Simcere Zaiming, an innovative oncology company and a subsidiary of Simcere Pharmaceutical Group (2096.HK), announced that the investigational new drug (IND) application of SIM0508, a DNA polymerase θ (Pol θ) small molecule inhibitor, has been approved by the Food and Drug Administration (FDA). Currently, the antitumor candidate has been cleared to carry out clinical trials in patients with locally advanced/metastatic solid tumor in both China and the United States.

SIM0508 is a potent small molecule inhibitor, selectively targets and inhibits Pol θ, effectively blocking MMEJ repair and precisely inhibiting the proliferation of HRD tumor cells.  SIM0508 also has potential synergy when used in combination with poly (ADP-ribose) polymerase (PARP) inhibitors or chemotherapeutic agents. Preclinical studies of SIM0508 revealed favorable oral pharmacokinetics and safety, with no evident hematologic toxicities. These findings suggest that combining SIM0508 with PARP inhibitors or chemotherapeutic agents carries a low risk of additive toxicity. The preclinical data were presented at the 2023 and 2024 American Association for Cancer Research (AACR) Annual Meeting.

 

Source: simcere.com

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