Our lead drug candidate, JR8603, is a small molecule tumor-targeted peptide-drug-conjugate, which is in its IND-enabling and early stage clinical development for the treatment of a wide range of solid tumors, including breast, colon, prostate, ovarian gastric, bladder carcinomas and others.
Current Status
JR8603 has clearly demonstrated robust anticancer activity in a range of tumor-bearing rodent models after intravenous administration, confirming JR8603’s selectivity, potency, and proof of concept. JR8603 has finished comprehensive evaluations for drug stability, drug metabolism and pharmacokinetics. JR8603 possesses desirable pharmacokinetic properties and metabolic stability in preclinical species in vivo. JR8603 also demonstrates good solubility and stability characteristics using conventional IV formulations. Numerous exploratory rat and dog toxicology studies have successfully completed with solid safety profiles and have established a clear path towards IND-enabling studies. Data and IND-enabling plans have been discussed with the Oncology Division of the US/FDA and the written responses from US/FDA (Type B Meeting) provided with a clear path towards an IND-enabling program. Currently, JR8603 is scheduled for GLP toxicology in final IND-enabling evaluation. Synthesis of JR8603 is scalable, a non-GMP kilo lab engineering batch and the GMP batch have been synthesized. Final API supply and parenteral formulation development of the final drug product will be completed and included as part of the US IND regulatory filing.
Future Plan
JR8603 is planning to enter into Phase 1/2a clinical trial in US in early 2020. The initial clinical development strategy for JR8603 will evaluate the safety, tolerability and efficacy of JR8603 across a range of advanced solid malignancies. Prescreening of cancer patients is planned for evaluating legumain protein expression as a prognostic factor (biomarker) for the selection of patient populations likely to show greater benefit from JR8603 therapy (i.e. breast, colon, lung, gastric, others). Specific design elements of the Phase 1/2a clinical study program for JR8603 will be subject to review as part of the US IND regulatory filing.