In April 2025, BIOTIME announced that its CDC7 inhibitor, BIOT-006, has received clinical trial approval from the U.S. FDA, following approval from China NMPA in March. No CDC7 inhibitor has yet been marketed globally to date.
Medicilon, BIOTIME ‘s strategic partner, provided end-to-end preclinical R&D services for BIOT-006, from drug discovery to IND filing. This collaboration follows the earlier success of dual approval of BIOTIME ‘s BIOT-001, further strengthening their partnership.
CDC7: An Emerging Oncology Target with Global First-in-Class Potential
CDC7 is a serine/threonine kinase essential for DNA replication and cell cycle progression, whose overexpression, along with its regulatory subunit DBF4, has been detected in multiple tumor types. Preclinical data demonstrate that CDC7 inhibition selectively impairs S-phase replication fork formation in tumor cells, triggering p53-dependent apoptosis, while in normal cells it induces only reversible cell cycle arrest. This tumor-selective cytotoxicity provides a broad therapeutic window, highlighting CDC7 as a promising target for anticancer therapy. Although no CDC7 inhibitors are commercially available, of 13 candidates in clinical or preclinical development, 7 have advanced to clinical stages.
BIOT-006, an innovative CDC7 inhibitor developed by BIOTIME, featuring a novel structure and its promising preclinical results:
- Precision Targeting: Inhibits CDC7 downstream signaling and blocks the G2/M phase, reducing tumor cell proliferation and inducing apoptosis.
- High Potency: Shows superior activity (IC50 10-50nM) against pancreatic and colorectal cancer cell lines compared to reference compound TAK-931 in phosphorylation modulation, cell cycle arrest, and apoptosis induction.
- Broad Efficacy: Demonstrates significant antitumor efficacy in COLO205 colorectal cancer and PANC-1 pancreatic cancer xenograft models.
Medicilon’s One-Stop Service for Oncology Innovation
Medicilon has established a comprehensive preclinical R&D platform to support oncology drug R&D. By the end of 2024, Medicilon had provided full IND application services for 73 projects. Its services include more than 440 oncology models covering PDX, syngeneic, xenograft, and humanized tumor models, supporting efficacy evaluation for various drug types. Conducting toxicology studies in multiple species in a 29,000㎡ GLP laboratory that meets FDA, TGA, and EMEA standards.
Medicilon congratulates to BIOTIME on BIOT-006’s dual approvals and looks forward to its clinical success. Medicilon will continue to enhance its one-stop preclinical platform, leveraging cutting-edge technology and rigorous quality standards to accelerate innovative therapies for patients worldwide.
