendation from the Data Safety and Monitoring Committee (DSMC) to advance its clinical-stage radiotherapeutic asset, 177Lu-RAD202 (RAD202), to the next dose level of 130mCi in the Phase 1 ‘HEAT’ clinical trial in patients with Human Epidermal Growth Factor Receptor 2 (HER2)-positive advanced solid tumors. The DSMC is a multidisciplinary committee that conducts detailed reviews of study data, discusses potential safety events and provides recommendations regarding trial continuation. The Phase 1 ‘HEAT’ study is currently being conducted at clinical centers across Australia. The announcement of the previous dose level in this study of 75mCi was released on 1 October 2025. Ankündigung • Mar 27
Radiopharm Theranostics Doses First Patient in Phase 1 Clinical Study of RAD 402 in Advanced Prostate Cancer Radiopharm Theranostics announced that the first patient has been dosed in its first-in-human Phase 1 clinical trial of RAD 402, a monoclonal antibody targeting KLK3 radiolabelled with Terbium 161 being evaluated in advanced prostate cancer. The Phase 1 clinical trial (NCT07259213) is designed to study the safety, tolerability, whole-body distribution, and preliminary clinical activity of RAD 402 in patients with advanced prostate cancer. The dose escalation Phase 1 study is designed to determine the Maximum Tolerated Dose (MTD) and/or recommended phase 2 dose (RP2D) for expansion. Targeting KLK3 and leveraging the dual emission of Tb161 represents an innovative approach for radiotherapies in Prostate Cancer. Preclinical proof-of-concept mouse xenografts demonstrated RAD 402’s strong tumor targeting with minimal bone/marrow uptake and expected hepatic clearance. RAD 402 (NCT07259213) is an anti-KLK3 monoclonal antibody radiolabelled with the radionuclide 161Tb that is being evaluated in a Phase 1/2a clinical trial for the treatment of prostate cancer. Prostate Specific Antigen (PSA) is a widely used biomarker to detect prostate cancer and is encoded by the KLK3 gene. KLK3 is highly expressed in prostate cancer cells along with most adenocarcinomas of the prostate including their metastases and has limited expression in sites outside of the prostrate. Preclinical proof-of-concept biodistribution studies of RAD 402 in mouse xenografts showed strong tumor targeting, limited bone and marrow uptake, and a hepatic excretion profile consistent with expectations for a monoclonal antibody. Ankündigung • Mar 24
Radiopharm Theranostics Limited Achieves Primary Endpoint In 90% Of Patients At Second Interim Analysis Of RAD101 Phase 2b Imaging Trial In Brain Metastases Radiopharm Theranostics Limited announced the second interim data from twenty patients in its U.S. Phase 2b clinical imaging trial of RAD 101 in brain metastases. RAD 101 is Radiopharm's novel, small-molecule imaging agent targeting fatty acid synthase (FASN) and radiolabelled with Fluorine-18 for the diagnosis of suspected recurrent brain metastases from solid tumors of different origins. The second interim analysis showed that 90% (18/20) of the patients dosed with RAD101 achieved concordance between PET imaging and MRI (the primary endpoint). The results showed significant and selective tumor uptake in the brain metastases. Images confirm metabolic activity in brain metastases compared to equivocal MRI findings. In addition, the first five patients with evaluable six-month follow-up and/or biopsy data show a positive trend for sensitivity and specificity (the secondary objectives). Sensitivity and specificity are two of the fundamental hallmarks of any diagnostic test including in imaging. They measure an imaging test's ability to correctly identify patients with a disease (sensitivity, true positive rate), as well as patients without the disease (specificity, true negative rate). RAD 101 has received U.S. Food and Drug Administration (FDA) Fast Track Designation to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origin, including leptomeningeal disease. In the U.S. alone, there are more than 300,000 patients diagnosed annually with cerebral metastases. The incidence of Intracranial Metastatic Disease (IMD) continues to increase, in part, due to improvements in systemic therapy resulting in a more durable control of the primary tumor. Contrast-enhanced Magnetic Resonance Imaging (CE-MRI) is the preferred method for imaging IMD, but has limitations, particularly in follow-up surveillance scans to optimise patient care. The U.S. multicenter, open-label, single arm Phase 2b clinical trial 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. Secondary endpoints are accuracy, sensitivity and specificity of RAD101 in identifying tumor recurrence versus radiation necrosis in previously stereotactic radiosurgery (SRS)-treated brain metastases. RAD101 is the Company's 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. Targeting FASN activity may allow for the more accurate detection of cancer cells, representing a clinically relevant method for the imaging of brain metastases. Positive data from the Imperial College of London's Phase 2a imaging trial of 18F-RAD101 in patients with brain metastases (both SRS pre-treated and treatment na ve patients) showed significant tumor uptake that was independent from the tumor of origin. The study further indicated that PET-MRI may potentially represent a non-invasive prediction of overall-survival, warranting larger studies. Ankündigung • Feb 24
