M701 / YZY Biopharma, Sino Biopharm - LARVOL DELTA

Development and clinical trial of M701, an Anti-EpCAM × Anti-CD3 bispecific antibody: a targeted intraperitoneal therapy for malignant ascites stemming from advanced solid tumors. (PubMed, Exp Hematol Oncol) - "When treated with M701, patients with MA had significantly longer puncture intervals and a trend of extended survival time. The results were encouraging for patients with MA. A phase III clinical trial of M701 aimed at further validation is ongoing."

Journal • Colorectal Cancer • Hematological Disorders • Oncology • Ovarian Cancer • Solid Tumor

A phase II, randomized, controlled, open label study of M701 intra-pleural infusion in patients with malignant pleural effusion caused by NSCLC: Intermediate results (ESMO 2025) - P1/2 | "Flow cytometry analysis revealed that EpCAM+ cells in effusions were significantly decreased after 3 infusions of M701, but not in the control arm. Table: 1880P mPuFS (days) M701 arm Cisplatin arm HR P value All patients (26 vs 28) 130 85 0.8 0.542 Driven gene negative patients or with a history of IP chemotherapy (13 vs 14) 253 71 0.26 0.021 Driven gene positive patients without previous IP chemotherapy (13 vs 14) 127 114 1.58 0.366 Conclusions M701 IP infusion demonstrated remarkable efficacy in managing MPE compared with cisplatin, and was well tolerated, supporting further clinical development, especially in NSCLC patients with no driven gene mutation or patients who received IP chemotherapy previously."

Clinical • P2 data • Pleural effusion • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

PHASE II STUDY INTERIM DATA OF M701 FOR MALIGNANT PLEURAL EFFUSION PRESENTED AT THE ESMO CONGRESS 2025 (HKEXnews) - "As of March 7, 2025, 54 eligible advanced NSCLC patients with symptomatic MPE who had failed in at least 1 line of systemic treatment were enrolled....The PuFS of the experimental group was longer than that of the control group (median PuFS 130 days versus 85 days, HR (Hazard Ratio)=0.80, p=0.542). The patient with driven gene negative (median PuFS not reached versus 44.5 days, HR (Hazard Ratio)＜0.01, p＜0.001) or patients who had a history of IP chemotherapy (median PuFS 253 days versus 72 days, HR (Hazard Ratio)=0.31, p=0.076) got significant benefit in the experimental group."

P2 data • Non Small Cell Lung Cancer

Treat Malignant Ascites Caused by Gastrointestinal or Ovarian Cancer With M701 Bispecific Antibody (clinicaltrials.gov) - P2 | N=115 | Completed | Sponsor: Wuhan YZY Biopharma Co., Ltd. | Active, not recruiting ➔ Completed | N=80 ➔ 115 | Trial completion date: Dec 2024 ➔ Aug 2024

Enrollment change • Platinum resistant • Trial completion • Trial completion date • Oncology • Ovarian Cancer • Solid Tumor

A Phase Ib/II Clinical Trial of M701 in the Treatment of Malignant Pleural Effusions Caused by NSCLC (clinicaltrials.gov) - P1/2 | N=96 | Recruiting | Sponsor: Wuhan YZY Biopharma Co., Ltd. | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2024 ➔ Oct 2026 | Trial primary completion date: Jun 2024 ➔ Apr 2026

Enrollment open • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Respiratory Diseases • Solid Tumor

Treatment of Malignant Ascites Caused by Advanced Epithelial Solid Tumors With M701 Bispecific Antibody (clinicaltrials.gov) - P3 | N=312 | Active, not recruiting | Sponsor: Wuhan YZY Biopharma Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Aug 2025 ➔ Nov 2025

Enrollment closed • Trial primary completion date • Solid Tumor

A Study of M701 (EpCAM and CD3) in Malignant Ascites (clinicaltrials.gov) - P1 | N=35 | Completed | Sponsor: Wuhan YZY Biopharma Co., Ltd. | Recruiting ➔ Completed

Trial completion • Oncology • CA 19-9 • CA724

Updated results of a phase II trial evaluating an anti-EpCAM x anti-CD3 bispecific antibody, M701, for the treatment of malignant ascites (ESMO Asia 2024) - P2 | "The ≥ 13% RLC subgroup pts received better benefit in PuFS and significant benefit in OS, which is consistent with the mechanism of action of M701. Those findings are encouraging and support further clinical trials of M701."

P2 data • Gastric Cancer • Oncology • Solid Tumor

An anti-EpCAM x CD3 bispecific antibody, M701, for the treatment of malignant pleural effusion in NSCLC patients: Intermediate results of a prospective multicenter phase Ib trial (ESMO 2024) - P1/2 | "IP infusion with M701 demonstrates a favorable safety profile and efficacy on preventing the re-accumulation of pleural effusions. And RP2D had been decided (400μg, 4 doses). Data accrual of efficacy and safety parameters within a controlled phase II trial exploring IP infusion of M701 or cisplatin in MPE pts is ongoing."

Clinical • P1 data • Pleural effusion • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • EPCAM

An anti-EpCAM x anti-CD3 bispecific antibody, M701, for the treatment of malignant ascites due to epithelial cancer: Interim results of a prospective randomized controlled phase II trial. (ASCO 2024) - "IP infusions of M701, based on systemic tumor therapy, were well tolerated and did not pose a higher risk compared to the control arm. Epithelial cancer patients with MA who received M701 treatment had longer PuFS and OS. These results are promising and support the pivotal trial of M701 as a novel treatment for MA."

Clinical • P2 data • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Treatment of Malignant Ascites Caused by Advanced Epithelial Solid Tumors With M701 Bispecific Antibody (clinicaltrials.gov) - P3 | N=270 | Recruiting | Sponsor: Wuhan YZY Biopharma Co., Ltd.

Metastases • New P3 trial • Oncology • Solid Tumor • EPCAM

Treat Malignant Ascites Caused by Gastrointestinal or Ovarian Cancer With M701 Bispecific Antibody (clinicaltrials.gov) - P2 | N=80 | Active, not recruiting | Sponsor: Wuhan YZY Biopharma Co., Ltd.

New P2 trial • Gastrointestinal Disorder • Oncology • Ovarian Cancer • Solid Tumor

[VIRTUAL] Interim results of a phase I study of M701, a recombinant anti-EpCAM and anti-CD3 bispecific antibody in EpCAM-positive cancer patients with malignant ascites (ESMO 2021) - P1 | "I.p. infusion with M701 prevented the accumulation of ascites. OS showed an improved trend in pts with gastric and ovarian cancer. These interim data support further development of M701 for pts with malignant ascites."

Clinical • P1 data • Gastric Cancer • Gastrointestinal Cancer • Oncology • Ovarian Cancer • Solid Tumor • PTPRC

A Phase Ib/II Clinical Trial of M701 in the Treatment of Malignant Pleural Effusions Caused by NSCLC (clinicaltrials.gov) - P1/2 | N=96 | Not yet recruiting | Sponsor: Wuhan YZY Biopharma Co., Ltd.

New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Respiratory Diseases • Solid Tumor • EPCAM