IBI-3003 / Innovent Biologics - LARVOL DELTA

Initial Results of the first-in-human Phase 1 study of IBI3003, a novel trispecific antibody targeting GPRC5D, BCMA and CD3, in patients with relapsed or refractory multiple myeloma (ASH 2025) - P1/2 | "The current follow-up period is relatively short, and the anti-tumor response is anticipated tobe more profound following continuous treatment. The dose escalation and expansion of IBI3003 isongoing in the phase 1 study."

Clinical • First-in-human • IO biomarker • P1 data • Trispecific • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • GPRC5D

Innovent Announces IBI3003 (GPRC5D/BCMA/CD3 Trispecific Antibody) Receives Fast Track Designation from the U.S. FDA for Relapsed or Refractory Multiple Myeloma (PRNewswire) - "This designation applies to the treatment of relapsed or refractory multiple myeloma, (R/R MM) in patients who have received four or more lines of previous anti-myeloma therapies, that include at least a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody....Clinical data presented at the American Society of Hematology (ASH) Annual Meeting on December 7, 2025, demonstrated a tolerable safety profile and promising efficacy signals for IBI3003 in patients who had failed ≥2 prior lines of myeloma therapy..."

Fast track • Multiple Myeloma

A Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1/2 | N=360 | Not yet recruiting | Sponsor: Fortvita Biologics (USA)Inc.

First-in-human • New P1/2 trial • Hematological Malignancies • Multiple Myeloma • Oncology

ASH 2025 Oral Presentation: Innovent Biologics Announces Initial Results of the First-in-Human Phase 1 Study of Trispecific Antibody IBI3003 in Relapsed or Refractory Multiple Myeloma (PRNewswire) - "A total of 39 patients were enrolled in this phase in China and Australia, with a dose range of 0.1 μg/kg to 800 μg/kg....Encouraging efficacy was observed with a median follow-up of 3.25 months: Among patients treated with ≥120 μg/kg (n=24), the overall response rate (ORR) was 83.3%, including 4 cases of stringent complete response (sCR), 7 cases of very good partial response (VGPR), and 9 cases of partial response (PR). Among patients treated with ≥120 μg/kg, the ORR was 80% in 10 patients with EMD and 77.8% in 9 patients who had previously received anti-BCMA and/or anti-GPRC5D therapies."

P1 data • Multiple Myeloma

VTS105: A novel and potent BCMA/GPRC5D/CD3 trispecific T cell engager (TCE) for the treatment of hematologic malignancies and autoimmune diseases (AACR 2025) - "Recently approved T cell engagers targeting BCMA (e.g., Teclistamab) and GPRC5D (e.g., Talquetamab) have demonstrated clinical responses; however, high relapse rates persist due to suboptimal complete response (CR) rates and minimal residual disease (MRD)...VTS105 exhibits potent human PBMC-mediated tumor cell killing across various heterogeneous MM cell lines, outperforming competitors such as JNJ-79635322, IBI3003, and SCR-8572...Evaluations in this indication are currently underway. Currently VTS105 is advancing into CMC and toxicology studies, with an Investigational New Drug (IND) filing planned for the second half of 2026."

IO biomarker • Late-breaking abstract • Trispecific • Hematological Malignancies • Multiple Myeloma • Oncology • GPRC5D

A Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1/2 | N=116 | Recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting ➔ Recruiting | Initiation date: Feb 2024 ➔ Jul 2024

Enrollment open • Trial initiation date • Hematological Malignancies • Multiple Myeloma • Oncology

A Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1/2 | N=116 | Not yet recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

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