Ironfist Therapeutics Announces Preclinical Proof of Concept for Novel Nanomedicine Radiopharmaceutical, Tamrada™

⁶⁴Cu/¹⁷⁷Lu-Tamrada selectively targets tumor associated macrophages (TAMs) arresting tumor growth

Excerpt from the Press Release:

REDWOOD CITY, Calif.–(BUSINESS WIRE)–Ironfist Therapeutics (“Ironfist”), a preclinical-stage company developing a nanomedicine radiopharmaceutical (Tamrada) that selectively targets tumor associated macrophages without a targeting ligand, will be presenting positive preclinical proof of concept results in anti-PD-1 resistant triple negative breast (TNB) cancer models using ¹⁷⁷Lu-Tamrada at the 38^th Annual Congress of the European Association of Nuclear Medicine (EANM).

TNB cancer is aggressive and unresponsive to anti-PD-1 antibody therapy in humans and preclinical models. Previous studies in the TNB cancer (4T1) mouse model presented at the Society for Nuclear Medicine and Molecular Imaging (SNMMI 2025) indicated a maximum ⁶⁴Cu-Tamrada uptake of 41% ID/g in tumors. In this follow-up study, xenograft and orthotopic TNB cancer models were treated with the ¹⁷⁷Lu-Tamrada at different radiation doses and regimens with and without anti-PD-1 antibody.

Key findings include:

• Tamrada was tuned to optimize selectivity for TAMs and retention of ¹⁷⁷Lu to maximize in vivo delivery to tumors
• ¹⁷⁷Lu-Tamrada was retained in TAMs for over 10 days from a single administration (SPECT/CT)
• ¹⁷⁷Lu-Tamrada alone caused tumor inhibition in both xenograft and orthotopic 4T1 mouse models
• 30 MBq ¹⁷⁷Lu-Tamarada alone as a single or fractionated equivalent total dose (2x or 3x/week) caused significant (p < 0.05) tumor growth inhibition in orthotopic 4T1 tumor bearing mice compared to vehicle and anti-PD-1 treated mice.
• At equivalent total radiation doses, fractionated doses were better tolerated and caused greater tumor accumulation than single doses.

“These preclinical results coupled with our other 7 studies in a range of tumor types clearly demonstrate the therapeutic potential of targeting TAMs,” said Jeffrey L Cleland, PhD, Chief Executive Officer of Ironfist Therapeutics. “With this theragnostic approach, ⁶⁴Cu/¹⁷⁷Lu-Tamrada has the potential to precisely treat a wide range of tumors, kill tumor cells through bystander effects, and unlock the immune system. We look forward to sharing our compelling efficacy results in a PSMA negative mouse model at a subsequent meeting in 2026.”

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