US FDA clears Nuvation Bio’s application for solid tumour therapy

The US Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application submitted by Nuvation Bio for assessing NUV-868 to treat advanced solid tumours.

The BD2-selective oral small molecule bromodomain and extra-terminal (BET) inhibitor is indicated to treat tumours, including pancreatic cancer, ovarian cancer.

NUV-868 can also be used to treat patients with metastatic castration-resistant prostate cancer (mCRPC) and triple-negative breast cancer (TNBC).

Nuvation Bio founder, president and CEO David Hung said: “The clearance of our IND application for NUV-868 is an important milestone for Nuvation Bio as it marks the fourth IND in the last 14 months across our deep pipeline of innovative cancer therapeutics targeting multiple tumour types.

“We are encouraged by the selectivity and potentially improved tolerability demonstrated by NUV-868 in preclinical studies, and we look forward to advancing the programme into Phase I development in mid-2022.”

Following the IND clearance, the company will now commence a Phase I/II trial of NUV-868 as a single agent and along with olaparib or enzalutamide in different types of tumours.

The NUV-868-01 protocol is set to commence with a Phase I monotherapy dose-escalation study of the therapy in patients with advanced solid tumours.

A Phase Ib study will explore NUV-868 in combination with olaparib and enzalutamide followed by a Phase IIb study to study the efficacy and safety after determining the recommended Phase II combination dose.

Additionally, Nuvation Bio will start a Phase II monotherapy study in mCRPC patients to analyse safety and efficacy.

NUV-868, which hinders BRD4, a key BET family member, has been designed to be more selective for BD2 than BD1 for preventing the therapeutic limiting gastrointestinal (GI) and bone marrow toxicities, other BRD4 inhibitors.