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Aktis Oncology Launches Phase 1B Clinical Trial of AKY-1189

On May 28, 2025, Aktis Oncology, Inc. made a significant stride in cancer therapy by announcing the initiation of a Phase 1B clinical trial for its promising radiopharmaceutical candidate, AKY-1189. This trial, named NECTINIUM-2, has received clearance from the U.S. FDA for Investigational New Drugs (INDs) related to two variants, namely [225Ac]Ac-AKY-1189 and [64Cu]Cu-AKY-1189, and aims to treat patients battling locally advanced or metastatic urothelial carcinoma (mUC), triple negative breast cancer (TNBC), and potentially other tumors expressing the NECTIN-4 protein.

Unveiling AKY-1189 and Its Target

At the forefront of innovation in oncology, AKY-1189 is a first-in-class radiopharmaceutical that uniquely targets NECTIN-4, a cell-surface protein found in several solid tumors, but with minimal presence in normal tissues. This quality positions NECTIN-4 as a crucial target for precision therapies aimed at improving outcomes for patients with high unmet medical needs. The NECTINIUM-2 trial is designed to evaluate the safety and efficacy of this novel approach with an estimated enrollment of around 150 patients who will receive up to six doses of the compound.

Dr. Akos Czibere, the Chief Medical Officer of Aktis Oncology, emphasized the significance of this advancement, noting that the early data suggests a substantial tumor uptake in various Nectin-4 expressing tumor types without significant exposure to normal tissues. This could pave the way for more effective treatments and a broader therapeutic window.

The Path Ahead: Trial Design and Expectations

The NECTINIUM-2 trial consists of two main parts: initial dose escalation followed by dedicated expansion cohorts focusing on specific malignancies like mUC, TNBC, lung, colorectal, and cervical cancers. This multi-center study is set to unfold primarily across institutions within the United States.

The data revealed thus far, presented during the prestigious 2024 EORTC-NCI-AACR Symposium, showcased AKY-1189's impressive biodistribution profile. The findings indicated substantial tumor uptake in patients suffering from mUC, metastatic breast cancer, and other cancers, thus garnering support for advancing this candidate into therapeutic studies.

In support of the trial's objective, Dr. Matthew Galsky, co-director of the Center of Excellence for Bladder Cancer at Mount Sinai Hospital, underscored the importance of radiopharmaceutical therapy targeting Nectin-4. It allows for the precise delivery of radiation to cancer cells, combining imaging techniques with therapeutic strategies to tailor treatments for patients with advanced stages of urothelial carcinoma and other solid tumors.

Aktis Oncology: A Brief Overview

Aktis Oncology is dedicated to harnessing the potential of targeted radiopharmaceuticals specifically designed to meet the needs of large patient populations whose conditions remain unaddressed by conventional methods. Founded under the guidance of MPM BioImpact, the company's proprietary miniprotein radioconjugate platform has fostered significant advancements in the treatment landscape.

By focusing on maximizing tumor destruction while minimizing toxicity to healthy tissues, Aktis' innovative approach to cancer therapy aims not only to improve survival rates but also to enhance the quality of life for patients. Their ongoing collaboration with Eli Lilly and Company seeks to broaden the implications of their miniprotein platform, further strengthening their commitment to advancing oncology treatment options.

As the NECTINIUM-2 trial unfolds, the oncology community is eagerly watching to see if AKY-1189 can deliver on its promise of providing actionable treatment avenues for patients grappling with challenging solid tumors. Those interested in further details about Aktis Oncology and its innovations can visit their website at www.aktisoncology.com.