MBS314 / Beijing Mabworks Biotech, KYinno - LARVOL DELTA

MBS314, a GPRC5DxBCMAxCD3 trispecific antibody, in relapsed/refractory multiple myeloma (RRMM): Updated results from a Phase 1 dose escalation study (ASH 2025) - P1/2 | "MBS314 demonstrates encouraging clinical activity in heavily pretreated RRMM, particularly at doses of21.0-30.0 mg where ORR exceeded 80%. The safety profile appears manageable, with deep and durableresponses observed even in anti-BCMA-exposed patients. These promising preliminary results warrantfurther investigation of MBS314 as a potential therapeutic option for RRMM."

P1 data • Trispecific • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Respiratory Diseases • GPRC5D

BTL-101, A FULLY HUMAN TRISPECIFIC BCMA×GPRC5D×CD3 T-CELL ENGAGER FOR THE TREATMENT OF MULTIPLE MYELOMA (EHA 2026) - "In myeloma co-cultures (H929, MM.1S, U266), BTL-101 mediated potent killing exceeding talquetamab+teclistamab, depleted dual- and single-antigen–positive cells (including low-to-intermediate BCMA expressers), and retained activity against BCMA- or GPRC5D-knockdown targets, consistent with efficacy under heterogeneous antigen expression...In 48-h PBMC–H929 co-cultures (E:T=5:1), BTL-101 showed higher-potency killing with attenuated cytokines and outperformed JNJ-79635322, SIM0500, and MBS-314...Summary/Conclusion BTL-101 demonstrates strong dual-antigen cytotoxicity with an attenuated cytokine profile and resistance to soluble BCMA. A Phase I/II clinical study is currently ongoing to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of BTL-101 in patients with relapsed/refractory multiple myeloma."

IO biomarker • Trispecific • Hematological Malignancies • Multiple Myeloma • CD69 • IL2RA • IL6

MBS314, a G Protein-Coupled Receptor Family C Group 5 Member D (GPRC5D) x B-Cell Maturation Antigen (BCMA) x CD3 Trispecific Antibody, in Relapsed and/or Refractory Multiple Myeloma (RRMM): Preliminary Results from a Phase Ⅰ, First-in-Human, Open-Label, Dose Escalation Study (ASH 2024) - P1/2 | "Background : T-cell-engaging (TCE) therapeutical antibodies, such as Teclistamab and Talquetamab have shown promising efficacy in RRMM...All four patients (100.0%) experienced grade (G) 1 cytokine release syndrome (CRS) that was cured without treatment with tocilizumab, and no G2 or higher occurred...The two pts in the 1st and 2nd dose levels achieved stable disease and partial response, respectively. Conclusion : This study demonstrated that in pts with heavily pretreated RRMM, MBS314 showed favorable safety and remarkable antitumor activity in the preliminary data, even at low doses."

Clinical • First-in-human • IO biomarker • P1 data • Trispecific • Cardiovascular • Hematological Malignancies • Hypertension • Multiple Myeloma • Oncology • GPRC5D

A Study of MBS314 in Participants With Relapsed/Refractory Multiple Myeloma. (clinicaltrials.gov) - P1/2 | N=154 | Recruiting | Sponsor: Beijing Mabworks Biotech Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology

A Study of MBS314 in Participants With Relapsed/Refractory Multiple Myeloma. (clinicaltrials.gov) - P1/2 | N=154 | Not yet recruiting | Sponsor: Beijing Mabworks Biotech Co., Ltd. | Initiation date: Jan 2024 ➔ Apr 2024

Trial initiation date • Hematological Malignancies • Multiple Myeloma • Oncology

A Study of MBS314 in Participants With Relapsed/Refractory Multiple Myeloma. (clinicaltrials.gov) - P1/2 | N=154 | Not yet recruiting | Sponsor: Beijing Mabworks Biotech Co., Ltd.

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

A novel T-cell-engaging therapeutical antibody against GPRC5D&BCMA for multiple myeloma treatment (AACR 2023) - "T-cell-engaging therapeutical antibodies, such as Talquetamab (targeting GPRC5D and CD3 with 1:1 formation) and CC-93269(targeting BCMA and CD3 with 2:1 formation) have shown promise in multiple myeloma (MM) treatment. In addition, owning to the low affinity to CD3, MBS314 has no detectable toxicity in CD3 humanized mice. In summary, our data show MBS314 is a promising TCE for MM treatment with high efficacy and broad spectrum targeting both GPRC5D and BCMA, and also has excellent safety with low CD3 binding affinity."

IO biomarker • Hematological Malignancies • Multiple Myeloma • Oncology • GPRC5D • SDC1