Beijing, April 20, 2025 — Dr. Jianfei Yang, President of R&D and Chief Scientific Officer of Beijing Phil Rivers Technology and Shenzhen Phil Rivers Biotechnology, announced that PR00012, an innovative drug candidate independently developed by Phil Rivers, has successfully been dosed and no DLT (Dose-Limiting Toxicity) occurred over the observing period in the Phase I trial for the treatment of pancreatic cancer and other advanced solid tumors. This achievement marks the official transition of PR00012 into the next phase of clinical trials, providing strong momentum and confidence for the continued development of PR000012.

Potential First-in-Class PR00012: Aiming for Best-in-Class efficacy across multiple solid tumors

As a potential first-in-class and best-in-class drug targeting its specific mechanism, PR00012 distinguishes itself through unique mechanisms of action, which is expected to overcome the limitations of current therapies for pancreatic cancer and other metastatic cancers. Phil Rivers will continue to advance the dose-expansion stage of the PR00012 trial based on its core “AI4S (AI for Science) + Disease” technology platform, further exploring its therapeutic potential in pancreatic cancer and other solid tumors such as highly aggressive KRAS-mutant colorectal cancer. 

About the Phase I clinical trial of PR00012 in metastatic solid tumors 

This trial is an open-label, single-arm, dose-escalation, first-in-human study, led by Changhai Hospital in Shanghai, China, designed to assess the safety, pharmacokinetics, and efficacy of PR00012 in patients with metastatic solid tumors, including pancreatic cancer and colorectal cancer: 

-Safety evaluation: To assess tolerability and safety through the incidence of DLT. 

-Pharmacokinetic analysis: To establish the drug’s metabolic and distribution profiles in humans. 

-Preliminary efficacy evaluation: To monitor dynamic changes in tumor biomarkers and early signals of antitumor activity. 

PR00012 reported no significant safety events after the first patient's enrollment during the DLT observation period, laying a solid foundation for subsequent dose escalation and expansion phases. 

Clinical trial milestone accelerates development 

The successful completion of First-in-Human enrollment and DLT observation marks a critical milestone for PR00012: 

- Initial safety validation: Provides key data for dose optimization. 

- Enhanced R&D efficiency: AI-driven virtual trials and real-world clinical data form a closed-loop system, accelerating decision-making. 

Further validation of the “AI4S + Disease” paradigm

Dr. Yang emphasized, “The high heterogeneity and complex mechanisms of pancreatic cancer pose formidable challenges for traditional drug development. Phil Rivers’ innovative ‘AI for Science (AI4S) + Disease’ paradigm integrates multimodal patient data to construct digital twin models of diseases, enabling precise decoding of disease mechanisms and optimized clinical trial design. Under this paradigm, PR00012’s development cycle was significantly shortened, facilitating efficient collaboration from target discovery to clinical trial executions.” Moving forward, Phil Rivers aims to introduce additional candidate drugs to benefit patients in the future. 

About Phil Rivers

Beijing Phil Rivers Technology Co., Ltd. is an AI-powered platform company accelerating pharmaceutical innovation through computational medicine and data-driven drug discovery. Focusing on  "AI4S + Disease" intelligence, the company develops computational medicine solutions, discovers new drug targets, and simulates clinical trials.

Shenzhen Phil Rivers Biotechnology Co., Ltd., a wholly-owned subsidiary of Beijing Phil Rivers Technology Co., Ltd., is dedicated to AI-driven drug discovery and clinical translation. Leveraging cutting-edge technological breakthroughs in solid tumors, central nervous system (CNS) disorders, and autoimmune diseases, the company is pioneering a new paradigm in biomedicine—one defined by data-driven innovation, accelerated clinical translation, and intelligent iterative development.