FDA clears IND application for NUV-1511 in solid tumors

The FDA has granted clearance to an investigational new drug (IND) application for NUV-1511 for the treatment of patients with advanced solid tumors, including metastatic castration-resistant prostate cancer (mCRPC), according to a news release from Nuvation Bio, the developer of the therapy.¹

“We believe NUV-1511 has the potential to provide favorable clinical benefit for patients with various solid tumors and we look forward to initiating the phase 1/2 study," said David Hung, MD.

According to Nuvation, NUV-1511 is the first clinical candidate from the company’s novel drug-drug conjugate (DDC) platform, which is designed to deliver anti-cancer therapies to tumor cells and exert greater toxicity against them than against healthy tissues.²

The clearance of the IND application for NUV-1511 will initiate the launch of a phase 1/2 clinical study of the therapy in patients with mCRPC, HER2-negative metastatic breast cancer, pancreatic cancer, and platinum-resistant ovarian cancer whose tumors have progressed following treatment with fam-trastuzumab-deruxtecan-nxki (Enhertu) and/or sacituzumab govitecan-hziy (Trodelvy).

The dose escalation portion of the study is set to explore the safety, tolerability, and initial efficacy of the therapy in those patient populations.

“This IND clearance expands our clinical pipeline and validates the approach of our proprietary DDC platform to design potent oncology-focused chimeric small molecules which combine tumor-targeting specificity with the anti-cancer activity of known oncology agents,” said David Hung, MD, in the news release.¹ Hung is the founder, president, and chief executive officer of Nuvation Bio.

The phase 1/2 study is scheduled to commence in the first half of 2024.

Hung added in the news release, “We believe NUV-1511 has the potential to provide favorable clinical benefit for patients with various solid tumors and we look forward to initiating the phase 1/2 study.”¹

NUV-1511 is the most recent addition to the company’s investigational compounds, which also includes NUV-868, a BD2-selective oral small molecule bromodomain and extra-terminal inhibitor. NUV-868 was first assessed in a phase 1/2 trial (NCT05252390) exploring the treatment as a monotherapy in patients with advanced solid tumors, which remains ongoing.³

The phase 1b dose escalation portion of the study was launched in December 2022 to explore the safety and dosing of NUV-868 in combination with olaparib (Lynparza) or enzalutamide (Xtandi).⁴ The therapy in combination with olaparib will be assessed in adult patients with mCRPC, ovarian cancer, triple-negative breast cancer, pancreatic cancer, and other solid tumors. The therapy with enzalutamide will be assessed in adult patients with mCRPC.

The phase 1b study remains ongoing for both combination arms. Treatment will be administered at escalating dose levels until a recommended phase 2 combination dose level is determined. The company also noted plans for a phase 2 monotherapy study of NUV-868 to further assess the safety and efficacy in patients with mCRPC.³

References

1. Nuvation Bio announces FDA clearance of investigational new drug application for NUV-1511 for the treatment of advanced solid tumors. News release. Nuvation Bio Inc. January 8, 2024. Accessed January 10, 2024. https://investors.nuvationbio.com/news/news-details/2024/Nuvation-Bio-Announces-FDA-Clearance-of-Investigational-New-Drug-Application-for-NUV-1511-for-the-Treatment-of-Advanced-Solid-Tumors/default.aspx

2. Pipeline. Nuvation Bio. Accessed January 10, 2024. https://www.nuvationbio.com/pipeline/

3. Nuvation Bio announced FDA clearance of investigational new drug application for NUV-868 for the treatment of advanced solid tumors. News release. Nuvation Bio Inc. January 20, 2022. Accessed January 10, 2024. https://investors.nuvationbio.com/news/news-details/2022/Nuvation-Bio-Announces-FDA-Clearance-of-Investigational-New-Drug-Application-for-NUV-868-for-the-Treatment-of-Advanced-Solid-Tumors/default.aspx

4. Nuvation Bio doses first patient in phase 1b combination study of NUV-868. News release. Nuvation Bio Inc. December 19, 2022. Accessed January 10, 2024. https://investors.nuvationbio.com/news/news-details/2022/Nuvation-Bio-Doses-First-Patient-in-Phase-1b-Combination-Study-of-NUV-868/default.aspx