ATNM-400 / Actinium - LARVOL DELTA

Actinium Highlights Expanded Data Set for ATNM-400 in Prostate Cancer Demonstrating Superior Efficacy to Enzalutamide and Ability to Overcome Resistance to ARPI Therapy and PSMA-Ac-225/Lu-177 Labelled Radiotherapy at the Society of Nuclear Medicine & Molecular Imaging Annual Meeting (PRNewswire) - "ATNM-400 shows consistent tumor uptake, rapid clearance from the blood and clearance from vital organs including intestines, liver, and kidneys...ATNM-400 exhibited potent killing of all Xtandi resistant prostate cancer cells that remained following treatment with Xtandi, with Xtandi only killing 50% of the resistant prostate cancer cells; ATNM-400 monotherapy and in combination with Xtandi had superior anti-tumor efficacy in vivo compared to Xtandi alone in a prostate cancer model; all treatments were well-tolerated with no change in body weight; ATNM-400 inhibited tumor growth of Xtandi resistant tumors whereas re-treatment with Pluvicto or additional enzalutamide did not....ATNM-400 was more potent than both Pluvicto (177Lu-PSMA-617) and 225Ac-PSMA-617 in prostate cancer cell killing."

Preclinical • Castration-Resistant Prostate Cancer • Prostate Cancer

First-in-class Actinium-225 (Ac-225) antibody radioconjugate ATNM-400 exhibits potent anti-tumor activity in preclinical solid tumor models (SNMMI 2025) - "Pluvicto® (lutetium Lu 177 vipivotide tetraxetan) and Lutathera® (lutetium Lu 177 dotatate), both FDA-approved beta-emitting therapies, have demonstrated efficacy in metastatic prostate cancer and gastroenteropancreatic neuroendocrine tumors, respectively, highlighting the potential of TR in addressing unmet clinical needs. ATNM-400 demonstrated robust anti-tumor efficacy in multiple preclinical models of solid tumors, supporting its potential as a novel therapeutic option for patients with limited treatment options or resistant to current targeted therapies. These findings underscore the promise of ATNM-400 for clinical translation and its role in addressing unmet needs in cancer therapy."

Preclinical • Breast Cancer • Endocrine Cancer • Genito-urinary Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Prostate Cancer • Solid Tumor

First-in-class Actinium-225 (Ac-225) antibody radioconjugate ATNM-400 exhibits potent anti-tumor activity in preclinical solid tumor models (SNMMI 2025) - "Pluvicto® (lutetium Lu 177 vipivotide tetraxetan) and Lutathera® (lutetium Lu 177 dotatate), both FDA-approved beta-emitting therapies, have demonstrated efficacy in metastatic prostate cancer and gastroenteropancreatic neuroendocrine tumors, respectively, highlighting the potential of TR in addressing unmet clinical needs. ATNM-400 demonstrated robust anti-tumor efficacy in multiple preclinical models of solid tumors, supporting its potential as a novel therapeutic option for patients with limited treatment options or resistant to current targeted therapies. These findings underscore the promise of ATNM-400 for clinical translation and its role in addressing unmet needs in cancer therapy."

Preclinical • Breast Cancer • Endocrine Cancer • Genito-urinary Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Prostate Cancer • Solid Tumor

Actinium Presents Data Showing ATNM-400 is More Efficacious than Pluvicto and is Highly Efficacious after Pluvicto Resistance in Prostate Cancer Tumor Models at the American Association for Cancer Research Annual Meeting (PRNewswire) - "In mice bearing Pluvicto-failed tumors, ATNM-400 was administered on day 14 following Pluvicto treatment, demonstrating robust antitumor activity and tumor growth inhibition in Pluvicto- resistant tumor models.; Expression of the target receptor for ATNM-400 persists following Pluvicto therapy and ATNM-400 demonstrates sustained tumor control after Pluvicto stops working; ATNM-400 demonstrated greater efficacy than Pluvicto in prostate cancer models with 99.8% tumor growth inhibition achieved with a single 40 µCi/kg dose of ATNM-400 supporting its potential to be offered as an alternative option; ATNM-400 internalizes rapidly, exhibiting potent cytotoxicity and prostate cancer cell killing via double strand DNA breaks that are produced by the Ac-225 alpha-particle emitting radionuclide payload of ATNM-400...'we look forward to validating the potential of this exciting radiotherapy candidate as we advance its development with additional data expected later this year.'"

Preclinical • Castration-Resistant Prostate Cancer • Prostate Cancer

ATNM-400 is a novel Actinium-225 antibody radioconjugate with strong efficacy in preclinical models of prostate cancer (AACR 2025) - "ATNM-400 showed strong anti-tumor efficacy and a favorable safety profile in preclinical PCa models. These results highlight ATNM-400's potential as a transformative therapeutic option for PCa patients with unmet clinical needs."

Preclinical • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • FOLH1

Actinium Pharmaceuticals Provides Business Update After Presentation at Trump Mar-A-Lago Club Announcing Novel Non-PSMA Prostate Cancer Radiotherapy ATNM-400 and Outlining Revitalized Clinical Pipeline with 2025 Corporate Objectives (PRNewswire) - "Actinium Pharmaceuticals...provided a business update detailing recent achievements and anticipated milestones from its revitalized and expanding clinical pipeline. The update featured the unveiling of ATNM-400, Actinium's new Actinium-225 (Ac-225) solid tumor program, which is a novel, non-PSMA targeting, first-in-class radiotherapy for prostate cancer. Initial preclinical data from ATNM-400 will be presented at AACR on April 27, 2025....Pipeline Expansion into Prostate Cancer with ATNM-400, a first-in-class, non-PSMA targeting Ac-225 radiotherapy."

Preclinical • Prostate Cancer