- |||||||||| DISC-3405 / Disc Medicine
Pharmacological Inhibition of TMPRSS6 Decreases Hemoglobin Concentration and Red Blood Cell (RBC) Hemolysis in a Mouse Model of Sickle Cell Disease (Halls G-H (San Diego Convention Center)) - Nov 6, 2024 - Abstract #ASH2024ASH_6580; P1 DISC-3405 is a humanized monoclonal antibody blocking the biological action of TMPRSS6 with subsequent upregulation of hepcidin, leading to decreased iron absorption by enterocytes and decreased iron release from stores...r4K12B treatment at 10 mg/kg significantly reduced the spleen index compared to the vehicle group, indicating decreased extramedullary erythropoiesis. Taken together, these results suggest that iron restriction, through inhibition of TMPRSS6, may provide therapeutic benefits to SCD patients by reducing HbS concentration within the RBCs.
- |||||||||| DISC-3405 / Disc Medicine
Phase 1 Healthy Volunteer Study of DISC-3405, a Recombinant Humanized Antibody Targeting TMPRSS6 (Halls G-H (San Diego Convention Center)) - Nov 6, 2024 - Abstract #ASH2024ASH_4765; Preliminary findings of both SAD and MAD cohorts of DISC-3405 in healthy volunteers suggest an acceptable safety and tolerability profile, with consistent evidence of target engagement. The dosing phase of this study was completed, and detailed results across all cohorts will be presented.
- |||||||||| MWTX-003 / Disc Medicine
PHASE 1 HEALTHY VOLUNTEER STUDY OF DISC-3405, A RECOMBINANT HUMANIZED ANTIBODY TARGETING TMPRSS6 (Poster Area (Hall 7)) - May 15, 2024 - Abstract #EHA2024EHA_4096; Preliminary findings of single doses of DISC-3405 in healthy volunteers suggest anacceptable safety and tolerability profile, with consistent evidence of target engagement. The study is currentlyongoing, and detailed results across all available dose levels will be presented at the meeting.
- |||||||||| Enweida (envafolimab) / 3DMed, Tracon Pharma, Ascletis, suvemcitug (APX003) / Mabwell (Shanghai) Biosci, Pyxis Oncology
Trial completion date, Trial termination, Combination therapy, Metastases: A Phase II Study of Envofolimab and BD0801 With/Without Chemotherapy in Patients With Advanced Solid Tumors (clinicaltrials.gov) - Mar 15, 2024 P2, N=86, Terminated, The improvement in PFS, ORR and DCR gained by adding Suvemcitug to single-agent CT was observed with no new safety concern. Trial completion date: Dec 2023 --> Jul 2023 | Recruiting --> Terminated; The study was terminated due to the sponsor's research and development strategy adjustment.
- |||||||||| suvemcitug (APX003) / Simcere, Mabwell (Shanghai) Biosci, Pyxis Oncology
Enrollment closed, Trial completion date: A Phase III Study of BD0801 Combined With Chemotherapy in Recurrent, Platinum-resistant Epithelial Ovarian Cancer (clinicaltrials.gov) - Jan 11, 2024 P3, N=421, Active, not recruiting, A single dose of 3000 mg 9MW1411 is appropriate for use in subsequent studies. Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Dec 2024
- |||||||||| MWTX-003 / Disc Medicine
Enrollment open: A Study of DISC-3405 in Healthy Volunteers (clinicaltrials.gov) - Oct 4, 2023 P1, N=64, Recruiting, A Phase I clinical trial with MWTx-003 in healthy volunteers has been initiated in China. Not yet recruiting --> Recruiting
- |||||||||| Enweida (envafolimab) / 3DMed, Alphamab, Tracon Pharma, Ascletis, suvemcitug (APX003) / Simcere, Mabwell (Shanghai) Biosci, Pyxis Oncology
Combination therapy of envafolimab, suvemcitug, and FOLFIRI in patients with metastatic microsatellite stable (MSS) or mismatch-repair proficient (pMMR) colorectal cancer: Results from a phase II clinical trial () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2220; P2 Eligible pts had received at least one prior line of treatment for MSS/pMMR mCRC and were treated with envafolimab plus suvemcitug and FOLFIRI (Irinotecan, Leucovorin, and 5-Fluorouracil)...Conclusions To the best of our knowledge, this is the first study demonstrated promising antitumor activity and a manageable safety profile of immunotherapy plus anti-angiogenic agent and chemotherapy in pts with MSS/ pMMR mCRC who had failed at least one line of therapy. The results support further evaluation of the therapy in a larger population.
