Pioneering Targeted Alpha Therapy: Actinium-225 FPI-2068 and Indium-111 FPI-2107 in Solid Tumours

This article aims to provide an overview of the groundbreaking targeted alpha therapy using Actinium-225 FPI-2068 and its complementary imaging agent 111In-FPI-2107. The focus on EGFR and cMET as key targets in various solid tumours, coupled with the precision and effectiveness of alpha particle radiation, heralds a new era in personalised cancer treatment. The FDA’s approval of IND applications for these agents is a pivotal step forward, potentially transforming the landscape of cancer therapy and offering new hope to patients worldwide.

Breakthrough in Cancer Treatment: Understanding Actinium-225 FPI-2068

In the dynamic landscape of cancer therapy, the introduction of targeted alpha therapy (TAT) stands as a beacon of hope for patients with various solid tumours. The latest addition to this innovative therapeutic field is 225Ac-FPI-2068, a novel drug designed to deliver the radioactive isotope actinium-225 directly to tumours expressing specific cellular markers. This groundbreaking approach targets tumours that express the Epidermal Growth Factor Receptor (EGFR) and cMET, both of which are key players in tumour growth and spread in several cancer types. Furthermore, this therapy is complemented by the imaging agent indium-111 FPI-2107, enabling precise diagnostics and treatment monitoring.

Actinium-225 FPI-2068 represents a significant advance in the treatment of solid tumours. The drug utilises a fragment antigen-binding (Fab) ligand to bind to cancer cells expressing EGFR and cMET specifically. These receptors are validated targets in oncology, co-expressed in multiple cancer types, including head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal cancer, and pancreatic ductal adenocarcinoma.

The mechanism of action of 225Ac-FPI-2068 is centred around the delivery of actinium-225, a potent alpha particle emitter, directly to cancer cells. Alpha particles are highly effective in damaging cancer cells due to their high energy and short range. This ensures maximum therapeutic effect within the tumour while minimising damage to surrounding healthy tissue.

Synergistic approach with Indium-111 FPI-2107 Imaging Agent

The treatment strategy becomes more robust with the incorporation of the imaging agent 111In-FPI-2107. This agent is designed to complement 225Ac-FPI-2068 by providing real-time imaging feedback. It allows oncologists to visualise the distribution of the therapeutic agent within the body, ensuring that the drug is effectively targeting the tumour. This precision in diagnosis and monitoring enhances the overall efficacy and safety of the treatment.

FDA Approval and the Path Forward

In April 2023, the U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug (IND) applications for both 225Ac-FPI-2068 and its corresponding imaging analogue 111In-FPI-2107. This approval marks a significant milestone, paving the way for clinical trials and further research. The potential of this therapy to revolutionise cancer treatment is immense, offering a new ray of hope for patients battling these aggressive forms of cancer.

The Impact on Cancer Care

The development of 225Ac-FPI-2068 and 111In-FPI-2107 holds great promise for improving cancer care. By specifically targeting EGFR and cMET, this approach offers a more personalised treatment, potentially leading to better outcomes and fewer side effects compared to traditional therapies. Furthermore, the ability to monitor treatment in real-time with 111In-FPI-2107 can lead to more informed clinical decisions and adjustments in therapy, ensuring optimal patient care.

Addressing the Challenge of Resistance in Cancer Treatment

One of the critical hurdles in cancer therapy is the development of resistance to treatment. 225Ac-FPI-2068 offers a novel approach by utilising the unique properties of alpha particles. These particles can effectively kill cancer cells, including those that might be resistant to other forms of radiation or chemotherapy. This could potentially overcome one of the significant barriers in current cancer treatment strategies, leading to improved outcomes for patients with resistant tumour types.

The Future of Targeted Alpha Therapy

The development of 225Ac-FPI-2068 and 111In-FPI-2107 represents a significant leap forward in the field of targeted alpha therapy. As research continues, the potential applications of this therapy could expand to include other types of cancers. The specificity and potency of TAT offer a promising avenue for treating cancers that are currently difficult to manage with existing therapies.


The FDA’s clearance of the IND applications for 225Ac-FPI-2068 and 111In-FPI-2107 marks a significant advance in the fight against solid tumours. This targeted alpha therapy, focused on the EGFR and cMET pathways, brings a new level of precision to cancer treatment. With its ability to deliver potent alpha particles directly to cancer cells while monitoring treatment efficacy in real-time, this therapy stands out as a potential game-changer in oncology. As clinical trials and research progress, the hope is that 225Ac-FPI-2068 and indium-111 FPI-2107 will offer new, effective treatment options for patients battling these challenging forms of cancer, ultimately improving survival rates and quality of life.

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