CHICAGO, IL and FORT WORTH, TX – Actuate Therapeutics, Inc. (Actuate), a clinical stage biopharmaceutical company, announced today that interim results from their 1801 Phase 1/2 study (NCT03678883, EudraCT #: 2018-003739-32) will be presented at this year’s American Society of Clinical Oncology (ASCO) Annual Meeting which will take place virtually on May 29th, 2020. Dr. Benedito Carneiro, Brown University’s principal investigator on the 1801 study, will give an oral presentation titled, “Phase I study of 9-ING-41, a small molecule selective glycogen synthase kinase-3 beta (GSK-3β) inhibitor, as a single agent and combined with chemotherapy, in patients with refractory tumors” (Abstract #3507). His presentation will be available on May 29th, 2020 at https://meetinglibrary.asco.org/record/185088/abstract
“Thanks to Dr. Carneiro and our collaborating investigators at US and EU world leading cancer centers, the 1801 Clinical Study has accrued a large diverse cohort of patients and is confirming 9-ING-41’s very favorable safety profile, specifically in heavily pre-treated patients with a wide spectrum of malignancies”, said Ludimila Cavalcante, MD, Lead Medical Affairs at Actuate. “Importantly, 9-ING-41, at therapeutic dose levels, has demonstrated no serious adverse events reported in over 170 patients enrolled on the study to date. Based on encouraging initial results in patients with advanced cancers treated with 9-ING-41, we are now moving to the efficacy stage of the 1801 study starting with a Phase 2 trial of 9-ING-41 in combination with gemcitabine and nab-paclitaxel in previously untreated patients with advanced pancreatic cancer. We are also opening our clinical studies in patients with advanced myelofibrosis and in pediatric oncology patients, the designs of which has been significantly informed by the positive data to date from the 1801 study.”
“9-ING-41 has given us our first opportunity to assess the impact of GSK-3β modulation in patients with cancer” said Professor Pamela Munster, Principle Investigator on the 1801 study at the University of California, San Francisco. “At a range of doses, both as a single agent and in combination with cytotoxic agents, 9-ING-41 is very well tolerated. Evolving pre-clinical data on its modes of action, anti-fibrotic activity, and immune-modulatory effects are being mirrored by positive clinical data on the 1801 study. We are excited to move 9-ING-41 into efficacy Phase 2 studies and I am particularly interested in exploring its potential in cancers with DNA damage repair gene aberrations.”
About Actuate Therapeutics, Inc. Actuate is a clinical stage pharmaceutical company focused on the development and commercialization of novel therapeutics for cancers and fibrotic diseases. For additional information, please visit the Company’s website at http://www.actuatetherapeutics.com