Radiopharm Theranostics Doses First Patient in Phase 1/2a Clinical Study of BetaBart (RV-01) Radiopharm Theranostics announced the dosing of the first patient in its First-In-Human (FIH) Phase 1/2a clinical trial of 177Lu-Betabart (RV-01). The Phase 1/2a clinical trials is a dose escalation and expansion trial of 177Lu-BetaBart, designed to evaluate its safety, biodistribution and radiation dosimetry of 177Lu-BetaBART, along with its preliminary anti-tumor activity. The trial will also determine the recommended dose of 177Lu-BetaB art for future studies. This agent was developed by Radiopharm Ventures, a joint venture between Radiopharm and The University of Texas MD Anderson Cancer Center. 177Lu-Betabart is a Lu177-tagged engineered monoclonal antibody, designed with a strong affinity for the 4Ig isoform of B7-H3. In preclinical studies, 177Lu-BetaBart has shown evidence of efficacy and targeting of the specific 4Ig isoform ofB7-H3, supporting its potential use in multiple indications, including prostate, pancreatic, breast and other solid tumors. RV-01 is the first radiopharmaceutical therapeutic agent developed by Radiopharm Venture, the Joint Venture formed between Radiopharm Theranostics and The University of Texas MDAnderson Cancer Center. RV-01 is a 177Lutetium-conjugated therapeutic that targets B7-H3, an immune checkpoint molecule that is overexpressed in several tumor types. Multiple preclinical studies with RV-01 have shown tumor shrinkage and prolonged survival in animals treated with the radiotherapeutic agent. The FIH Phase 1/2a study (NCT07189871) is designed to establish the safety profile, biodistribution, pharmacokinetics, and radiation dosimetry of177Lu-Betabart (RV-01). The study aims to enroll 61 eligible participants who have a documented history of histopathologically confirmed castrate resistant prostate cancer, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell cancer, cervical cancer, endometrial cancer, triple negative breast cancer, or esophageal squamous cell carcinoma. Ankündigung • Dec 17
Radiopharm Theranostics Limited has filed a Follow-on Equity Offering. Radiopharm Theranostics Limited has filed a Follow-on Equity Offering.
Security Name: American Depositary Shares
Security Type: Depositary Receipt (Common Stock)
Transaction Features: Subsequent Direct Listing Ankündigung • Dec 16
Radiopharm Theranostics Achieves Primary Endpoint in 92% of Patients At Interim Analysis of RAD 101 Phase 2b Imaging Trial in Brain Metastases Radiopharm Theranostics announced interim data from the first twelve patients in its U.S. Phase 2b clinical imaging trial of RAD 101 in brain metastases. RAD 101 is Radiopharm's novel, small-molecule imaging agent targeting fatty acid synthase (FASN) and radiolabelled with Fluorine-18 for the diagnosis of suspected recurrent brain metastases from solid tumors of different origins, also known as the Pivalate technology. The interim analysis showed that 92% (11/12) of the patients treated with RAD 101 achieved concordance with MRI (the primary endpoint) as assessed by PET imaging of brain metastases. "Integrating RAD 101 PET (Pivalate) with standard MRI has the potential to transform patient management and enable better treatment decisions for the more than 300,000 patients in the U.S. diagnosed with brain metastases each year. Independent commercial assessments estimate RAD 101's U.S. market opportunity at more than $500 million annually, positioning it to become one of the top three imaging agents in the market." The Company recently achieved 50% patient enrollment in the Phase 2b trial evaluating RAD 101 imaging in brain metastases and RAD 101 has received U.S. Food and Drug Administration (FDA) Fast Track Designation to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origin, including leptomeningeal disease. In the U.S. alone, there are more than 300,000 patients diagnosed annually with cerebral metastases. The incidence of Intracranial Metastatic Disease (IMD) continues to increase, in part, due to improvements in systemic therapy resulting in a more durable control of the Primary tumor. Concordance definition: "Agreement or correlation between MRI and Pivalate images".rast-enhanced Magnetic Resonance Imaging (CE-MRI) is the preferred method for imaging IMD, but has limitations, particularly in follow-up surveillance scans to optimise patient care. Ankündigung • Nov 18
