Akeso, Inc. has announced that its novel trispecific antibody candidate, AK150, has received Investigational New Drug (IND) clearance from the National Medical Products Administration (NMPA), enabling the start of clinical trials in patients with advanced solid tumors. The milestone marks a significant step forward for the company as it brings its first trispecific molecule into human studies.
AK150 is designed to simultaneously target three immune-related proteins—ILT2, ILT4, and CSF1R—making it the only trispecific antibody of its kind currently in development worldwide. The therapy was engineered using Akeso’s proprietary AI-driven drug discovery platform alongside its Tetrabody technology, highlighting the company’s growing capabilities in multispecific antibody innovation.
The targets of AK150 are known to play critical roles in the tumor microenvironment, particularly in cancers characterized by strong immune suppression. These include non-small cell lung cancer, hepatocellular carcinoma, pancreatic cancer, and certain treatment-resistant breast cancers. While therapies targeting individual or dual pathways such as ILT2, ILT4, or CSF1R have shown promise, they have not been sufficient to fully overcome the complex immunosuppressive networks that allow tumors to evade immune detection.
AK150 aims to address this limitation by delivering a multi-pronged approach. By blocking CSF1R, the therapy works to reduce the population of immunosuppressive myeloid cells within tumors. At the same time, inhibition of ILT2 and ILT4 helps release inhibitory signals that limit immune activation, effectively “unlocking” immune responses. This coordinated mechanism is designed to activate both innate and adaptive immunity, including CD8+ T cells and natural killer (NK) cells, which are essential for mounting an effective anti-tumor response.
One of the key challenges in cancer immunotherapy has been the treatment of so-called “cold tumors,” which lack sufficient immune cell infiltration and are less responsive to existing therapies. AK150’s trispecific design is intended to convert these cold tumors into “hot tumors,” making them more susceptible to immune attack and improving the overall efficacy of treatment.
The IND clearance represents an important validation of Akeso’s scientific approach and opens the door for clinical evaluation of AK150’s safety and efficacy. As the company advances this first-in-class candidate, it aims to address significant unmet needs in solid tumor treatment and further establish itself as a leader in next-generation immunotherapies.
With global interest in multispecific antibodies continuing to rise, AK150’s progression into clinical trials underscores the growing momentum behind innovative approaches that seek to tackle cancer through more comprehensive immune system modulation.