Aphexda (motixafortide) / BioLineRx, GenFleet Therap, Gloria Pharma, Ayrmid - LARVOL DELTA

MORPHEUS-PDAC: A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer) (clinicaltrials.gov) - P1/2 | N=290 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Nov 2022 ➔ Jun 2024 | Trial primary completion date: Nov 2022 ➔ Jun 2024

Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • PD-L1

MORPHEUS-PDAC: A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer) (clinicaltrials.gov) - P1/2 | N=290 | Recruiting | Sponsor: Hoffmann-La Roche | Active, not recruiting ➔ Recruiting

Enrollment open • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • PD-L1

MORPHEUS-PDAC: A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer) (clinicaltrials.gov) - P1/2 | N=290 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Nov 2021 ➔ Nov 2022 | Trial primary completion date: Nov 2021 ➔ Nov 2022

Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • PD-L1

MORPHEUS-PDAC: A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer) (clinicaltrials.gov) - P1/2 | N=340 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Recruiting ➔ Active, not recruiting

Enrollment closed • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • PD-L1

MORPHEUS-PDAC: A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer) (clinicaltrials.gov) - P1/2 | N=341 | Completed | Sponsor: Hoffmann-La Roche | Active, not recruiting ➔ Completed

Trial completion • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • PD-L1

MORPHEUS-PDAC: A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer) (clinicaltrials.gov) - P1/2 | N=205 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Sep 2020 ➔ Feb 2022 | Trial primary completion date: Nov 2019 ➔ Feb 2022

Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • PD-L1

MORPHEUS-PDAC: A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer) (clinicaltrials.gov) - P1/2 | N=260 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Feb 2022 ➔ Nov 2021 | Trial primary completion date: Feb 2022 ➔ Nov 2021

Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • PD-L1

MORPHEUS-PDAC: A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer) (clinicaltrials.gov) - P1/2 | N=340 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Oct 2026 ➔ Jan 2025 | Trial primary completion date: Oct 2025 ➔ Jan 2025

Trial completion date • Trial primary completion date • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • PD-L1

MORPHEUS-PDAC: A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer) (clinicaltrials.gov) - P1/2 | N=205 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Apr 2020 ➔ Sep 2020

Trial completion date • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • PD-L1

MORPHEUS-PDAC: A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer) (clinicaltrials.gov) - P1/2 | N=290 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Recruiting ➔ Active, not recruiting

Enrollment closed • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • PD-L1

MORPHEUS-PDAC: A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer) (clinicaltrials.gov) - P1/2 | N=185 | Recruiting | Sponsor: Hoffmann-La Roche

New P1/2 trial • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • PD-L1

MORPHEUS-PDAC: A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer) (clinicaltrials.gov) - P1/2 | N=340 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Jun 2024 ➔ Oct 2026 | Trial primary completion date: Jun 2024 ➔ Oct 2025

Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • PD-L1

Theranostic applications of CXCR4-targeted imaging ligands in lymphoma: integrating diagnosis and precision therapy. (PubMed, Am J Nucl Med Mol Imaging) - "Therapeutic strategies include peptide antagonists (BL-8040, Balixafortide), radioligand therapies ([177Lu]Pentixather, [177Lu]Lu-BL02), small-molecule inhibitors (Plerixafor, WK1), and monoclonal antibodies (PF-06747143, Ulocuplomab, LY2624587). Key challenges include off-target uptake due to physiological CXCR4 expression and compensatory signaling via CXCR7. Future directions involve dual-receptor targeting, nanoparticle-based delivery, and integration into precision oncology for both hematologic and solid tumors."

Journal • Review • Hematological Disorders • Hematological Malignancies • Lymphoma • Oncology • Solid Tumor • ACKR3 • CXCR4

Single-cell MRD profiling identifies CXCR4-high AML as a responder population to CXCR4 inhibition with Motixafortide (AACR 2026) - P2 | "While the BLAST trial showed no overall difference in RFS, single-cell MRD analysis revealed differential treatment effects according to CXCR4 expression. These findings suggest that CXCR4 may serve as a biomarker for response to Motixafortide and highlight the potential of single-cell profiling to inform patient stratification."