Radiopharm Theranostics Announces 50% Enrollment in Phase 2B Clinical Trial of Rad101 Imaging in Brain Metastases Radiopharm Theranostics announced that the Phase 2b trial evaluating RAD101 imaging in brain metastases has achieved 50% patient enrollment threshold. RAD101 is the Company's 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 Brain metastases. These promising early results are in line with the previously published Phase 2a results and, if confirmed, will trigger the preparation of a multi-center, global Phase 3 registrational trial. In the U.S. alone, there are more than 300,000 patients diagnosed annually with cerebral metastases. The incidence of Intracranial Metastatic Disease (IMD) continues to increase, in part, due to improvements in systemic therapy resulting in a more durable control of the Primary tumor. Contrast-enhanced Magnetic Resonance Imaging (CE-MRI) is the preferred method for imaging IMD, but has limitations, particularly in follow-up surveillance scans to optimise patient care. RAD101 has received U.S. Food and Drug Administration (FDA) Fast Track Designation to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origin including leptomeningeal disease. The U.S. multicenter, open-label, single arm Phase 2b clinical trial 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. Secondary endpoints are accuracy, sensitivity and specificity of RAD101 in identifying tumor recurrence versus radiation necrosis in previously stereotactic radiosurgery (SRS)-treated brain metastases. About RAD101 is the Company's Novel imaging small molecule that targets fatty Acid synthase (FASN) a multi-enzymeprotein that cat analyses fatty acid synthesis and is overexressed in many solid tumors,including cerebral metastases. Targeting FASN activity may allow for the more accurate detection of cancer cells, representing a clinically relevant method for the imaging of brain metastases. Positive data from the Imperial College of London's Phase 2a imaging trial of 18F-RAD 101 in patients with brain metastases (both SRS pre-treated and treatment naive patients) showed significant tumor uptake that was independent from the tumor of origin. The study further indicated that PET-MRI may potentially represent a non-invasive prediction of overall- survival, issuing larger studies. Ankündigung • Nov 13
Radiopharm Theranostics Starts Enrollment of Third Cohort of Phase 1 Dose Escalation Clinical Trial of 177Lu-RAD204 Radiopharm Theranostics announced the completion of enrollment for the second cohort of patients in the Phase 1 dose escalation trial of 177Lu-RAD204 in PD-L1 positive advanced cancers, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), triple-negative breast cancer (TNBC), cutaneous melanoma, head and neck squamous cell carcinoma (HNSCC) and endometrial cancer. The open-label Phase 1 trial, entitled "Phase 0/1 Study of the Safety and Tolerability of 177Lu-RAD 204, a Lutetium-177 Radiolabelled Single Domain Antibody Against Programmed Cell Death-Ligand 1 in Patients with Metastatic Solid Tumors," is a first-in-human study to evaluate the safety, tolerability, biodistribution, radiation dosimetry and preliminary anti-tumour activities of 177Lu-RAD2041 in eligible individuals with PD-L1 expressing advanced cancers. RAD204 is a single-domain monoclonal antibody (sdAb) that targets PD-L1, a protein that helps control the immune system and is overexpressed in many solid cancers, making it an attractive therapeutic target in multiple tumor types, including NSCLC, SCLC, TNBC, Cutaneous Melanoma, HNSCC, and Endometrial Cancer. Previously published Phase 1 imaging data of 16 NSCLC patients with 19Tc-RAD204 demonstrated that the diagnostic compound is safe and is associated with acceptable dosimetry2. Tumor targeting with radioimmunotherapies such as 177Lu-RAD204 has the potential to address resistance mechanisms to current standard-of-care treatment options. Ankündigung • Oct 23
Radiopharm Theranostics Limited, Annual General Meeting, Nov 20, 2025 Radiopharm Theranostics Limited, Annual General Meeting, Nov 20, 2025. Location: level 3, 62 lygon street, carlton, victoria 3053, Australia Ankündigung • Oct 21
