Pipeline

Nuvation Bio is focused on treating patients with the most difficult-to-treat cancers, for which conventional therapies have failed. We are advancing multiple compounds that have resulted from our drug discovery and development programs, which include a clinical stage bromodomain and extra-terminal (BET) inhibitor program and novel small molecule drug-drug conjugate (DDC) platform that to date has yielded investigational compounds targeting solid tumors.
Program
potential indication(s)
Current Stage
preclinical
phase 1
Phase 2
Phase 3
ANTICIPATED MILESTONES &
RECENT UPDATES
Advanced
Solid Tumors
NUV-868
First Patient Dosed in Phase 1 Dose Escalation in Q1 2022
NUV-868
(BET)
Ovarian, TNBC,
Pancreatic &
mCRPC
NUV-868 +
Olaparib
Dose First Patient by Year End 2022
mCRPC
NUV-868 +
Enzalutamide
Dose First Patient by Year End 2022
Drug-Drug
Conjugate
Platform
SolidTumors
Select Clinical Candidate by Year End 2022
BET: Bromodomain and Extra-Terminal Motif Proteins; mCRPC: Metastatic Castration-Resistant Prostate Cancer; TNBC: Triple-Negative Breast Cancer

BET

NUV-868, a BD2-selective oral small molecule bromodomain and extra-terminal (BET) inhibitor, inhibits BRD4, a key member of the BET family that epigenetically regulates proteins that control tumor growth and differentiation.

NUV-868 is almost 1,500 times more selective for BD2 than BD1 and is designed to alleviate the therapeutic limiting toxicities observed by other non-BD2 selective BET inhibitors. NUV-868 in combination with androgen-receptor directed therapies may help to overcome resistance in prostate cancer. In addition, NUV-868 in combination with PARP inhibitors may have synergistic activity to increase efficacy across multiple solid tumors.

We dosed the first patient in a Phase 1 dose escalation study of NUV-868 for the treatment of patients with advanced solid tumors in the first quarter of 2022 and enrollment is ongoing. The Phase 1 study is designed to determine the safety and dose of NUV-868 to be used as a monotherapy and in combination with olaparib or enzalutamide for the Phase 2 and 2b portions of the study.

DDC Platform

Our proprietary, small molecule Drug-Drug Conjugate (DDC) platform leverages a novel therapeutic approach within the drug-conjugate class of anti-cancer therapies. The platform is designed to selectively deliver potent anti-cancer therapeutics to cancer cells to exert greater toxicity against these target tumor cells than against healthy non-target tissues.

Utilizing this platform, we are able to conjugate tissue-selective targeted small molecules with anti-tumor agents to create unique therapeutic candidates. We believe our DDC technology will be broadly applicable and can be replicated across many existing therapies to transform the standard-of-care in multiple oncology indications. We plan to select the first clinical candidate from our DDC platform by the end of 2022.