9MW-2821
- Generic Name
- 9MW-2821
Mabwell to Showcase Six Novel Cancer Therapeutics at 2025 AACR Annual Meeting
• Mabwell will present six preclinical studies at the 2025 AACR Annual Meeting in Chicago, highlighting their expanding oncology pipeline with innovative antibody-drug conjugates and T-cell engagers.
• The company's presentations include promising data on novel therapeutics targeting B7-H3, CLDN1, and cadherin 17 for solid tumors, as well as a LILRB4xCD3 bispecific T-cell engager for acute myeloid leukemia.
• Mabwell's research demonstrates significant advances in cancer treatment approaches, including synergistic effects between their B7-H3-targeting ADC and PARP inhibitors, and a new T-cell engager platform optimized for both hematologic and solid tumors.
Mabwell's 9MW2821 Receives Breakthrough Therapy Designation in China for Urothelial Carcinoma
• Mabwell's 9MW2821, a Nectin-4 targeted ADC, has been granted Breakthrough Therapy Designation (BTD) in China for urothelial carcinoma by the NMPA's Center for Drug Evaluation.
• The BTD was awarded for 9MW2821 in combination with toripalimab for treatment-naïve, unresectable, locally advanced or metastatic urothelial carcinoma.
• Initial results from 40 patients showed an objective response rate (ORR) of 87.5% and a disease control rate (DCR) of 92.5% with the 9MW2821 and toripalimab combination.
• A Phase III trial is underway comparing 9MW2821 plus toripalimab to chemotherapy in treatment-naïve locally advanced or metastatic urothelial carcinoma patients.
Guangshengtang's Innovative Hepatitis B Drug Included in Breakthrough Therapy List
Fujian Guangshengtang Pharmaceutical Co., Ltd. announced that its innovative hepatitis B treatment drug, Neracorvir, has been added to the Breakthrough Therapy List, potentially accelerating its development. This inclusion recognizes the drug's significant clinical advantages and novel antiviral mechanism, distinguishing it from existing treatments.
Emerging Intravesical and Systemic Therapies Revolutionize Bladder Cancer Treatment
• Intravesical therapies like cretostimogene and TAR-200 show promising complete response rates in BCG-unresponsive NMIBC, but duration of response remains a key factor.
• Perioperative systemic therapies, including neoadjuvant chemo-immunotherapy with durvalumab, aim to improve event-free and overall survival in muscle-invasive urothelial carcinoma.
• Antibody-drug conjugates (ADCs) targeting Nectin-4 and HER2, such as enfortumab vedotin and disitamab vedotin, demonstrate significant potential in metastatic urothelial cancer.
• Novel strategies, including dual-targeting antibodies and combinations of ADCs with immunotherapies, are being explored to further enhance treatment efficacy and overcome resistance.
Mabwell's Nectin-4 ADC, 9MW2821, Receives Approval for Two New Clinical Trials in China
• Mabwell's 9MW2821, a novel Nectin-4 targeting antibody-drug conjugate (ADC), has been approved by China's NMPA for two new clinical trials.
• One trial will evaluate 9MW2821 in combination with a PD-1 inhibitor for perioperative urothelial carcinoma.
• The second trial will investigate 9MW2821 combined with other antitumor agents for advanced solid tumors, expanding its therapeutic potential.
• 9MW2821 is already in Phase III trials for urothelial and cervical cancers and has received FDA Fast Track designation for multiple indications.
Mabwell's Nectin-4 ADC, 9MW2821, Advances with Two New Clinical Trial Approvals
• Mabwell's 9MW2821, a novel Nectin-4 targeting ADC, has been approved for two new clinical trials by China's NMPA.
• One trial will evaluate 9MW2821 in combination with a PD-1 inhibitor for perioperative urothelial carcinoma.
• The second trial will investigate 9MW2821 with other antitumor agents for advanced solid tumors, expanding its potential use.
• 9MW2821 is already in Phase III trials for urothelial and cervical cancers, with FDA Fast Track designation for several indications.
Robust Clinical Trial Pipeline Fuels Hope for Renal and Breast Cancer Advances
• The renal cancer clinical trial pipeline is robust, with over 70 companies developing more than 75 therapies, including novel immunotherapies and targeted agents.
• Breast cancer research is also thriving, with over 100 companies exploring 120+ new drugs, such as antibody-drug conjugates and PARP inhibitors, in clinical trials.
• Recent FDA actions, including Fast Track and Breakthrough Therapy designations, highlight the potential of emerging therapies for both renal and breast cancer.
• Advances in diagnostics, such as PET imaging agents for clear cell renal cell carcinoma, are also contributing to improved management of these diseases.
Antibody-Drug Conjugates for Cancer Show Promise with Multiple FDA Approvals Anticipated by 2027
• The cancer antibody-drug conjugate (ADC) market is experiencing substantial growth, driven by the demand for targeted therapies that improve efficacy and reduce side effects.
• Over 600 ADCs are currently in clinical trials, with more than 20 in Phase 3, indicating a robust pipeline of potential new cancer treatments.
• Several ADC candidates are in late-stage clinical trials, targeting various malignancies, including lung, breast, and urogenital cancers.
• ADCs combine monoclonal antibodies with cytotoxic agents, enabling targeted drug delivery to cancer cells, improving patient outcomes and diagnostic accuracy.
Mabwell's 9MW2821 and Astellas' Padcev Advance in China for Urothelial Cancer Treatment
• Mabwell's 9MW2821 receives Breakthrough Therapy Designation from China's NMPA for advanced urothelial carcinoma post-platinum and PD-(L)1 inhibitor failure.
• Astellas' Padcev (enfortumab vedotin) gains approval in China for locally advanced or metastatic urothelial cancer after prior treatments.
• 9MW2821 shows promising objective response rates (62.2%) and disease control (91.9%) in urothelial carcinoma, according to Phase 1/2 trial data.
• Phase 3 trials are underway for both 9MW2821 and Padcev to further evaluate efficacy and safety in urothelial carcinoma patients.
FDA Grants Orphan Drug Designation to Mabwell's 7MW3711 for Small Cell Lung Cancer
• The FDA has granted Orphan Drug Designation to 7MW3711, a novel B7-H3-targeting antibody-drug conjugate (ADC), for the treatment of small cell lung cancer (SCLC).
• 7MW3711, developed using Mabwell's IDDC™ platform, has demonstrated superior tumor-killing effects compared to other ADCs in preclinical models, showing a promising safety profile.
• A phase 1/2 clinical trial (NCT06008366) is currently evaluating 7MW3711 in patients with advanced solid tumors to determine safety, tolerability, and optimal dosing.
• Mabwell's IDDC platform, which is used to develop 7MW3711, includes site-specific conjugation technology and a novel payload called Mtoxin™ (TOP1i).
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