I-Mab Biopharma (IMAB) and ABL Bio Receive US FDA Approval to Initiate Phase 1 Trial of Bispecific Antibody TJ-CD4B/ABL111 in Patients with Advanced or Metastatic Solid Tumors

I-Mab (the “Company”) (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the development of novel biologics, and ABL Bio, Inc. (Kosdaq:298380, hereafter “ABL”), a South Korean biotech specializing in bispecific antibody technology, jointly announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for initiating phase 1 trial for bispecific antibody TJ-CD4B/ABL111. The phase 1 clinical trial will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of TJ-CD4B/ABL111 in advanced or metastatic solid tumors.

TJ-CD4B/ABL111 is a novel bispecific antibody that works through binding to a tumor antigen Claudin 18.2 (CLDN18.2) which is selectively expressed in several cancers and to 4-1BB, a co-stimulatory molecule expressed on T cells, to activate immune response within tumor for better anti-tumor activity. Preclinical studies demonstrate that TJ-CD4B/ABL111 has superior anti-tumor property as compared to the two monoclonal antibodies when acting alone or in combination. This superior anti-tumor activity is achieved locally on tumor site, thus minimizing the risk of liver and systemic side effects commonly associated with 4-1BB antibody when used alone.

"With its high specificity and novel properties, TJ-CD4B/ABL111 could have significant advantages over other 4-1BB monoclonal antibodies in terms of the efficacy and toxicities. It could become a key player against various advanced cancers. We are very excited about the initiation of the clinical study and hope to bring this highly valuable compound to the cancer patients with the critical unmet needs," said Dr. Taylor Guo, chief scientific officer of I-Mab.

"With the FDA approval of the IND application to initiate a phase 1 clinical trial of TJ-CD4B/ABL111, we expect to progress rapidly with the clinical development of TJ-CD4B/ABL111," said Dr. Sang Hoon Lee, Founder and CEO of ABL. "In partnership with I-Mab, we look forward to providing a superior therapeutic option for patients with advanced and metastatic solid cancers."

The phase 1 clinical study will be a multi-center, dose escalation study in the U.S. I-Mab also plans to conduct dose expansion studies for TJ-CD4B/ABL111 in patients with gastric cancers, gastro-esophageal junction adenocarcinoma, esophageal adenocarcinoma and pancreatic ductal adenocarcinoma in China later this year.

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