Pentixapharm Holding AG announced a comprehensive strategic shift in its clinical development approach, refocusing its radiopharmaceutical pipeline on theranostic precision oncology opportunities targeting the CXCR4 chemokine receptor. The decision, approved by the company's Supervisory Board, follows a management review led by recently appointed CEO and CMO Dr. Dirk Pleimes and CBO Henner Kollenberg.
Strategic Refocus on CXCR4 Theranostic Platform
The clinical-stage biopharmaceutical company will implement a theranostic basket program designed to evaluate the efficacy of CXCR4-targeted therapeutic approaches across various hematological malignancies that overexpress the CXCR4 chemokine receptor. This strategic pivot aims to enhance the value proposition of Pentixapharm's lead assets by focusing on larger indications with higher market potential.
"This strategic decision will help us to contribute significantly to the value of our theranostic CXCR4 pipeline," said Dr. Dirk Pleimes, CEO of Pentixapharm. "The basket trial program is designed to systematically identify indications where our CXCR4 theranostic platform can deliver the greatest clinical benefit and value to patients with hematologic malignancies."
Clinical Trial Portfolio Restructuring
As part of the strategic realignment, Pentixapharm will discontinue its PTF301 diagnostic trial in Marginal Zone Lymphoma (MZL) due to low patient recruitment challenges. The company's current PTT101 therapeutic trial in Central Nervous System (CNS) Lymphoma will be integrated into the new theranostic basket program.
Additionally, Pentixapharm is preparing new CXCR4-targeted trials, including a clinical Phase I/II trial in bladder cancer. The company plans to provide further details on these new trials at upcoming scientific and investor conferences.
Market Positioning and Commercial Rationale
Henner Kollenberg, CBO of Pentixapharm, explained the business rationale behind the strategic shift: "While the previous trials delivered supportive data on our compounds and underlined the strengths of our CXCR4 portfolio, the business case for the orphan drug diagnostic and long recruitment times for both programs represented a significant challenge for their future commercialization."
The new strategy targets improved treatment options for patients with aggressive forms of leukemias, myeloma, and lymphoma, representing broader high-value opportunities in precision oncology radiopharmaceuticals.
Continued Development Beyond Oncology
Outside its oncology focus, Pentixapharm maintains its commitment to advancing [68Ga]Ga-PentixaFor as a first-in-class, non-invasive diagnostic solution for primary aldosteronism (PA). The company continues exploring optimal pathways for registrational clinical development and commercialization of this diagnostic application.
The strategic refocus positions Pentixapharm to leverage its CXCR4-targeted radiopharmaceutical platform across multiple high-need therapeutic areas while addressing previous challenges related to patient recruitment and market positioning in orphan indications.
