misitatug blivedotin (RC88) / Rongchang Pharma - LARVOL DELTA

Anti MSLN ADC RC88 engages unique binding to target positive tumor cells with less interference from the soluble MSLN protein (AACR 2025) - P1/2, P2 | "Our findings show RC88 has unique binding kinetics to different MSLN regions, with a dominant N-terminal binding site by rigorous methods. RC88 displayed superior binding to MSLN-positive cancer cells than other anti MSLN antibodies and maintained effectiveness despite sMSLN interference. Its stronger binding to the C-terminal MSLN fragment compared with other antibodies further underscores its targeting potential in tumor cells."

Tumor cell • Mesothelioma • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • MSLN • MUC16

A Phase I /IIa Study of RC88-ADC in Subjects with Advanced Malignant Solid Tumors (clinicaltrials.gov) - P1/2 | N=200 | Recruiting | Sponsor: RemeGen Co., Ltd. | Trial completion date: Sep 2025 ➔ Dec 2025 | Trial primary completion date: Sep 2024 ➔ Nov 2025

Trial completion date • Trial primary completion date • Breast Cancer • Gastric Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • MSLN

A Study to Assess the Safety and Tolerability of RC88 for Patients with Advanced Solid Tumours (clinicaltrials.gov) - P1 | N=81 | Active, not recruiting | Sponsor: RemeGen Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Jun 2024 ➔ Jun 2025

Enrollment closed • Trial completion date • Trial primary completion date • Oncology • Solid Tumor • MSLN

A Study of RC148 As a Single Agent and Combination Therapy in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors (clinicaltrials.gov) - P1/2 | N=221 | Recruiting | Sponsor: RemeGen Co., Ltd. | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial primary completion date • Gastric Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-1

A Study of RC148 As a Single Agent and Combination Therapy in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors (clinicaltrials.gov) - P1/2 | N=221 | Recruiting | Sponsor: RemeGen Co., Ltd. | Phase classification: P1 ➔ P1/2 | N=25 ➔ 221

Enrollment change • Phase classification • Gastric Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-1

RC88 in Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer (clinicaltrials.gov) - P2 | N=88 | Recruiting | Sponsor: RemeGen Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

The efficacy and safety of RC88 in patients with ovarian cancer, non-squamous-non-small-cell lung-carcinoma and cervical cancer: Results from a first-in-human phase 1/2 study. (ASCO 2024) - P1/2 | "Thirty-three (55%) had prior bevacizumab, and 29 (48.3%) had prior PARPi. RC88 demonstrated tolerable safety and encouraging preliminary efficacy in MSLN-expressing solid tumors, warranting further investigations."

Clinical • P1/2 data • Anemia • Cervical Cancer • Hematological Disorders • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • MSLN

RemeGen Reports Proof-of-Concept Phase I/II Clinical Study Results for Self-Developed, Potential First-in-Class Antibody-Drug Conjugate RC88 (PRNewswire) - P1/2 | N=200 | NCT04175847 | Sponsor: RemeGen Co., Ltd. | "RemeGen...presented the results of the first-in-human, single-arm, open-label, multi-center Phase I/II study...at the American Society of Clinical Oncology Annual Meeting (ASCO 2024)....As of February 21, 2024, 170 patients with advanced solid tumor were enrolled....In the ovarian cancer (OC) cohort, 54 patients were enrolled, all with 2+ or 3+ MSLN expression....Among them, the ORR and confirmed ORR (cORR) were 45.2% (14/31, 95%CI 27.3, 64.0) and 41.9% (13/31, 95%CI 24.5, 60.9), respectively. The median DoR was 8.02 months (95%CI 2.83, 8.54). In the non-squamous non-small cell lung cancer (NSCLC) cohort, 16 EGFR/ALK wild-type (WT) patients were efficacy-evaluable. The ORR and cORR were 31.3% (5/16) and 25% (4/16), respectively....In the cervical cancer (CC) cohort, 18 patients who had progressed on previous systemic therapies were enrolled. The ORR and cORR were 33.3% (6/18) and 27.8% (5/18), respectively."

P1/2 data • Cervical Cancer • Non Small Cell Lung Cancer • Ovarian Cancer

A Phase I /IIa Study of RC88-ADC in Subjects With Advanced Malignant Solid Tumors (clinicaltrials.gov) - P1/2 | N=200 | Recruiting | Sponsor: RemeGen Co., Ltd. | Trial completion date: May 2024 ➔ Sep 2025 | Trial primary completion date: Dec 2023 ➔ Sep 2024

Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • MSLN

Rongchang Biotechnology's ADC RC88 has obtained the US FDA's fast track qualification for targeting MSLN for the treatment of ovarian cancer and other tumors. [Google translation] (Jiaodong) - "On January 8, Rongchang Biopharmaceutical (Yantai) Co., Ltd...announced that it has received a certification letter from the U.S. Food and Drug Administration (FDA), and the ADC drug RC88 independently developed by the company has obtained FDA approval. Fast Track Designation (FTD) granted for patients with platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer (PROC)."

