Pentixapharm Submits IND to FDA for Phase 3 PANDA Trial of First-in-Class CXCR4-Targeted Cardiovascular Diagnostic
核心洞察
Pentixapharm (搜索) has submitted an Investigational New Drug (IND) application to the FDA for its Phase 3 PANDA trial evaluating a novel CXCR4 (搜索)-targeted imaging approach in treatment-resistant hypertension (搜索) with underlying primary aldosteronism (搜索).
The first-in-class [68Ga]Ga-PentixaFor PET/CT imaging diagnostic aims to enable non-invasive subtype differentiation in primary aldosteronism (搜索), potentially replacing the complex and invasive adrenal venous sampling procedure.
The trial design follows FDA guidance from a Type B pre-IND meeting and is benchmarked against established diagnostic standards, representing a key value driver for the Berlin-based clinical-stage biotech company.
Pentixapharm (搜索) Holding AG announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for its Phase 3 PANDA clinical trial, marking a significant milestone for the Berlin-based clinical-stage biotech company's lead CXCR4 (搜索)-targeted diagnostic program in cardiovascular disease.
The IND submission supports the initiation of Pentixapharm (搜索)'s U.S.-focused Phase 3 trial evaluating its novel imaging approach to guide treatment decisions in primary aldosteronism (搜索), a condition that enables precise subtype differentiation and selection of appropriate therapeutic pathways.
Regulatory Pathway and Trial Design
The planned Phase 3 PANDA trial has been designed following prior interactions with the FDA, including formal feedback received in a Type B pre-IND meeting, which provided guidance on key statistical and methodological aspects as well as evidence requirements toward a potential approval pathway. The trial design is benchmarked against a performance standard derived from established guideline-based standards of diagnosis and is intended to support a registrational development strategy.
"This IND submission marks an important value inflection point as we advance our flagship PANDA program into late-stage clinical development in cardiovascular disease," said Dirk Pleimes, Chief Executive Officer of Pentixapharm (搜索). "We are executing a focused and capital-efficient strategy to bring our lead diagnostic asset into Phase 3 while continuing to advance a broader pipeline of CXCR4 (搜索)-targeted programs across cardiovascular and oncology indications."
Addressing Unmet Medical Need in Primary Aldosteronism
Pentixapharm (搜索)'s CXCR4 (搜索)-targeted imaging platform represents a first-in-class approach in cardiovascular diagnostics, enabling non-invasive assessment of disease biology and supporting key decision-making processes in hypertensive patients with underlying primary aldosteronism (搜索). The program is designed to address key limitations of adrenal venous sampling (AVS), a complex and invasive standard-of-care procedure, by offering a scalable, non-invasive imaging alternative with the potential to streamline diagnostic pathways and enable more targeted therapeutic intervention.
Primary aldosteronism (搜索) is a common but historically underdiagnosed cause of secondary hypertension (搜索), largely because reliably distinguishing unilateral (lateralization) from bilateral (non-lateralizing) disease remains challenging with current diagnostic tools. Unilateral disease is typically treated by surgical removal of the affected adrenal gland whereas bilateral disease requires life-long medical therapy.
Novel Diagnostic Technology
[68Ga]Ga-PentixaFor is a novel gallium-68 (搜索)-labeled radiodiagnostic designed to selectively target and visualize the chemokine receptor CXCR4 (搜索) using high-resolution PET/CT imaging. Clinical experience with [68Ga]Ga-PentixaFor PET/CT in more than 2000 patients across different indications has demonstrated its ability to non-invasively image CXCR4 expression in vivo.
Recent research has shown strong CXCR4 (搜索) overexpression in aldosterone-producing adrenal tumors, a hallmark of unilateral primary aldosteronism (搜索). By visualizing CXCR4 expression in aldosterone-producing tissue, [68Ga]Ga-PentixaFor has the potential to support more reliable subtyping of primary aldosteronism and thereby better guide appropriate treatment decisions.
Manufacturing and Strategic Development
"Advancing into Phase 3 requires not only strong clinical and regulatory preparation, but also a robust and scalable manufacturing and supply infrastructure," said Erik Merten, Chief Technology Officer of Pentixapharm (搜索). "We have been building the necessary CMC and GMP capabilities to ensure reliable supply as we move toward clinical execution and potential market entry, supported by our established isotope sourcing and GMP manufacturing and radiopharmaceutical networks."
Following the IND submission, Pentixapharm (搜索) is preparing for the initiation of its Phase 3 program in the United States, subject to FDA review. In parallel, the company continues to advance its manufacturing and supply infrastructure to support late-stage development and future commercialization.
Pentixapharm (搜索) is also actively evaluating strategic partnerships with imaging companies, cardiovascular-focused pharmaceutical partners, and U.S.-based commercial organizations, alongside financing options to support Phase 3 execution and U.S. expansion.
Company Pipeline and Market Position
Pentixapharm (搜索) is a clinical-stage biotech expanding the boundaries of radiopharmaceuticals. The company develops precision diagnostics and therapeutics in oncology and cardiovascular fields to transform patient care. Its clinical pipeline is anchored by CXCR4 (搜索)-targeted PET-CT programs aimed at enabling precise, non-invasive molecular imaging across a range of high-unmet-need indications including treatment resistant hypertension (搜索) with underlying primary aldosteronism (搜索) and multiple myeloma (搜索).
CXCR4 (搜索)-based developments also include pioneering theranostic programs in hematological cancers (搜索). Furthermore, Pentixapharm (搜索) is advancing a next-generation antibody platform targeting CD24 (搜索), an emerging immune-checkpoint marker over-expressed in multiple hard-to-treat cancers.