Pipeline

Our clinical pipeline encompasses PentixaTher, an Yttrium-90 based therapeutic against non-Hodgkin lymphomas (NHL), and PentixaFor, a Gallium-68-based companion diagnostic. Clinical studies for both compounds have already commenced in Europe, including a dose-finding study for PentixaTher and a Phase III registration study for PentixaFor in marginal zone lymphoma. Additionally, PentixaFor is being developed as a diagnostic tool for primary aldosteronism (PA), a significant cause of hypertension. Pentixapharm is currently preparing a US-centric Phase III registration study with PentixaFor in PA that will start in 2025.

Clinical Assets

  • PentixaFor is currently tested in an EMA endorsed Phase III pivotal study for the staging of Marginal Zone Lymphoma (MZL), a subtype of Non-Hodgkin B Cell Lymphoma.

    The study anticipates enrolling 150 lymphoma patients across up to 30 participating European clinics, with the objective of enhancing the accuracy of staging and consequently the quality of treatment for MZL.

    Clinicaltrials.gov ID: NCT06125028

  • PentixaFor offers a new approach in identifying Primary Aldosteronism (PA), a condition linked to hypertension in a significant portion of adults in Western countries. Primary Aldosteronism is characterized by an excessive aldosterone production, usually from one adrenal gland, and accounts for 1-5% of hypertension cases. Once this malfunctioning gland is identified, patients can undergo an adrenalectomy, which will lead to complete biochemical normalization in the majority of patients.

  • PentixaTher the complementary therapeutic agent to PentixaFor, equipped with the high energy beta emitter Yttrium-90 for the treatment of Central Nervous System (CNS) Lymphoma. This compound is currently being evaluated in a dose-finding clinical Phase I/II study.

    (Clinicaltrials.gov ID: NCT06132737)

CXCR4 as target molecule

Our target protein is the G-protein-coupled receptor C-X-C motif chemokine receptor 4 (CXCR4). This receptor is involved in the regulation of a variety of processes such as the regulation of blood formation (haematopoiesis), the movement of stem cells (migration) and the formation of new blood vessels (angiogenesis). These processes take place in a healthy body, but if they degenerate, they contribute to the supply of oxygen and nutrients to tumors.

An increased occurrence of CXCR4 has been observed in benign tumors of the adrenal gland and in over 20 malignant cancers, in which the receptor is associated with tumor growth, metastasis and resistance to therapy. The receptor is therefore a suitable target molecule for the precise detection of tumors and their treatment.

Established and validated mode of action

A radioactive isotope (payload) is conjugated to a biologically active molecule, known as a ligand. This compound is then administered into the bloodstream via intravenous injection and will navigate to all the affected cells in the body, including small metastases. The choice of radioisotope determines the outcome: High-energy isotopes are used to kill the targeted cells, while low-energy isotopes are used for imaging.

Literature

CXCR4 is one of the most thoroughly researched targets of the last decade:

  • 9 Reviews, 2 method articles, >100 Publications on [68Ga]Ga-PentixaFor

  • More than 2,500 Patients have already been imaged with [68Ga]Ga-PentixaFor without any safety issues

  • Since 2024, 474 patients were diagnosed for PA with [68Ga]Ga-PentixaFor

To support academic research, PTX sponsors more than 20 investigator initiated clinical studies (IIS). You can find an overview of the most important publications, listed by topic and area, here.