Actuate Therapeutics

About Actuate Therapeutics

Actuate Therapeutics, Inc. is a clinical-stage biopharmaceutical firm, established in 2015, that concentrates on creating treatments for cancers that are difficult to address. Initially incorporated as Apotheca Therapeutics, Inc., the company rebranded in October 2015. The company was co-founded by Daniel M. Schmitt and Andrew P. Mazar. Schmitt, the President and CEO, brings over three decades of experience in the pharmaceutical and biotechnology sectors, having held senior roles at companies like Fujisawa and Ilex Oncology. His career is marked by the successful launch of multiple pharmaceutical products and high-value licensing deals. Co-founder and COO, Andrew P. Mazar, is a translational researcher with over 30 years of experience in oncology and fibrosis programs, bridging academia and industry. His work has been pivotal in advancing multiple targeted oncology drugs from pre-clinical to clinical development.

The company's core business revolves around the clinical development of its lead drug candidate, elraglusib (formerly 9-ING-41), a small molecule inhibitor of glycogen synthase kinase-3 beta (GSK-3β). GSK-3β is an enzyme implicated in various diseases, but in oncology, it plays a role in promoting tumor growth and resistance to conventional therapies. Actuate's strategy is to develop elraglusib as both a monotherapy and in combination with other treatments like chemotherapy and immunotherapy to improve outcomes for patients with advanced cancers. The company's business model is rooted in biopharmaceutical research and development, with its revenue dependent on the successful clinical progression and eventual commercialization of its therapeutic candidates. It collaborates with academic institutions and other biopharma companies to advance its clinical trials.

Elraglusib is currently being evaluated in multiple clinical trials for various cancers. It is in Phase 2 trials for metastatic pancreatic ductal adenocarcinoma and has shown potential in treating refractory pediatric malignancies like Ewing sarcoma, as well as melanoma and colorectal cancer. The U.S. FDA has granted elraglusib Fast Track and Orphan Drug designations for the treatment of pancreatic cancer. The drug works through a multimodal mechanism of action. It targets molecular pathways that promote tumor growth and chemoresistance. Furthermore, elraglusib has demonstrated an immunomodulatory effect by enhancing the ability of the immune system, specifically T cells and NK cells, to recognize and attack cancer cells. This is achieved by increasing the expression of MHC-I molecules on tumor cells and reducing immune checkpoint molecules like PD-1, TIGIT, and LAG-3. The company went public and was listed on the NASDAQ exchange in August 2024 under the ticker ACTU.