NUV-868 / Nuvation Bio - LARVOL DELTA

NUV-868-01: NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=82 | Terminated | Sponsor: Nuvation Bio Inc. | Phase classification: P1/2 ➔ P1

Monotherapy • Phase classification • Platinum resistant • Breast Cancer • Castration-Resistant Prostate Cancer • Estrogen Receptor Positive Breast Cancer • Genito-urinary Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer • BRCA

NUV-868-01: NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=82 | Terminated | Sponsor: Nuvation Bio Inc. | N=657 ➔ 82 | Trial completion date: Nov 2026 ➔ Jul 2024 | Recruiting ➔ Terminated | Trial primary completion date: Jun 2026 ➔ Jul 2024; The Sponsor has achieved its objectives.

Enrollment change • Monotherapy • Trial completion date • Trial primary completion date • Trial termination • Breast Cancer • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hepatology • Oncology • Ovarian Cancer • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer • BRCA

Nuvation Bio Reports Second Quarter 2024 Financial Results and Provides Business Update (Businesswire) - "Completed an internal analysis of efficacy and safety data collected from the Phase 1 monotherapy and Phase 1b combination studies of NUV-868. Following this analysis, Nuvation Bio decided not to initiate a Phase 2 study of NUV-868 as a monotherapy or in combination with olaparib or enzalutamide in the advanced solid tumor indications that were part of the Phase 1 and Phase 1b study designs. The Company is evaluating next steps for the NUV-868 program, including further development in combination with approved products for indications in which BD2-selective BET inhibitors may improve outcomes for patients."

Trial status • Breast Cancer • Castration-Resistant Prostate Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Metastatic Castration-Resistant Prostate Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer

Nuvation Bio Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update (Businesswire) - "NUV-868, BD2-selective BETi: Advanced solid tumors: (i) Phase 1 monotherapy study is complete. Nuvation Bio has completed the Phase 1 monotherapy study in advanced solid tumors and determined the MTD in patients; (ii) Phase 1b combination studies remain ongoing. Nuvation Bio continues to conduct the Phase 1b studies of NUV-868 in combination with olaparib in patients with ovarian cancer, pancreatic cancer, metastatic castration-resistant prostate cancer (mCRPC), triple negative breast cancer and other solid tumors, and in combination with enzalutamide in patients with mCRPC."

Trial status • Metastatic Castration-Resistant Prostate Cancer • Ovarian Cancer • Pancreatic Cancer • Triple Negative Breast Cancer

Nuvation Bio Announces Formation of Oncology-Focused Scientific Advisory Board (Businesswire) - "...'We look forward to collaborating with our Scientific Advisory Board as we continue to study NUV-868, a BD2-selective BET inhibitor, and work towards submitting an IND for our first drug-drug conjugate (DDC) clinical candidate by year end'."

IND • Oncology

NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=657 | Recruiting | Sponsor: Nuvation Bio Inc. | N=246 ➔ 657 | Trial completion date: Feb 2026 ➔ Nov 2026 | Trial primary completion date: Jan 2026 ➔ Jun 2026

Enrollment change • Trial completion date • Trial primary completion date • Breast Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatology • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer • BRCA

Nuvation Bio Reports First Quarter 2023 Financial Results and Provides Business Update (Businesswire) - "NUV-868, BD2-Selective BETi: Advanced solid tumors: (i) Dosing underway in both regimens of the Phase 1b combination study. The Company continues to enroll the Phase 1b study of NUV-868 in combination with olaparib in patients with ovarian cancer, pancreatic cancer, metastatic castration-resistant prostate cancer (mCRPC), triple negative breast cancer and other solid tumors, and in combination with enzalutamide in patients with mCRPC; (ii) Dosing underway in the Phase 1 monotherapy study. The Company continues to enroll the Phase 1 monotherapy study in advanced solid tumors."

Trial status • Breast Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer

NUV-868, a novel BD2-selective BET inhibitor, in combination with enzalutamide or olaparib, inhibits growth of solid tumor xenografts (AACR 2023) - P1/2 | "Our preclinical data demonstrate that NUV-868, a BD2-selective BET inhibitor, inhibits growth of tumor xenografts in combination with enzalutamide or olaparib and provides rationale for examination of these combinations in the clinic. An ongoing, phase 1 clinical study (NCT05252390) is evaluating NUV-868 as a monotherapy and in combination with olaparib or enzalutamide in patients with advanced solid tumors."

