Onconova Therapeutics, Inc. (ONTX - Free Report) announced that it has commenced an investigator-initiated phase I/IIa study of oral rigosertib plus Bristol-Myers Squibb’s (BMY - Free Report) Opdivo (nivolumab) in advanced metastatic KRAS mutated (KRAS+) lung adenocarcinoma.
Rigosertib,Onconova’s lead candidate is a proprietary phase III small molecule. The candidatehas been tested in an intravenous formulation as a single agent for patients with higher-risk myelodysplastic syndromes (MDS) and an oral formulation as a single agent in lower-risk MDS or in combination with azacitidine for patients with higher-risk MDS.
Opdivo is a prescription medicine used to treat people with a type of advanced-stage lung cancer called non-small cell lung cancer. Opdivo is a human IgG4 monoclonal antibody that blocks PD-1.
The phase I investigator-initiated study will be followed by a phase IIa dose-expansion phase to study the combination of oral rigosertib and Opdivo in metastatic KRAS+ lung adenocarcinoma patients who have progressed on standard frontline treatment.
The novel combination of rigosertib andOpdivo targets two of the most important oncogenic pathways in cancer biology. The study will evaluate the safety and tolerability of this combination in KRAS-mutated NSCLC, in which patients have failed frontline immunotherapy. The study will explore the efficacy of the combination in this common lung cancer subset and also determine if rigosertib may restore sensitivity to the PD-1 blockade.
Shares of Onconova have surged 60.4% year to date against the industry’s decline of 4%.
Onconova has a phase III clinical-stage product candidate . The company has two other clinical-stage product candidates (one of which has been studied for the treatment of acute radiation syndromes) and preclinical programs.
Zacks Rank and Other Stocks to Consider
Onconova is currently a Zacks Rank #2 (Buy) stock.
Some other top-ranked stocks in the biotech sector are Amneal Pharmaceuticals Inc. (AMRX - Free Report) and BioLineRx Ltd. (BLRX - Free Report) , both carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Amneal’s earnings per share estimates have increased from 49 cents to 57 cents for 2020 and from 63 cents to 67 cents for 2021 in the past 60 days.
BioLineRx’s loss per share estimates have narrowed from $2.77 to $2.24 for 2020 and from $3.01 to $2.88 for 2021 in the past 60 days.
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