Radiopharm Theranostics Provides Positive Clinical Updates Across Four Programs Radiopharm Theranostics announced an update on its pipeline of clinical programs and outlined expected milestones through the end of 2025 and into 2026. 18F-RAD101 - Small molecule targeting fatty acid synthase radiolabelled with Fluorine-18. The Company continues to evaluate RAD 101 in a single-arm U.S. Phase 2b clinical trial evaluating the diagnostic performance of the molecule in 30 individuals with suspected recurrent brain metastases from solid tumors of different origin. RAD 101 has received U.S. Food and Drug Administration (FDA) Fast Track Designation to expedite the review process and help bring the novel imaging small molecule to the more than 300,000 patients diagnosed annually in the U.S. with cerebral metastases. The study has currently enrolled 12 patients and the Company anticipates to complete enrollment in the first quarter of 2026. These promising early results are in line with the previously published Phase 2a results and, if confirmed, will trigger the preparation of a multi-center, global Phase 3 registrational trial.177Lu-RAD202 - Nanobody targeting HER2 radiolabelled with Lutetium 177 The Company continues to evaluate RAD 202 in the Phase 1 'HEAT' clinical trial in patients with Human Epidermal Growth Factor Receptor 2 (HER2)-positive advanced solid tumors. HER2 is overexpressed or amplified in breast cancer and several other solid tumors and represents a validated target in oncology. RAD 202 has demonstrated clinical proof-of-concept with favourable safety and biodistribution and was recently recommended by the Data Safety and Monitoring Committee (DSMC) to progress to the next dose level of 75mCi in the 'HEAT' trial. Dosing at the 30mCi dose level of RAD202 has been completed and the study is advancing to the next dose level of75mCi following recommendation from the DSMC. Data available from the first three patients in the first cohort of the study show very significant tumor uptake in HER2 positive tumors. Initial data from the first six patients across the first two cohorts show tumor uptake in the PD-L1-positive tumors, in line with published results of the previously conducted imaging study. RAD 301 has previously received Orphan Drug Administration (DSMC) to advance to Phase 2 imaging trial in patients with local-regional pancreatic cancer. RAD 301 has previously received orphan Drug Administration (DSMC). Ankündigung • Oct 01
Radiopharm Theranostics Receives Positive Recommendation from Data Safety and Monitoring Committee to Accelerate 177Lu-RAD202 Phase 1 'HEAT' Dose Escalation Clinical Trial Radiopharm Theranostics announced that it has received a positive recommendation from the Data Safety and Monitoring Committee (DSMC) to advance its clinical-stage radiotherapeutics asset, 177Lu-RAD202 (RAD202), to the next dose level of 75mCi in the Phase 1 'HEAT' clinical trial in patients with Human Epidermal Growth Factor Receptor 2 (HER2)-positive advanced solid tumors. The DSMC is a multidisciplinary committee that conducts detailed reviews of study data, discusses potential safety events and provides recommendations regarding trial continuation. The DSMC reviewed the first cohort of patients treated with 30mCi of Lu177-RAD202 and confirmed there was positive safety, pharmacokinetic, and biodistribution data and agreed that the study may continue without modifications and accelerate to the second cohort of patients at 75mCi of Lu177 -RAD202. The second cohort of patients is expected to be enrolled by fourth quarter 2025. The Phase 1 'HEAT' study is currently being conducted at clinical centers across Australia. Ankündigung • Jul 30
Radiopharm Theranostics Receives Ind Approval from Us Fda to Initiate Phase I Therapeutic Clinical Study to Target B7h3 with Betabart (Rv-01) Radiopharm Theranostics announced that the U.S. Food and Drug Administration (FDA) has provided clearance of the Company's Investigational New Drug (IND) application for Betabart (RV-01), its Lu177-B7H3 monoclonal antibody designed with strong affinity for the 4Ig isoform of B7H3 that is highly expressed in tumors and not in healthy tissues. Recent reported preclinical studies demonstrated that RV-01 exhibits hepatic clearance, allowing the isotope sufficient time to effectively target tumors while potentially minimizing adverse effects such as hematological toxicities. Unlike peptides or small molecules, monoclonal antibodies are primarily cleared by the liver--an organization known for its radio-resistance. This characteristic, combined with the shortened half-life of RV-01 and the strong affinity for the target make this agent stand out and may offer a significant advantage not just over other monoclonal antibodies but also targeted radiotherapeutics with renal excretion pathway, the latter of which are often associated with higher