Jesin Pharma's Aurora A Inhibitor VIC-1911 in Combination with Olaparib Receives IND Approval in China for Advanced Breast Cancer

On December 26, 2023, JSI (Jiesida Pharmaceutical Technology Co., Ltd.) announced that its Investigational New Drug (IND) application for the clinical trial of VIC-1911, a novel small-molecule Aurora A inhibitor, in combination with olaparib for the treatment of advanced breast cancer, had been accepted by the National Medical Products Administration (NMPA) of China (Acceptance No.: CXHL2301448). This Phase I/II clinical study aims to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of VIC-1911 tablets as monotherapy or in combination with olaparib in patients with advanced solid tumors, as well as the safety and efficacy of the combination therapy in patients with advanced HER2-negative breast cancer.

VIC-1911 is a next-generation, highly selective inhibitor of the cell cycle-regulating kinase Aurora A. It has been the first to demonstrate clinically an absence of significant bone marrow suppression toxicity. Currently ranking among the international forefront, it holds the potential to be a global first-in-class therapy.

Globally, new cases of female breast cancer surpassed lung cancer for the first time in 2020, reaching 2.26 million, making it the most commonly diagnosed cancer. Currently, targeted therapies for HER2-negative breast cancer primarily consist of PARP inhibitors based on the synthetic lethality mechanism; however, their clinical benefit is limited. Approximately half of patients exhibit primary resistance, and among those who initially respond, the majority develop acquired resistance within one year of treatment. Aurora A kinase plays a critical role in DNA damage repair mechanisms. Multiple preclinical studies have demonstrated that VIC-1911 exhibits significant synergistic effects when combined with PARP inhibitors and holds promise for resensitizing resistant patients to PARP inhibitor therapy, thereby expanding the population that may benefit from this treatment approach.

JSI has taken the lead in China by filing for clinical trials of the combination of an Aurora A inhibitor and olaparib, which is expected to benefit a broader population of breast cancer patients with homologous recombination deficiency (HRD) and overcome resistance to PARP inhibitors, demonstrating significant clinical value.

JSI is a biopharmaceutical company focused on the research and development of novel drugs for precision oncology therapies. Driven by clinical needs and the latest advances in translational medicine, the company is dedicated to the discovery of original innovative drugs. Its senior and international executive team has successfully developed and launched more than 20 new drugs in China and the United States throughout their careers. JSI collaborates with leading clinicians and research institutions both domestically and internationally to conduct cutting-edge translational and clinical studies. Key clinical development areas include: the development of novel anticancer agents targeting RAS gene mutations; overcoming resistance to targeted therapies such as EGFR and KRAS inhibitors; prevention of graft-versus-host disease (GVHD) and leukemia relapse following allogeneic hematopoietic stem cell transplantation; and research on synthetic lethality and combination therapy strategies. Currently, three of JSI’s product candidates are in or approaching Phase II clinical trials.