IMP7068 / IMPACT Therap - LARVOL DELTA

Targeting WEE1 Kinase for Breast Cancer Therapeutics: An Update. (PubMed, Int J Mol Sci) - "Adavosertib's clinical promise was challenged by inter-individual variations in response and side effects. Because of these promising preclinical outcomes, other WEE1 kinase inhibitors (Azenosertib, SC0191, IMP7068, PD0407824, PD0166285, WEE1-IN-5, Zedoresertib, WEE1-IN-8, and ATRN-1051) are being developed, with several currently being evaluated in clinical trials or as an adjuvant to chemotherapies...Reliable predictors of clinical responses based on mechanistic insights remain an important unmet need. Herein, we review the role of WEE1 inhibition therapy in breast cancer."

Journal • Review • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CDC25C • CDK1 • CDK2 • GNRP • PKMYT1 • STING

Phase I, multi-center, dose-escalation and dose-expansion study of IMP7068, a WEE1 inhibitor, in patients with advanced solid tumors (ESMO 2023) - P1 | "80mg was defined as a potential PR2D in 3/4 schedule, and a second potential RP2D is being explored in 5/2 schedule. RP2D for IMP7068 will be determined soon."

Clinical • Metastases • Endometrial Serous Adenocarcinoma • Oncology • Ovarian Cancer • Solid Tumor • Uterine Cancer • CDK1

Discovery and development of a potent and highly selective WEE1 inhibitor IMP7068 (AACR 2023) - P1 | "Small molecule WEE1 inhibitors, such as AZD1775, showed good clinical POC (proof of concept) data in several tumors including ovarian, colon, and uterine carcinoma. Anti-tumor efficacy of IMP7068 has been demonstrated in mice CDX models of colorectal LoVo, non-small cell lung cancer NCI-H1299 and a PDX model of uterine UT5318 with good dose-response tumor inhibition and tolerability. IMP7068 is currently in a phase I study to evaluate its safety, tolerability, pharmacokinetics, and anti-tumor activity in patients with advanced solid tumors (ClinicalTrials.gov Identifier: NCT04768868)."

Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Uterine Cancer • PLK1

A phase 1 dose-escalation and -expansion study of IMP7068, a WEE1 inhibitor, in patients with advanced solid tumors. (ASCO 2022) - P1 | "IMP7068 was well-tolerated with no DLTs, and conferred a meaningful PD effect and preliminary antitumor activity at doses of up to 160 mg in pts with advanced solid tumors. Dose escalation to establish the recommended phase 2 dose and/or maximum tolerated dose is continuing."

Clinical • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CDK1

Safety, pharmacokinetic (PK), and pharmacodynamic profiles of the WEE1 inhibitor IMP7068 in patients (pts) with advanced solid tumors (ESMO 2022) - P1 | "Dose escalation including a BID regimen is under evaluation. The RP2D is expected to be determined soon, and multiple expansion cohorts (including uterine serous carcinoma and biomarker-selected populations) are planned for initiation later this year."

Clinical • PK/PD data • Colorectal Cancer • Endometrial Serous Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • Uterine Cancer • CDK1

WEE1: The Safety and Pharmacokinetics Preliminary Efficacy of IMP7068 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=350 | Recruiting | Sponsor: Impact Therapeutics, Inc. | N=150 ➔ 350

Enrollment change • Monotherapy • Oncology • Solid Tumor • MSI • NTRK • PD-L1

"#ESMO22 so high frequency ≥Gr3 QT prolonged with WEE1 inhibitor IMP7068" (@ksrcristianchen)

Oncology

WEE1: The Safety and Pharmacokinetics Preliminary Efficacy of IMP7068 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=150; Recruiting; Sponsor: Impact Therapeutics, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Monotherapy • Oncology • Solid Tumor • MSI • NTRK • PD-L1

Impact Therapeutics Announced First-Patient-Dose of Wee1 Inhibitor IMP7068 in the U.S. (PRNewswire) - "Impact Therapeutics announced today that the first patient was recently dosed in the first-in-human Phase 1 clinical study of Wee1 Inhibitor IMP7068 in the United States...This is a Phase 1, open-label, multi-center, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of IMP7068 monotherapy in patients with advanced solid tumors....'It is exciting that IMP7068 has been approved by the TFDA for Phase 1 study in Taiwan soon after the approval by the NMPA in mainland China in early February 2021.'"

Trial status • Oncology • Solid Tumor