Verizon (opamtistomig) / Leads Biolabs - LARVOL DELTA

Assessment of efficacy of LBL-024, a novel and uniquely designed bispecific antibody against PD-L1 and 4-1BB, combined with etoposide/platinum-based chemotherapy in treatment-naive advanced extrapulmonary neuroendocrine carcinoma (EP-NEC): A multicenter phase Ib/II trial. (ASCO 2025) - P1/2 | "Here we report the safety and efficacy of LBL-024 combined with etoposide and cisplatin or carboplatin (EP/EC) as first line treatment in patients with advanced NEC. LBL-024 combined with chemotherapy was well-tolerated. The extremely improved response observed in EP-NECs is significantly higher than the historic reports (about 30%~55%). Data including ER analysis of this ongoing study will be updated by a follow-up submission to ASCO."

Clinical • Metastases • P1/2 data • Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor • PD-L1

A Clinical Trial of LBL-024 Combined With Etoposide and Platinum in Patients With Advanced Neuroendocrine Carcinoma (clinicaltrials.gov) - P1/2 | N=178 | Recruiting | Sponsor: Nanjing Leads Biolabs Co.,Ltd | Trial completion date: Jul 2027 ➔ Mar 2027

Trial completion date • Endocrine Cancer • Neuroendocrine Carcinoma • Oncology • Solid Tumor

A Clinical Trial of LBL-024 Combination Drug in Patients With Advanced Solid Tumours[Substudy 02(BTC&HCC)] (clinicaltrials.gov) - P2 | N=140 | Recruiting | Sponsor: Nanjing Leads Biolabs Co.,Ltd | Trial completion date: Dec 2026 ➔ Dec 2027 | Trial primary completion date: Dec 2026 ➔ Dec 2027

Trial completion date • Trial primary completion date • Hepatocellular Cancer • Oncology • Solid Tumor

A Phase II Clinical Study of LBL-024 Combination Therapy in Patients With Advanced Solid Tumour[Substudy 03(ESCC)] (clinicaltrials.gov) - P2 | N=110 | Recruiting | Sponsor: Nanjing Leads Biolabs Co.,Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Solid Tumor

Nanjing Leads Biolabs…is pleased to announce that the first patient has been successfully enrolled in a Phase II clinical study evaluating Opamtistomig (LBL-024, a PD-L1/4-1BB bispecific antibody) for the treatment of first-line esophageal squamous cell carcinoma (ESCC) (HKEXnews) - "The open-label, multi-center Phase II clinical study...is being conducted across multiple hospitals in China. The trial aims to evaluate the efficacy and safety of Opamtistomig administered in patients with first-line ESCC."

Trial status • Esophageal Squamous Cell Carcinoma

A Trial of LBL-024 Monotherapy or Combination Drug in Patients With Triple Negative Breast Cancer (clinicaltrials.gov) - P1/2 | N=220 | Recruiting | Sponsor: Nanjing Leads Biolabs Co.,Ltd | Not yet recruiting ➔ Recruiting

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

Nanjing Leads Biolabs…announced that the first patient has been successfully dosed in a Phase Ⅰb/Ⅱ clinical study evaluating Opamtistomig (LBL-024), the company’s core investigational PD-L1/4-1BB bispecific antibody, for the treatment of recurrent or metastatic triple-negative breast cancer (TNBC) (Leads Biolabs Press Release) - "The newly initiated open-label, multi-center Phase Ib/II clinical study, led by Professor Yin Yongmei of Jiangsu Province Hospital, is being conducted across multiple hospitals in China. The study is designed to evaluate the efficacy and safety of Opamtistomig as monotherapy or in combination with albumin-bound paclitaxel in patients with recurrent or metastatic TNBC."

Trial status • Triple Negative Breast Cancer

A Phase II Clinical Trial of LBL-024 Combination Drug in Patients With Advanced Solid Tumour[Substudy 04] (clinicaltrials.gov) - P2 | N=110 | Not yet recruiting | Sponsor: Nanjing Leads Biolabs Co.,Ltd

New P2 trial • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Solid Tumor

A Phase II Clinical Study of LBL-024 Combination Therapy in Patients With Advanced Solid Tumour[Substudy 03(ESCC)] (clinicaltrials.gov) - P2 | N=110 | Not yet recruiting | Sponsor: Nanjing Leads Biolabs Co.,Ltd

New P2 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Solid Tumor

Nanjing Veolizhibo Biotechnology Co., Ltd…announced that its independently developed anti-PD-L1/4-1BB bispecific antibody, Verizon (LBL-024), has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of extrapulmonary neuroendocrine carcinoma (EP-NEC). [Google translation] (Leads Biolabs Press Release)

Fast track • Neuroendocrine Carcinoma

LBL-024 dosed first patient in phase Ib/II trial for platinum-resistant ovarian cancer (HKEXnews) - "The open-label, multi-center Phase Ib/II clinical study is led by Professor Lingying Wu of Cancer Hospital, Chinese Academy of Medical Sciences and is being conducted across multiple hospitals in China."

