LBL-034 / Leads Biolabs - LARVOL DELTA

Population pharmacokinetics (popPK) and exposure-response (ER) analyses of lbl-034, a potent GPRC5D T cell engager in patients with relapsed/refractory multiple myeloma (ASH 2025) - P1/2 | "Additionally, higher doses were associated with improved clinical responses without increased safety risk. These findings provide important insights for optimizing dose and dosing frequency in future clinical development of LBL-034."

Clinical • PK/PD data • Dermatology • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukopenia • Multiple Myeloma • Neutropenia • Pruritus • Respiratory Diseases • Thrombocytopenia

Pharmacokinetics, pharmacodynamics, and biomarkers of lbl-034, a GPRC5D-targeted T cell engager, in a first-in-human phase Ⅰ/Ⅱ study in relapsed/refractory multiple myeloma (ASH 2025) - P1/2 | "In the intent-to-treat (ITT) population (n=56), the MRD negativity rate at 10⁻⁵ for LBL-034 wasapproximately 20% higher than the historical rate reported for talquetamab (Rasche et al., ASCO 2025,Abstract 7528).T cell redistribution, characterized by a transient decrease in peripheral CD3+ T cells, was observedfollowing the first priming dose, with recovery by C2D1, consistent with the mechanism of action of LBL-034. LBL-034 exhibited an excellent PK profile, characterized by a prolonged half-life that supports Q3W orQ4W dosing schedules. Its proposed mechanism of action, initially validated in a humanized MMxenograft mouse model, was further confirmed in clinical settings by peripheral T cell redistribution andminimal cytokines release. Reduction in bone marrow GPRC5D+CD138+CD19- plasma cells and serumsBCMA levels correlated strongly with clinical responses and MRD status."

Biomarker • First-in-human • IO biomarker • P1 data • PK/PD data • Hematological Malignancies • Inflammation • Multiple Myeloma • CD8 • HAVCR2 • IFNG • IL2RA • IL6 • KIT • NCAM1 • PD-1 • PTPRC • SDC1 • TNFA

Proof of concept and mechanistic evaluation of lbl-034, a potent GPRC5D-targeting T cell engager with affinity-optimized, sterically engineered anti-CD3 arm, in a multiple myeloma xenograft mouse model (ASH 2025) - P1/2 | "Compared to talquetamab, LBL-034's unique moleculardesign facilitated a faster anti-tumor response, reduced risk of CRS, and an extended half-life. Thesepreclinical findings have been further supported by results from the ongoing Phase Ⅰ/Ⅱ clinical trial."

IO biomarker • Preclinical • Hematological Malignancies • Multiple Myeloma • CD8 • GPRC5D • IFNG • PTPRC

A first-in-human, phase I/II, open-label, multicenter, dose escalation and expansion study of lbl-034, a conditionally activated bispecific antibody targeting GPRC5D and CD3 with a 2:1 format, in patients with relapsed/refractory multiple myeloma (ASH 2025) - P1/2 | "These compelling efficacy andsafety results strongly support the continued clinical development of LBL-034 in RRMM. Updated data,including longer PFS follow-up and extended safety analyses, will be presented at the upcoming ASHAnnual Meeting."

Clinical • First-in-human • IO biomarker • P1/2 data • Dermatology • Hematological Disorders • Hematological Malignancies • Leukopenia • Multiple Myeloma • Neutropenia • Thrombocytopenia • GPRC5D

Median PFS Trending Beyond One Year: Leads Biolabs' LBL-034 Showcases Breakthrough Clinical Data in Oral Presentation at the 2025 ASH Annual Meeting (PRNewswire) - "Strong efficacy across dose levels 400–1200 μg/kg (n=40). ORR reached 82.5%, with ≥CR at 52.5%, ≥VGPR at 72.5%, and MRD negativity at 80.0%. At 800 μg/kg, ORR and ≥CR were 90.9% and 63.6%, respectively. Robust activity in difficult-to-treat RRMM subgroups. Extramedullary disease (EMD): ORR 75.0%, including two sCRs. At 1200 μg/kg, ORR in EMD patients reached 100%, with rapid EMD lesion regression observed. Prior BCMA-treated patients: ORR 85.7%, with CR/sCR 57.1%."

