ABL Bio has entered into a clinical trial collaboration and supply agreement with MSD to evaluate ABL103, a bispecific antibody, in combination with MSD’s anti-PD-1 therapy, Keytruda (pembrolizumab), in patients with advanced or metastatic solid tumors. The Phase 1b/2 clinical trial will assess the safety and efficacy of the combination therapy.
ABL103: A Novel Bispecific Antibody
ABL103 is designed to simultaneously target B7-H4 and 4-1BB. It utilizes ABL Bio’s bispecific antibody platform 'Grabody-T', which is engineered to activate T cells specifically within the tumor microenvironment. This targeted activation aims to reduce liver toxicity typically associated with conventional 4-1BB monoclonal antibodies while enhancing antitumor activity.
The mechanism of ABL103 involves activating 4-1BB signaling pathways in tumor microenvironments where B7-H4 antigens are present. This allows T cells to selectively target and attack tumor cells, sparing normal cells. A Phase 1 clinical trial evaluating ABL103 as a monotherapy is currently underway in South Korea, with dose escalation ongoing.
Clinical Trial Collaboration
Under the agreement, ABL Bio will conduct the Phase 1b/2 clinical trial, and MSD will supply Keytruda. The study will focus on patients with advanced or metastatic solid tumors who have not responded to previous treatments. The primary endpoints will include safety and tolerability, while secondary endpoints will assess efficacy, including objective response rate (ORR) and progression-free survival (PFS).
Management Commentary
Sang Hoon Lee, CEO of ABL Bio, expressed enthusiasm about the collaboration, stating, “We are pleased to enter into this clinical collaboration agreement with MSD... We hope that the combination of ABL103 and KEYTRUDA contributes to a better life for patients with advanced or metastatic solid tumors.” He also noted the smooth progress of the Phase 1 study for ABL103 monotherapy and reiterated the company's commitment to achieving meaningful clinical results.
ABL Bio's Broader Pipeline
ABL Bio is actively developing various clinical and non-clinical assets based on its 'Grabody' bispecific antibody platform. The company has more than 15 clinical projects underway for over seven assets, including ABL001, ABL111, ABL503, ABL105, ABL202, ABL301, and ABL103, across different indications in multiple countries. The U.S. FDA recently granted Fast Track designation to ABL001 to support its rapid development. Clinical trials for ABL104 are also being prepared, and research continues on other product candidates, including bispecific antibody-drug conjugates (ADCs).
