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- ABL503 is a bispecific “Grabody-T” that targets both PD-L1 and 4-1BB
- Positive interim Phase 1 data for ABL503 were reported at ASCO 2024… including 1 complete response (CR) and 6 partial responses (PR)
- Accelerated development plan announced for bispecific antibodies, while the Company prepares new INDs for bispecific ADCs
ABL Bio (CEO Sang Hoon Lee), a company specializing in bispecific antibodies, today announced that ABL503 (ragistomig) patent has been issued in Indonesia and China. ABL503 is being jointly developed with ABL’s global partner I-Mab (NASDAQ: IMAB).
ABL503 is a bispecific antibody that simultaneously targets PD-L1, an immune checkpoint protein, and 4-1BB, which is involved in immune T cell activation. Promising Phase 1 data were presented at the American Society for Clinical Oncology Annual Meeting (ASCO 2024).
ABL Bio already has ABL503 patents in Eurasia, Japan, Chile, and South Africa. By securing additional patents in Indonesia and China, the global rights for ABL503 will be protected in numerous countries around the world until 2039. Patent examination is currently underway in Europe, the United States, and Canada.
ABL503 was developed using ABL Bio’s 4-1BB-based bispecific antibody platform ‘Grabody-T’. A Phase 1 clinical trial for patients with solid tumors is currently underway in the United States and Korea. The dose escalation portion of the study is underway in the United States. Two segments of the study are ongoing in the United States and Korea: the dose expansion portion of the study, focused on the preliminary antitumor activity of a specific dose for which safety has been confirmed, and the tumor expansion portion, which is being carried out for selected specific cancer types.
According to data disclosed at ASCO 2024, one complete response (CR) and six partial responses (PRs) were observed at the cut-off date of April 19, 2024. Five of these patients did not respond to prior PD-(L)1 inhibitor treatment or experienced cancer recurrence after PD-(L)1 treatment. Notably, the one patient who experienced a CR had been diagnosed with ovarian cancer and had received more than seven prior treatments, including recurrence after prior PD-(L)1 inhibitor treatment.
In addition to ABL503, ABL Bio is developing various bispecific antibodies utilizing the Grabody-T platform. For ABL111 (givastomig), ABL’s global development partner, I-Mab, is conducting a monotherapy study and a combination therapy study. Clinical trials for other Grabody-T-based bispecific antibodies, ABL103 and ABL105, are progressing as planned.
“ABL503 has shown encouraging safety and efficacy in clinical trials for PD-(L)1 relapsed and refractory patients. Securing the patents for ABL503 in various countries around the world marks an important milestone for the Company” said Sang Hoon Lee, CEO of ABL Bio. Sang also stated, “the Company will use internal resources and potential milestone payments to invest in accelerating the development of bispecific antibodies, while also working to submit clinical trial applications (INDs) for at least three bispecific ADCs next year.”
About ABL Bio
ABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. More than 15 clinical projects for over 7 pipelines, including ABL001, ABL111, ABL503, ABL105, ABL202, ABL301, and ABL103, are underway for different indications in various countries, including the United States, China, Australia, and Korea. In the case of ABL001, the U.S. Food and Drug Administration (FDA) recently granted Fast Track designation to support the rapid development of this new drug candidate. Meanwhile, ABL Bio is preparing to initiate clinical trials for ABL104. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs).
Note: this is a translated version of the original Korean language document, prepared and provided solely for readers’ convenience. In case of any discrepancy or dispute, the Korean document prevails.