Clinical • Acute Myelogenous Leukemia • Oncology • CXCL12 • CXCR4

An open-label, multi-center Phase 2 study to assess the safety and efficacy of burixafor (GPC-100) and propranolol with G-CSF for the mobilization of hematopoietic progenitor cells in patients with multiple myeloma (ASH 2025) - P2 | "Mediantimes to neutrophil and platelet engraftment were 11 days (range 11-17 days) and 15 days (range 11-27days), respectively.ConclusionsBurixafor, in combination with propranolol and G-CSF, demonstrated an excellent safety profile andeffectively mobilized sufficient HPCs for AHCT, including patients previously treated with lenalidomideand daratumumab. Notably, burixafor enabled same-day administration with leukapheresis, offering akey advantage over other CXCR4 inhibitors, such as plerixafor and motixafortide through its rapidmobilization kinetics. Its favorable safety profile, characterized by minimal adverse events, supporting itspotential clinical utility."

Clinical • IO biomarker • P2 data • Cardiovascular • Constipation • Diabetes • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Hypotension • Multiple Myeloma • Musculoskeletal Diseases • Musculoskeletal Pain • CD34 • CXCR4

MOTIXAFORTIDE AND G-CSF TO MOBILIZE HEMATOPOIETIC STEM CELLS FOR AUTOLOGOUS TRANSPLANTATION IN HIGH-RISK MULTIPLE MYELOMA: TWO CASES CLINICAL REPORT (EBMT 2026) - "The combination of Motixafortide and G-CSF provides a new and effective option for the mobilization of high-risk or plethasafu-intolerant MM patients with its excellent mobilization efficiency, convenient administration and good safety."

Clinical • Hematological Malignancies • Multiple Myeloma • Transplantation • CD34 • CXCL12

Atezolizumab and Motixafortide, Cobimetinib or Simlukafusp Alfa in Pretreated Advanced Pancreatic Cancer: Phase I/IIb MORPHEUS-PDAC Umbrella Study. (PubMed, Oncologist) - P1/2 | "The overall safety of atezolizumab combinations was manageable and consistent with each agent's known safety profile. This novel trial design enabled rapid evaluations of three atezolizumab combinations; all had limited efficacy as 2 L or 3 L treatment for metastatic PDAC. New treatments are needed to improve outcomes in previously treated PDAC."

Journal • P1/2 data • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

WBC Growth Factors: ASCO Guideline Update. (PubMed, J Clin Oncol) - "Prophylactic use of CSFs to reduce the risk of febrile neutropenia is warranted when the risk of febrile neutropenia from chemotherapy is approximately 20% or higher and no other equally effective and safe regimen that does not require CSFs is available. For patients receiving chemotherapy with a <20% risk of febrile neutropenia, primary prophylaxis with a CSF may be warranted if patients are at a high risk of febrile neutropenia based on age, medical history, or disease characteristics. For stem-cell mobilization, CSFs may be used either alone, after chemotherapy, or in combination with plerixafor or motixafortide. The guideline also provides information about the dosing and selection of CSFs.Additional information is available at www.asco.org/supportive-care-guidelines."

Journal • Febrile Neutropenia • Hematological Disorders • Neutropenia • Oncology • CXCR4

Evaluating Premedication Regimens (Methylprednisolone vs Dexamethasone-based) for the Prevention of Systemic and Injection Site Reactions to Motixafortide in Patients With Multiple Myeloma Undergoing Stem Cell Mobilization, PARADE Trial (clinicaltrials.gov) - P4 | N=94 | Recruiting | Sponsor: Emory University | Trial completion date: Dec 2026 ➔ Dec 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Allergy • Hematological Malignancies • Multiple Myeloma • Oncology

Safety Outcomes of CXCR4 Antagonists for Stem Cell Mobilization in Patients with Multiple Myeloma (TCT-ASTCT-CIBMTR 2026) - "CXCR4 antagonists plerixafor and motixafortide, when combined with G-CSF, are widely used to mobilize hematopoietic stem and progenitor cells. Integrating structured nursing assessments into mobilization protocols enhances patient safety and the overall mobilization experience. Future nursing-led initiatives should aim to refine toxicity prophylaxis and management—particularly for motixafortide—to optimize safety and promote best practices in patient-centered mobilization care."

Clinical • Hematological Malignancies • Immunology • Multiple Myeloma

Adverse Drug Effects Following Motixafortide for Hematopoietic Progenitor Cell Mobilization in Patients with Multiple Myeloma (TCT-ASTCT-CIBMTR 2026) - "Introduction Despite the use of plerixafor, a low-affinity, short-acting CXCR4 inhibitor, over 25% of multiple myeloma (MM) patients are unsuccessful at mobilizing their target CD34+ hematopoietic progenitor cells (HPCs)...Standard premedications included acetaminophen, diphenhydramine, famotidine, and montelukast. Due to treatment emergent adverse events (TEAEs), intravenous dexamethasone 10 mg was added to the premedication regimen starting May 2025...Premedication, longer monitoring, and reaction treatment medication use with motixafortide impacts resource utilization for patients undergoing mobilization. (1) To describe the efficacy outcomes of using motixafortide for mobilization in a real world MM population (2) To describe the treatment emergent adverse effects of motixafortide when used in a real world MM population (3) To describe injection reaction rates with motixafortide following addition of dexamethasone as premedication"

Clinical • Dermatology • Hematological Malignancies • Immunology • Multiple Myeloma • Pruritus • Urticaria • CD34 • CXCR4

An Open-Label, Multi-Center Phase 2 study to Assess the Safety and Efficacy of Burixafor (GPC-100) and Propranolol with G-CSF for the Mobilization of Hematopoietic Progenitor Cells in Patients with Multiple Myeloma (TCT-ASTCT-CIBMTR 2026) - P2 | "All received lenalidomide-based induction therapy, with 70% also receiving daratumumab. Assess the efficacy of the above treatment combination. Demonstrate the fast kinetics of mobilization of burixafor, allowing for leukapheresis within an hour after burixafor administration, as opposed to 10-12 hours with other CXCR4 inhibitors, plerixafor and motixafortide."

Clinical • IO biomarker • P2 data • Cardiovascular • Constipation • Diabetes • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Hypotension • Multiple Myeloma • Musculoskeletal Diseases • Musculoskeletal Pain • CD34 • CXCR4

Motixafortide Is Effective in Hematopoietic Progenitor Cell Mobilization in Multiple Myeloma Patients Treated with Quadruplet Therapy (TCT-ASTCT-CIBMTR 2026) - "Majority of patients were lenalidomide-exposed (98.6%), anti- CD38 antibody-exposed (92.9%), and quadruplet therapy exposed (90%). In addition, this will increase apheresis space efficiency. (1) To describe efficacy outcomes in using motixafortide for hematopoietic progenitor cell mobilization in a real world patient population with multiple myeloma (2) To describe motixafortide efficacy for hematopoietic progenitor cell mobilization in patients receiving quadruplet induction therapy (3) To report engraftment outcomes in patients receiving transplant following mobilization with motixafortide"

Clinical • Hematological Malignancies • Multiple Myeloma • CXCR4

A Cohort Comparison of CXCR4 Antagonists for Multiple Myeloma Mobilization (TCT-ASTCT-CIBMTR 2026) - "Plerixafor and motixafortide are CXCR4 antagonists used with G-CSF to mobilize CD34⁺ stem cells by disrupting CXCL12–CXCR4. Further prospective and risk-balanced studies are needed to confirm these signals, identify patients most likely to benefit, and clarify operational and cost implications to guide agent selection. Compare Day 1 CD34 count in patients getting 2 different CXCR4 Antagonists"

Amyloidosis • Hematological Malignancies • Leukemia • Multiple Myeloma • Plasma Cell Leukemia • CD34 • CXCL12

Impact of Motixafortide on Apheresis Chair Utilization and Mobilization Efficiency Compared to Plerixafor in Autologous Stem Cell Transplant Candidates (TCT-ASTCT-CIBMTR 2026) - "Motixafortide plus G-CSF demonstrated comparable apheresis efficiency to plerixafor-based mobilization in the multiple myeloma patient population, with similar mean chair and procedure run times. These findings suggest both mobilization strategies provide equivalent operational efficiency in routine clinical practice."

Hematological Malignancies • Multiple Myeloma • Transplantation • CD34 • CXCR4