21^st February, 2022, Shanghai,  IMPACT Therapeutics recently announced that China NMPA approved Investigational New Drug (IND) application of PARP inhibitor Senaparib (IMP4297) in combination with temozolomide (TMZ) for clinical study in China.  

This is a PhaseⅠb/Ⅱ open-label, multi-center, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficiency of Senaparib in combination with temozolomide in patients with advanced solid tumors and small cell lung cancer. The study has previously been approved for clinical trials in the United States, Australia, South Korea and other countries and regions. 

Senaparib is a PARP inhibitor developed by IMPACT. The compound is currently in a Phase III study for ovarian cancer, and Phase II studies for prostate cancer, small cell lung cancer and other indications worldwide, including China. Senaparib’s preliminary clinical data demonstrated superior tolerability and wider therapeutic window compared to other marketed PARP inhibitors, showing the best-in-class potential. At present, clinical trials conduction and commercialization preparations of Senaparib for various indications in mainland China, Hong Kong and Macau are being performed by a joint venture company established by IMPACT Therapeutics and Junshi Biosciences.

Temozolomide (TMZ) is an orally available alkylating anti-tumor agent. In preclinical animal models, combination of Senaparib and TMZ showed potential to mimic synthetic lethality, demonstrating highly significant synergistic anti-tumor activity, while not producing additive toxicity.

Dr. Chih-Yi Hsieh, Executive Vice President and Chief Medical Officer said, “IMPACT values the differentiated clinical development approach, and carries out customized development of its own pipeline through innovative clinical trial design and exploration of combination therapy. We expect to fully use the unique advantages of Senaparib to address the clinical needs that other PARP inhibitors are not able to address. We are actively accumulating the clinical experience of Senaparib and TMZ combination in this global clinical trial and will cooperate with regulatory agencies and partners to initiate clinical trials in China as soon as possible.”

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 responses (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), ATR inhibitor (IMP9064) and other novel DDR pathway inhibitors. The lead clinical program, PARP inhibitor (senaparib/ IMP4297), is in Phase II/III studies for ovarian cancer, prostate cancer, small cell lung cancer and other indications worldwide, including China. 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. ATR Inhibitor IMP9064 has received US IND Clearance from FDA to start clinical studies in the U.S. and subsequently China IND application was submitted. Hedgehog pathway inhibitor (IMP5471) has received IND approval from NMPA to initiate clinical studies in China.