Fast track designation • Fallopian Tube Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Rongchang Biological’s MSLN-targeted ADC RC88 has been approved by the US FDA to conduct international multi-center phase II clinical studies (Jiaodong) - "Rongchang Biopharmaceutical...announced that RC88, an ADC drug targeting MSLN independently developed by the company, is used in the treatment of gynecological tumors. A Phase II clinical trial application has been approved by the US FDA, and international multi-center clinical research will be carried out in the United States, China, the European Union and other countries and regions. This is an open-label, dose-optimized phase II study for the treatment of patients with platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer."

IND • New P2 trial • Fallopian Tube Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

A Phase I /IIa Study of RC88-ADC in Subjects With Advanced Malignant Solid Tumors (clinicaltrials.gov) - P1/2 | N=200 | Recruiting | Sponsor: RemeGen Co., Ltd. | N=51 ➔ 200

Enrollment change • Metastases • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • MSLN

A Study of RC88 Combined With JS001 for Advanced Solid Tumours (clinicaltrials.gov) - P1/2 | N=82 | Recruiting | Sponsor: RemeGen Co., Ltd. | Not yet recruiting ➔ Recruiting | Initiation date: Apr 2023 ➔ Jul 2023

Enrollment open • Trial initiation date • Oncology • Solid Tumor • MSLN

A Study to Assess the Safety and Tolerability of RC88 for Patients With Advanced Solid Tumours (clinicaltrials.gov) - P1 | N=81 | Recruiting | Sponsor: RemeGen Co., Ltd. | Trial completion date: Mar 2024 ➔ Dec 2024 | Trial primary completion date: Dec 2023 ➔ Jun 2024

Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor • MSLN

RC88 in Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer (clinicaltrials.gov) - P2 | N=88 | Not yet recruiting | Sponsor: RemeGen Co., Ltd.

New P2 trial • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Innovent and RemeGen Enter into Clinical Trial Collaboration Investigating Combination Therapy of TYVYT (sintilimab injection) and Novel ADC Candidates for Advanced Solid Tumors in China (PRNewswire) - "Innovent Biologics...and RemeGen...announced that they entered into a clinical trial collaboration and supply agreement with for the combination therapies of TYVYT® (sintilimab injection) with RC88, a novel mesothelin(MSLN)-targeting antibody-drug conjugate (ADC), or RC108, a novel c-Met-targeting ADC, respectively, as potential treatment options for advanced solid tumors in China. Under the agreement, Innovent will provide clinical drug supplies of TYVYT® (sintilimab injection) during the clinical trial collaboration. RemeGen will conduct Phase 1/2a clinical studies to evaluate the anti-tumor activity and safety of the combination therapy of TYVYT® (sintilimab injection) with RC88 or RC108 in Chinese patients with advanced solid tumors."

Licensing / partnership • Oncology • Solid Tumor

Translation of the efficacy of antibody-drug conjugates from preclinical to clinical using a semimechanistic PK/PD model: A case study with RC88. (PubMed, Clin Transl Sci) - "TSC from mice and predicted human PK were integrated to predict human efficacy dose. Results showed that 2 cell lines were sensitive to drugs, and the predicted efficacy dose was between 0.82 and 1.96 mg/kg q1w."

Journal • PK/PD data • Preclinical • Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • MSLN

A Study of RC88 Combined With JS001 for Advanced Solid Tumours (clinicaltrials.gov) - P1/2 | N=82 | Not yet recruiting | Sponsor: RemeGen Co., Ltd.

Metastases • New P1/2 trial • Oncology • Solid Tumor • MSLN

Rongchang Bio-B (09995.HK)'s new drug clinical research application for the treatment of advanced solid tumors was approved by NMPA (Finet Group) - "Rongchang Bio-B...announced that the National Medical Products Administration of China ('NMPA') has approved RC88 combined with toripalimab injection for injection (trade name: Tuoyi^®) an investigational new drug application (IND) for the treatment of patients with advanced malignant solid tumors."

New trial • Oncology • Solid Tumor

A Study to Assess the Safety and Tolerability of RC88 for Patients With Advanced Solid Tumours (clinicaltrials.gov) - P1 | N=81 | Recruiting | Sponsor: RemeGen Co., Ltd.

New P1 trial • Lung Cancer • Oncology • Solid Tumor • MSLN

A Phase I /IIa Study of RC88-ADC in Subjects With Advanced Malignant Solid Tumors (clinicaltrials.gov) - P1/2 | N=51 | Recruiting | Sponsor: RemeGen Co., Ltd. | Phase classification: P1 ➔ P1/2 | N=31 ➔ 51 | Trial completion date: May 2022 ➔ May 2024 | Trial primary completion date: Dec 2021 ➔ Dec 2023

Enrollment change • Phase classification • Trial completion date • Trial primary completion date • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • MSLN

Newly added product (clinicaltrials.gov) - P1, Oncology

Pipeline update