Clinical Candidates - Leads Biolabs

LBL-024

LBL-024 is a PD-L1 and 4-1BB dual-targeting bispecific antibody. It stands as the first molecule targeting co-stimulatory receptor 4-1BB to have reached pivotal stage globally. LBL-024 has the potential to become the first drug specifically approved for treating EP-NEC, a cancer type with highly unmet medical needs.

By harnessing our proprietary X-Body™ platform, a robust 4-1BB engager platform developed in-house, LBL-024 is engineered in a 2:2 format, features two binding domains for each of PD-L1 and 4-1BB and a significantly differentiated affinity ratio of approximately 1:300 for 4-1BB versus PD-L1. The dual functions of LBL-024 — lifting PD-1/L1 immune inhibition and intensifying 4-1BB modulated T cell activation — allow it to achieve synergistic tumor-killing effects and promising broad-spectrum cancer therapeutic potential comparable to PD-1/L1 inhibitors. The unique molecular design of LBL-024 enables it to effectively minimize the systemic toxicity typically associated with 4-1BB agonists while achieving synergistic antitumor effects through both immune activation and the alleviation of immune suppression.

LBL-024 has demonstrated encouraging efficacy signals with a favorable safety profile for the treatment of advanced EP-NEC, either as a monotherapy or in combination with chemotherapy, in our Phase I/II clinical trials in China. The absence of a standard of care for EP-NEC allows us to pursue an accelerated regulatory approval through a single-arm pivotal trial. Additionally, we have received the Breakthrough Therapy Designation (BTD) for LBL-024 in treating late-line EP-NEC from the National Medical Products Administration (NMPA) in October 2024, as well as the Orphan Drug Designation (ODD) in treating NEC from the U.S. Food and Drug Administration (FDA) in November 2024.

Beyond NECs, LBL-024 monotherapy has also generated preliminary efficacy signals in multiple other large cancer indications, particularly SCLC, BTC and NSCLC. Moreover, we see extensive indication expansion opportunities with LBL-024, considering the selective expression of 4-1BB on tumor-experienced cytotoxic T cells, its key co-stimulatory effects, and the broad expression of PD-L1 across various cancer types. These attributes make LBL-024 a promising candidate for treating additional prevalent cancer types, such as ESCC, HCC and GC.

Leads Biolabs is developing LBL-024 in-house and owns the global rights to develop and commercialize LBL-024.
LBL-034

LBL-034, is a humanized bispecific T-cell engager targeting both GPRC5D and CD3. LBL-034 is one of the lead assets among our portfolio of CD3 T-cell engagers.

By harnessing our proprietary LeadsBody™ platform, a robust CD3 T-cell engager platform developed in-house, LBL-034 is designed with a 2:1 format, with two high-affinity Fabs targeting GPRC5D and one scFv targeting CD3. LBL-034 effectively redirects and activates T cells to target GPRC5D+ cancer cells, exhibiting higher GPRC5D binding affinity and potency while being less prone to inducing T cell exhaustion and cell death, and minimizing the risk of cytokine release syndrome (CRS) and immunotoxicity.

We are currently evaluating the therapeutic potential of LBL-034 in a Phase I/II trial for the treatment of relapsed/refractory multiple myeloma (MM) in China. LBL-034 has exhibited promising efficacy signals in our preclinical and clinical studies, at a level comparable to or exceeding its major competitors. LBL-034 is the second most clinically advanced GPRC5D-targeted CD3 T-cell engagers globally, according to Frost & Sullivan, as of November 2024. Further, LBL-034 obtained the ODD from the FDA for the treatment of MM in October 2024.

Leads Biolabs is developing LBL-034 in-house and owns the global rights to develop and commercialize LBL-034.
LBL-007

LBL-007 is a fully human IgG4 monoclonal antibody targeting LAG3. It ranks among the top three LAG3-targeted clinical-stage monoclonal antibodies globally in terms of clinical development (other than the only one marketed LAG3-targeted drug), and is the first in its class with proven efficacy in nasopharyngeal cancer (NPC), according to Frost & Sullivan, as of November 2024.

Configured to target unique epitopes of LAG3, LBL-007 can bind to LAG3 with high affinity and block LAG3’s engagement with all four identified immune inhibitory ligands. Upon binding to LAG3, LBL-007 induces potent endocytosis, reducing LAG3 expression on the cell surface, which further blocks ligand interaction and enhances immune responses. LBL-007 has exhibited stronger inhibition of tumor growth and superior efficacy compared to the analog of relatlimab, the LAG3 antibody component in Opdualag^TM, in our preclinical studies.

In China, we completed a Phase Ia study of LBL-007 monotherapy in advanced solid tumors and lymphomas in June 2022. We also commenced a Phase Ib/II study of LBL-007 in combination with toripalimab in solid tumors in December 2021. Currently, we have substantially completed this trial and are in the process of finalizing the clinical study report. Additionally, we initiated a Phase Ib/II study for its combination with tislelizumab and/or chemotherapy in advanced NPC and other solid tumors in September 2022 and completed patient enrollment in January 2024. We also completed a Phase I trial of LBL-007 in combination with toripalimab and/or chemotherapy for thetreatment of advanced acral melanoma in China in August 2024.

Leads Biolabs is developing LBL-007 in-house and owns the global rights to develop and commercialize LBL-007.
LBL-033

LBL-033 is a bispecific T-cell engaging antibody targeting both MUC16 and CD3. LBL-033 is being developed for the treatment of solid tumors with high MUC16 expression, particularly gynecological cancers such as ovarian cancer, cervical cancer and endometrial cancer. LBL-033 is among the only two MUC16/CD3 bispecific antibodies globally to have entered clinical stage, according to Frost & Sullivan, as of November 2024.

Developed on our LeadsBody™ platform, LBL-033 is designed with a 2:1 format and to specifically bind a membrane-proximal domain of MUC16 with an affinity ten times higher than its affinity for CD3. This design enhances its targeting specificity, unaffected by the serum form of MUC16, CA125, in the blood circulation. LBL-033 is showed to conditionally activate T cells in the presence of MUC16+ tumor cells in preclinical studies, leading to reduced off-target toxicity and lowered risks of CRS. LBL-033 has demonstrated robust antitumor activity and a manageable safety profile in our preclinical and early clinical studies.

Leads Biolabs is developing LBL-033 in-house and owns the global rights to develop and commercialize LBL-033.
LBL-019

LBL-019 is a TNFR2-targeted monoclonal antibody that can effectively stimulate T-cell proliferation and activation, thereby modulating immune responses. It exhibited promising single-agent efficacy and synergistic effects with anti-PD-1 antibody in our preclinical studies. The clinical trial results from its completed monotherapy Phase I study indicated that LBL-019 was safe and well tolerated in human subjects.

Leads Biolabs is developing LBL-019 in-house and owns the global rights to develop and commercialize LBL-019.
LBL-015

LBL-015, a novel tetravalent bispecific fusion protein, targets both the PD-1/PD-L1 axis
and the transforming growth factor-β (TGF-β) signaling pathway, and is designed for the treatment of solid tumors. Preliminary clinical data from our Phase I/II clinical trial have already demonstrated a robust safety and efficacy profile for LBL-015, suggesting promising potential for its development as a therapeutic agent in solid tumors.

Leads Biolabs is developing LBL-015 in-house and owns the global rights to develop and commercialize LBL-015.

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