Leads Biolabs and Aditum Bio Launch Oblenio Bio with $35M Upfront for First-in-Class Trispecific T-Cell Engager LBL-051
Aditum Bio
Developer and Investor in Biopharmaceutical R&D Technology
Leads Biolabs
Innovative Therapy Developer
Another “NewCo Model” Cross-Border Deal Emerges.
On November 7, 2024, it was announced that Nanjing Leadsbiolabs Co., Ltd. (“Leadsbiolabs”) and venture capital firm Aditum Bio (“Aditum”) have established a new drug development company, Oblenio Bio (“Oblenio”), based on Leadsbiolabs’ globally first-in-class CD19xBCMAxCD3 trispecific T-cell engager antibody LBL-051, and have entered into an exclusive option and license agreement. Aditum will provide funding to Oblenio, and both parties will collaborate to rapidly advance LBL-051 into clinical studies.
Under the terms of the agreement, Leads Biolabs will grant Oblenio an exclusive option and license to develop, manufacture, and commercialize LBL-051 on a global basis. Leads Biolabs is entitled to receive an upfront payment and near-term payments totaling $35 million (approximately RMB 240 million). Upon the achievement of development, regulatory registration, and sales milestones, Leads Biolabs will also be eligible for total deal consideration of up to $579 million, as well as royalties on future product sales. In addition, Leads Biolabs will have the right to obtain equity interests in Oblenio.
World's First Antibody Therapy
Leads Biolabs has established a comprehensive and efficient antibody drug development platform at the Nanjing Bio-Medicine Valley, encompassing process development (cell culture, protein purification, and formulation), analytical method development, quality control, and pilot-scale bulk drug substance production. The GMP- and cGMP-compliant pilot production platform is equipped with Cytiva’s 50 L/200 L/500 L single-use bioreactors and purification systems, allowing for flexible scale-up to meet the supply demands for preclinical pharmacology and toxicology studies, IND filings, and Phase I/II clinical trials. The CMC team supports and undertakes preclinical CMC development, pilot-scale GMP manufacturing, technology transfer, preparation of global IND registration dossiers, process characterization, process validation, and BLA registration filings.
Leveraging a profound understanding of molecular mechanisms and disease biology, Leads Biolabs has developed a series of proprietary technology platforms targeting diverse molecules, mechanisms of action, and modalities. These platforms provide extensive tools and technologies for antibody design, screening, and development, enabling Leads Biolabs to engineer highly specific, customized drug assets that meet the clinical needs of various indications.
Its core technology platforms primarily consist of two T-cell engager platforms: the LeadsBody™ platform (CD3 engager platform) and the X-body™ platform (4-1BB engager platform), as well as other bispecific antibody and antibody fusion protein platforms.
To achieve an optimal balance between the safety and efficacy of T-cell engagers, Leads Biolabs has developed proprietaryLeadsBody™Platform, which enables diverse modifications to the molecular design of CD3-targeting bispecific antibodies. These key modifications include, among others, variable expression levels of binding to tumor-associated antigens (TAAs), modulation of CD3 affinity to differentially engage cytokine release, conditional T-cell redirection and activation mechanisms within the tumor microenvironment, and distinct spatial configurations. By leveraging this platform technology, Leads Biolabs’ various CD3-targeting bispecific T-cell engagers for the treatment of solid tumors and hematologic malignancies (such as LBL-034 and LBL-033) have demonstrated robust anti-tumor efficacy and favorable safety profiles in preclinical studies.
The pipeline asset LBL-051 involved in this transaction is a novel trispecific T-cell engager developed using LeadsBody™, an independently proprietary technology platform of Leads Biolabs. The binding domains for each target—CD19, BCMA, and CD3—have been meticulously designed and optimized to achieve an optimal balance between efficacy and safety.
Recent clinical data on CD19- and BCMA-targeted therapies have demonstrated favorable efficacy in refractory autoimmune diseases; however, unmet clinical needs remain in enhancing therapeutic efficacy and achieving durable remission. By simultaneously targeting CD19 and BCMA, LBL-051 is poised to eliminate a broader spectrum of pathogenic B cells in various antibody-mediated autoimmune diseases, thereby eliciting more potent and sustained therapeutic effects.
Bringing More Possibilities to CD30 Bispecific Antibodies, with the Most Advanced Candidate in Phase 2
Similarly, the innovative bispecific antibody LBL-034, also based on LeadsBody™, appears to better showcase the highlights of Leads Biolabs’ technology platform.
On November 1, 2024, LBL-034, a Class 1 innovative drug with global intellectual property rights owned by Leads Biolabs, was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of multiple myeloma (MM).
LBL-034 is a next-generation humanized bispecific T-cell engager antibody targeting GPRC5D and CD3, developed using LeadsBody™, Leads Biolabs’ proprietary CD3 bispecific antibody technology platform. It is the third GPRC5D-targeting CD3 T-cell engancer worldwide to enter clinical development. LBL-034 selectively binds to T cells only in the presence of GPRC5D-positive cells, thereby conditionally activating T cells within the tumor microenvironment where GPRC5D is expressed. Across cell lines with high, moderate, or low GPRC5D expression, LBL-034 consistently demonstrates potent tumor cell cytotoxicity and robust dose-dependent anti-tumor activity, highlighting its potential as a best-in-class anti-cancer therapeutic.
LBL-034 received approval to initiate clinical trials in both China and the United States in July 2023, and an open-label, multicenter, dose-escalation/expansion Phase I/II study in patients with relapsed/refractory multiple myeloma (RRMM) was launched in China in November 2023. This multicenter clinical trial, led by Professor Lu Jin from Peking University People’s Hospital, has demonstrated favorable safety and efficacy profiles.
Overall, Leads Biolabs’ CD3 bispecific antibody design offers an alternative approach to CD3 bispecifics. On one hand, it reduces toxicity caused by TAA-independent nonspecific activation; on the other, it leverages a multivalent design to enhance binding and cross-linking capacity at the TAA end. This design improves both the safety profile and the efficacy of the antibody.
Dr. Kang Xiaoqiang, Founder, Chairman, and CEO of Leads Biolabs, stated, “LBL-051 provides a differentiated therapeutic option for certain autoimmune diseases and is poised to become a blockbuster revolutionary drug with a ‘Pipeline in a Product’ profile. We are delighted to collaborate with the high-caliber team at Aditum Bio to bring this innovative therapy to patients worldwide.”
Joe Jimenez, Co-founder and Managing Director of Aditum Bio, stated, “Compared with single-target therapies, LBL-051 aims to achieve ‘immune reset’ by simultaneously targeting CD19 and BCMA, providing patients with autoimmune diseases with deeper responses and more durable efficacy.”