Leads Biolabs Announces Updated Results for LBL-007 to be Presented at 2023 American Society of Clinical Oncology (ASCO) Annual Meeting

NANJING, China, June 1, 2023--Nanjing Leads Biolabs Co.，Ltd. (hereinafter referred to as "Leads Biolabs" or "Company") today announces that the latest updated clinical data on the safety and efficacy of its anti-LAG-3 (lymphocyte activating gene-3) antibody LBL-007 and toripalimab combination therapy with or without axitinib for the treatment of advanced or metastatic melanoma will be presented in a poster session at American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, to be held from June 2 to June 6, 2023 (EDT). The study is an open-label, multicenter, dose-escalation/expansion Phase I clinical study conducted in China evaluating the safety, RP2D, and investigating the pharmacokinetics and pharmacodynamics of LBL-007.

As of January 11, 2023, at a median follow-up of 9.7 months, the study results showed that:

In 55 patients with advanced or metastatic melanoma treated with first line LBL-007 and toripalimab combination therapy, the ORR was 23.6% and the median PFS was 5.7 months. No new safety signals were identified compared to the preliminary safety and efficacy data previously disclosed at the 2022 ASCO meeting.

The triple-combination therapy of LBL-007 combined with toripalimab/axitinib demonstrated a manageable safety profile with an ORR of 45.4%, a DCR of 72.7% and a median PFS of 5.5 months in the evaluable patients (n=11) with melanoma (10 mucosal, 1 acral). The study is undergoing to continuously collect safety and efficacy data.

"Combining an anti-LAG-3 antibody with an anti-PD-1 antibody may achieve synergistic activation of T cells, demonstrating good safety, tolerability and better efficacy in patients with progressive advanced malignant melanoma. As one of the new targets, LAG-3 has great potential for tumor immunotherapy," said Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, "In addition to melanoma, the anti-LAG-3 antibody LBL-007 in combination with an anti-PD-1 antibody has also demonstrated encouraging efficacy signals in clinical trials in other malignancies, and these findings will be reported at future conferences. We expect the anti-LAG-3 antibody to bring more benefits to patients with cancers."

Abstract information:

1.        Abstract Title:

Updated safety and efficacy results from the phase Ⅰ study of either LBL-007 (an anti-LAG-3 antibody) in combination with Toripalimab (an anti-PD-1 antibody) or LBL-007 in combination with Toripalimab and Axitinib in patients with advanced melanoma

2.        Abstract Number:

Abstract 9541/Poster 304

3.        Clinical Trial Information:

NCT04640545/CTR20202145

4.        Full Text Link:

Https://meetings.asco.org/abstracts-presentations/220179

About LBL-007：

LBL-007 is a fully humanized anti-LAG-3 (lymphocyte activating gene-3) monoclonal IgG4 antibody consisting of two IgG4 heavy chains and two κ light chains linked by disulfide bonds, with high affinity to human LAG-3, and exerts antitumor effects by blocking LAG-3 activation of immune function. In preclinical models, LBL-007 in combination with anti-programmed cell death protein 1 (PD-1) showed synergistic antitumor activity. Results from the phase Ⅰa study of LBL-007 monotherapy have been published in ASCO 2021 (Abstract 2523); preliminary safety and efficacy data for LBL-007 combined with toripalimab in patients with advanced melanoma (Part A) have been reported in ASCO 2022 (Abstract 9538/Poster 131), showing a favorable safety profile and better antitumor activity, particularly in anti PD-(L)1 naïve patients with acral melanoma. Several clinical studies of LBL-007 are currently in rapid progress based on global layout.

MOA of LBL-007（Excerpt from 2023 ASCO Poster 304）

Nanjing Leads Biolabs Co.，Ltd. is a clinical-stage R&D biotech company founded in Nanjing by a team of senior U.S.-educated antibody drug developers. Since 2014, Leads Biolabs has been dedicated to the research and development of novel antibody drugs with independent intellectual property rights for the treatment of oncology and other major diseases, mainly focused on the unmet pharmaceutical needs, especially the problems and challenges in tumor immunotherapy areas. Leads Biolabs already have a rich R&D pipeline with more than twenty novel tumor immunotherapy antibody projects based on monoclonal antibody and bispecific antibody development technology platform. Leads Biolabs will continue to expand its innovation to provide patients with safe, effective, accessible and affordable new drugs to meet the unmet pharmaceutical needs.