Lu177-anditixafortide (Lu177-PentixaTher) / Pentixapharm - LARVOL DELTA

Alternate PET Radiotracers for the Assessment of Multiple Myeloma (SNMMI 2025) - "Lu177-Pentixather is a therapeutic pair to Ga68-Pentixafor which is also in clinical trials...Phase 1 trials have shown higher sensitivity of Cu64-daratumumab PET/CT compared to FDG PET/CT. F18-fluciclovine (Axumin) is an analogue of L-leucine which shows increased uptake in cells with high expression of amino acid transporters. It is currently only approved by the FDA for use in metastatic prostate cancer, though increased uptake may be incidentally noted in plasmacytomas. F18-sodium fluoride (NaF) displaces the hyroxyl group in hydroxyapatite to form fluorapatite preferentially in areas of high bone turnover."

IO biomarker • Anemia • Endocrine Cancer • Genito-urinary Cancer • Hematological Malignancies • Multiple Myeloma • Musculoskeletal Diseases • Neuroendocrine Tumor • Oncology • Plasmacytoma • Prostate Cancer • Solid Tumor • CXCR4 • HK2 • SSTR2

Alternate PET Radiotracers for the Assessment of Multiple Myeloma (SNMMI 2025) - "Lu177-Pentixather is a therapeutic pair to Ga68-Pentixafor which is also in clinical trials...Phase 1 trials have shown higher sensitivity of Cu64-daratumumab PET/CT compared to FDG PET/CT. F18-fluciclovine (Axumin) is an analogue of L-leucine which shows increased uptake in cells with high expression of amino acid transporters. It is currently only approved by the FDA for use in metastatic prostate cancer, though increased uptake may be incidentally noted in plasmacytomas. F18-sodium fluoride (NaF) displaces the hyroxyl group in hydroxyapatite to form fluorapatite preferentially in areas of high bone turnover."

IO biomarker • Anemia • Endocrine Cancer • Genito-urinary Cancer • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Musculoskeletal Diseases • Neuroendocrine Tumor • Oncology • Plasmacytoma • Prostate Cancer • Solid Tumor • CXCR4 • HK2 • SSTR2

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

PENTILULA: Study Assessing RLT Using [177Lu]Lu-PentixaTher for Relapsed/refractory CXCR4+ Acute Leukemia. (clinicaltrials.gov) - P1/2 | N=21 | Recruiting | Sponsor: Nantes University Hospital | Not yet recruiting ➔ Recruiting | Trial completion date: May 2027 ➔ Oct 2027 | Trial primary completion date: May 2027 ➔ Oct 2027

Enrollment open • Trial completion date • Trial primary completion date • Hematological Malignancies • Leukemia • Oncology

First Patient Treated in Phase I/II Trial in Acute Myeloid and Acute Lymphoblastic Leukemia with Lu177-PentixaTher, Expanding the Evidence Base for Targeted Radiotherapy Approach (GlobeNewswire) - "Pentixapharm Holding...today announced that the first patient has been treated in a Phase I/II clinical trial evaluating the safety and efficacy of Lu177-PentixaTher, a novel radiopharmaceutical therapy, in adults for relapsed/refractory CXCR4 positive acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL)....The investor-initiated study, named PENTILULA (ClinicalTrials.gov ID: NCT06356922) is a multicenter, open-label trial in which up to 21 patients with relapsed/refractory AML or ALL will be enrolled over a period of 24 months, with a total study duration of 36 months. The primary objective is to determine the maximal tolerated dose (MTD) of Lu177-PentixaTher, and to examine key efficacy parameters such as overall response rate (ORR) and complete remission (CR) after infusion of the novel radiotherapeutic agent."

Trial status • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia