Actuate Therapeutics Secures $21.7 Million to Support Phase I/II Clinical Trial

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Five months after taking its GSK-3β inhibitor into the clinic, Texas-based Actuate Therapeutics raised $21.7 million in a Series B financing round

The funds from the round will be used to expand the ongoing Phase I/II 1801 clinical trial of 9-ING-41, a proprietary glycogen synthase kinase-3 beta inhibitor. The company is examining the medication in patients with refractory hematologic malignancies or solid tumors. Extensive preclinical data on 9-ING-41 has shown both single-agent activity and significant synergy with an array of standard cytotoxic chemotherapy agents in a broad range of solid tumors and lymphomas, the company said. In addition to the expansion of the Phase I/II trial, Daniel Schmitt, president and chief executive officer of Actuate, said the proceeds from the Series B will be used to advance its pediatric neuroblastoma program.

Actuate Chief Medical Officer Frank Giles said the company has been able to secure a “dynamic and productive collaboration” with global oncology leaders for its 1801 study.

“Their appreciation of, and involvement in, the very meticulous design of the study, based on the safest conduct that will facilitate the generation of clear data on 9-ING-41, is reflected in the robust study patient accrual we have experienced to date,” Giles said in a statement.

The 1801 study is being conducted in places like Brown University Rhode Island Hospital, Miami Cancer Institute and the Mayo Institute. But now, the company will be able to expand the trial to Europe, Schmitt said.

“Our collaborations with expert colleagues on the development of Investigator Initiated Trials will rapidly expand our knowledge beyond that derived from the 1801 study, and these studies are a high priority for us. We are also focused on using the initial 1801 study data to inform the design of 9-ING-41 regimens for children and adolescents with refractory tumors, with an initial focus on neuroblastoma, where 9-ING-41’s pre-clinical activity is noteworthy,” Giles added.

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The 1801 study is being eyed as both a single agent and also for potential combination regimens. The company said the initial data from the Phase I/II trial will allow it to then focus on regimens in specific cancer histologies or molecularly-defined patient cohorts that would potentially warrant regulatory approval.

The Series B financing round was led by early-stage investors Kairos Ventures. The financing round was supported by DEFTA Partners and Tech Coast Angels. Existing investor Bios Partners, which supported the company’s 2017 Z$3.8 million Series A, participated as well.

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