U.S. biopharma company Nuvation Bio Inc. says the Food and Drug Administration (FDA) has placed a partial clinical hold on the company’s phase 1 dose escalation study of NUV-422 in solid tumors, including high grade glioma, HR+/HER2- advanced breast cancer and metastatic castration resistant prostate cancer.
The company’s Phase 1 trial began enrolling patients in December 2020 and, in recent months, was exploring higher doses to define a maximum tolerated dose.
Following the emergence of uveitis, a form of inflammation in the eye, in certain patients receiving NUV-422, the company said it proactively paused enrolment of new patients in order to further assess these adverse events with investigators and uveitis experts, and also reached out to the FDA for guidance around an appropriate path forward.
While the partial hold is in place, no new patients will be enrolled in the NUV-422 program, although current study participants may continue to be treated in the phase 1 study.
Patient safety
“We are committed to patient safety across all of our studies and to working collaboratively with the FDA to develop, as efficiently as possible, new medicines where existing therapies are inadequate,” said David Hung, founder, president and chief executive officer of Nuvation Bio.
“Based upon the recent development of uveitis as a potential safety signal, we will conduct an overall risk/benefit analysis of the NUV-422 program. Our goal is always to ensure that we deploy our resources on programs that have the highest probability of success and of generating value for patients and our investors.
“With $737.7 million in cash as of March 31, 2022, we are well positioned to continue developing all of our internal product candidates.”
The company said it will provide updates on the direction of the NUV-422 program after it has completed its internal risk-benefit analysis, which will factor in feedback from FDA.
About Nuvation Bio
Nuvation Bio’s portfolio includes mechanistically distinct oncology therapeutic product candidates, each targeting some of the most difficult-to-treat types of cancer. Nuvation Bio, with locations in New York and San Francisco, was founded in 2018 by biopharma David Hung, who previously founded Medivation, Inc., which launched a prostate cancer medicine.