▎This article is reprinted from PHIL RIVERS

On April 20, 2025, Dr. Jianfei Yang, R&D President and Chief Scientific Officer of PHIL RIVERS TECHNOLOGY Co., Ltd., announced that PR00012, a Class 1 innovative drug independently developed by PHIL RIVERS, successfully enrolled the first patient (First-In-Human, FIH) in a Phase 1 clinical trial for the treatment of malignant solid tumors such as pancreatic cancer. It also smoothly passed the Dose-Limiting Toxicity (DLT) observation period, with preliminary safety data showing excellent results. This milestone marks PR00012's official entry into the next stage of human clinical trials, injecting strong momentum and confidence into the drug's development process.

Potential FIC/BIC

As a potential "first-in-class (FIC)" and "best-in-class (BIC)" drug targeting this site, PR00012's breakthrough lies in its differentiated mechanism of action, which is expected to overcome the limitations of current treatments for malignant tumors such as pancreatic cancer. PHIL RIVERS will rely on its core technology platform of "AI4S + disease" to continuously advance the dose-expansion phase trial of PR00012, further exploring its therapeutic potential in pancreatic cancer and more solid tumors.

• PR00012 significantly inhibits the most malignant KRAS-mutant colorectal cancer (CRC) and is expected to achieve remarkable results in clinical treatment.

• PR00012 has demonstrated clear therapeutic value for a specific patient population with pancreatic cancer, increasing patient survival hope and is expected to achieve globally remarkable results in the next phase of clinical trials.

Regarding PR00012 Phase 1 Clinical Trial

This clinical trial is an open, single-arm, dose-escalation first-in-human study,It is led by Shanghai Changhai Hospital, with core objectives including:

• Safety Assessment: The preliminary verification of the drug's tolerability and safety in the human body is conducted through rigorous monitoring during the DLT observation period.

• Pharmacokinetic Analysis: Clarify the metabolic and distribution characteristics of the drug in the body;

• Preliminary Efficacy Exploration: Observing the Dynamic Changes of Tumor Biomarkers and Early Anti-Tumor Activity Signals.

After the enrollment of the first patient, no significant safety events were reported for PR00012 during the DLT observation period, laying a solid foundation for subsequent dose escalation and expansion phase trials.

Clinical Trials Reach Milestone, Clinical Progress Accelerates Comprehensively

The enrollment of the first patient and the successful completion of the DLT observation period mark a phased achievement in the PR00012 clinical trial:

• Preliminary Validation of Safety: Providing Critical Basis for Dose Exploration;

• Improved R&D Efficiency: AI-driven virtual trials and real-world clinical data form a closed loop, accelerating the decision-making process.

The paradigm of "AI4S + Disease" has been further validated.

Dr. Yang Jianfei emphasized: "The high heterogeneity and complex mechanisms of pancreatic cancer are barriers that traditional drug development struggles to overcome. PHIL RIVERS' innovative 'AI4S+Disease' paradigm integrates multi-modal patient data to construct digital twin models of diseases, precisely decoding disease mechanisms and designing clinical trial protocols. Under this paradigm, the development cycle of PR00012 has been significantly shortened, achieving full-link efficient collaboration from target discovery to clinical trials." The company will subsequently deliver more candidate products that benefit patients.

References:

[1]PHIL RIVERS' First-in-Class New Drug PR00012 Completes First Patient Enrollment and Successfully Passes DLT Observation Period, Marking a New Chapter in Clinical Trials. Retrieved Apr 20，2025, From https://mp.weixin.qq.com/s/y7DkhDrhafdOv9FSBE8sbw