FDA Grants Fast Track Designation to NUV-422 in High-Grade Gliomas

The FDA has granted a fast track designation to NUV-422 for the treatment of patients with high-grade gliomas which includes glioblastoma multiforme, according to a press release from the drug’s developer, Nuvation Bio Inc.1

In preclinical phase 1/2 study (NCT04541225), NUV-422, a CDK 2/4/6 inhibitor, has demonstrated favorable blood-brain barrier penetration in a population of patients with recurrent or refractory high-grade gliomas. Additionally, NUV-422 was designed to limit CDK1 inhibition, which is a probable source of toxicity in other second-generation inhibitors.

“We are pleased that NUV-422 received FDA Fast Track designation because it highlights the serious unmet need of patients with brain cancer and the potential of our lead drug candidate NUV-422 to serve as an innovative new treatment option for high-grade gliomas, including glioblastoma multiforme,” David Hung, MD, founder, president, and chief executive officer of Nuvation Bio, said in the press release.

In the trial, NUV-422 is also being examined in several other solid tumors types, including breast and prostate cancer. The non-randomized study has an estimated enrollment of 218 patients. In the phase 1 portion of the study, patients were to receive NUV-422 at escalating dose levels until the maximum tolerated dose was reached. The second phase 2 of the study will administer NUV-422 at the recommended dose.

The primary end points included phase 1 dose escalation with incidence of treatment-emergent adverse effects, serious adverse effects, and dose limiting toxicities. The phase 2 dose expansion cohort included determining an objective response rate and duration of response.

Eligibility criteria for all phase cohorts required that patients must have recovered from toxicity from prior anti-cancer therapy. Other criteria include having adequate bone marrow and organ function, as well as having a life expectancy of more than 3 months.

NUV-422 has previously received an orphan drug designation during in March 2021.2 NUV-422 is currently being studied in hormone receptor–positive, HER2-negative advanced breast cancer, with and without brain metastases, and metastatic castration resistant prostate cancer.

“Enrollment is ongoing in our expanded phase 1/2 monotherapy study of NUV-422 for the treatment of adults with recurrent or refractory high-grade gliomas and solid tumors. We look forward to continuing to work closely with the FDA to expedite the development of NUV-422 with data from the Phase 1 portion of the study, which is on track for 2022,” Hung concluded.

References

1. Nuvation Bio receives FDA fast track designation for NUV-422 for the treatment of high-grade gliomas, including glioblastoma multiforme. News Release. Nuvation Bio Inc. December 15, 2021. Accessed December 15, 2021. https://prn.to/3DZ967h

2. Nuvation Bio granted orphan drug designation for NUV-422 for the treatment of patients with malignant gliomas. News Release. March 11, 2021. Accessed December 15, 2021. https://bit.ly/326ost7