yttrium(90Y)anditixafortide ([90Y]Y-PentixaTher) / Pentixapharm - LARVOL DELTA

Pentixapharm Holding AG…announced that the U.S. Food and Drug Administration (FDA) has completed its 30-day safety review of two Investigational New Drug (IND) applications for the Company’s CXCR4-targeted theranostic program in hemato-oncology and confirmed that the proposed clinical study may proceed (ACCESS Newswire) - "Proposed phase I/II trial designed to confirm the suitability of CXCR4-directed radiotherapy for bone marrow conditioning in patients undergoing stem cell transplant. Overall aim is to complement or reduce conventional chemotherapy for acute myeloid leukemia (AML) and multiple myeloma (MM) patients....The Company will determine the timing of future clinical studies under the IND in accordance with its broader portfolio prioritisation and resource planning."

New P1/2 trial • Acute Myelogenous Leukemia • Multiple Myeloma

Myeloablative Radioligand Therapy Targeting C-X-C Motif Chemokine Receptor 4 in Advanced Multiple Myeloma. (PubMed, Clin Nucl Med) - "CXCR4-directed RLT exerted relevant myeloablative effects. When performing HSCT after applying additional CON, successful neutrophile engraftment was reached in the vast majority of the cases."

Journal • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation • CXCR4

Myeloablative Radioligand Therapy Targeting C-X-C Motif Chemokine Receptor 4 in Advanced Multiple Myeloma. (PubMed, Clin Nucl Med) - "CXCR4-directed RLT exerted relevant myeloablative effects. When performing HSCT after applying additional CON, successful neutrophile engraftment was reached in the vast majority of the cases."

Journal • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation • CXCR4

[90Y]Y-PTT Endoradiotherapy in CNS Lymphoma Patients (clinicaltrials.gov) - P1/2 | N=15 | Recruiting | Sponsor: Pentixapharm AG | Trial completion date: Apr 2026 ➔ Mar 2028 | Trial primary completion date: Dec 2025 ➔ Sep 2027

Trial completion date • Trial primary completion date • CNS Lymphoma • Hematological Malignancies • Lymphoma • Oncology • Secondary Central Nervous System Lymphoma

First CNS Lymphoma Patient Dosed in Phase I/II PTT101 Study with Yttrium (90Y) Anditixafortide (PentixaTher) (PharmiWeb) - "Pentixapharm AG...has announced that a first patient has been treated in a dose-finding clinical phase I/II study with Yttrium (90Y) anditixafortide (PentixaTher) at the University Hospital in Essen, Germany. This study, PTT101 (ClinicalTrials.Gov ID: NCT06132737), is a prospective, open-label dose-escalation, multicenter study to evaluate the safety, tolerability, biodistribution and efficacy of PentixaTher in patients with CNS lymphoma (cancer affecting the central nervous systems). PentixaTher is targeting the CXCR-4 cytokine receptor which is widely expressed in different cancer indications."

Trial status • CNS Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology