Adlai Nortye is advancing Buparlisib, a pan-PI3K inhibitor, through a Phase III trial (BURAN) for patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that has progressed after prior anti-PD-(L)1 treatment. If successful, Buparlisib could become the first PI3K inhibitor approved for this indication, addressing a significant unmet need in a market projected to exceed $2.0 billion.
Buparlisib: Targeting PI3K in HNSCC
Buparlisib, in-licensed from Novartis, targets phosphoinositide 3-kinase (PI3K) enzymes, which play a crucial role in cell growth and proliferation. Elevated PI3K signaling is a hallmark of cancer, making it a key target for therapeutic intervention. By inhibiting PI3K, Buparlisib aims to slow down cancer growth in HNSCC patients who have progressed after anti-PD-(L)1 therapy.
The BURAN trial is an open-label study evaluating the efficacy of once-daily Buparlisib in combination with weekly paclitaxel compared to weekly paclitaxel alone. The primary endpoint is overall survival (OS), with data expected in the first quarter of 2025. This trial is crucial as it could establish Buparlisib as a new treatment option in a challenging therapeutic landscape.
Current Treatment Landscape and Unmet Needs
Head and neck squamous cell carcinoma affects over 850,000 individuals worldwide annually. Current treatments include EGFR inhibitors like Eli Lilly's Erbitux, and PD-1 blocking antibodies (immune checkpoint inhibitors) like Bristol-Myers Squibb's Opdivo and Merck's Keytruda. However, many patients progress after these treatments, highlighting the need for novel therapeutic approaches.
Adlai Nortye's Broader Pipeline
In addition to Buparlisib, Adlai Nortye has two other investigational drugs in clinical testing:
- AN4005: An orally available, small-molecule PD-L1 inhibitor currently in a Phase Ia trial for advanced tumors, with data expected by the end of the year.
- AN0025: A potential enhancer of chemoradiotherapy, being evaluated in investigator-initiated trials for esophageal cancer, rectal cancer, and non-small cell lung cancer.
The company also has two preclinical assets, AN8025 for advanced tumors and AN8025 for RAS-addicted solid tumors, further expanding its oncology pipeline.
Financial Position
As of June 30, 2024, Adlai Nortye reported cash, cash equivalents, and marketable securities of $98 million, which is projected to fund operations into the second half of 2025. The company's American depositary shares are listed on the Nasdaq Global Market under the ticker symbol "ANL".
