NiKang Therapeutics Enters into Clinical Trial Collaboration and Supply Agreement to Evaluate NKT2152 in Combination with Standard-of-Care in First-Line Advanced Hepatocellular Carcinoma

- Study will evaluate the potential of triple combination of NKT2152, atezolizumab and bevacizumab versus atezolizumab and bevacizumab alone, in first line advanced hepatocellular carcinoma -

- Expected to begin patient enrollment in 2024 -

WILMINGTON, Del.--(BUSINESS WIRE)--NiKang Therapeutics Inc. (“NiKang”), a clinical stage biotech company focused on developing innovative small molecule oncology medicines to help patients with unmet medical needs, today announced that it has entered into a clinical trial collaboration and supply agreement with F. Hoffmann-La Roche Ltd. (“Roche”) to evaluate NKT2152, a small molecule that inhibits hypoxia inducible factor 2α (HIF2α), in combination with standard-of-care atezolizumab (Tecentriq^®) and bevacizumab (Avastin^®) in first-line treatment of unresectable/advanced hepatocellular carcinoma (HCC). This collaboration will utilize Roche’s MORPHEUS-LIVER phase 1b/2 platform for rapid and efficient combination development.

This randomized multi-regional phase 1b/2 trial is intended to evaluate the efficacy and safety of NKT2152 in combination with atezolizumab and bevacizumab versus atezolizumab and bevacizumab in patients with unresectable/advanced HCC not previously treated with systemic therapy. Patient enrollment will begin in 2024. Under the collaboration, Roche will sponsor the study, and each company will supply its respective anti-cancer agent to support the trial. NiKang retains its development and commercialization rights of NKT2152. Additional financial details of the agreement were not disclosed.

“We are thrilled to enter this collaboration with Roche, which allows us to explore the broader potential of our HIF2α inhibitor NKT2152 in treating solid tumors beyond clear cell Renal Cell Carcinoma (ccRCC),” said Zhenhai Gao, Ph.D., co-founder, president, and CEO of NiKang. “Based on the compelling scientific rationale and supporting preclinical studies, we have a keen interest in assessing NKT2152 in HCC patients. This collaboration enables us to leverage Roche’s MORPHEUS-LIVER phase 1b/2 platform to explore this promising opportunity expeditiously.”

NKT2152 is currently in a phase 1/2 dose escalation and expansion trial (NCT05119335) that is designed to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity in patients with advanced ccRCC.

About NiKang Therapeutics

NiKang Therapeutics is a clinical stage biotech company focused on discovering and developing innovative small molecule oncology medicines to help patients with unmet medical needs. Our target selection is driven by deep insights into disease biology and molecular pathways. Our discovery approach is informed by target structure biology and capitalizes on structure-based drug design. The successful implementation of our strategy enables us to rapidly and efficiently discover and advance proprietary drug candidates with the most desirable pharmacological features into clinical studies. We strive to bring transformative medicines to patients in need.

For more information, please visit http://www.nikangtx.com