Immuno-oncology Drug  

PRJ1-3024: A small molecule HPK1 inhibitor

PRJ1-3024 is a small molecule HPK1 inhibitor that is designed to enhance T cell function and antitumor responses. Hematopoietic progenitor kinase 1 (HPK1), also known as MAP4K1, is a protein kinase that reduces the T cell response to tumor cells. Specifically, HPK1 is a negative regulator of T cell receptor (TCR) signaling. As a result, HPK1 is an attractive druggable target to improve immunotherapies by exploiting small molecule HPK1 inhibitors.

Dr. Liao, our co-founder and scientific consultant, had demonstrated that HPK1 mediates T cell dysfunction and is a druggable target to ameliorate T cell exhaustion and enhance the function of T cell-based immunotherapies. The research was reported in Cancer Cell, a top scientific journal, in August 2020. Based on the discovery of Dr. Liao, we have developed PRJ1–3024, a novel small molecule inhibitor targeting HPK1 for the treatment of advanced solid tumors. Preclinical in vivo studies in tumor models revealed that PRJ1-3024 was able to significantly inhibit the growth of multiple types of tumors, including ones that are less likely to trigger a strong immune response and therefore do not respond well to immunotherapies.  

We are among the first companies to clinically develop HPK1-targeted drug candidates, according to Frost & Sullivan. We filed an IND application to the FDA for a Phase I clinical trial of PRJ1-3024 for advanced solid tumors in the United States and received its approval in November 2021. We also submitted an IND application to the NMPA for a Phase I/II clinical trial for advanced solid tumors in China in December 2021 and received its approval in February 2022. PRJ1-3024 is regulated as novel drugs by the FDA and classified as a Class 1 new chemical drug by the NMPA. We are currently conducting the Phase I clinical trial in the United States and the Phase I part of the Phase I/II clinical trial in China to evaluate the safety, tolerability, preliminary efficacy and pharmacokinetics profiles, among others, of PRJ1-3024.