risk of radiopharmaceutical-induced kidney toxicity. B7-H3 is an immune checkpoint molecule that is overexpressed across several tumor types and has emerged as a compelling target for antibody-based cancer immunotherapy. Deregulated B7-H3 expression is consistently related with enhanced tumor aggressiveness and poor clinical outcomes. Targeting the 4 Ig isoform of B7-H3 with a selective radioligand therapy may offer a novel strategy for treating refractory or high-risk tumors. About RV-01 is the first radiopharmaceutical therapeutic agent developed by Radiopharm Ventures, the Joint Venture formed between Radiopharm Theranostics and MD Anderson Cancer Center (MDACC). RV-01 is a 177Lutetium-conjugated therapeutic that targets B7-H3, an immune checkpoint molecule that is excessxpressed in several tumor types. Multiple preclinical studies with RV-01 have shown tumor shrinkage and prolonged survival in animals treated with the radiotherapeutics agent. RV-01 has received IND-clearance from the U.S. FDA and plans to initiate a first-In-human Phase 1 study in the second half of 2025. Ankündigung • Jul 23
Radiopharm Theranostics Appoints Oliver Sartor to Scientific Advisory Board Radiopharm Theranostics announced the appointment of Dr Oliver Sartor, MD to the Company’s Scientific Advisory Board (SAB). Dr Sartor is an internationally recognised medical oncologist and scientist specialising in prostate cancer and radiopharmaceutical therapies. He currently serves as Director of Radiopharmaceutical Clinical Trials and Chair of the Genitourinary Cancer Disease Group at the world-renowned Mayo Clinic, in Rochester, Minnesota. He was previously Laborde Professor of Medicine and Urology and Medical Director of Tulane Cancer Center in New Orleans under Tulane University School of Medicine.Dr Sartor has also held senior roles at LSU Health Sciences Center, Dana-Farber/Harvard Medical School, and as Medical Oncology Co-Chair of the GU Committee of NRG Oncology.Dr Sartor received his MD with honours from Tulane University School of Medicine in 1982, completed internal medicine residency at Tulane, and a medical oncology fellowship at the National Cancer Institute (NCI).Since 1990 he has focused on prostate cancer clinical research, authoring more than 500 peer-reviewed publications and leading multiple pivotal Phase 3 trials that resulted in FDA approvals for therapies including samarium-153 EDTMP, cabazitaxel, radium-223, and PSMA-targeted radioligand therapy. Ankündigung • Jun 11
Radiopharm Theranostics Grants U.S. Food and Drug Administration Fast Track Designation for RAD101 Imaging in Brain Metastases Radiopharm Theranostics announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for RAD101 to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origin including leptomeningeal disease.RAD101 is the Company’s 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 metastases. The FDA’s Fast Track designation is designed to facilitate the development and expedite the review of drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to address an unmet medical need. A Sponsor that receives Fast Track designation may be eligible for more frequent meetings and communications with the FDA and rolling review of any application for marketing approval. A Sponsor’s drug receiving Fast Track designation also may be eligible for Priority Review if relevant criteria are met. The U.S. multicenter, open-label, single arm Phase 2b clinical trial 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. Secondary endpoints are accuracy, sensitivity and specificity of RAD101 in identifying tumor recurrence versus radiation necrosis in previously stereotactic radiosurgery (SRS)-treated brain metastases. RAD101 is the Company’s 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. Targeting FASN activity may allow for the more accurate detection of cancer cells, representing a clinically relevant method for the imaging of brain metastases. Positive data from the Imperial College of London’s Phase 2a imaging trial of 18F-RAD101 in patients with brain metastases (both SRS pre-treated and treatment naïve patients) showed significant tumor uptake that was independent from the tumor of origin. The study further indicated that PET-MRI may potentially represent a non-invasive prediction of overall-survival, warranting larger studies.About Radiopharm Theranostics. Ankündigung • Jun 04
