k8凯发(中国)天生赢家·一触即发

IMPACT Therapeutics announced recently that its hedgehog inhibitor IMP5471 has received approval from the National Medical Products Administration (NMPA) for clinical trials, and the clinical study will be initiated in China.

This will be a single-arm, open-label, multicenter, Phase I clinical study The aim is to evalsuate the safety, tolerance, pharmacokinetics, and preliminary efficacy of IMP5471 as a monotherapy or combined with LDAC in patients with myeloid malignancies. The study consists of Phase Ia and Phase Ib. The Phase Ia study approved for IMP5471 is a dose-escalation study of the drug as a monotherapy. IMPACT Therapeutics will apply for the Phase Ib study of IMP5471 in combination with LDAC after obtaining data from the monotherapy study.

IMP5471 is a hedgehog signaling pathway inhibitor developed by IMPACT Therapeutics (referred to as Hedgehog inhibitor). It is a new chemical molecule with a differentiated design targeting the SMO protein. The drug is intended to be used for the treatment of hematological malignancy, including the newly diagnosed adult acute myelogenous leukemia (AML) patients who haven't received systematic AML treatment and are not suitable for high-intensity chemotherapy treatment as well as for the treatment of solid tumors (e.g. basal cell carcinoma). Preclinical studies have shown that IMP5471 has high in-vitro and in-vivo pharmacodynamic activity, high in-vitro selectivity, good oral absorption in both rats and dogs, and wide efficacy window and safety window in animals. Presently, there isn't a drug with similar mechanism approved for these indications in relation to malignant hematological diseases in China.

The hedgehog signaling pathway plays a key role in mammalian embryonic development. In adult tissues, the activation of the hedgehog signaling pathway also plays an important role in the regulation of stem cells, tissue damage repair, and angiogenesis. The hedgehog signaling pathway, once abnormally activated, is closely related to the occurrence and development of various malignant tumors. Therefore, the hedgehog signaling pathway has become an increasingly popular target for cancer treatment in recent years. IMPACT Therapeutics has discovered three series of novel Hedgehog inhibitors, and has applied 4 patent applications. One of the patent application has been granted in China, the United States, Canada, Japan, Australia and Europe.

"The approval of IMP5471 for clinical trials has further expanded our clinical pipeline," said Dr. Jun Bao, CEO of IMPACT Therapeutics. "We'll continue to drive the fast development, to validate the results of preclinical studies. We'll also explore the possibility of expanding the indications. We're committed to meeting the unmet clinical needs and delivering benefits to patients around the world."

About IMPACT Therapeutics

IMPACT Therapeutics is a biopharmaceutical company dedicated to the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality. IMPACT Therapeutics has assembled one of the most comprehensive DNA damage response (DDR) global pipeline of novel drug candidates generated by in-house discovery efforts and is expanding to other novel synthetic lethality targets to broaden its pipeline. IMPACT pipeline products include PARP inhibitor (senaparib/ IMP4297), Wee1 inhibitor (IMP7068), and other novel DDR pathway inhibitors. The lead clinical program, PARP inhibitor (senaparib/ IMP4297), is in Phase III study in China, and a global clinical trial-mCRPC study which has received FDA IND approval. Senaparib’s preliminary clinical data demonstrated superior tolerability and wider therapeutic window compared with other PARPi. Phase I study of Wee1 inhibitor (IMP7068) is conducted globally.