SunHiTrail (aponermin) / Wuhan HITECK biopharmaceutical - LARVOL DELTA

Efficacy and Safety of Aponermin (Rhtrail)-Kd-Based Regimens in Relapsed/Refractory Multiple Myeloma: A Single-Center Retrospective Analysisultiple Myeloma, a Single-Center Retrospective Study (IMS 2026) - "Combined with carfilzomib and dexamethasone, aponermin may sensitize resistant clones to DR-mediated cell death... Between May 2024 and February 2026, we retrospectively analyzed RRMM patients treated with ApoKd-based regimens (±selinexor or chemotherapy)... In this heavily pre-treated cohort characterized by high rates of EMD and triple-class prior exposure, ApoKd-based regimens achieved an ORR of 64.1% and a median PFS of 6.8 months. Notably, the depth of response appeared independent of triple-class exposure history, and the regimen demonstrated comparable activity in patients with and without EMD. The toxicity profile was predominantly hematologic and manageable."

Retrospective data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukopenia • Multiple Myeloma • Neutropenia • Pneumonia • Respiratory Diseases • Thrombocytopenia

Venetoclax Synergizes with Circularly Permuted TRAIL Through DR5 Upregulation and Bid-Dependent Crosstalk in Multiple Myeloma (IMS 2026) - "Circularly permuted TRAIL (CPT, Aponermin) activates death receptor-mediated apoptosis and may complement Venetoclax-induced mitochondrial apoptosis... CPT and Venetoclax demonstrated significant synergistic anti-myeloma activity across multiple myeloma cell lines, including bortezomib-resistant cells, as well as primary patient samples.RNA sequencing revealed upregulation of TNFRSF10B (death receptor 5, DR5) following Venetoclax treatment... Venetoclax enhances CPT sensitivity through DR5 upregulation, whereas CPT promotes BID-dependent mitochondrial apoptotic amplification. DR4 and DR5 may serve as predictive biomarkers for this combination strategy. These findings provide a strong mechanistic and translational rationale for further clinical evaluation of CPT plus Venetoclax in relapsed/refractory MM."

IO biomarker • Hematological Malignancies • Multiple Myeloma • BID • CASP3 • CASP7 • CASP8 • CASP9 • SDC1 • TNFRSF10B

Aponermin Combined with Carfilzomib, Pomalidomide, and Dexamethasone in RRMM Patients Relapsing After CAR-T or Bite Therapy: A Subgroup Analysis of a Prospective, Single-Arm, Multicenter Trial (IMS 2026) - P=N/A | "The Apo+KPd regimen demonstrated substantial efficacy (ORR 69.3%) with a manageable safety profile in this subgroup who relapsed after CAR-T or BiTE therapy. These results support Apo+KPd as an effective salvage option for immunotherapy refractory relapses, warranting further validation."

CAR T-Cell Therapy • Clinical • IO biomarker • Cardiovascular • Hematological Disorders • Hypertension • Infectious Disease • Leukopenia • Multiple Myeloma • Neutropenia • Thrombocytopenia • CD38 • TP53

Aponermin+Kt-Decp, a Good Bridging Regimen for Relapsed/Refractory Multiple Myeloma with Extramedullary Disease (IMS 2026) - P | "Clinical trial information: NCT05013190 Apo-KT-DECP: Apo 10 mg/kg, days 1 – 3 and 15 – 18; carfilzomib: 27 mg/m ² , days 1 – 2, 8 – 9, 15 – 16; thalidomide: 100 mg, days 1 – 10 and 15 – 24; cisplatin, etoposide, cyclophosphamide, and dexamethasone at protocol-specified doses. Conclusion ： Our study demonstrates that PFS p rolong ed o bviously with less toxicity in RRMM with EMD . ORR of 2 -cycle was 86.2 %, could be a good choice as bridging regimen ."

Hematological Malignancies • Infectious Disease • Leukopenia • Multiple Myeloma • Respiratory Diseases • Thrombocytopenia

Aponermin: First Approval. (PubMed, Drugs) - "Aponermin () is a recombinant circularly permuted human tumour necrosis factor-related apoptosis-inducing ligand (TRAIL) developed by Beijing Sunbio Biotech (a wholly owned subsidiary of Wuhan Hiteck Biological Pharma CO., LTD) for the treatment of multiple myeloma. In November 2023, aponermin in combination with thalidomide and dexamethasone received its first approval in China for the treatment of patients with relapsed or refractory multiple myeloma who have received at least two prior therapies. This article summarizes the milestones in the development of aponermin leading to this first approval for relapsed or refractory multiple myeloma."

Journal • Review • Hematological Malignancies • Multiple Myeloma • Oncology

Synergistic antitumor effects of circularly permuted TRAIL with doxorubicin in triple-negative breast cancer. (PubMed, Acta Biochim Biophys Sin (Shanghai)) - "Collectively, our findings demonstrate that treatment with CPT in combination with Dox exerts synergistic antitumor effects through activation of the caspase cascade pathway, a mechanism that is partly dependent on the Dox-induced upregulation of death receptor 4 and death receptor 5. Therefore, CPT combined with Dox may be a feasible therapeutic strategy for the management of TNBC."

Journal • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CASP3 • CASP8 • TNFRSF10B

[VIRTUAL] Circularly Permuted TRAIL (CPT) Combined with Thalidomide and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study (IMW 2021) - "The combination of CPT with TD significantly prolonged the PFS and OS, increased the ORR. CPT combined with TD was well tolerated, the adverse events were mild, transient and reversible."

Clinical • P3 data • Hematological Malignancies • Immune Modulation • Infectious Disease • Inflammation • Multiple Myeloma • Oncology • Respiratory Diseases

[VIRTUAL] Circularly Permuted TRAIL (CPT) Combined with Thalidomide and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study (CPT-MM301) (ASH 2020) - "CPT combined with TD was well tolerated, the adverse events were mild, transient and reversible. CPT is expected to be the first available anti-myeloma drug that targets death receptor 4/5."

Clinical • P3 data • Diabetes • Hematological Malignancies • Hepatology • Immune Modulation • Infectious Disease • Inflammation • Multiple Myeloma • Oncology • Pneumonia • Respiratory Diseases