Radiopharm Theranostics Limited Doses First Patient in Phase 1 ‘HEAT’ Trial of 177Lu-RAD202 for Treatment of Advanced Her2-Positive Solid Tumors Radiopharm Theranostics Limited announced the dosing of the first patient in its Phase 1 'HEAT' clinical trial of RAD202, a proprietary nanobody that targets Human Epidermal Growth Factor Receptor 2 (HER2)-positive expression in a wide array of advanced solid tumors. The open-label Phase 1 "HEAT' clinical trial is a dose escalation trial of 177Lu-RAD202 that is designed to determine the recommended Phase 2 dose and to evaluate the safety and preliminary clinical activity of this novel radiotherapeutic in individuals with HER2-expressing advanced cancers. The study is currently being conducted at clinical centers across Australia. HER2 is overexpressed in breast cancer as well as several other solid tumors and represents a validated target in oncology. RAD202 is a proprietary single domain antibody that targets HER2. Ten HER2-positive breast cancer patients previously dosed in a Phase 1 diagnostic study of RAD202 demonstrated clinical proof-of concept as well as the safety and biodistribution of RAD202, validating its potential for the treatment of advanced HER2-expressing cancers. Preclinical findings examining the therapeutic effect in HER2-positive xenografts were also recently reported with 177Lu-RAD202. Collectively, these data further justify first in humans dose finding studies. Ankündigung • Jun 02
Radiopharm Theranostics Limited Reports Preclinical Lu177-B7H3-Mab Data Demonstrating Favourable Biodistribution and High Tumour Uptake Radiopharm Theranostics Limited announced that preclinical data from studies with the Lu177-B7H3-monoclonal antibody RV01 demonstrated favourable biodistribution and showed that RV01 maintained high tumour uptake. In addition, the Fc region modifications of the monoclonal antibody (mAb) confirm a shorter half-life, compared to traditional mAbs. The shorter half-life and other Fc modifications have the potential to limit off-target exposure to the isotope and mitigate toxicities associated with traditional monoclonal antibody therapies. RV01 is the Company's B7-H3-targeted radiopharmaceutical therapy designed with strong affinity for the 4Ig isoform of B7H3 that is highly expressed in tumours and not in healthy tissues, which is being developed in partnership with MD Anderson Cancer Center. This, combined with the faster excretion due to the shortened half-life, potentially offers important advantages compared to excretion via the kidneys, where the elimination of radiopharmaceuticals can result in significant potential toxicities. The new preclinical data corroborate conclusions from earlier preclinical mouse studies that identified a high-affinity antibody highly selective to the cancer-specific 4Ig isoform of the B7-H3 receptor, demonstrated complete regression of established solid tumours with treatment and showed promising evidence of immune system stimulation and the ability to confer immune memory. Ankündigung • May 12
Radiopharm Theranostics Accelerates 177Lu-RAD204 Phase 1 Dose Escalation Clinical Trial Based on Positive Recommendation from Data Safety and Monitoring Committee (DSMC) Radiopharm Theranostics announced that it has achieved a key milestone in its ongoing clinical development program for its clinical-stage radiotherapeutic asset, 177Lu-RAD204, as the Data and Safety Monitoring Committee (DSMC) has approved to proceed to the next dose in its Phase 1 clinical trial in patients with PD-L1 positive advanced cancers1. The DSMC is an independent multidisciplinary group that conducts detailed reviews of unblinded study data, discusses potential safety concerns and provides recommendations regarding trial continuation. The DSMC reviewed the first cohort of four patients treated with 30mCi of 177Lu-RAD204 and confirmed that there was positive safety, pharmacokinetic and biodistribution data and agreed that the study may continue without modifications. The second cohort of patients will start at 60mCi of Lu177 rather than 40mCi previously assumed in the protocol. The second cohort of patients is expected to be enrolled by mid-year 2025 and will include expansion to multiple tumor types including NSCLC, Small-Cell Lung Cancer (SCLC), Triple-negative Breast Cancer (TNBC), Cutaneous Melanoma, head and neck squamous cell carcinoma (HNSCC) and Endometrial Cancer. There are currently four clinical trial sites actively screening and recruiting patients in Australia. About 177Lu-RAD204: RAD204 is a single-domain monoclonal antibody (sdAb) that targets PD-L1, a protein that helps control the immune system and is overexpressed in many solid cancers, making it an attractive therapeutic target in multiple tumor types, including NSCLC, SCLC, TNBC, Cutaneous Melanoma, HNSCC, and Endometrial Cancer. Previously published Phase I imaging data of 16 NSCLC patients with 99Tc-RAD204 demonstrated that the diagnostic compound is safe and is associated with acceptable dosimetry2. Tumor targeting with radioimmunotherapies such as 177Lu-RAD204 has the potential to address resistance mechanisms to current standard-of-care treatment options. Ankündigung • Apr 28
