On November 30, 2021 NiKang Therapeutics Inc. ("NiKang"), a clinical stage biotech company focused on developing innovative small molecule oncology medicines to help patients with unmet medical needs, reported that it has entered into a clinical trial collaboration and supply agreement with Pfizer Inc. (NYSE: PFE) to evaluate NKT2152, a small molecule that inhibits hypoxia inducible factor 2α (HIF2α), in combination with palbociclib, a CDK4/6 inhibitor, and sasanlimab, a subcutaneously administered PD-1 inhibitor for the treatment of advanced clear cell renal cell carcinoma (ccRCC) (Press release, NiKang Therapeutics, NOV 30, 2021, View Source [SID1234596285]). It will comprise two different combination regimens to treat ccRCC patients who have not responded to or relapsed from prior therapies. Under the terms of the agreement, NiKang will sponsor the study, and Pfizer will co-fund the trials and provide its drugs at no cost to NiKang. The two companies will form a Joint Development Committee to oversee this collaboration.
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"We are excited to work with Pfizer, a company that has been a leader in RCC drug development for nearly two decades, and appreciate its recognition of the potential for these important combination strategies in helping ccRCC patients in need. The scientific rationale of these novel combinations is compelling as they target different and complementary pathways," said Zhenhai Gao, Ph.D., co-founder, president, and CEO of NiKang. "This clinical collaboration provides an excellent framework under which both companies pool their proprietary products and resources together to effectively explore the potential of these combination therapies."
NKT2152 is currently in a phase 1/2 dose escalation and expansion trial (NCT05119335). It 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 and Pfizer’s palbociclib and sasanlimab will commence.