P1/2 data • Multiple Myeloma

Lbl-034, a Highly Differentiated T-Cell Engaging Bispecific Antibody Targeting GPRC5D for the Treatment of Relapsed or Refractory Multiple Myeloma (ASH 2023) - "In summary, LBL-034 is a novel T cell engaging bispecific antibody targeting GPRC5D expressing R/R MM with well differentiated binding of GPRC5D and CD3 to enhance anti-tumor activity, while mitigate the risk of CD3-induced CRS, showing a great in vitro potency and in vivo anti-tumor efficacy. LBL-034 IND has been approved by both FDA and NMPA and a FIH study in patients with R/R MM will begin in the 2nd half of 2023."

Hematological Malignancies • Multiple Myeloma • Oncology • CD69 • GPRC5D • IFNG • IL2RA • IL6 • TNFA

An Uniquely Designed Asymmetric Bispecific Antibody Against GPRC5D and CD3 (LBL-034) in Patients with Relapsed/Refractory Multiple Myeloma: A Phase I/II, First in Human, Open-Label, Multicenter, Dose Escalation/Expansion Study (ASH 2024) - P1/2 | "Conclusions : LBL-034 has demonstrated good safety profile and promising antitumor effects in patients with RR MM and the preliminary data support to develop monotherapy and combination therapy in this malignancy. Update data will be present on ASH meeting."

Clinical • First-in-human • P1/2 data • Anemia • Dyslipidemia • Endocrine Disorders • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Hypertriglyceridemia • Multiple Myeloma • Oncology • GPRC5D

LBL-034 Oral Presentation (HKEXnews) - "The Phase I/II trial (NCT06049290)...is being conducted across 17 hospitals in China. LBL-034 demonstrated favorable safety and promising anti-tumor activity in patients with relapsed/refractory multiple myeloma (RRMM), including those with high-risk, refractory disease, particularly at doses of 800-1200 μg/kg. Updated efficacy and safety results will be presented as the opening presentation in this highly anticipated oral session on the first day of the 2025 ASH Annual Meeting."

P1/2 data • Multiple Myeloma

Acceleration in Clinical Development! Leads Biolabs' LBL-034 Dosed First Patient in Phase Ⅱ Trial (PRNewswire)

Trial status • Multiple Myeloma

Leads Biolabs Receives Orphan Drug Designation from the US FDA for LBL-034, a Uniquely Designed, Highly Differentiated Anti-GPRC5D/CD3 Bispecific Antibody, for the Treatment of Multiple Myeloma (PRNewswire) - "On November 1, Nanjing Leads Biolabs Co., Ltd...announced that LBL-034, a humanized bispecific T-cell engaging antibody targeting both GPRC5D and CD3 which is independently developed by Leads Biolabs with global intellectual property rights for treatment of multiple myeloma (MM), has been granted the Orphan Drug Designation (ODD) by the US Food and Drug Administration (FDA)."

Orphan drug • Hematological Malignancies • Multiple Myeloma • Oncology

A Phase I/II Clinical Trial of LBL-034 in Patients With Relapsed Refractory Multiple Myeloma (clinicaltrials.gov) - P1/2 | N=418 | Recruiting | Sponsor: Nanjing Leads Biolabs Co.,Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology

A Phase I/II Clinical Trial of LBL-034 in Patients With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - P1/2 | N=418 | Not yet recruiting | Sponsor: Nanjing Leads Biolabs Co.,Ltd

New P1/2 trial • Hematological Malignancies • Multiple Myeloma • Oncology

NMPA and FDA Approved the First-in-Human Clinical Trial Applications to Evaluate LBL-034, An Anti-GPRC5D/CD3 Bispecific Antibody Developed by Leads Biolabs, in Relapsed/Refractory Multiple Myeloma (PRNewswire) - "Nanjing Leads Biolabs Co., Ltd...announced today that the National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) have approved its first-in-human Investigational New Drug (IND) applications for LBL-034, an anti-GPRC5D/CD3 bispecific antibody invented by Leads Biolabs with global intellectual property rights, for the treatment of relapsed/refractory multiple myeloma. Currently, no GPRC5D-targeting antibody has been approved for marketing. This is a first-in-human, single-arm, multicenter, open-label, dose-escalation and expansion clinical study, and plans to enroll patients with relapsed/refractory multiple myeloma who have failed prior therapies including but not limited to at least one proteasome inhibitor (PI), one immunomodulator (IMiD) as well as other standard treatments."

IND • New trial • Hematological Malignancies • Multiple Myeloma • Oncology