IMPACT Therapeutics announces that the topline results of the phase 2 study investigating the PARP inhibitor Senaparib in BRCA1/2 mutated recurrent platinum sensitive ovarian cancer and the preliminary data from first-in-human study dose escalation phase for the ATR inhibitor IMP9064 have been presented as posters at ESMO2023 during Oct 20-24 in Madrid, Spain.

Highlights of posters (refer to ESMO2023 for more details):

Poster Board：765P

Title: SABRINA study: A phase II study of Senaparib monotherapy for patients with BRCA1/2 mutated recurrent platinum-sensitive ovarian cancer.

Session：Gynaecological cancer

Session Date: 10/22/2023

SABRINA is an open label, multicenter, single arm, phase II study, enrolled 93 BRCA1/2 mutated recurrent platinum-sensitive non-mucinous epithelial ovarian cancer patients with at least 2 lines of prior systemic treatment (Data cutoff: 2023.6.30), median follow-up duration was 22 months.

ORR assessed by IRC was 66.3%. Median PFS was 11.1 months and median DOR was 10.4 months. Median OS did not reach.

Senaparib demonstrated a tolerable safety profile, with no new safety signals identified.

Poster Board：681P

Title: First-in-human study of ATR inhibitor IMP9064 monotherapy and in combination with PARP inhibitor Senaparib in patients with advanced solid tumors

Session：Developmental therapeutics

Session Date: 10/23/2023

The preliminary results from IMP9064 first-in-human study (NCT05269316) indicated that the IMP9064 exposure increased as the dose increased with minimal accumulation. IMP9064 monotherapy is well-tolerate and MTD has not reached. Dose escalation is continuing.

There were 20 efficacy evaluable patients. Clinical benefit was observed with DCR of 60% and CBR of 30%.

PK/PD analysis supports an exposure-related target engagement of IMP9064 within the doses explored.

More ctDNA monitoring and biomarker analysis are underway.

About Senaparib

Senaparib, developed by IMPACT Therapeutics, is a potent and novel PARP (1/2) inhibitor. Its distinctive molecular structure ensures exceptional target selectivity and wide safety window. The early-phase trials demonstrated the promising anti-tumor effect of Senaparib, including significant efficacy in ovarian cancer, and has met its primary endpoint for advanced ovarian cancer maintenance treatment following first-line therapy in the pivotal FLAMES phase 3 study. In September 2023, Impact Therapeutics announced that the National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for Senaparib in China, as a first-line maintenance treatment of adult patients with ovarian epithelial carcinoma, fallopian tube cancer or primary peritoneal cancer following a response to platinum-based chemotherapy. In addition, in August 2022, the fixed dose combination capsules of Senaparib and temozolomide for the treatment of adult patients with small cell lung cancer was granted orphan-drug designation by the U.S. Food and Drug Administration (FDA).

About IMP9064

IMP9064, developed by IMPACT Therapeutics, is a potent and highly selective ATR inhibitor. Studies demonstrated that IMP9064 has good oral absorption, and anti-tumor activities in vitro against a broad range of solid tumor cell lines and in vivo against tumor xenograft models.

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 PARP1 selective inhibitor (IMP1734, in collaboration with Eikon Therapeutics), as well as other novel DDR pathway inhibitors. The lead clinical program, PARP inhibitor (Senaparib/IMP4297), has successfully completed Phase III pivotal trial in ovarian cancer first-line maintenance (FLAMES study) setting with best-in-class efficacy and safety profile. Based on the results of the FLAMES study, The Senaparib New Drug Application (NDA) has been accepted for review by the National Medical Products Administration (NMPA) of China. Wee1 inhibitor IMP7068 and ATR inhibitor IMP9064 is undergoing global Phase I clinical study. PARP1 selective inhibitor IMP1734 has obtained IND clearance from FDA.