I-Mab and ABL Bio Announce Latest Updates of PD-L1 and 4-1BB Bispecific Antibody TJ-L14B/ABL503

I-Mab, a global biotechnology company, has recently announced significant developments in their collaboration with ABL Bio on TJ-L14B/ABL503, a differentiated PD-L1 x 4-1BB bispecific antibody. This innovative antibody is designed to target tumors that are resistant to PD-(L)1 antibodies by conditionally activating 4-1BB upon binding to its target, PD-L1.

One of the notable achievements is the successful patent registration of TJ-L14B/ABL503 in eight Eurasian countries, securing patent rights until 2039. The patent has also been granted in Chile, South Africa, and Japan, with ongoing examinations in more than 20 countries, including the U.S., China, and Europe. This is a significant milestone that ensures the protection of TJ-L14B/ABL503’s rights and facilitates its seamless entry into the global market.

In terms of clinical progress, TJ-L14B/ABL503 is currently undergoing a Phase 1 dose-escalation study in patients with progressive, locally advanced, or metastatic solid tumors who have relapsed or are refractory to prior treatments. Among the 14 efficacy-evaluable patients, one achieved a complete response, one had a partial response, and two achieved unconfirmed partial responses. These preliminary efficacy signals are promising, although the maximum tolerated dose (MTD) has not yet been reached.

The dose-expansion portion of the Phase 1 study is actively progressing in the U.S. and South Korea, and the top-line Phase 1 clinical data is expected to be presented at a major medical conference in the first half of 2024. Raj Kannan, CEO of I-Mab, expressed encouragement by these early results, highlighting the potential of TJ-L14B/ABL503 to address tumor types with significant unmet needs.

Sanghoon Lee, CEO of ABL Bio, also emphasized the clinical responses observed in the Phase 1 study, which not only validate their technology platform but also provide proof of the mechanism behind this innovative bispecific antibody. Lee expressed gratitude to the patients, healthcare professionals, study investigators, and partners for their collaboration in achieving this milestone.

TJ-L14B/ABL503 is a differentiated PD-L1-based bispecific antibody that activates T-cells in a tumor-dependent and conditional manner. Preclinical studies have demonstrated its superior anti-tumor activity compared to single agents alone or in combination. The Phase 1 study is currently ongoing in the U.S. and South Korea, and I-Mab is dedicated to advancing the development, regulatory milestones, and commercialization of TJ-L14B/ABL503.

I-Mab is a global biotechnology company focused on bringing highly differentiated medicines to patients worldwide through the discovery, development, and commercialization of novel immunotherapies and biologics. Their innovative pipeline is driven by Fast-to-Proof-of-Concept and Fast-to-Market development strategies, as well as global partnerships.

These recent updates on TJ-L14B/ABL503 highlight the progress made by I-Mab and ABL Bio in developing a highly differentiated treatment for tumors with significant unmet needs. With patent registrations secured in multiple countries and promising preliminary data from the Phase 1 study, the potential impact of TJ-L14B/ABL503 on the lives of cancer patients is reaffirmed. Both companies are committed to furthering the global development of this innovative bispecific antibody.