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Nuvation (NUVB) Gets FDA Clearance for Oncology Candidate

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Nuvation Bio Inc. (NUVB - Free Report) announced that the FDA has cleared its investigational new drug (IND) application to evaluate its pipeline candidate NUV-868., a BD2-selective oral small molecule bromodomain and extra-terminal (BET) inhibitor.

The IND application has been cleared to evaluate the candidate for the treatment of advanced solid tumors, including ovarian cancer, pancreatic cancer, metastatic castration-resistant prostate cancer (mCRPC) and triple-negative breast cancer (TNBC). The candidate will be advanced into phase I development in mid-2022.

Nuvation will be initiating a phase I/II study of NUV-868 as a monotherapy and in combination with Lynparza or Pfizer’s (PFE - Free Report)   Xtandi in multiple tumor types.

The company will begin a phase I monotherapy dose-escalation study in advanced solid tumor patients. Thereafter, a phase Ib study will be initiated evaluating NUV-868 in combination with Lynparza in previously treated ovarian cancer, pancreatic cancer, mCRPC and TNBC patients and in combination with Xtandi for mCRPC patients. The company will then initiate a phase IIb study to further explore safety and efficacy once the recommended phase II combination dose is determined. A phase II monotherapy study will also be initiated in mCRPC patients to further examine safety and efficacy.

We note that Pfizer’s Xtandi is approved to treat three forms of prostate cancer in the United States.

Per the company, preclinical studies have shown NUV-868 is almost 1,500 times more selective for BD2 than BD1. Non-selective BD1/2 inhibitors in development have been associated with tolerability issues, potentially due to too much BD1 inhibition.

Shares of the company have plunged 49.4% in the past year compared with the industry’s decline of 38%.

Zacks Investment ResearchImage Source: Zacks Investment Research

The successful development of the candidate will be a significant boost for this clinical-stage biopharmaceutical company.

Nuvation proprietary portfolio includes six novel and mechanistically distinct oncology therapeutic product candidates.

Nuvation began treating high-grade glioma patients in a phase I/II study of NUV-422, its lead product candidate, in December 2020. The FDA has granted Fast Track designation to NUV-422, a cyclin-dependent kinase (CDK) 2/4/6 inhibitor, for the treatment of patients with high-grade gliomas, including glioblastoma multiforme. The candidate also received Orphan Drug Designation to treat patients with malignant gliomas from the FDA in the first quarter of 2021.

Nuvation currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector are Vir Biotechnology (VIR - Free Report) and Alkermes (ALKS - Free Report) , each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Earnings estimates for Vir have moved up $2.05 in the past 30 days for 2022. VIR has gained 100.4% in the past two years.

Earnings estimates for Alkermes have moved up a cent for 2022 in the past 60 days. ALKS has jumped 30.9% in the past year.