ABL Bio Announces Publication of Preclinical Data Demonstrating Safety and Efficacy of ABL503/TJ-L14B, a Novel Anti-PD-L1 X 4-1BB Bispecific Antibody

ABL503/TJ-L14B demonstrates stronger anti-tumor efficacy than anti-PD-L1 or anti-4-1BB monotherapy as well as a good safety profile

ABL503 currently in Phase 1 trial to evaluate the safety,tolerability,MTD PK and PD in patients with advanced or metastatic solid tumors

SEONGNAM,South Korea,July 9,2021 -- ABL Bio,Inc. (KOSDAQ: 298380),a clinical-stagebiotech developing bispecific antibody technology for immuno-oncology and neurodegenerative diseases,today announced the publication of pre-clinical data highlighting the safety and anti-tumor efficacy of ABL503/TJ-L14B in the Journal for ImmunoTherapy of Cancer(JITC).

Jointly developed with I-Mab (NASDAQ: IMAB),ABL503 is a bispecific antibody combining PD-L1 checkpoint pathway with 4-1BB agonistic activity to overcome the current limitation of PD-(L)1 therapy and 4-1BB related toxicity. Using ABL's Grabody-T bispecific antibody platform technology,ABL503 induces 4-1BB activation only in the presence of PD-L1 expressing tumors to minimize the risk of 4-1BB related peripheral toxicity. ABL503 is currently being evaluated in a Phase 1 study in the U.S. in patients with locally advanced or metastatic solid tumors (NCT04762641).

The paper,"Novel anti-4-1BB X PD-L1 bispecific antibody augments anti-tumor immunity through tumor-directed T-cell activation and checkpoint blockade," was published in collaboration with Su-Hyung Park,PhD,Professor at the KAIST Graduate School of Medical Science and Engineering. The paper highlights key in vitro and in vivo research that demonstrate ABL503's potential as a promising immunotherapeutic agent against cancer.

In the study,ABL503 induced complete tumor regression in humanized mice,which was superior to anti-PD-L1 or anti-4-1BB monotherapy. Moreover,no tumor growth was observed in these mice when they were rechallenged at 40 days after their first ABL503 treatment,demonstrating that ABL503 treatment yields a prolonged anti-tumor response despite a short-term administration schedule.

In addition,ABL503 was well-tolerated following a repeated high dose administration of ABL503 in monkeys. Monkeys treated with ABL503 exhibited overall good tolerance with normal liver functions.

"These published data validate our Grabody-T platform technology to achieve anti-tumor efficacy with a low risk of off-tumor liver toxicity and support the therapeutic value of ABL503 as a potential best-in-class treatment for cancer," said Sang Hoon Lee,CEO of ABL Bio. "We have great expectations for the program and look forward to further evaluating ABL503 in our Phase 1 study with I-Mab."

About ABL Bio

ABL Bio,Inc. (KOSDAQ: 298380) is a clinical-stage biotechnology 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. For more information,please visit www.ablbio.com

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