Pharma’s partner for phase Ib of RCC trial

Merck partners with HiberCell for Phase Ib renal carcinoma trial

The Phase Ib trial will evaluate the combination therapy of Welireg and HC-7366 in patients with clear cell renal cell carcinoma and is expected to start in Q1 2024

Merck & Co (MSD) and HiberCell have partnered to conduct a Phase Ib trial to evaluate the combination therapy of MSD’s Welireg (belzutifan) and HiberCell’s HC-7366 for treating clear cell renal cell carcinoma (RCC).

Welireg is an oral hypoxia-inducible factor-2α (HIF-2α) inhibitor. It was approved as a treatment for certain patients with von Hippel-Lindau (VHL) disease including those with associated RCC. The drug has received a priority review as a treatment for advanced RCC by the US Food and Drug Administration (FDA), with the Prescription Drug User Fee Act (PDUFA) set for 17 January 2024.

HC-7366 is a selective general control nonderepressible 2 (GCN2) kinase activator. GCN2 kinase is part of an integrated stress response, and its prolonged activation can have an anti-tumour and immunomodulatory effect.

The Phase Ib study is designed to evaluate the safety, tolerability, and preliminary efficacy of the combination therapy. The trial will have dose-escalation and dose-expansion phases, which will determine the recommended Phase II dose.

Additionally, the study will have an independent HC-7366 monotherapy cohort. The trial will enrol up to 80 participants across multiple US sites. The study is planned to start in Q1 2024.

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