AN2025 (Buparlisib)

AN2025 is an oral pan-P13K inhibitor that targets all class I P13K and is active in both hematologic malignancies and solid tumors, which has received a Fast-Track designation and initiated the phase III clinical study from FDA. 

Being studied as a potential combination therapy with pactitaxel in recurrent or metastatic neck squamous cell carcinoma (HNSCC), it has shown promising efficacy in combination with paclitaxel.

 Mechanism of Action
Clinical research
Latest progress
The first patient has been dosed in the global phase III clinical trial for the treatment of recurrent or metastatic head and neck squamous cell carcinoma
Adlai Nortye released the animal model data of Buparlisib (AN2025) at the 7th ICHNO, the International Conference on Innovative Approaches in Head & Neck Oncology. The data suggests AN2025 could potentially be a treatment option for anti-PD-1 antibodies refractory tumors.
Adlai Nortye Received NMPA, FDA and Health Canada Approval for AN2025 Phase III Clinical Trials.
Received Fast-Track designation from FDA

Head and neck squamous cell carcinomas (HNSCC) are a heterogeneous group of tumors, including neck tumor, otolaryngology tumor and oral and maxillofacial tumor. HNSCC is the 8th leading cancer by incidence worldwide and constitutes 90% of all head and neck cancers.

Although anti-PD-(L)1 therapy has been approved by the FDA and EMA for the treatment of recurrent or metastatic HNSCC, the response rate of listed PD-(L)1 varieties is lower than 20%. There is still a large unmet medical need for the treatment of HNSCC with no response to PD-(L)1.