MR001 / Shenzhen Majory Biotechnology - LARVOL DELTA

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

Preclinical study on the efficacy of CD4/TGF-β bispecific antibody (MR001) and temozolomide combination therapy for the treatment of multiple metastatic melanoma based on MagIC-PDX model. (ASCO 2026) - "MR001 synergizes with TMZ to exert potent antitumor activity in the murine multiple metastatic melanoma model and MagIC-PDX model. The MagIC‑PDX model accurately reproduced patient‑like metastatic dissemination. These findings support further development of MR001 based combination therapies and highlight MagIC-PDX as a rapid, patient-relevant platform for preclinical testing and precision modeling."

Bispecific • Combination therapy • First-in-human • Metastases • Preclinical • Melanoma • Solid Tumor • CD4 • TGFB1

A Study of MR001 in Patients With Locally Recurrent or Metastatic Advanced Triple-Negative Breast Cancer (TNBC) (clinicaltrials.gov) - P1/2 | N=42 | Recruiting | Sponsor: Shenzhen Majory Biotechnology Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

A Study of MR001 Combined With Chemotherapy in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) After First-line Therapy (clinicaltrials.gov) - P1/2 | N=45 | Recruiting | Sponsor: Shenzhen Majory Biotechnology Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

A Study of MR001 in Patients With Locally Recurrent or Metastatic Advanced Triple-Negative Breast Cancer (TNBC) (clinicaltrials.gov) - P1/2 | N=42 | Not yet recruiting | Sponsor: Shenzhen Majory Biotechnology Co., Ltd. | Trial primary completion date: Oct 2027 ➔ Sep 2028

Trial primary completion date • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

A Study of MR001 Combined With Chemotherapy in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) After First-line Therapy (clinicaltrials.gov) - P1/2 | N=45 | Not yet recruiting | Sponsor: Shenzhen Majory Biotechnology Co., Ltd.

New P1/2 trial • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma