bulumtatug fuvedotin (9MW2821) / Mabwell (Shanghai) Biosci - LARVOL DELTA

9MW2821, a novel Nectin-4 antibody-drug conjugate (ADC), combined with toripalimab in treatment-naïve patients with locally advanced or metastatic urothelial carcinoma (la/mUC): Results from a phase 1b/2 study. (ASCO 2025) - P1/2, P3 | "9MW2821 combined with Toripalimab in treatment-naïve patients with la/mUC demonstrated remarkable efficacy and well-tolerated safety profile. A pivotal phase 3 study is ongoing currently. Clinical trial identification: NCT06592326."

Clinical • Metastases • P1/2 data • Bladder Cancer • Breast Cancer • Cervical Cancer • Esophageal Cancer • Oncology • Solid Tumor • Urothelial Cancer • NECTIN4

9MW2821 Combined With Other Antitumor Drugs in Patients With Advanced Gynecological Tumors (clinicaltrials.gov) - P1/2 | N=260 | Not yet recruiting | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

New P1/2 trial • Gynecologic Cancers • Oncology

Mabwell to Present Clinical Data of 9MW2821 Combined with Toripalimab in Patients with UC in an Oral Presentation at 2025 ASCO (PRNewswire) - "Mabwell...announced that the Phase Ib/II clinical study results of the novel Nectin-4-targeting ADC 9MW2821 combined with toripalimab in patients with locally advanced or metastatic urothelial carcinoma will be presented in an oral presentation at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago, USA, May 30-June 3, 2025. Clinical data from 3 ADC clinical studies will also be published as poster presentations at the meeting."

Clinical data • Urothelial Cancer

A Clinical Study of 9MW2821 Monotherapy or Combined With Other Anticancer Therapy in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=188 | Not yet recruiting | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

Monotherapy • New P1/2 trial • Oncology • Solid Tumor

9MW2821, a next-generation Nectin-4 targeting antibody-drug conjugate, in patients with advanced solid tumors: a first-in-human, open label, multicenter, phase Ⅰ/Ⅱ study (Ann Oncol) - P1/2 | N=208 | NCT05216965 | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. | "Between June 11, 2022, and Apr 3, 2024, 274 patients were enrolled, including 51 with urothelial cancer, 62 with cervical cancer, 49 with esophageal cancer, 20 with triple negative breast cancer and 92 with other solid tumors. In dose escalation phase, one dose limiting toxicity was observed in 1.5mg/kg group, which was grade 4 neutropenia lasted more than 5 days. Maximum tolerated dose of 9MW2821 was not reached....Among 226 patients evaluable for efficacy, objective response rates were 54.1%, 32.1%, 14.0% and 50% in urothelial cancer, cervical cancer, esophageal cancer and triple negative breast cancer, respectively."

P1/2 data • Cervical Cancer • Esophageal Cancer • Triple Negative Breast Cancer • Urothelial Cancer

9MW2821, a next-generation Nectin-4 targeting antibody-drug conjugate, in patients with advanced solid tumors: a first-in-human, open label, multicenter, phase Ⅰ/Ⅱ study. (PubMed, Ann Oncol) - P1/2, P3 | "The results suggest that 9MW2821 was tolerable and clinically significant in efficacy in various types of solid tumors besides urothelial cancer. Several pivotal trials are currently in progress. (NCT06196736, NCT06592326, NCT06692166)."

Clinical • Journal • P1 data • Breast Cancer • Cervical Cancer • Esophageal Cancer • Genito-urinary Cancer • Hematological Disorders • Neutropenia • Oncology • Pain • Solid Tumor • Triple Negative Breast Cancer • Urothelial Cancer • NECTIN4

9MW2821-2023-CP301: A Study to Evaluate 9MW2821 Versus Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (clinicaltrials.gov) - P3 | N=432 | Recruiting | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. | Trial completion date: Dec 2028 ➔ Jul 2027 | Trial primary completion date: Dec 2026 ➔ Sep 2026

Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

A Dose Randomization Study of Bulumtatug Fuvedotin in TNBC Patients Previously Treated With ADCs (clinicaltrials.gov) - P1 | N=52 | Not yet recruiting | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

New P1 trial • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

9MW2821 + Toripalimab vs 9MW2821 for 1st Line Locally Advanced or Metastatic Urothelial Carcinoma (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

New P2 trial • Bladder Cancer • Kidney Cancer • Oncology • Solid Tumor • Urothelial Cancer

A Clinical Study of 9MW2821 (and PD-1 Inhibitor) in Locally Advanced or Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. | Not yet recruiting ➔ Recruiting

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

Mabwell's Nectin-4 Targeted ADC 9MW2821 Combination Therapy Demonstrates 87.5% ORR and Granted CDE Breakthrough Therapy Designation (PRNewswire) - P3 | N=460 | NCT06592326 | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. | "Mabwell...announced a significant milestone for its proprietary Nectin-4 targeted ADC (9MW2821). On January 8, 2025, 9MW2821 was granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. 9MW2821 is given in combination with toripalimab, an anti-PD-1 monoclonal antibody, for treatment-naïve, unresectable, locally advanced or metastatic urothelial carcinoma(la/mUC). Up to now, 40 treatment-naïve patients with la/mUC were enrolled and received the combination therapy. ORR was 87.5% (comfirmed ORR was 80%) and DCR was 92.5%. Median PFS and DoR were not reached....A pivotal Phase III study of 9MW2821 in combination with PD-1 is ongoing."

Breakthrough therapy • P3 data • Urothelial Cancer

Mabwell's Novel Nectin-4 Targeting ADC 9MW2821 Approved for 2 Clinical Trials by CDE of NMPA (PRNewswire) - "Mabwell...announced that its novel Nectin-4 targeting ADC (R&D code: 9MW2821) has received IND approval for two clinical studies. The first will explore its use in combination with a PD-1 monoclonal antibody in the treatment of perioperative urothelial carcinoma, while the second will investigate its combination with other antitumor agents for the treatment of advanced solid tumors....The recent approval of a multi-drug combination treatment program for cervical cancer and esophageal squamous cell carcinoma, along with the expansion of 9MW2821's indication to include the perioperative stage for urothelial carcinoma, is anticipated to significantly broaden the therapeutic reach of 9MW2821, potentially benefiting a larger patient population."

IND • Cervical Cancer • Esophageal Squamous Cell Carcinoma • Urothelial Cancer

A Study to Evaluate 9MW2821 Versus Treatment of Physician's Choice for Subjects With Recurrent or Metastatic Cervical Cancer (clinicaltrials.gov) - P3 | N=420 | Recruiting | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

Metastases • New P3 trial • Cervical Cancer • Oncology • Solid Tumor

9MW2821 in Combination With Toripalimab vs Standard Chemotherapy in Locally Advanced or Metastatic Urothelial Cancer (clinicaltrials.gov) - P3 | N=460 | Recruiting | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

Combination therapy • Metastases • New P3 trial • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

9MW2821-2023-CP301: A Study to Evaluate 9MW2821 Versus Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (clinicaltrials.gov) - P3 | N=420 | Recruiting | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial Cancer (clinicaltrials.gov) - P1/2 | N=100 | Recruiting | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Maiwei Biopharma initiates Phase III clinical trial of Nectin-4 ADC+PD-1 in advanced urothelial carcinoma [Google translation] (Eastmoney.com) - "Recently, the clinical trials website showed that Mywell Biopharma has registered a Phase 3 clinical trial (NCT06592326) of the Nectin-4 ADC drug 9MW2821 combined with toripalimab and standard chemotherapy in the first-line treatment of locally advanced or metastatic urothelial carcinoma. This is a randomized, controlled, open-label, multicenter Phase 3 clinical study designed to evaluate the efficacy, safety, and immunogenicity of 9MW2821 combined with toripalimab and standard chemotherapy in first-line locally advanced or metastatic urothelial carcinoma."

