InnoCare Pharma Announces Clinical Data for Novel CAR-T Therapy XYF19 and Receives IND Approval in China for First-in-Class HPK1 Inhibitor PRJ1-3024

On February 14, MingMed announced two new breakthroughs in its research field around the HPK1 target. One is the clinical data of the novel CAR-T cell therapy product XYF19, which reduces the expression of HPK1 protein in T cells, disclosed at the 4th European CAR-T Cell Conference (EHA CAR-T Conference) hosted by the European Hematology Association (EHA). The other is the potential "first-in-class" HPK1 small molecule inhibitor PRJ1-3024, which has been approved for clinical trials in China.

According to the press release, HPK1 is an important target in tumor immunology. Targeting HPK1 can effectively regulate several types of key immune cells and activate their synergistic anti-tumor effects. Mr. Zhang Yan, CEO of MingMed, stated that HPK1 is a key kinase expressed in immune cells. It negatively regulates the functions of various immune cells in the anti-tumor immune cycle and can modulate the expression of PD-1 in T cells. Therefore, it is considered the next super target in immunotherapy.

Among them, XYF19 is a novel CD19 CAR-T cell therapy product manufactured using a technology platform developed by Xi'an Yufan Biotechnology, a subsidiary of MingMed, which reduces HPK1 protein expression in T cells. At the EHA CAR-T conference, exploratory clinical research data on XYF19 for the treatment of adult relapsed or refractory acute precursor B-cell lymphoblastic leukemia (B-ALL) was presented.

Study results showed that among the 11 adult B-ALL patients treated with XYF19, 10 had a high tumor burden (Bone Marrow Blasts > 25%). During the treatment, the reinfusion dose of XYF19 was one order of magnitude lower than that of the marketed control product, and the proportion of patients achieving complete remission (CR) reached 73%. No subjects experienced cytokine release syndrome (CRS) reactions of grade 3 or higher, and no subjects exhibited neurotoxicity.

MingMed Director and Tsinghua University School of Pharmaceutical Sciences Professor Xuebin Liao believes that adult relapsed or refractory acute precursor B-cell lymphoblastic leukemia has always been a difficult disease to treat. Although there are many CAR-T products currently under research, globally, there is only one approved CAR-T product for treating this disease. Based on clinical trial results, XYF19 demonstrated both good efficacy and significant safety by reducing the expression of the HPK1 protein in T cells, preliminarily showing promising therapeutic potential.

In this news, another product approved for clinical trials, PRJ1-3024, is a small molecule HPK1 inhibitor fully independently developed by MingMed. It has a series of advantages such as better selectivity. Since HPK1 is upstream of PD-1, targeting HPK1 therapy is expected to produce broader anti-cancer effects. Preclinical studies in animal tumor models found that the candidate drug can significantly inhibit the growth of various types of tumors, including some "cold" tumors. According to the press release, PRJ1-3024 had previously been approved for clinical trials in the United States, and this approval is for clinical trials in China, where it will soon be tested in advanced solid tumors.

We hope that MingMed's novel CAR-T cell therapy product and PRJ1-3024 will proceed smoothly in clinical research and achieve more progress soon, providing patients with greater clinical benefits.

References:

[1] MingMed Achieves Two New Breakthroughs in HPK1 Target Research: Cellular Therapy Clinical Data Presented at EHA CAR-T Conference, Small Molecule Drug Approved for Clinical Trials in China. Retrieved Feb 14, 2022, from https://mp.weixin.qq.com/s/xja0Xq1qANY1_yklBqFqrQ

▽Follow 【WuXi AppTecGermany】WeChat Official Account