- |||||||||| 9MW1411 / Mabwell (Shanghai) Biosci
Journal: Glycosaminoglycans from the Starfish Lethasterias fusca: Structures and Influence on Hematopoiesis. (Pubmed Central) - May 1, 2023 The main fraction LF, having MW 14.5 kDa and dispersity 1.28 (data of gel-permeation chromatography), was solvolytically desulfated and giving rise to preparation LF-deS with a structure of dermatan core [?3)-?-d-GalNAc-(1?4)-?-l-IdoA-(1?], which was identified according to NMR spectroscopy data...Preparations LF and LF-deS were studied as stimulators of hematopoiesis in vitro. Surprisingly, it was found that both preparations were active in these tests, and hence, the high level of sulfation is not necessary for hematopoiesis stimulation in this particular case.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, 6MW3211 / Mabwell (Shanghai) Biosci
Enrollment open, Phase classification, Enrollment change, Trial completion date, Trial primary completion date, Combination therapy, Monotherapy: A Clinical Study of 6MW3211 Monotherapy or Combination Therapy for AML or MDS (clinicaltrials.gov) - Mar 15, 2023 P1/2, N=120, Recruiting, Surprisingly, it was found that both preparations were active in these tests, and hence, the high level of sulfation is not necessary for hematopoiesis stimulation in this particular case. 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
- |||||||||| 9MW1911 / Mabwell (Shanghai) Biosci
Trial completion: A Clinical Study in Healthy Subjects to Evaluate 9MW1911 Injection (clinicaltrials.gov) - Mar 15, 2023 P1, N=28, Completed, 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 Recruiting --> Completed
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, Mailishu (denosumab biosimilar) / Mabwell (Shanghai) Biosci, Binnopharm
Trial completion: Efficacy and Safety of MW032 and Xgeva (clinicaltrials.gov) - Feb 24, 2023 P3, N=708, Completed, Recruiting --> Completed Active, not recruiting --> Completed
- |||||||||| 8MW0511 / Mabwell (Shanghai) Biosci
Trial completion, Enrollment change, Trial completion date: Trial to Compare the Efficacy and Safety Of MW05 and PEG-rhG-CSF (clinicaltrials.gov) - Dec 2, 2022 P2/3, N=586, Completed, These results support the development of 6MW3211 for the treatment of PD-L1 and CD47 double positive cancers. Recruiting --> Completed | N=348 --> 586 | Trial completion date: Sep 2023 --> Nov 2022
- |||||||||| 9MW1411 / Mabwell (Shanghai) Biosci
Trial completion, Trial completion date, Trial primary completion date: A Clinical Study in Health Subjects to Evaluate 9MW1411 Injection (clinicaltrials.gov) - Jun 15, 2022 P1, N=42, Completed, Not yet recruiting --> Recruiting Active, not recruiting --> Completed | Trial completion date: Feb 2022 --> Aug 2021 | Trial primary completion date: Dec 2021 --> Aug 2021
- |||||||||| 9MW2821 / Mabwell (Shanghai) Biosci
Enrollment open, Trial initiation date, Metastases: A Clinical Study of 9MW2821 in Subjects With Advanced Malignant Solid Tumors (clinicaltrials.gov) - Jun 15, 2022 P1/2, N=208, Recruiting, Active, not recruiting --> Completed | Trial completion date: Feb 2022 --> Aug 2021 | Trial primary completion date: Dec 2021 --> Aug 2021 Not yet recruiting --> Recruiting | Initiation date: Mar 2022 --> Jun 2022
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