Pentixapharm Holding AG announced significant clinical advances for its CXCR4-targeted radiopharmaceutical platform at the European Association of Nuclear Medicine (EANM 2025) congress in Barcelona, Spain. The Berlin-based biotech presented extensive data from independent investigator-initiated studies demonstrating the diagnostic potential of [⁶⁸Ga]Ga-PentixaFor in Primary Aldosteronism and early therapeutic activity of [¹⁷⁷Lu]Lu-PentixaTher in bladder cancer.
Breakthrough in Primary Aldosteronism Diagnosis
The congress featured four oral presentations and seven e-posters showcasing new data on [⁶⁸Ga]Ga-PentixaFor PET/CT imaging in Primary Aldosteronism (PA), a condition frequently underdiagnosed despite being one of the leading causes of secondary hypertension. The presentations included comparative clinical trial results evaluating [⁶⁸Ga]Ga-PentixaFor against adrenal venous sampling (AVS), the current invasive gold standard for subtyping PA.
The data demonstrate the high potential of [⁶⁸Ga]Ga-PentixaFor to significantly improve subtyping of patients, thereby enabling better therapy decisions and more precise patient management in PA. Primary Aldosteronism accounts for an estimated 5-10% of all hypertension cases, corresponding to roughly 100-200 million people worldwide.
First-in-Human Oncology Data
Complementing the cardiovascular and endocrine disease results, the scientific program also showcased the expanding role of Pentixapharm's CXCR4-targeted platform in oncology. Among the highlights were first-in-human data on the company's therapeutic candidate [¹⁷⁷Lu]Lu-PentixaTher in patients with bladder cancer. The early findings demonstrate initial signs of therapeutic activity, adding to the growing body of evidence supporting [¹⁷⁷Lu]Lu-PentixaTher as a precision treatment candidate for CXCR4-positive malignancies.
Clinical Significance of CXCR4 Target
CXCR4 is a well-characterized cell membrane receptor with a pivotal role in the bone marrow microenvironment. It is highly overexpressed in multiple aggressive blood cancers - including acute myeloid leukemia, multiple myeloma, and large B-cell lymphoma - where it drives tumor growth and metastasis. CXCR4 has been clinically validated in multiple hematologic cancers, making it a validated high-value target in areas of high unmet medical need.
Beyond oncology, CXCR4 is being explored as a diagnostic imaging target in cardiovascular and endocrine disorders, particularly Primary Aldosteronism. In PA, CXCR4 expression is elevated in benign adrenal tumors, making it a valuable tool for functional diagnosis, PA sub-typing, and lateralization of aldosterone overproduction.
Company Leadership Perspective
"The strong scientific presence of our CXCR4 program at EANM 2025 reflects both the clinical relevance of our platform and the growing recognition of CXCR4 as a key target across multiple disease areas," said Dr. Dirk Pleimes, CEO/CMO of Pentixapharm AG. "The findings in Primary Aldosteronism highlight how our lead candidate, [⁶⁸Ga]Ga-PentixaFor, could transform the diagnosis of hypertensive patients while the oncology data further validate CXCR4 as a cornerstone target for our radiopharmaceutical platform."
Dr. Pleimes emphasized that the wealth of CXCR4-directed research presented at EANM highlights the diagnostic value of CXCR4-targeted imaging, reinforcing the strength and versatility of their approach. "Together, these findings demonstrate how Pentixapharm is expanding the boundaries of radiopharmaceuticals across cardiovascular, endocrine, and oncologic diseases," he added.
Platform Development Strategy
Pentixapharm's late-stage pipeline is anchored by CXCR4-targeted programs, including a Phase 3-ready diagnostic candidate for primary aldosteronism and pioneering therapeutic programs in hematological and solid cancers. The dual diagnostic and therapeutic potential illustrates CXCR4's versatility as a first-in-class target for next-generation radiopharmaceuticals, enabling both precision diagnostics and targeted radioligand therapy.
