Nanjing Leads Biolabs Co., Ltd. (Leads Biolabs) announced that Oblenio Bio, its NewCo partner formed with Aditum Bio, has administered first doses to patients in a European Phase Ia, first-in-human clinical study of LBL-051, a trispecific T-cell engager targeting BCMA, CD19 and CD3 for refractory autoimmune diseases.
The open-label, multicentre trial, cleared by Germany’s Paul Ehrlich Institute, employs a subcutaneous, step-up dose-escalation design to assess safety, tolerability, clinical response, B-cell and plasma-cell depletion, and biomarker dynamics across multiple autoimmune indications. Pre-clinical data showed complete depletion of B cells and plasma cells with minimal cytokine release, alongside dose-dependent immunoglobulin reductions in non-human primates.
LBL-051 was generated via the proprietary LeadsBodyTM platform and is intended to induce a durable “immune reset,” offering potential drug-free remission by simultaneously targeting BCMA, CD19 and CD3. The programme represents the platform’s second clinical validation after LBL-034 in haematological malignancies. Leads Biolabs will continue providing technical support to Oblenio and remains eligible for milestone payments and royalties as the asset progresses toward global commercialisation.
SUPPLEMENTAL INFORMATION Leads Biolabs also clarified that a recent grant of share awards to executive director Mr Zuo Honggang constitutes a connected transaction under Hong Kong Listing Rules. As the awards form part of his remuneration and involve no new share issuance, the transaction is exempt from reporting, announcement and independent shareholder-approval requirements under Rules 14A.73(6) and 14A.95.
Cautionary Note The company emphasised that successful development and commercialisation of LBL-051 are not guaranteed and advised shareholders and investors to exercise caution when dealing in its shares.
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