Radiopharm Theranostics Doses First Patient with 18F-Rad101 in U.S. Phase 2B Imaging Study of Brain Metastasis Radiopharm Theranostics 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-R AD101 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, a multi-enzyme protein that analyses 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-RAD 101 in patients with brain metastases showed significant tumor uptake that was consistent with and independent from the tumor of origin. Ankündigung • Mar 18
Radiopharm Theranostics Limited Announces New RAD202 Data Confirms Positive Tumor Uptake Radiopharm Theranostics Limited announced a poster presentation at EMIM 2025, with findings that support the clinical utility of imaging and therapy with 68Ga-RAD202 and 177Lu-RAD202 respectively, and validate an optimized therapeutic dosing regimen in murine models. The poster presentation is by Drs. Felix Mottaghy, Betul Altunay and colleagues, from the University Hospital RWTH Aachen in Germany. The imaging data reported that 68Ga-RAD202 binds specifically to the Human Epidermal growth factor Receptor 2 (HER2) in HER2-positive xenografts, with a high tumor-to-background ratio. The removal of a His-tag from the RAD202 nanobody, a modification which impacts biodistribution and tumor targeting, was shown to be superior for PET imaging due to the higher tumor-to-organ ratio. Furthermore, therapy with 177Lu-RAD202 was well-tolerated, demonstrating significantly prolonged survival time. Fractionated dosing proved more effective in inhibiting tumor growth compared to single-dose therapy. HER2 is overexpressed in breast cancer as well as several other solid tumors, and represents a validated target in oncology. RAD202 is a proprietary single domain antibody that targets HER2. Previous data demonstrated the safety and biodistribution of 99mTc-RAD202 in humans. Preclinical findings examining the therapeutic effect in HER2-positive xenografts were also recently reported with 177Lu-RAD202. Collectively, these data further justify First-In-Human (FIH) dose finding studies. A FIH open-label dose escalation Phase 1 study of 177Lu-RAD202 is currently recruiting in Australia4. The trial is designed to evaluate the safety and preliminary activity of this novel radiotherapeutic in eligible individuals with advanced HER2-positive solid tumors. Ankündigung • Feb 10
Radiopharm Theranostics Announces New Clinical Trial Data Highlights Rad 101 (18F-Pivalate) Successfully Detects Brain Metastases Radiopharm Theranostics announced the publication of a novel imaging approach demonstrating proof-of-concept for the use of RAD 101 for successful detection of brain metastases (both treatment-naive and previously treated) from a variety of primary solid tumors. The clinical study, recently published by Islam et al. in the prestigious European Journal of Nuclear Medicine and Molecular Imaging1, reports a novel methodology of detecting brain metastases using the proprietary RAD 101 in a hybrid imaging test that combines Positron Emission Tomography and Multiparametric Magnetic Resonance Imaging (PET-mpMRI). The study investigated the imaging characteristics of brain metastases in 12 treatment-naive (no prior brain radiotherapy) patients and 10 patients who had previously been treated with brain radiation2. All brain metastases, regardless of the tumor of origin, were detected with 18F-RAD101 PET-mpMRI, with a high tumor-to- background ratio. RAD 101 is a novel imaging small molecule that targets fatty acid metabolism, which is upregulated in many solid tumors, including cerebral metastases. Targeting the transport and metabolism of fatty acid synthase, RAD 101 enables accurate detection of cancer cells, representing a viable target for the imaging of brain metastases. In October 2022, preliminary positive data from the Imperial College of London's Phase 2a imaging trial of RAD 101 in patients with brain metastases showed significant tumor uptake that was independent from the tumor of origin, now confirmed in the larger study. Radiopharm's RAD 101 Phase 2b clinical trial, entitled "An Open-Label, Single Dose, Single Arm, Multicenter Phase 2b Study to Establish the Imaging Performance of RAD101 Positron EmissionTomography (PET) in Participants with Suspected Recurrent Brain Metastases from Solid Tumors", is currently open and recruiting in the United States4. The trial is designed to evaluate the diagnostic performance of 18F-RAD101 in individuals with suspected recurrent brain metastasis from solid tumors of different origins.