Platinum resistant • Trial status • Ovarian Cancer

A Clinical Trial of LBL-024 Combination Drug in Patients With Advanced Solid Tumours[Substudy 02(BTC&HCC)] (clinicaltrials.gov) - P2 | N=172 | Recruiting | Sponsor: Nanjing Leads Biolabs Co.,Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatocellular Cancer • Solid Tumor

A Trial of LBL-024 Monotherapy or Combination Drug in Patients With Triple Negative Breast Cancer (clinicaltrials.gov) - P1/2 | N=220 | Not yet recruiting | Sponsor: Nanjing Leads Biolabs Co.,Ltd

Monotherapy • New P1/2 trial • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

A Phase Ib/Ⅱ Clinical Trial of LBL-024 Combined With Paclitaxel in Patients With Platinum-resistant Ovarian Cancer (clinicaltrials.gov) - P1/2 | N=110 | Recruiting | Sponsor: Nanjing Leads Biolabs Co.,Ltd | Not yet recruiting ➔ Recruiting | Trial completion date: Mar 2028 ➔ Dec 2028

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

LBL-024 DOSED FIRST PATIENT IN PHASE II TRIAL OF FIRST-LINE TREATMENT FOR HEPATOCELLULAR CARCINOMA (HKEXnews) - "The open-label, multi-center Phase II clinical study...is being conducted across multiple hospitals in China. The trial aims to evaluate the efficacy and safety of Opamtistomig in combination regimens for the first-line treatment of patients with hepatocellular carcinoma."

Trial status • Hepatocellular Cancer

LBL-024 DOSED FIRST PATIENT IN PHASE II TRIAL OF FIRST-LINE TREATMENT FOR BILIARY TRACT CANCER (HKEXnews) - "The open-label, multi-center Phase II clinical study...is being conducted across multiple hospitals in China. The trial aims to evaluate the efficacy and safety of Opamtistomig in combination regimens for the first-line treatment of patients with advanced biliary tract cancer."

Trial status • Biliary Tract Cancer

A Clinical Trial of LBL-024 Combination Drug in Patients With Advanced Solid Tumours[Substudy 02(BTC&HCC)] (clinicaltrials.gov) - P2 | N=172 | Not yet recruiting | Sponsor: Nanjing Leads Biolabs Co.,Ltd

New P2 trial • Hepatocellular Cancer • Solid Tumor

A Trial of LBL-024 Monotherapy, LBL-024 Combined With LBL-007 or Toripalimab in Patients With Advanced Melanoma (clinicaltrials.gov) - P1/2 | N=200 | Recruiting | Sponsor: Nanjing Leads Biolabs Co.,Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Melanoma • Oncology • Solid Tumor

LBL-024: ORR data from P2 trial (NCT06157827) 1L EP-NEC in H2 2025 (Leads Biolabs) - H1 2025 Results: ORR data from P2 trial for 1L SCLC in Q4 2025/Q1 2026 and OS data in mid-2026

P2 data • Neuroendocrine Carcinoma • Oncology • Small Cell Lung Cancer

LBL-024: Regulatory submission in China for 3L+ extra-pulmonary neuroendocrine carcinoma in Q3 2026 (Leads Biolabs) - H1 2025 Results: Approval in China for 3L+ extra-pulmonary neuroendocrine carcinoma in mid-2027; Regulatory submissions in China for 1L extra-pulmonary neuroendocrine carcinoma and 1L SCLC in combination with chemotherapy in 2029; Regulatory submission in China for NSCLC and other solid tumors in 2030

China approval • China filing • Neuroendocrine Carcinoma • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

LBL-024: ORR data from P1b/2 trial (NCT05170958) for 3L + EP-NEC in H1 2026 and OS data in H2 2026 (Leads Biolabs) - H1 2025 Results: ORR data for 2L + EP-NEC in H2 2026 and OS data in H2 2026

P1/2 data • Neuroendocrine Carcinoma • Oncology

LBL-024: “LBL-024 – Monotherapy phase I/II- efficacy results in EP-NEC (2/3)”; Extra pulmonary neuroendocrine carcinoma (Leads Biolabs) - H1 2025 Results: “LBL-024 in combination with chemotherapy – Ph Ib/II 1L EP-NEC”

P1/2 data • Neuroendocrine Carcinoma • Oncology

Nanjing Leads Biolabs…announced the first patient has been successfully dosed in a Phase 1b/II clinical trial (NCT07099430) evaluating Opamtistomig…as monotherapy or in combination with other agents for the ‌first-line treatment of advanced melanoma‌‌ (PRNewswire)

Trial status • Melanoma

LBL-024: “LBL-024 in combination with chemotherapy – Phase II 1L SCLC”; Small cell lung cancer (Leads Biolabs) - H1 2025 Results: “As of June 5, 2025, among 52 evaluable patients, ORR of 86.5% (45/52) and DCR of 96.2% (50/52) were observed in the 1L SCLC cohort in the Phase II trial”

P2 data • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer

A Trial of LBL-024 Monotherapy, LBL-024 Combined With LBL-007 or Toripalimab in Patients With Advanced Melanoma (clinicaltrials.gov) - P1/2 | N=200 | Not yet recruiting | Sponsor: Nanjing Leads Biolabs Co.,Ltd

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