Trial status • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Mabwell Announces CDE Approval to Initiate Phase III Clinical Trial of 9MW2821 for Urothelial Carcinoma in Combination with PD-1 Inhibitor (PRNewswire) - "Mabwell...announced that its submission to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for 'a randomized, controlled, open-label, multicenter Phase III clinical study of 9MW2821 in combination with Toripalimab versus standard chemotherapy in first-line locally advanced or metastatic urothelial cancer' has been approved. The corresponding Phase III clinical study has been initiated and is currently in the enrollment stage. As of the announcement, 9MW2821 has been approved for three pivotal clinical trials."

Trial status • Urothelial Cancer

Mabwell Announces the CDE Approval of Novel Nectin-4 Targeting ADC to Initiate Phase III Clinical Trial for the Treatment of Cervical Cancer (PRNewswire) - "Mabwell...announced that its submission to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the 'A Randomized, Open-label, Phase III Study to Evaluate 9MW2821 vs Investigator's Choice of Chemotherapy in Subjects with Recurrent or Metastatic Cervical Cancer Who Progressed on or after Platinum-based Chemotherapy' has been approved. The company will initiate the Phase III clinical study to assess the efficacy and safety of 9MW2821 in patients with recurrent or metastatic cervical cancer (CC) that has progressed on or after platinum-based chemotherapy."

New P3 trial • Cervical Cancer

Safety and Efficacy of 9MW2821 in the Treatment of High-risk Non-muscle-invasive Bladder Cancer (NMIBC) (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

New P1 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Maiwei Biopharma: Maiwei Biopharma voluntarily discloses summary of announcement regarding inclusion of 9MW2821 for urothelial carcinoma in breakthrough therapy designation [Google translation] (Stockstar) - "Maiwei (Shanghai) Biotechnology Co., Ltd. announced that its independently developed innovative drug 9MW2821 has been included in the list of breakthrough therapeutics by the Center for Drug Evaluation of the National Medical Products Administration. The drug is used to treat locally advanced or metastatic urothelial carcinoma that has failed previous platinum chemotherapy and PD-(L)1 inhibitor treatment."

Breakthrough therapy • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Mabwell Receives NMPA Approval for Clinical Trial of Novel Nectin-4 Targeting ADC in TNBC (PRNewswire) - "Mabwell...announced its novel Nectin-4 targeting ADC (R&D code: 9MW2821) has been approved by the NMPA to enter Phase II clinical trial as monotherapy or in combination with a PD-1 inhibitor for the treatment of triple-negative breast cancer (TNBC). The Phase II clinical trial recently approved aims to evaluate the efficacy and safety of 9MW2821 as monotherapy or in combination with a PD-1 inhibitor in patients with locally advanced or metastatic TNBC. The study includes two cohorts: Cohort A will enroll patients with locally advanced or metastatic TNBC who have previously received taxane/anthracycline-based chemotherapy and topoisomerase inhibitor based antibody-drug conjugate treatment, and will receive 9MW2821 monotherapy; Cohort B will enroll patients with locally advanced or metastatic TNBC who have not previously received systemic therapy, and will receive a combination treatment of 9MW2821 and a PD-1 inhibitor."

New P2 trial • Triple Negative Breast Cancer

FDA Grants Fast Track Designation to 9MW2821 for the Treatment of Patients with Locally Advanced or Metastatic Nectin-4 Positive TNBC (PRNewswire) - "Mabwell...announces that its self-developed novel Nectin-4-targeting ADC (R&D Code: 9MW2821) has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of locally advanced or metastatic Nectin-4 positive triple negative breast cancer (TNBC)."

Fast track • Triple Negative Breast Cancer

A Clinical Study of 9MW2821 (and PD-1 Inhibitor) in Locally Advanced or Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov) - P2 | N=160 | Not yet recruiting | Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

Metastases • Monotherapy • New P2 trial • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Development and validation of bioanalytical assays for the quantification of 9MW2821, a nectin-4-targeting antibody-drug conjugate. (PubMed, J Pharm Biomed Anal) - "In conclusion, we developed and validated series of bioanalytical assays to quantify multiple forms of 9MW2821, a new ADC, and used the assays to evaluate the serum stability and monkey pharmacokinetic characteristics. The results indicate good linker stability and suggest that the developed assays can be further used in clinical settings."

Journal • NECTIN4