Onconova Therapeutics (ONTX): All Eyes on Phase 3 INSPIRE Study Readout


Onconova’s (NASDAQ:ONTX) most advanced program is the Phase 3 INSPIRE trial for patients with higher-risk MDS, after failure of hypomethylating agent, or HMA, therapy. In January, the company announced that the independent Data Monitoring Committee (DMC) recommended continuation of the Phase 3 INSPIRE as well as expansion of the enrollment as per its prespecified adaptive design based on the interim analysis. The study continued with an Intent To Treat (ITT) study population, but increased enrollment by 135 patients to a new target of 360 patients.

“The enrollment should complete in early 2019”, says Maxim analyst Jason McCarthy. “The trial is event (death) driven, needing 288. Given that over 70% of patients are very high risk (VHR) and the unfortunate poor life expectancy of ~4 months untreated, there is a scenario where the trial could complete (reach 288 deaths) concurrent with or even before enrollment completes.”

“Onconova has traversed two troughs, in our view; a data trough and a capital trough. With the capital needs resolved and multiple data points ahead, including pivotal data in less than 12-months, we see a company at a “distressed” valuation poised to generate value for investors,” the analyst concluded.

H.C Wainright’s Joseph Pantginis opined, “Thus far, INSPIRE trial enrollment population consists of about 70% of the predefined subgroup of very high risk (VHR) patients. Importantly, there are no other Phase 3 studies being conducted in this line of patients and since data exist supporting rigosertib activity in these patients the company has been successful in attracting patients to the study.”

Net net, both analysts rate ONTX stock a Buy with a $3.00 price target, which implies over 400% upside from current levels. The stock jumped as much as 75% this week before giving back some of the gains today.

Onconova is a Phase 3-stage biopharmaceutical company focused on discovering and developing novel small molecule drug candidates to treat cancer, with a primary focus on Myelodysplastic Syndromes (MDS).

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