IBI-3003 / Innovent Biologics, Fortvita Biologics - LARVOL DELTA

IBI3003, a Novel Trispecific Antibody Targeting GPRC5D, BCMA and CD3, in Patients (Pts) With Relapsed or Refractory Multiple Myeloma (R/R MM): Results of a Phase 1 Study (IMS 2026) - P1/2 | "IBI3003 continues to demonstrate encouraging durable responses, with a manageable safety profile, in heavily pretreated R/R MM pts. The efficacy and safety data support further exploration of IBI3003 in the ongoing phase III study."

Clinical • First-in-human • P1 data • Trispecific • Hematological Malignancies • Infectious Disease • Multiple Myeloma

A Study in Participants With Relapsed or Refractory Multiple Myeloma for IBI3003 (clinicaltrials.gov) - P3 | N=255 | Recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology

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

A Open-Label Phase in Participants With Multiple Myeloma (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

New P2 trial • Hematological Malignancies • Multiple Myeloma • Oncology

A Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1/2 | N=240 | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | N=100 ➔ 240

Enrollment change • First-in-human • Hematological Malignancies • Multiple Myeloma • Oncology

Innovent Biologics Announces First Patient Dosed in a Phase 3 Clinical Trial of IBI3003(GPRC5D/BCMA/CD3 Tri-specific Antibody) for the Treatment of Multiple Myeloma (PRNewswire) - "TriadicMM-1 (NCT07623798) is a multicenter, randomized, controlled, open-label Phase 3 clinical trial designed to evaluate the efficacy and safety of IBI3003 versus investigator's choice of regimen (pomalidomide, bortezomib and dexamethasone [PVd] or daratumumab, pomalidomide and dexamethasone [DPd]). The primary endpoint of the study is progression-free survival (PFS) assessed by the Independent Review Committee (IRC)."

Trial status • Multiple Myeloma

MAGNETICALLY INDUCED CELL-PATIENT OR CELL LINE DERIVED XENOGRAFT (MAGIC-PDX/CDX) MODELS FOR THE RAPID ESTABLISHMENT OF MULTIPLE MYELOMA AND DRUG SCREENING (EHA 2026) - "Drugs screened using this platform include the combination therapy thalidomide/dexamethasone (THA/DEX); a first-in-class novel drug MR001, which is a CD4/TGF β bispecific antibody that reprograms the tumor microenvironment by activating CD4 ⁺ T cells and blocking TGF β signaling (Shenzhen Majory BioTech Co...Mice were randomly divided into 4 groups (Control, THA/DEX, MR001, and IBI3003)...A parallel study involving MagIC-PDX models and MM patients is ongoing. Fig 1: Bioluminescent Signal Comparison Between Day 3 and Day 28 Across Treatment Groups."

Preclinical • Hematological Malignancies • Multiple Myeloma • Solid Tumor • CD4 • TGFB1

A Study in Participants With Relapsed or Refractory Multiple Myeloma for IBI3003 (clinicaltrials.gov) - P3 | N=255 | Not yet recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

New P3 trial • Hematological Malignancies • Multiple Myeloma • Oncology

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

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

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