safimestomig (6MW3211) / Mabwell (Shanghai) Biosci - LARVOL DELTA

A Clinical Study of 6MW3211 Monotherapy or Combination Therapy for AML or MDS (clinicaltrials.gov) - P1/2 | N=120 | Recruiting | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. | Not yet recruiting ➔ Recruiting | Phase classification: P1 ➔ P1/2 | N=30 ➔ 120 | Trial completion date: Dec 2023 ➔ Oct 2024 | Trial primary completion date: Jul 2023 ➔ Jun 2024

Combination therapy • Enrollment change • Enrollment open • Monotherapy • Phase classification • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

Blockade of dual immune checkpoint inhibitory signals with a CD47/PD-L1 bispecific antibody for cancer treatment. (PubMed, Theranostics) - "In addition, multiplex fluorescent immunohistochemistry (mIHC) staining shows that PD-L1 and CD47 co-express on several different types of human tumor tissues. These results support the development of 6MW3211 for the treatment of PD-L1 and CD47 double positive cancers."

Checkpoint inhibition • Journal • Immune Modulation • Inflammation • Oncology • CD47 • SIRPA

Maiwei Biological Publishes Preclinical Research Results of CD47/PD-L1 Double Antibody in Theranostics [Google translation] (Stockstar) - "Recently, Mywell Biosciences published the preclinical research results of CD47/PD-L1 dual antibody (6MW3211) online in the international journal 'Theranostics'....Preclinical studies have shown that 6MW3211 does not bind to human and rhesus monkey red blood cells at all. Further crystal structure data showed that two N-glycosylation sites on CD47 were involved in the binding to 6MW3211, suggesting the structural basis for the specific binding of 6MW3211 to CD47 on the surface of tumor cells....6MW3211 has shown a good therapeutic effect on Raji/NCG and hCD47/hSIRPα/hPD-L1 triple transgenic mouse models, significantly inhibiting tumor growth and prolonging the survival of mice. The results of in vivo and in vitro functional studies showed that the expression of PD-L1 on tumor cells can greatly enhance the anti-tumor effect of the CD47 antibody arm in 6MW3211."

Preclinical • Oncology • Solid Tumor

A Clinical Study of 6MW3211 Injection to Treat Relapsed/Refractory AML or MDS (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

A Phase IIa Study to Evaluate the Efficacy and Safety of 6MW3211 in Patients With Advanced Lung Cancer (clinicaltrials.gov) - P2a | N=36 | Not yet recruiting | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

New P2a trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • EGFR • ROS1

A Phase 2 Study of 6MW3211 in Patients With Advanced Clear Cell Renal Cancer (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

New P2 trial • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

A Clinical Study of 6MW3211 Injection in the Treatment of Relapsed/Refractory Lymphoma (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

New P2 trial • Hematological Malignancies • Lymphoma • Oncology

A Clinical Study of 6MW3211 Injection in the Treatment of Advanced Malignant Neoplasm (clinicaltrials.gov) - P1/2 | N=272 | Recruiting | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology

A Clinical Study of 6MW3211 Injection in the Treatment of Advanced Malignant Neoplasm (clinicaltrials.gov) - P1/2; N=272; Not yet recruiting; Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

Clinical • New P1/2 trial • Oncology