FDA Granted Orphan Drug Designation to IMP4297+TMZ for SCLC
SHANGHAI, China, Aug. 19, 2022 (GLOBE NEWSWIRE) -- IMPACT Therapeutics, a biopharmaceutical company dedicated to the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality, announced today that the US Food and Drug Administration (FDA) has granted Orphan-Drug Designation (ODD) to our fixed-dose combination capsule of Senaparib (PARP inhibitor) and temozolomide (TMZ) for the treatment of adult patients with small cell lung cancer (SCLC).
Dr. Jun Bao, CEO of IMPACT Therapeutics, said “This is the first ODD IMPACT received from US FDA, which is a major development milestone for our company. This reflects efforts of our colleagues and collaborators. We shall take this as a further encouragement to our mission 'Make IMPACT on Cancer Treatment'.”
IMPACT Therapeutics is conducting a global Phase ?b/? 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 (NCT04434482). The study has been approved for clinical trials in the United States, Australia, South Korea and other countries and regions.
The preliminary clinical results for a phase I b/II study investigating the PARP inhibitor Senaparib in combination with temozolomide (TMZ) for the treatment of advanced solid tumors have been presented as a poster at the 2022 ASCO Annual Meeting. A total of 14 patients were enrolled for dose escalation and the dose escalation has been completed in all planned dose levels. The MTD and RP2D were determined as senaparib 80 mg once daily plus temozolomide 20 mg once daily. The ORR was observed in 4 of 12 (33.3%) evaluable patients, including 3 confirmed PR. The DCR was 83.3%. Median DOR was 3.6 months. Two patients remain on treatment for more than 1 year. A total of 14 patients with extensive stage small cell lung cancer post first-line treatment were enrolled as of the date. The ORR was observed in 3 of 7 (42.9%) evaluable patients, including 2 confirmed PR who were still on treatment. All AEs reported were manageable. The recruitment for part 2 is still ongoing.
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 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, the combination of Senaparib and TMZ showed potential to mimic synthetic lethality, demonstrating significant synergistic anti-tumor activity, while not producing additive toxicity.
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, 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 and China IND application from NMPA and Phase I dose escalation is ongoing. Hedgehog pathway inhibitor (IMP5471) has received IND approval from NMPA.
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