Adlai Nortye's Buparlisib (AN2025) Set to Become a Potential Treatment for Anti-PD-1 Non-responding Tumor in HNSCC

NORTH BRUNSWICK,N.J.,March 15,2019 --Adlai Nortye Ltd. ("Adlai Nortye"),a global clinical-stage biopharmaceutical company today 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.

Head and neck squamouscellcarcinoma(HNSCC)is one of the most common cancers in the world. Although anti-PD-1 antibodies have been approved by the FDA and EMA for the treatment of relapsed,refractory HNSCC,the response rates following nivolumab and pembrolizumab are both lower than 20%. Treatment of anti-PD-1 antibodies refractory patients remains to be an unmet medical need.

Buparlisib is an oral pan-PI3K inhibitor that targets all class I PI3K isoforms and is active in both hematologic malignancies and solid tumors. In the animal model,Buparlisibsignificantly inhibited tumor growth and shows a dose response trend in anti-PD-1 refractory tumor bearing mice. The dose range of Buparlisib is consistent with previous preclinical studies conducted with BKM120 (Buparlisib,AN2025) by Novartis.

With the promising data from the BERIL-1 study,along with this supportive non-clinical work,a Phase III clinical trial is underway to evaluate Buparlisib (AN2025) plus Paclitaxel versus Paclitaxel alone in refractory,recurrent or metastatic HNSCC patients who have progressed after prior platinum-based chemotherapy with or without prior anti-PD1/anti PDL1 antibody treatment (The BURAN Study).

"We are encouraged by the results of animal model study,combined with the phase II data,it supports including anti PD1 exposed patients in our phase III clinical trial. Check point inhibitors are being studies in the first line setting and Buparlisib may fill the second line space in patients who fail treatment," said Dr. Lars Birgerson,CDO,President and CEO of Adlai Nortye USA Inc.

Carsten Lu,CEO of Adlai Nortye,remarked,"We are firmly committed to bringing Buparlisib to the market for the treatment of HNSCC,to meet the unmet medical need,and to fulfill our mission to transform cancer into a chronic disease condition,even cure the cancer disease."

About Buparlisib (AN2025）

AN2025 is an oral pan-PI3K inhibitor that targets all class I PI3K isoforms and is active in both hematologic malignancies and solid tumors. It has shown promising efficacy in combination with paclitaxel in HNSCC and received a Fast-Track designation and an approval for initiating the phaseIIIclinical study from FDA.

About Adlai Nortye

Adlai Nortye is a global clinical-stage biopharmaceutical company that is developing differentiated,innovative immuno-oncology medicines.Adlai Nortye focuses on discovering and developing important new treatments for cancer with a mission to improve patient lives by identifying and developing differentiated innovative medicines that help people live better,live longer. Through close collaborations with global partners,Adlai Nortye have successfully positioned itself in the field of immuno-oncology and have several programs ongoing from early pre-clinical to phase III ready.

For further information,please visit: http://www.adlainortye.com/en.php

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