On August 4, 2021 ABL Bio, Inc. (KOSDAQ: 298380), a clinical-stage biotech developing bispecific antibody technology for immuno-oncology and neurodegenerative diseases, reported that the Investigational New Drug (IND) application for ABL501 has been approved by South Korea’s Ministry of Food and Drug Safety (MFDS) (Press release, ABL Bio, AUG 4, 2021, View Source [SID1234585755]).

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The Phase 1 clinical trial is an open-label, multi-center dose escalation and dose expansion study designed to evaluate the safety, tolerability, maximum tolerated dose (MTD) and preliminary efficacy of ABL501 in patients with advanced or metastatic solid tumors.

ABL501 uses Grabody-I platform technology to simultaneously block PD-L1 and LAG-3-mediated T cell inhibition. Preclinical results demonstrate a synergistic increase of T cell activation that is higher than the enhancements induced by combination of anti-PD-L1 and LAG-3. ABL501 also showed a good safety profile in monkeys.

"LAG-3 is emerging as a promising target for cancer immunotherapy. We look forward to verifying ABL501’s potential as a best-in-class bispecific antibody that overcomes the limitations of current LAG-3 targeting antibodies," said Sang Hoon Lee, Ph.D., CEO of ABL Bio. "This is already our third IND approval this year, demonstrating our strong commitment to building a robust portfolio of bispecific antibody immunotherapies. Carrying on this momentum, we expect to submit multiple additional INDs next year."