NiKang Therapeutics Inc., a clinical-stage biotech company specializing in small molecule oncology medicines, has announced a significant clinical trial collaboration and supply agreement with F. Hoffmann-La Roche Ltd. (Roche). This partnership focuses on evaluating NiKang’s NKT2152, a novel small molecule that inhibits hypoxia-inducible factor 2α (HIF2α), in combination with Roche’s atezolizumab (Tecentriq) and bevacizumab (Avastin) for the first-line treatment of unresectable or advanced hepatocellular carcinoma (HCC).

The collaboration leverages Roche’s MORPHEUS-LIVER phase 1b/2 platform, which is designed for rapid and efficient development of combination therapies. The randomized, multi-regional phase 1b/2 trial aims to assess the efficacy and safety of NKT2152 in combination with atezolizumab and bevacizumab versus the control treatment in patients with unresectable/advanced HCC who have not previously received systemic therapy. Patient enrollment is scheduled to begin in 2024.

Zhenhai Gao, Co-founder, President, and CEO of NiKang, expressed enthusiasm for the collaboration, highlighting the potential of NKT2152 in treating solid tumors beyond clear cell Renal Cell Carcinoma (ccRCC). This partnership allows NiKang to explore NKT2152’s application in HCC patients, building on preclinical studies and scientific rationale.

Under the agreement, Roche will sponsor the study, and each company will supply its respective anti-cancer agent to support the trial. NiKang retains development and commercialization rights for NKT2152. Financial details of the agreement were not disclosed.

Currently, NKT2152 is in a phase 1/2 dose escalation and expansion trial evaluating its safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity in patients with advanced ccRCC.

This collaboration marks a significant step in oncology research, offering hope for patients with HCC. It showcases NiKang’s commitment to developing innovative treatments for cancer and Roche’s support in pioneering new therapeutic approaches. The partnership aims to expedite the development and accessibility of promising cancer treatments, potentially transforming the landscape of cancer care.

  atezolizumab, Avastin, bevacizumab, Hepatocellular carcinoma, NiKang Therapeutics, NKT2152, Roche, Tecentriq, Zhenhai Gao