RC148 / Rongchang Pharma - LARVOL DELTA

A phase I/II study of RC148 (PD-1/VEGF bispecific antibody) monotherapy or in combination with docetaxel for the treatment of first- or second-line locally advanced or metastatic non-small cell lung cancer (la/mNSCLC) without actionable genomic alterations (AGA) (ESMO-IO 2025) - P1/2 | "Conclusions RC148 monotherapy showed encouraging anti-tumor activity and an acceptable safety profile in 1L PD-L1-positive la/m NSCLC pts. RC148 + docetaxel also showed promising efficacy in la/m NSCLC pts who were previously treated with PD-(L)1 inhibitor and platinum-based chemo; the dose of 20mg/kg Q3W was well-tolerated and demonstrated more favorable efficacy over 10mg/kg Q3W and thus, selected as the optimal dose.Clinical trial identification NCT06016062.Legal entity responsible for the study RemeGen Co., Ltd."

Clinical • Combination therapy • Metastases • Monotherapy • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

RC118 (CLDN18.2-targeted ADC) combined with PD-1 blockade or RC148 (PD-1/VEGF bispecific antibody) for locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma (la/m G/GEJA) (ESMO 2025) - P1/2 | "RC118 plus toripalimab (Tor) or RC148 is expected to enhance antitumor activity. Conclusions RC118 plus either RC148 or Tor showed promising ORR and manageable safety in CLDN18.2-positive la/m G/GEJA. A trend toward improved PFS was observed with RC118 + RC148."

IO biomarker • Late-breaking abstract • Metastases • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • CLDN18 • PD-L1

Rongchang Biopharma (09995): The National Medical Products Administration's Center for Drug Evaluation has granted Breakthrough Therapy Designation to RC148 for the treatment of non-small cell lung cancer. [Google translation] (Zhitong Finance) - "The inclusion of RC148 in the Breakthrough Therapy designation by the CDE is based on a multicenter, open-label Phase I/II clinical study (RC148-C001) conducted in China."

Breakthrough therapy • Non Small Cell Lung Cancer

RemeGen's Independently-Developed Bispecific Antibody RC148 Approved to Proceed Phase II Clinical Trial in US by FDA (PRNewswire) - "On August 8th, RemeGen Co., Ltd...announces clearance of IND application by Food and Drug Administration (FDA) for phase II clinical trials for its independently-developed bispecific antibody, RC148, for the treatment of multiple advanced malignant solid tumors in the US."

IND • New P2 trial • Oncology • Solid Tumor

Efficacy and safety of disitamab vedotin in combination with RC148 versus albumin-bound paclitaxel ± toripalimab for patients with HR-negative HER2-low-expressing unresectable locally advanced or metastatic breast cancer: An open-label, randomized, controlled phase II study. (ASCO 2025) - P2 | "The secondary endpoints are ORR in the PD-L1-positive pts; investigator-assessed progression-free survival, disease control rate, duration of response, and overall survival in all pts and the PD-L1-positive pts. This study was initiated in August 2024."

Clinical • Combination therapy • IO biomarker • Metastases • P2 data • Breast Cancer • Gastric Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor • HER-2 • PD-L1

A Phase Ib Study of RC148 as Monotherapy or Combination for Locally Advanced or Metastatic NSCLC (clinicaltrials.gov) - P1 | N=150 | Recruiting | Sponsor: RemeGen Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Phase Ib Study of RC148 as Monotherapy or Combination for Locally Advanced or Metastatic NSCLC (clinicaltrials.gov) - P1 | N=150 | Not yet recruiting | Sponsor: RemeGen Co., Ltd.

Monotherapy • New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

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

Efficacy and Safety Study of Disitamab Vedotin + RC148 vs. Albumin-Paclitaxone ± Toripalimab in HR-/HER2-low Breast Cancer (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: RemeGen Co., Ltd. | Not yet recruiting ➔ Recruiting | Initiation date: Nov 2024 ➔ Feb 2025

Enrollment open • Trial initiation date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor

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

Efficacy and Safety Study of Disitamab Vedotin + RC148 vs. Albumin-Paclitaxone ± Toripalimab in HR-/HER2-low Breast Cancer (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: RemeGen Co., Ltd.

Combination therapy • Metastases • New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor

RC148, a novel bispecific antibody targeting PD-1 and VEGF for cancer immunotherapy (AACR 2024) - "RC148 allows dimeric VEGF crosslinking and gradually enhances PD-1 binding activity, potentially reduces systemic toxicity of anti-VEGF therapy and enhances antitumor potency via VEGF trigged enrichment in tumor areas. In preclinical studies, RC148 blocks the binding of VEGF to VEGFR and PD-1 to PD-L1, prevents the growth and migration of human umbilical vein endothelial cells, enables efficient T cell activation, exhibited synergistic antitumor effects in rodent models and showed safety profiles in non-human primate studies."

Oncology

A Study of RC148 in Patients With Locally Advanced Unresectable or Metastatic Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=25 | Recruiting | Sponsor: RemeGen Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor • PD-1