Impact Announced Dosing of the First Patient in Senaparib and Temozolomide Combination Study
Impact Therapeutics announced that the first patient was dosed recently in the combination study of its PARP inhibitor senaparib (IMP4297) and temozolomide (TMZ). This study is a Phase I, open-label, multi-center, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of senaparib in combination with temozolomide in patients with advanced solid tumors and small cell lung cancer.
Senaparib is a novel agent targeting PARP (poly-ADP ribose polymerase) developed by Impact. The company completed two Phase I studies of senaparib in China and Australia, respectively. The Phase I data readout was first presented in ASCO 2019, showing that senaparib had the potential to be the best-in-class PARP inhibitor with better safety profile and wider therapeutic window. Impact is conducting a phase II pivotal study of senaparib monotherapy in treating advanced ovarian cancer patients with BRCA mutation who have received at least 2 prior lines of standard treatment, and a Phase III study of senaparib as the first-line maintenance treatment in platinum-sensitive advanced ovarian cancer patients.
Temozolomide (TMZ) is an orally available alkylating agent with broad range of anti-tumor activity and the ability to penetrate blood-brain barrier, which make it the treatment of choice in certain types of brain tumors. The combination of TMZ with senaparib is supported by synthetic lethality mechanism of action, that due to its PARP inhibiting and trapping activity, senaparib could prevent tumor cells from repairing DNA damages caused by TMZ, and result in induced synthetic lethality. In preclinical animal models, combination of senaparib and TMZ demonstrated highly significant synergistic anti-tumor activity, with no additive toxicity.
Dr. Chih-Yi Hsieh, Senior Vice President and Chief Medical Officer, stated that “There is a highly unmet medical need in treatment of small cell lung cancer patients. Based on the mechanism of synthetic lethality and the unique profile of senaparib, we are delighted to start the clinical study to explore the combination of senaparib and TMZ in small cell lung cancer in which there is still no approved targeted therapy. We will try our best to advance the clinical programs of senaparib and bring clinical benefit to patients around the world.”
Impact Therapeutics is a privately held clinical-stage biopharmaceutical company incorporated in Nanjing, China, and dedicated to the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality. Impact has assembled a most comprehensive global DNA damage response (DDR) pipeline of novel drug candidates generated by in-house discovery platform, and is expanding to other novel synthetic lethality targets to broaden its pipeline. Impact has been invested by recognized venture capital firms including Lilly Asia Ventures.