BeOne Medicines Ltd. and Taiwan‑based Senhwa Biosciences have entered into a clinical supply agreement that will supply BeOne’s PD‑1 inhibitor tislelizumab and Senhwa’s G‑quadruplex stabilizer CX‑5461 (Pidnarulex) for a global, multi‑center Phase 1b/2a study of the combination in patients with advanced solid tumors, including pancreatic ductal adenocarcinoma and immune‑checkpoint‑inhibitor refractory melanoma.
The trial will evaluate safety, tolerability and preliminary efficacy of the combination, with the goal of converting immunologically “cold” tumors into “hot” ones to enhance response to checkpoint blockade. CX‑5461 stabilizes G‑quadruplex structures, inducing replication stress and potentially acting as a topoisomerase II poison, while tislelizumab blocks PD‑1/PD‑L1 interactions to unleash T‑cell activity. Together, the agents are expected to synergize by remodeling the tumor microenvironment and amplifying antitumor immunity.
Strategically, the partnership expands BeOne’s oncology portfolio beyond its established hematologic indications into the solid‑tumor arena, a key growth area for the company. For Senhwa, the deal marks a first foray into immuno‑oncology, leveraging CX‑5461’s preclinical promise and its selection for the NCI‑NExT program to broaden its therapeutic reach. The collaboration also provides both companies with access to a global patient cohort and a shared regulatory pathway, positioning them to accelerate development and potentially capture a share of the projected $338.4 billion cancer immunotherapy market by 2034.
Management emphasized the significance of the collaboration. Benny T. Hu, Chairman of Senhwa, said the agreement “represents a major step forward for Senhwa as we expand into the heart of immuno‑oncology. By leveraging the unique mechanism of CX‑5461 in modulating the tumor microenvironment, we hope to discover and confirm new treatment options for patients who do not currently benefit from existing therapies.” BeOne’s leadership highlighted the opportunity to broaden the clinical utility of tislelizumab and to address unmet needs in pancreatic cancer and refractory melanoma, underscoring the partnership’s potential to accelerate both companies’ growth trajectories.
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