Covington Firm Announces Pediatric Phase of Cancer Drug
After recently announcing that its cancer treatment drug showed positive results in adults, Bexion Pharmaceuticals said last week that it will conduct a new open-label phase-one safety study of the drug, BXQ-350, for pediatric patients with recurrent solid tumors, brain tumors, and diffuse intrinsic pontine gliomas (DIPG).
Bexion is a clinical stage oncology company based in Covington.
In a phase-one, part-one adult dose ranging study, BXQ-350 was well tolerated at all five doses tested with no dose limiting toxicities observed and no serious adverse events attributed to the therapy, the company said.
Preliminary data in part-two of the phase-one study support a safe and tolerable drug profile, the company said.
In December 2018, the FDA cleared a Phase I Pediatric Protocol as part of Bexion’s current IND to move BXQ-350 into the pediatric population.
“With this initiation of Pediatric Phase 1 studies, we are confirming our commitment to the pediatric patient community,” said Dr. Ray Takigiku, founder and CEO of Bexion. “It is our goal to develop BXQ- 350 as quickly as possible for both adult and pediatric cancer patients, particularly those with difficult to treat tumors including high grade gliomas and other brain tumors. We are very grateful to the patients, participating clinical trial sites, and our partners for their engagement and their support.”
The technology supporting BXQ-350 was discovered over fifteen years ago by Dr. Xiaoyang Qi, then a faculty member at Cincinnati Children’s. CancerFree KIDS, a non-profit focused on eradicating cancer a life- threatening disease in children, provided the first grant that supported this discovery. Cincinnati Children’s licensed the technology to Bexion to continue development and ultimately commercialize the discovery.
“The very first research grant CancerFree KIDS ever awarded was to Dr. Qi in 2004”, explained Ellen Flannery, Founder and Executive Director of CancerFree KIDS. “It was for the study that eventually led to the formation of Bexion Pharmaceuticals. We have followed this research and Bexion since that time, waiting for this pivotal moment of the initiation of a Pediatric Phase I trial. It is rare for a pediatric trial to happen so early in the development of a new treatment. CancerFree KIDS is grateful to Bexion, Cincinnati Children’s and CTI Clinical Trial and Consulting Services, Bexion’s Clinical Research Organization for initiating this trial as quickly as feasibly possible. This means we have an opportunity to get this extremely promising new treatment approved for the children who need it as quickly as possible.”
Additional sites are planned, including Nationwide Children’s Hospital in Columbus, Ohio and several children’s hospitals in the western United States.
Photo: Biologic building in Covington where Bexion operates (RCN file)