Cancer has long been among the top three causes of death worldwide. Beyond surgery, radiation, and chemotherapy, immunotherapy has recently achieved significant advances, signaling a more comprehensive approach to cancer treatment. Current immunotherapies mainly involve immune checkpoint inhibitors targeting molecules such as CTLA-4, PD-1, and PD-L1, which enhance immune cell activity to better recognize and eliminate tumor cells.
Founded in 2019, Ascendo Biotechnology focuses on innate immunity rather than the more commonly targeted adaptive immunity. Its platform centers on regulating the innate immune checkpoint CD11b, identifying and developing CD11b as a novel innate immune target to intervene upstream in disease progression.
Ascendo’s Chief Strategy Officer, Hsueh-Yen Ku, explained: “The CD11b target was developed over nearly 20 years by Dr. Yen-Ta Lu, former director of the Pulmonary Medicine Department at Mackay Memorial Hospital, and is a global first. Our core technology activates upstream innate immune cells, which is expected to deliver more significant effects compared to current therapies targeting downstream T cells.” Ascendo is actively developing two antibody drugs: ASD141 and ASD001.
Pipeline Focuses on Upstream Immune Modulation
ASD141 has completed IND submissions in both the U.S. and Taiwan and has entered Phase 1 clinical trials, aiming to enroll 27 patients with advanced solid tumors. Currently in the third dosing stage, preliminary efficacy has been observed. The Phase 1 trial is expected to complete by the end of 2026, after which international licensing or co-development discussions will be pursued.
ASD141 works by inhibiting the CD11b molecule, thereby reversing the immune suppression imposed by tumor cells within the tumor microenvironment. Its key advantage lies in activating innate immune cells.
Ku elaborated that current mainstream PD-1/PD-L1 checkpoint inhibitors act on downstream adaptive immunity and often have limited efficacy restricted to certain cancer types and low response rates. ASD141 acts upstream on innate immunity, akin to “turning on the main valve of immune response,” and is expected to be effective against a broader range of solid tumors, including those with poor PD-1 response such as ovarian, colorectal, prostate, and cervical cancers, thereby expanding the responsive patient population.
In contrast, ASD001 targets the same CD11b but uses an opposite mechanism as an activating monoclonal antibody to suppress overactive immune responses. Currently in preclinical development, ASD001 has undergone multiple mouse model validations at a contracted Japanese preclinical research institute, showing promising potential for treating inflammatory bowel diseases. ASD001 is expected to file a U.S. IND in 2026 and continue preclinical safety and efficacy studies, with plans to expand into other autoimmune diseases such as lupus erythematosus.
Photo caption: The Ascendo Biotechnology team — Core technology originates from nearly 20 years of research by company founder and CSO, Dr. Yen-Ta Lu (third from left in back row), former director of Pulmonary Medicine at Mackay Memorial Hospital. The technology has received clinical trial approvals from Taiwan and U.S. FDA and has shown preliminary efficacy in Phase 1 trials.
Cancer and autoimmune diseases remain major medical challenges. Ascendo Biotechnology is pioneering new therapeutic approaches with its unique innate immune modulation platform. Beyond developing globally first-in-class targets and mechanisms, Ascendo adopts a dual-track product strategy, also innovating on molecular glue drugs like ASD011 to balance risk control and clinical progress efficiency, with ongoing co-development discussions underway. The company plans to list on the Emerging Stock Market in 2027 and steadily advance international licensing, partnerships, and IPO toward becoming a global innovative drug player.
Resource: 【專訪先知生技】創新CD11b免疫療法邁入臨床一期，拚癌症治療新突破
