About a year after closing a $30 million raise, a Triangle biotech has hit another milestone.
The U.S. Food and Drug Administration has cleared Incyclix Bio, based in Research Triangle Park, to move its lead compound into a phase 1/2 study. It's the first move into clinical trials for the relatively young company led by industry veterans.
The study is designed to evaluate the safety, tolerability and preliminary anti-tumor activity of the compound, called INX-315, in patients with recurrent advanced/metastatic cancer, according to the federal government's clinical trial database. The study has an estimated enrollment of 81 participants with an estimated primary completion date of December 2025.
"The approval of our (investigational new drug application) for INC-315 is a significant milestone in our mission to advance the care of cancer patients through the development of precision treatments that regain cell cycle control," Incyclix CEO Patrick Roberts said in a statement.
The company – formerly known as Arc Therapeutics – was founded by former employees of G1 Therapeutics (Nasdaq: GTHX). Incyclix formed in 2020 with a $6 million investment, led by Eshelman Ventures – an investment company started by PPD founder and former CEO Fred Eshelman.
Incyclix followed this funding with a $30 million Series B round in March 2022 led by new investor Boxer Capital with participation from RA Capital Management and Eshelman Ventures. At the time, Roberts said the funding would support the clinical development of INX-315.
The company licensed its lead compound from G1 Therapeutics in May 2020. In exchange, G1 received an upfront payment and equity in Incyclix with a combined total value of about $2.1 million. The public biopharma company is also eligible for a future development milestone payment of $2 million and, if the compound is successfully commercialized, future royalty payments in the mid-single digits based on net sales, according to G1's latest annual earnings report.
Roberts cofounded Incyclix with two other former G1 employees, Jay Strum, chief scientific officer for Incyclix, and John Bisi, the startup's senior vice president of research and development. The three executives joined G1 in its early days and were with the company as it moved three molecules into clinical development and went public. One of those molecules became G1's first commercial product after receiving FDA approval in 2021.
