Leads Biolabs’ Innovative Bispecific Antibody LBL-024 and novel monoclonal antibody LBL-007 Have Been Presented at 2024 CSCO

NANJING, China, September 27, 2024— Nanjing Leads Biolabs Co., Ltd. (hereinafter referred to as "Leads Biolabs" or "Company") today announces that the most recent clinical research findings of LBL-024, an anti-PD-L1/4-1BB bispecific antibody, and LBL-007, an anti-LAG-3 antibody, were showcased in an oral presentation during the Innovation Session at 2024 Chinese Society of Clinical Oncology（CSCO）Annual Meeting.

Professor Lu Ming from Beijing Cancer Hospital presents the clinical data of LBL-024 at 2024 CSCO Annual Meeting

The Phase I/II clinical study of LBL-024 (NCT05170958) in patients with advanced malignancies and neuroendocrine cancers aims to evaluate the safety and efficacy of LBL-024 as a monotherapy. The key findings from the study are as follows:

• The Phase I portion of the study enrolled 64 patients with advanced malignancies who had progressed after standard therapies. No dose-limiting toxicity (DLT) was observed, and the maximum tolerated dose (MTD) was not achieved, demonstrating an excellent safety profile.

• In the Phase I/II study, a noteworthy 33.3% objective response rate (ORR) was achieved among 45 patients with extrapulmonary neuroendocrine carcinoma (EP-NEC), more than double the efficacy data reported with existing treatments.

• LBL-024 has demonstrated robust antitumor activity and a favorable safety profile in EP-NEC patients. The observed ORR is significantly higher than the historical data of immunotherapy and chemotherapy, paving the way for pivotal studies in the EP-NEC indications.

Professor Yang Yunpeng from Sun Yat-sen University Cancer Center presents the clinical data of LBL-007 at 2024 CSCO Annual Meeting

The Phase Ib/II clinical study of anti-LAG-3 antibody LBL-007 (NCT05516914) aims to evaluate the safety and efficacy of LBL-007 in combination with anti-PD-1 antibody tislelizumab, with or without chemotherapy, in the treatment of advanced solid tumors (Phase Ib) and previously untreated patients with advanced nasopharyngeal carcinoma (NPC) (Phase II). The key findings from the study are as follows:

• In Phase Ib, 21 patients were enrolled and received LBL-007 in combination with tislelizumab. No DLT was observed during the dose escalation period.

• In Phase II, 42 previously untreated patients with recurrent or metastatic NPC were enrolled and received LBL-007 combined with tislelizumab and chemotherapy regimen. Among the 41 evaluable patients, the ORR was 90.2%, the disease control rate (DCR) was 100%, and the 3-month progression-free survival rate was 97.6%.

• The combination of LBL-007 with tislelizumab and the GC regimen demonstrated encouraging antitumor activity and manageable safety in previously untreated patients with advanced NPC.

Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, said, “We are extremely honored to have the opportunity to share our research findings with experts and peers from both home and abroad at the CSCO annual meeting. Leads Biolabs consistently puts patients' needs as the priority and is committed to addressing clinical challenges through technological innovation. In the future, we will continue to increase our investment in R&D, deepen our collaborations with domestic and international companies, as well as scientific research institutions, explore more innovative therapies, and contribute to the global effort in cancer prevention and treatment.”

About LBL-024

LBL-024 is a tetravalent bispecific antibody that simultaneously targets PD-L1 and 4-1BB, serving dual functions: blocking the immunosuppressive PD-1/PD-L1 pathway, and selectively co-stimulating 4-1BB in the tumor microenvironment to enhance immune responses. The dual functions of LBL-024—lifting PD-1/PD-L1 immune inhibition and intensifying 4-1BB modulated T cell activation—synergistically enhance the anti-tumor immune response.

About LBL-007

LBL-007 is a fully human IgG4 monoclonal antibody targeting LAG3. LBL-007 is designed with a unique structure that allows it to bind to specific epitope of LAG3 with high affinity and block LAG3’s interaction with all four identified ligands. Upon binding to LAG3, LBL-007 induces potent endocytosis, thereby modulating intracellular signaling pathways independently of ligand interaction and enhancing immune responses. LBL-007, as one of the pioneering LAG-3 antibodies, has exhibited robust efficacy in melanoma and other specific cancer types and is currently being evaluated under Phase II clinical trials mainly for the treatment of five cancer indications in China and worldwide.