Combination therapy • Gastrointestinal Cancer • Genito-urinary Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Solid Tumor • BRD4

"Check out @NuvationB NUV-868 trial (BET inhibitor) + olaparib https://t.co/wMAjcAqPqB" (@drallysonocean)

Nuvation Bio Doses First Patient in Phase 1b Combination Study of NUV-868 (Businesswire) - "Nuvation Bio...announced it has dosed the first patient in a Phase 1b study of its BD2-selective BET inhibitor, NUV-868, in combination with olaparib. The Phase 1b study will be conducted under two separate dosing regimens. Patients in the first regimen will be dosed with NUV-868 in combination with olaparib for the treatment of ovarian cancer, pancreatic cancer, metastatic castration-resistant prostate cancer (mCRPC), triple negative breast cancer and other solid tumors. Patients in the second regimen will be dosed with NUV-868 in combination with enzalutamide for the treatment of mCRPC."

Trial status • Breast Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer

Nuvation Bio Reports Third Quarter 2022 Financial Results and Provides Business Update (Businesswire) - "Dosing ongoing in the Phase 1 monotherapy study of NUV-868. Nuvation Bio continues to enroll the Phase 1 monotherapy study in advanced solid tumors. The Company expects to initiate the Phase 1b study of NUV-868 in combination with olaparib in ovarian, pancreatic, metastatic castration-resistant prostate and triple negative breast cancers, or in combination with enzalutamide in metastatic castration-resistant prostate cancer, by the end of 2022. Drug-Drug Conjugate Platform: Solid tumors: Nomination of first clinical candidate from the DDC platform is expected by the end of 2022."

Trial status • Breast Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer

Nuvation Bio Announces Discontinuation of NUV-422 Clinical Development Program (Businesswire) - "Nuvation Bio Inc...announced that it will prioritize NUV-868 and development of its novel small molecule DDC platform and discontinue clinical development of NUV-422. The decision to discontinue clinical development of NUV-422 is the result of an internal risk-benefit analysis factoring in feedback received from the U.S. Food and Drug Administration (FDA) in a partial clinical hold letter for the Company’s monotherapy Phase 1/2 study (Protocol NUV-422-02) and clinical hold letters for its combination Phase 1b/2 studies (Protocols NUV-422-03 and NUV-422-04)....Enrollment is ongoing in the Phase 1 monotherapy study of NUV-868, and the Company has planned Phase 1b studies of NUV-868 in combination with olaparib or enzalutamide to enhance the potential value of this program across multiple tumor types."

Discontinued • Trial status • Oncology • Solid Tumor

NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=246 | Recruiting | Sponsor: Nuvation Bio Inc. | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Monotherapy • Breast Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatology • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Pancreatic Cancer • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer • BRCA • HRD

NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=246 | Not yet recruiting | Sponsor: Nuvation Bio Inc.

Combination therapy • Monotherapy • New P1/2 trial • Breast Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatology • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Pancreatic Cancer • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer • BRCA • HRD

Nuvation Bio Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update (Businesswire) - "The Company will initiate a Phase 1 monotherapy dose escalation study of NUV-868 in mid-2022....The Company began a monotherapy Phase 1/2 study of NUV-422 in December 2020 in high grade gliomas and later amended the protocol in the second quarter of 2021 to include HR+/HER2- advanced breast cancer (with and without brain metastases) and mCRPC. The Company is continuing to enroll patients in the monotherapy Phase 1 dose escalation portion of the study, with safety data expected in 2022."

New P1 trial • P1 data • Brain Cancer • Breast Cancer • Glioma • Oncology • Prostate Cancer • Solid Tumor

Nuvation Bio Announces FDA Clearance of Investigational New Drug Application for NUV-868 for the Treatment of Advanced Solid Tumors (PRNewswire) - "Nuvation Bio Inc...announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate NUV-868, a BD2-selective oral small molecule bromodomain and extra-terminal (BET) inhibitor, for the treatment of advanced solid tumors, including ovarian cancer, pancreatic cancer, metastatic castration resistant prostate cancer (mCRPC), and triple negative breast cancer (TNBC)...'we look forward to advancing the program into Phase 1 development in mid-2022.'"

IND • New P1 trial • Breast Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer