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

APHEXDA Performance Update (PRNewswire) - "For the second quarter of 2026, APHEXDA sales were $1.6 million, which provided royalty revenue to the Company of $0.3 million."

Sales • Multiple Myeloma

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

Beyond Nature's Blueprint: Macrocyclic Peptides Containing Unnatural Amino Acids in Therapeutic Development. (PubMed, Angew Chem Int Ed Engl) - "In this review, we highlight recent clinical advances-including motixafortide and zilucoplan-and examine how UAAs are deployed to optimize drug-like characteristics across diverse therapeutic areas. We discuss emerging strategies, illustrative case studies, and design principles that collectively support the development of next-generation macrocyclic peptide drugs."

Journal • Review

Development Updates: Motixafortide (PRNewswire) - "Enrollment is continuing in the CheMo4METPANC Phase 2b clinical trial, which is being led by Columbia University, and supported by both Regeneron and BioLineRx....A prespecified interim/futility analysis is planned when 40% of progression-free survival (PFS) events are observed, which the Company continues to anticipate will occur in 2026."

Enrollment status • P2b data • Pancreatic Ductal Adenocarcinoma

SCD Stem Cell Mobilization and Apheresis Using Motixafortide (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: St. Jude Children's Research Hospital | N=15 ➔ 20

Enrollment change • Genetic Disorders • Hematological Disorders • Sickle Cell Disease

Motixafortide and G-CSF to mobilize hematopoietic stem cells for autologous transplantation in multiple myeloma: a randomized phase 3 trial. (PubMed, Nat Med) - P3 | "In conclusion, motixafortide + G-CSF mobilized significantly greater CD34 HSPC numbers within two apheresis procedures versus placebo + G-CSF while preferentially mobilizing increased numbers of immunophenotypically and transcriptionally primitive HSPCs. Trial Registration: ClinicalTrials.gov , NCT03246529."

Clinical • Journal • P3 data • Bone Marrow Transplantation • Dermatology • Hematological Malignancies • Multiple Myeloma • Oncology • Pain • Pruritus • Transplantation • CD34 • CXCR4

Chemo4METPANC Combination Chemokine Inhibitor, Immunotherapy, and Chemotherapy in Pancreatic Adenocarcinoma (clinicaltrials.gov) - P2 | N=118 | Active, not recruiting | Sponsor: Columbia University | Recruiting ➔ Active, not recruiting | N=10 ➔ 118

Checkpoint inhibition • Enrollment change • Enrollment closed • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Mobilization of Stem Cells With Motixafortide (BL-8040) in Combination With G-CSF in Multiple Myeloma Patients (clinicaltrials.gov) - P3 | N=60 | Recruiting | Sponsor: Guangzhou Gloria Biosciences Co., Ltd. | Trial primary completion date: Dec 2026 ➔ Sep 2026

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

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

MORPHEUS-EC: A Study of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Cancer (G/GEJ) or Esophageal Cancer (Morpheus-Gastric and Esophageal Cancer) (clinicaltrials.gov) - P1/2 | N=219 | Terminated | Sponsor: Hoffmann-La Roche | Completed ➔ Terminated; The study was closed because the sponsor decided not to continue the development of certain treatment combinations.

Trial termination • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2 • PD-L1 • TIGIT

Motixafortide for MRD Sensitization in AML (clinicaltrials.gov) - P2 | N=10 | Recruiting | Sponsor: Washington University School of Medicine | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Comparative analysis of motixafortide versus plerixafor for stem cell mobilization and collection in multiple myeloma: A single center real-world experience. (PubMed, Transfusion) - "In this first real-world comparison, use of motixafortide was feasible but not superior to plerixafor for MM mobilization. Motixafortide was associated with substantially higher rates of injection-site and systemic ARs requiring intervention and imposed additional workflow demands for premedication and post-injection monitoring. Due to the non-superiority of motixafortide, decreasing acquisition costs for plerixafor and motixafortide's higher resource utilization, our institution favors continuing plerixafor as the default for MM mobilization. We reserve motixafortide for select patients, with ongoing evaluation of poor mobilizers to clarify its role in collection and post-transplant outcomes."

Journal • Real-world evidence • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation • CD34 • CXCR4

BioLineRx Reports First Quarter 2026 Financial Results and Provides Corporate Update (PRNewswire) - "Announced two abstracts on GLIX1 that were selected for publication during the American Society of Clinical Oncology (ASCO) Annual Meeting, which is scheduled for May 29-June 2, in Chicago, IL...Enrollment is continuing in the CheMo4METPANC Phase 2b clinical trial....A prespecified interim/futility analysis is planned when 40% of progression-free survival (PFS) events are observed, which the Company continues to anticipate will occur in 2026."

P2 data • Preclinical • Trial status • Glioblastoma • Pancreatic Ductal Adenocarcinoma

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

Inhibition of high CXCR4 with Motixafortide and absence of single-cell MRD predict outcome after AML consolidation. (PubMed, Blood) - P2 | "In this randomized, double-blind, placebo-controlled phase II trial (NCT02502968; registered at ClinicalTrials.gov), 128 patients in first remission received high‑dose cytarabine (HiDAC) plus Motixafortide or placebo. Taken together, combining functional MRD profiling with biomarker-driven patient selection, such as CXCR4 expression, may enable more precise and effective post-remission interventions in AML. This clinical trial is registered at EudraCT number: 2014-002702-21."

Biomarker • Clinical • Journal • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • CXCL12 • CXCR4

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

Toward optimizing CXCR4 inhibition with beta adrenergic blockade to enhance chemotherapy response in acute myeloid leukemia (AACR 2024) - "The CXCR4 inhibitor plerixafor is used to increase mobilization of peripheral blood stem cells in combination with filgrastim...These have included use of plerixafor with 7+3 or MEC, BL-8040 with cytarabine, and ulocuplumab with MEC...The objective of this preclinical study is to identify the AML patient population most likely to respond to CXCR4 inhibition, and the role of combined beta-adrenergic blockade, as the latter has been shown pre-clinically to augment mobilization of HSCs when combined with a CXCR4 inhibitor, GPC-100 (Sukhtankar et al... These studies support further investigation of whether simultaneous blockade of CXCR4 and ADBR2 may potentiate chemotherapy response in AML by limiting microenvironment mediated chemotherapy protection and reveal that patients with new diagnosis may be more susceptible to this approach."

IO biomarker • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • ADRB2 • CD123 • CD34 • CXCL12 • CXCR4 • FLT3 • IL3RA • NPM1 • PTPRC

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