ABL Bio, Inc., a clinical-stage biotech developing bispecific antibody technology for immuno-oncology and neurodegenerative diseases, announced that the Investigational New Drug (IND) application for ABL501 has been approved by South Korea's Ministry of Food and Drug Safety (MFDS).

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."

About ABL Bio

ABL Bio, Inc. (KOSDAQ: 298380) is a clinical-stage bio pharmaceuticals company developing antibody therapeutics for immune-oncology and neurodegenerative diseases.

With internal R&D and global partnerships, ABL has developed multiple BsAb platforms, such as 'Grabody-T,' 'Grabody-I' and 'Grabody-B' and built an innovative pipeline of multiple clinical and pre-clinical stage drug candidates. In the oncology area, we have developed Grabody-T, a modular 4-1BB engaging platform that has demonstrated superior efficacy and safety. In the neurodegenerative disorder space, we have developed Grabody-B, which is designed to maximize blood-brain barrier(BBB) penetration. Grabody-B is applicable to various CNS targets across a plethora of neurological disorders, potentially providing a breakthrough to address the high unmet medical needs in neurodegeneration.