- ATNM-400 Outperforms Leading Therapies: Demonstrates 3-5x greater tumor growth inhibition compared to first-line osimertinib (TAGRISSO®), second-line Dato-DXd (DATROWAY®), and third-line amivantamab (RYBREVANT®).
- Synergistic Combination with Osimertinib: Achieves complete tumor regression in 100% of preclinical models, supported by increased target antigen expression post-EGFR inhibition.
- Strong Clinical Rationale for Combination Therapy: Builds on evidence of improved progression-free survival with osimertinib and external beam radiotherapy (EBRT), highlighting the potential of targeted alpha-therapy.
Actinium Pharmaceuticals, Inc. (NYSE: ATNM), a leader in targeted radiotherapy innovation, unveiled preclinical data showcasing the superior efficacy of its novel radioconjugate, ATNM-400, in non-small cell lung cancer (NSCLC) at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. Armed with the potent alpha-emitter Actinium-225 (Ac-225), ATNM-400 is a first-in-class antibody radioconjugate designed for multi-indication use, including NSCLC and prostate cancer.
Preclinical Breakthroughs:
- Monotherapy Superiority: ATNM-400 achieved 3-5x higher tumor growth inhibition (TGI) in EGFR-mutant NSCLC models compared to:
- First-line therapy: Osimertinib (TAGRISSO®)
- Second-line therapy: Dato-DXd (DATROWAY®)
- Third-line therapy: Amivantamab (RYBREVANT®)
- Synergistic Combination Therapy: When combined with osimertinib, ATNM-400 induced complete tumor regression in all preclinical models, outperforming either therapy alone. This synergy is attributed to increased ATNM-400 target antigen expression following EGFR inhibition by osimertinib.
- Targeting Resistance: ATNM-400’s target antigen is overexpressed in NSCLC, particularly in cases resistant to osimertinib, enhancing its cytotoxic efficacy in post-EGFR-resistance settings.
Expert Insights:
Dr. Sandip Patel, Professor of Medicine at UC San Diego, emphasized, “ATNM-400 represents a transformative approach in NSCLC treatment, leveraging targeted alpha-therapy to deliver potent radiation directly to tumors while minimizing off-target effects. These preclinical results are highly encouraging and underscore the potential of ATNM-400 as a first-in-class radiotherapy.”
Unmet Need in NSCLC:
Lung cancer remains the most common cancer globally, with over 2 million new cases annually. NSCLC accounts for 85% of lung cancer cases, with EGFR mutations present in 10-15% of Western cases and up to 60% in some Asian populations. Despite the success of EGFR-targeting therapies, resistance typically develops within 2-3 years, creating an urgent need for innovative treatments like ATNM-400.
ATNM-400’s Differentiated Potential:
- Mechanism of Action: Combines a high-affinity monoclonal antibody targeting an overexpressed antigen in NSCLC with Ac-225, an alpha-emitter that induces irreversible double-strand DNA breaks.
- Versatility: Effective as monotherapy, in combination with EGFR inhibitors like osimertinib, and in post-resistance settings.
- Multi-Tumor Applications: Beyond NSCLC, ATNM-400 is being developed for prostate cancer, addressing unmet needs in low-PSMA or PSMA-resistant cases.
CEO Perspective:
Sandesh Seth, Chairman and CEO of Actinium, stated, “ATNM-400’s preclinical data highlights its potential to redefine treatment paradigms in NSCLC and beyond. By addressing resistance mechanisms and demonstrating synergy with leading therapies, ATNM-400 is poised to become a cornerstone in the fight against lung cancer.”
Looking Ahead:
Actinium plans to advance ATNM-400 into clinical development, building on its promising preclinical results. With its innovative approach and multi-indication potential, ATNM-400 represents a significant step forward in targeted radiotherapy.
For more information, visit Actinium Pharmaceuticals.
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