Akeso Shares Exciting Preclinical Data on IL-1RAP Antibody AK135 at SITC 2025
In a significant announcement at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) held in National Harbor, Maryland, Akeso, Inc. (HKEX: 9926.HK) has unveiled promising preclinical data for its innovative monoclonal antibody, AK135, which strategically targets IL-1 receptor accessory protein (IL-1RAP). This noteworthy research indicates that AK135 effectively disrupts critical pro-inflammatory signaling pathways associated with IL-1, IL-33, and IL-36 at their source, a breakthrough for addressing conditions related to inflammation and chronic pain.
The preclinical findings point towards AK135’s potential to mitigate neuropathy—a common side effect of chemotherapy—demonstrating significant pain relief across various dosages. This is particularly vital given that chemotherapy-induced peripheral neuropathy (CIPN) affects a substantial percentage (50-90%) of patients undergoing treatment, with chronic pain developing in 30-40% of cases. The innovative approach of targeting IL-1RAP is expected to influence pain pathways effectively, offering a much-needed solution where treatment options have been scant.
The results derived from in vitro experiments involving ELISA, Fortebio molecular interaction technology, and flow cytometry validated that AK135 binds with high affinity to IL-1RAP, displaying activity that meets or exceeds that of existing control antibodies, such as CAN04. Further, reporter gene assays corroborated that AK135 inhibits the activation of pro-inflammatory pathways effectively, showcasing impressive half-maximal inhibitory concentration (IC50) values across all evaluated pathways. In experiments utilizing tumor cell models, AK135 has shown a marked decrease in the secretion of pro-inflammatory cytokines, such as IL-6 and IL-8, induced by the aforementioned signaling pathways, underscoring its therapeutic promise.
To explore the in vivo implications of AK135, researchers developed a model mimicking chemotherapy-induced peripheral neuropathy in mice. Following treatment with AK135 alongside low-dose paclitaxel, a noticeable increase in the paw withdrawal threshold (PWT) was observed, implying effective alleviation of mechanical allodynia. Throughout the treatment course, consistent body weight among all dosage groups, coupled with an absence of significant toxicity signs, pointed to an encouraging safety profile that distinguishes AK135 as a candidate worth pursuing further.
CIPN represents a complex clinical challenge, with many patients hampered by its debilitating effects and a lack of sufficient treatment modalities. Emerging evidence suggests that cytokines released from neurons suffering damage play a crucial role in the condition's pathology. By effectively targeting IL-1RAP, AK135 seeks to halt the inflammatory cascade and provide symptom relief right at the source. With preclinical studies indicating a robust ability to counteract neuropathic pain in a dose-dependent manner and maintaining good tolerability, AK135 is on the pathway to potentially transformative therapeutic applications.
Currently, AK135 is moving into Phase I clinical trials for the treatment of CIPN, and while Akeso remains forward-looking, they caution investors about the risks and uncertainties inherent in the pharmaceutical industry. Nevertheless, this preclinical data heralds a potential shift in how chemotherapy-related side effects may be managed in the future, making AK135 a critical research focus within Akeso’s expansive pipeline.
Founded in 2012, Akeso (HKEX 9926.HK) has risen to prominence as a leading biopharmaceutical entity committed to delivering the world's first or best-in-class innovative biological medicines. With a strong emphasis on research and development, their integrated ACE Platform and advanced technologies continue to facilitate the creation of groundbreaking treatments aimed at addressing significant health challenges, particularly in cancer, autoimmune diseases, inflammation, and metabolic disorders.
For further insights into Akeso’s research initiatives and innovative pipelines, visit their website and explore their ongoing efforts to transform healthcare solutions for patients globally.
Promising Preclinical Results
The preclinical findings point towards AK135’s potential to mitigate neuropathy—a common side effect of chemotherapy—demonstrating significant pain relief across various dosages. This is particularly vital given that chemotherapy-induced peripheral neuropathy (CIPN) affects a substantial percentage (50-90%) of patients undergoing treatment, with chronic pain developing in 30-40% of cases. The innovative approach of targeting IL-1RAP is expected to influence pain pathways effectively, offering a much-needed solution where treatment options have been scant.
In Vitro Assessments
The results derived from in vitro experiments involving ELISA, Fortebio molecular interaction technology, and flow cytometry validated that AK135 binds with high affinity to IL-1RAP, displaying activity that meets or exceeds that of existing control antibodies, such as CAN04. Further, reporter gene assays corroborated that AK135 inhibits the activation of pro-inflammatory pathways effectively, showcasing impressive half-maximal inhibitory concentration (IC50) values across all evaluated pathways. In experiments utilizing tumor cell models, AK135 has shown a marked decrease in the secretion of pro-inflammatory cytokines, such as IL-6 and IL-8, induced by the aforementioned signaling pathways, underscoring its therapeutic promise.
In Vivo Evaluation
To explore the in vivo implications of AK135, researchers developed a model mimicking chemotherapy-induced peripheral neuropathy in mice. Following treatment with AK135 alongside low-dose paclitaxel, a noticeable increase in the paw withdrawal threshold (PWT) was observed, implying effective alleviation of mechanical allodynia. Throughout the treatment course, consistent body weight among all dosage groups, coupled with an absence of significant toxicity signs, pointed to an encouraging safety profile that distinguishes AK135 as a candidate worth pursuing further.
Clinical Implications
CIPN represents a complex clinical challenge, with many patients hampered by its debilitating effects and a lack of sufficient treatment modalities. Emerging evidence suggests that cytokines released from neurons suffering damage play a crucial role in the condition's pathology. By effectively targeting IL-1RAP, AK135 seeks to halt the inflammatory cascade and provide symptom relief right at the source. With preclinical studies indicating a robust ability to counteract neuropathic pain in a dose-dependent manner and maintaining good tolerability, AK135 is on the pathway to potentially transformative therapeutic applications.
Future of AK135
Currently, AK135 is moving into Phase I clinical trials for the treatment of CIPN, and while Akeso remains forward-looking, they caution investors about the risks and uncertainties inherent in the pharmaceutical industry. Nevertheless, this preclinical data heralds a potential shift in how chemotherapy-related side effects may be managed in the future, making AK135 a critical research focus within Akeso’s expansive pipeline.
Company Overview
Founded in 2012, Akeso (HKEX 9926.HK) has risen to prominence as a leading biopharmaceutical entity committed to delivering the world's first or best-in-class innovative biological medicines. With a strong emphasis on research and development, their integrated ACE Platform and advanced technologies continue to facilitate the creation of groundbreaking treatments aimed at addressing significant health challenges, particularly in cancer, autoimmune diseases, inflammation, and metabolic disorders.
For further insights into Akeso’s research initiatives and innovative pipelines, visit their website and explore their ongoing efforts to transform healthcare solutions for patients globally.
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