On January 5, 2022 NiKang Therapeutics Inc. ("NiKang"), a clinical stage biotech company focused on developing innovative small molecule oncology medicines to help patients with unmet medical needs and AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company ("AVEO") , reported that they have entered into a clinical trial collaboration and supply agreement to evaluate NKT2152, NiKang’s small molecule that inhibits hypoxia inducible factor 2α (HIF2α), in combination with FOTIVDA (tivozanib), AVEO’s oral, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI), which is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies (Press release, AVEO, JAN 5, 2022, View Source [SID1234598202]). The phase 2 clinical trial will evaluate the safety and efficacy of the combination of NKT2152 and tivozanib in clear cell RCC (ccRCC) patients who have not responded to or relapsed from prior therapies (R/R RCC). Under the terms of the agreement, NiKang will sponsor the trial and AVEO will co- fund the trial. Both companies will provide its respective drugs at no cost. The two companies will form a Joint Development Committee to oversee this collaboration.

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"Preclinical and early clinical data have demonstrated enhanced anti-tumor activity by the combination of HIF2α and VEGFR inhibition. Given tivozanib’s established excellent clinical profile, we are excited to work with AVEO to explore such opportunity," said Zhenhai Gao, Ph.D., Co-founder, President and Chief Executive Officer of NiKang. "We look forward to collaborating with our partners to further advance NKT2152 into its next stage of development as part of our combination strategy. This clinical collaboration with AVEO is an excellent example of pooling expertise and resources together to maximize the potential of both NKT2152 and tivozanib in helping R/R ccRCC patients."

"This collaboration with NiKang, will play an important role in the advancement of both the tivozanib and NKT2152 programs," said Michael Bailey, President and Chief Executive Officer of AVEO. "The tivozanib and NKT2152 combination will build on the activity seen with VEGFR TKIs and HIF2α agents in ccRCC. We believe the best-in-class qualities of these two compounds provide a unique combination of efficacy and tolerability for patients with R/R ccRCC as a doublet or, potentially in the future, as part of a triple combination."

The phase 2 clinical trial is expected to commence in 2022.

About NKT2152

NKT2152 is a small molecule that inhibits HIF2α. It is currently in a phase 1/2 dose escalation and expansion trial (NCT05119335). This trial is designed to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity in patients with advanced ccRCC. Once an appropriate dose is identified, combination studies including NKT2152 will commence.