On October 10, 2023 I-Mab (Nasdaq: IMAB) (the "Company"), a global biotechnology company focused on bringing highly differentiated medicines to patients around the world through the discovery, development, and commercialization of novel immunotherapies and biologics, reported multiple recent developments in TJ-L14B/ABL503, a differentiated PD-L1 x 4-1BB bispecific antibody developed in collaboration with ABL Bio (Kosdaq: 298380) (Press release, I-Mab Biopharma, OCT 10, 2023, View Source [SID1234635809]). TJ-L14B/ABL503 is designed to address tumors resistant to PD-(L)1 antibodies through its unique ability to conditionally activate 4-1BB upon binding to its target, PD-L1. I-Mab owns 50% of the global rights of TJ-L14B/ABL503.

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On September 7, 2023, TJ-L14B/ABL503 successfully obtained patent registration in eight Eurasian countries. The patent, officially named "Anti-PD-L1/Anti-4-1BB Bispecific Antibody and Its Applications," secures patent rights extending through 2039. Furthermore, this patent has already been granted in Chile, South Africa, and Japan. Patent examinations are currently underway in over 20 countries, including the U.S., China, and Europe.

TJ-L14B/ABL503 is currently being investigated in a Phase 1 dose-escalation study in patients with progressive, locally advanced or metastatic solid tumors who are relapsed or refractory following prior lines of treatment. The dose-expansion portion of the Phase 1 study is actively progressing in the U.S. and South Korea. Currently, we have observed 1 complete response (CR), 1 partial response (PR), and 2 patients who achieved an unconfirmed objective response upon recent enrollment. While preliminary efficacy signals have emerged, the maximum tolerated dose (MTD) has not yet been reached. The Company anticipates presenting the top-line Phase 1 clinical data at a major medical conference in the first half of 2024.

"We’re encouraged by these early results of TJ-L14B/ABL503 as they continue to demonstrate the potential of this highly differentiated treatment for tumor types with significant unmet need," said Raj Kannan, CEO of I-Mab. "With the success of patent registrations across multiple countries, and promising preliminary data from the Phase 1 study, we’re reaffirming the possibility for TJ-L14B/ABL503 to make a significant impact on the lives of people with cancer. We look forward to sharing more progress on the global development of TJ-L14B/ABL503."

"The clinical responses observed in the Phase 1 clinical study of TJ-L14B/ABL503, though in early stages, not only provide validation of our technology platform but also offer proof of the mechanism behind this innovative bispecific antibody," said Sanghoon Lee, CEO of ABL Bio. "We express our heartfelt gratitude to the patients who participated in the study, healthcare professionals, study investigators, and our partners for their invaluable collaboration in achieving this milestone. Concurrently, we are expediting patent filings for TJ-L14B/ABL503 to safeguard its rights and facilitate its seamless entry into the global market."

About TJ-L14B/ABL503

Being developed jointly with ABL Bio (Kosdaq: 298380, hereafter "ABL"), TJ-L14B/ABL503 is a differentiated PD-L1-based bispecific antibody with the PD-L1 arm as the tumor-dependent T-cell activator and the 4-1BB arm as the conditional T cell activator upon tumor engagement. Using ABL’s "Grabody-T" bispecific antibody platform technology, TJ-L14B/ABL503 stimulates 4-1BB activation only in the presence of PD-L1 expressing tumor cells to minimize the risk of off-tumor toxicity. Preclinical studies have demonstrated that the bispecific antibody shows better anti-tumor activity than equimolar doses of single agents alone or in combination. A Phase 1 study is currently being conducted in the U.S. and South Korea.