SBE303 / Samsung - LARVOL DELTA

Transcriptomic analyses of molecular subsets and correlations with clinical outcomes from the phase 3 IMforte study of lurbinectedin (lurbi) + atezolizumab (atezo) maintenance treatment (Tx) in extensive-stage small-cell lung cancer (ES-SCLC). (ASCO 2026) - P3 | "Clinical outcomes in the 303 pts (median [m] PFS: 5.5 vs 2.4 months [mo], hazard ratio [HR] 0.61; mOS: 13.5 vs 11.7 mo, HR 0.72, for lurbi + atezo [n = 150] vs atezo [n = 153], respectively) were consistent with the full analysis set. The prevalence of the 4 SCLC subtypes and the TAM/T-eff pre-Tx data for IMforte are consistent with findings from IMpower133. PFS and OS were longer for lurbi + atezo vs atezo irrespective of molecular subset, though numerical trends suggest that lurbi may overcome TAM-mediated resistance to atezo."

Clinical • Clinical data • IO biomarker • P3 data • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • SLFN11

E303-1001: A Phase I, Open-label, Multi-center, First-in-human Trial to Investigate E303, in Participants with Advanced Refractory Solid Tumors (clinicaltrialsregister.eu) - P1 | N=40 | Not yet recruiting | Sponsor: Samsung Bioepis Co. Ltd.

First-in-human • New P1 trial • Oncology • Solid Tumor

Nonclinical characterization of SBE303: A nectin-4 targeted antibody drug conjugate (ADC) with novel topoisomerase 1 inhibitor shows a favorable safety margin (AACR 2026) - "The absence of significant histopathologic changes indicated a favorable systemic safety profile.These nonclinical findings support the advancement of SBE303into clinical development with a favorable therapeutic index based on higher tolerated doses and wider exposure margins compared to known approved anti-Nectin4 ADC. A first-in-human study is expected to initiate in 2026."

ADC • Clinical • First-in-human • Oncology • Solid Tumor • Urothelial Cancer

Samsung Bioepis Presents Nonclinical Data for its First Novel Antibody-Drug Conjugate Candidate SBE303 at AACR 2026 (Businesswire) - "SBE303 treatment resulted in robust anti-tumor activity with a differentiated tolerability profile, supporting an improved TI. Notably, the highest non severely toxic dose (HNSTD) was estimated to be 40 mg/kg and no intestinal lung disease (ILD) findings were observed at doses ≥40 mg/kg in repeat-dose toxicity studies."

Preclinical • Oncology

A Trial to Investigate the Safety of E303 in Participants With Advanced Refractory Solid Tumors (clinicaltrials.gov) - P1 | N=149 | Recruiting | Sponsor: Samsung Bioepis Co., Ltd.

First-in-human • New P1 trial • Oncology • Solid Tumor

Samsung Bioepis Initiates Phase 1 Clinical Trial for SBE303, Nectin-4 Targeting Antibody-Drug Conjugate (ADC) Candidate (Businesswire) - "The Phase 1 clinical trial for SBE303 is an open‑label, multi-center, first‑in‑human trial to evaluate the safety, tolerability and efficacy of SBE303 in participants with advanced refractory solid tumors."

First-in-human • Trial status • Solid Tumor

IntoCell nears Samsung Bioepis deal as phase 1 starts, milestone hopes rise (Chosun Biz) - "IntoCell is on the verge of signing a definitive technology transfer agreement with Samsung Bioepis....The research collaboration is expected to face its first test of turning into an actual commercialization deal. According to Samsung Bioepis on the 13th, the company plans to start a phase 1 trial within the first half for its Antibody-Drug Conjugate (ADC) drug candidate SBE303 targeting Nectin-4. SBE303 is the first new drug candidate independently developed by Samsung Epis Holdings, with the initial indication being bladder cancer."

Licensing / partnership • New P1 trial • Bladder Cancer

In December 2025, the FDA has cleared the IND Application for SBE303 (Businesswire) - "The Phase 1 first-in-human clinical trial, aiming to evaluate the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of SBE303 in participants with advanced refractory solid tumors, is set to begin this year."

First-in-human • IND • New P1 trial • Solid Tumor

Samsung Bioepis has submitted an investigational new drug (IND) application for a phase 1 clinical trial of an antibody-drug conjugate (ADC) drug candidate to the U.S. Food and Drug Administration (FDA) (Chosun Biz) - "The company is aiming to enter a global phase 1 trial next year and to produce interim results."

IND • New P1 trial • Bladder Cancer