A Phase 2, Multicenter, Non-Randomized, Open-Label, Single-Arm Study to Evaluate the Preliminary Efficacy and Safety of 6MW3211 in Patients With Relapsed or Refractory Lymphoma

This study is a single arm, non-randomized, open label phase 2 international, multicenter clinical trial to evaluate preliminary efficacy and safety in subjects with relapsed or refractory lymphoma.

Start Date01 Sep 2022

Sponsor / Collaborator

Mabwell (Shanghai) Bioscience Co., Ltd.

NCT05440045 / Not yet recruitingPhase 2

A Phase 2, Multicenter, Open-Label Study to Evaluate the Preliminary Efficacy and Safety of 6MW3211 in Patients With Advanced Clear Cell Renal Cancer

single arm, non-randomized, multicenter, open label, phase 2 clinical trial in patients with advanced clear cell renal cacer

Start Date01 Sep 2022

Sponsor / Collaborator

Mabwell (Shanghai) Bioscience Co., Ltd.

CTR20221557 / RecruitingPhase 2

6MW3211注射液治疗复发/难治性淋巴瘤患者的初步有效性和安全性的多中心、非随机、单臂、开放性的Ⅱa期临床试验

[Translation] A multicenter, non-randomized, single-arm, open-label phase IIa clinical trial to evaluate the preliminary efficacy and safety of 6MW3211 injection in the treatment of patients with relapsed/refractory lymphoma

主要目的：评价6MW3211注射液治疗复发/难治性淋巴瘤患者的初步有效性；次要目的：评价6MW3211注射液治疗复发/难治性淋巴瘤患者的安全性、药代动力学特征、免疫原性、药效学特征；评价生物标志物与疗效的关系。

[Translation]

Primary purpose: To evaluate the preliminary efficacy of 6MW3211 injection in the treatment of patients with relapsed/refractory lymphoma; Secondary purpose: To evaluate the safety, pharmacokinetic characteristics, immunogenicity, and pharmacodynamic characteristics of 6MW3211 injection in the treatment of patients with relapsed/refractory lymphoma; to evaluate the relationship between biomarkers and efficacy.

Start Date16 Aug 2022

Sponsor / Collaborator

Mabwell (Shanghai) Bioscience Co., Ltd.

100 Clinical Results associated with Safimestomig

100 Translational Medicine associated with Safimestomig

100 Patents (Medical) associated with Safimestomig

Literatures (Medical) associated with Safimestomig

01 Jan 2023·Theranostics

Blockade of dual immune checkpoint inhibitory signals with a CD47/PD-L1 bispecific antibody for cancer treatment

Article

Author: Zhang, Jiao ; Wang, Junchao ; Wang, An ; Li, Gang ; Zhang, Chang ; Wang, Rongjuan ; Liang, Wenlu ; Tang, Peipei ; Gui, Xun ; Cao, Yuting ; Zhang, Jinchao ; Wang, Mingzhu ; Wang, Shuang ; Wang, Min ; Ouyang, Zijun ; Jiao, Shasha ; Mao, Yu

Background: Even though PD-1/PD-L1 is an identified key "don't find me" signal to active adaptive immune system for cancer treatment, the overall response rate (ORR) for all cancer patients is still limited. Other effective therapeutic modalities to bridge the innate and adaptive immunity to improve ORR are urgently needed. Recently, CD47/SIRPα interaction is confirmed as a critical "don't eat me" signal to active innate immunity. However, the red blood cell (RBC) toxicity is the big concern for the development of CD47-based anti-cancer therapeutics. Methods: Here, we report the development of a CD47/PD-L1 bispecific antibody 6MW3211 to block both PD-1/PD-L1 and CD47/SIRPα signals, and studied the effects of 6MW3211 on anti-tumor immune functions in vitro and in vivo. The pharmacokinetic and toxicity profiles of 6MW3211 were evaluated in GLP non-human primate (NHP) studies. Results: The dual immune checkpoint inhibitory signaling blocker 6MW3211 shows high binding affinity to PD-L1 and low binding affinity to CD47. This inequivalent binding affinity design makes 6MW3211 preferentially bound to PD-L1 on tumor cells followed by disrupting the interaction of CD47/SIRPα. Complex structure determination and flow cytometry assay demonstrated that 6MW3211 has no binding to either human or rhesus monkey RBCs. 6MW3211 effectively blocked both PD-1/DP-L1 and CD47/SIRPα signaling and promoted macrophage phagocytosis of tumor cells. Potent therapeutic efficacies of 6MW3211 in three different mouse models were further observed. Moreover, 6MW3211 was demonstrated to have a fairly good safety profile in a GLP NHP study. In addition, multiplex fluorescent immunohistochemistry (mIHC) staining shows that PD-L1 and CD47 co-express on several different types of human tumor tissues. Conclusions: These results support the development of 6MW3211 for the treatment of PD-L1 and CD47 double positive cancers.

Biosensors

Towards the Application of a Label-Free Approach for Anti-CD47/PD-L1 Bispecific Antibody Discovery

Article

Author: Karbyshev, Mikhail S ; Chernyshova, Daria O ; Misorin, Alexey K ; Grevtsev, Artem S ; Azarian, Alexandra D ; Iakovlev, Pavel A

The engineering of bispecific antibodies that exhibit optimal affinity and functional activity presents a significant scientific challenge. To tackle this, investigators employ an assortment of protein assay techniques, such as label-free interaction methodologies, which offer rapidity and convenience for the evaluation of extensive sample sets. These assays yield intricate data pertaining to the affinity towards target antigens and Fc-receptors, instrumental in predicting cellular test outcomes. Nevertheless, the fine-tuning of affinity is of paramount importance to mitigate potential adverse effects while maintaining efficient obstruction of ligand–receptor interactions. In this research, biolayer interferometry (BLI) was utilized to probe the functional characteristics of bispecific antibodies targeting cluster of differentiation 47 (CD47) and programmed death-ligand 1 (PD-L1) antigens, encompassing affinity, concurrent binding to two disparate antigens, and the inhibition of ligand–receptor interactions. The findings derived from BLI were juxtaposed with data from in vitro signal regulatory protein-α (SIRP-α)/CD47 blockade reporter bioassays for two leading bispecific antibody candidates, each demonstrating distinct affinity to CD47.

100 Deals associated with Safimestomig

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Myeloid Leukemia	Phase 2	CN	Mabwell (Shanghai) Bioscience Co., Ltd.	31 Jan 2023
Myelodysplastic Syndromes	Phase 2	CN	Mabwell (Shanghai) Bioscience Co., Ltd.	31 Jan 2023
Locally Advanced Clear Cell Renal Cell Carcinoma	Phase 2	-	Mabwell (Shanghai) Bioscience Co., Ltd.	01 Sep 2022
Refractory Lymphoma	Phase 2	-	Mabwell (Shanghai) Bioscience Co., Ltd.	01 Sep 2022
Advanced Renal Cell Carcinoma	Phase 2	CN	Mabwell (Shanghai) Bioscience Co., Ltd.	28 Jul 2022
Lung Cancer	Phase 2	-	Mabwell (Shanghai) Bioscience Co., Ltd.	10 Jul 2022
Advanced cancer	Phase 2	CN	Mabwell (Shanghai) Bioscience Co., Ltd.	26 Sep 2021
Advanced cancer	Phase 2	US	Mabwell (Shanghai) Bioscience Co., Ltd.	26 Sep 2021

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