[2023. 11. 17.][NASDAQ:ANL]Adlai Nortye Announces Completion of Patient Enrollment in Global Phase III Clinical Trial of Buparlisib （AN2025） in Combination with Paclitaxel for the Treatment of Recurrent or Metastatic HNSCC

[2023. 11. 17.][NASDAQ:ANL]Adlai Nortye Announces Completion of Patient Enrollment in Global Phase III Clinical Trial of Buparlisib （AN2025） in Combination with Paclitaxel for the Treatment of Recurrent or Metastatic HNSCC

SINGAPORE and NORTH BRUNSWICK, N.J. and HANGZHOU, China, Nov. 17, 2023 (GLOBE NEWSWIRE) -- Adlai Nortye Ltd. (NASDAQ: ANL) is making waves in the biotechnology world with the announcement of a major milestone in their quest to revolutionize cancer treatment. The company has just completed patient enrollment for the Global Phase III Clinical Trial (BURAN) of their groundbreaking drug, Buparlisib (AN2025), in combination with Paclitaxel for the treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC). This groundbreaking study spans over 180 sites worldwide, covering 18 markets across North America, Europe, Asia, and South America.

The BURAN study is breaking new ground as the first global multicenter Phase III trial for HNSCC involving pan-PI3K inhibitors. Buparlisib (AN2025), an oral pan-PI3K inhibitor, is being evaluated alongside paclitaxel to combat recurrent or metastatic HNSCC.

Lars Birgerson, President and Chief Medical Officer of Adlai Nortye Ltd., highlighted the pressing need for innovative treatments in the field: "There is a high unmet medical need for patients with recurrent or metastatic HNSCC after anti-PD-1/anti-PD-L1 therapy. As the trial is now fully enrolled, we eagerly look forward to the results which may change the paradigm of second-line treatment for HNSCC and provide a new treatment option for patients worldwide."

The BURAN study is a randomized, open-label, multicenter phase III study designed to assess the treatment effect of once-daily buparlisib in combination with weekly paclitaxel, compared to weekly paclitaxel alone. It targets patients with recurrent or metastatic head and neck squamous cell carcinoma who have progressed after prior anti–PD–1/anti–PD–L1 monotherapy, prior anti–PD–1/anti–PD–L1 therapy in combination with platinum-based therapy, or after sequential treatment of anti–PD–1/anti–PD–L1 therapy, either prior to or post-platinum-based therapy.

AN2025 (buparlisib) is a game-changing oral pan-PI3K inhibitor that targets all class I PI3K isoforms and is active in both hematologic malignancies and solid tumors. In a global randomized Phase II clinical trial for the treatment of recurrent or metastatic HNSCC with buparlisib in combination with paclitaxel, the median overall survival reached an impressive 10.4 months, compared to 6.5 months in the paclitaxel-only group. The FDA has granted Fast-Track designation for buparlisib in this indication, underscoring its potential to transform cancer treatment. This ongoing study marks Adlai Nortye's inaugural global Phase III clinical trial.

Adlai Nortye (NASDAQ: ANL) is rapidly gaining recognition as a global clinical-stage biotechnology company with a laser focus on pioneering cancer therapies. The company's research and development centers in New Jersey and Hangzhou are at the forefront of innovative oncology solutions. With a robust pipeline of six drug candidates, Adlai Nortye boasts a management team and scientific advisory board comprised of industry leaders and influential scientists, providing international and strategic guidance. The company actively seeks partnerships with leading multinational pharmaceutical companies like Eisai and Novartis to fully unlock the potential of its pipeline programs. Adlai Nortye aims to lead the charge in the next era of immuno-oncology therapies through combination therapy strategies, with the ultimate goal of turning deadly cancers into manageable and curable diseases.

Forward-Looking and Cautionary Statements: This announcement contains forward-looking statements, made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements are characterized by terms like "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "potential," "continue," "ongoing," and "targets." They encompass the Company's beliefs and expectations, business outlook, and management's quotes. Forward-looking statements come with inherent risks and uncertainties, including factors like the progress and results of preclinical studies and clinical trials, regulatory approvals, commercialization, and market acceptance. Adlai Nortye remains committed to transforming the landscape of cancer treatment and will continue to provide updates on its progress.

Contacts: Investor Relations: Charles Zhou Amanda Kong

Adlai Nortye Ltd. ir@adlainortye.com