Aprea (APRE) Reports FDA Removal of Clinical Hold on Study

By Zacks Investment ResearchStock MarketsDec 09, 2021 10:30PM ET

www.investing.com/analysis/aprea-apre-reports-fda-removal-of-clinical-hold-on-study-200611197

Aprea (APRE) Reports FDA Removal of Clinical Hold on Study

By Zacks Investment Research | Dec 09, 2021 10:30PM ET

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Small biotech Aprea Therapeutics (NASDAQ:APRE), Inc. APRE announced that the FDA has removed the full clinical hold on a study evaluating its lead product candidate, eprenetapopt (APR-246), in combination with other cancer drugs for treating lymphoid malignancies.

The study is investigating eprenetapopt in combination with AstraZeneca (NASDAQ:AZN)’s AZN Calquence (acalabrutinib), or with AbbVie ABBV/Roche’s Venclexta (venetoclax) and Roche’s RHHBY (OTC:RHHBY) Rituxan (rituximab) for the given indication.

Aprea Therapeutics addressed the FDA’s concern and received clearance from the regulatory body to resume clinical evaluation of eprenetapopt in non-Hodgkin’s lymphomas.

Venclexta has been developed by AbbVie and Roche. The drug is being jointly commercialized by AbbVie and Roche in the United States while AbbVie markets the drug in ex-U.S. markets under the brand name Venclyxto.

AstraZeneca’s Calquence is approved for chronic lymphocytic leukemia (in frontline as well as relapsed/recurrent disease setting) and previously treated mantle cell lymphoma.

Shares of Aprea Therapeutics were up 2.2% on Thursday following the FDA’s removal of clinical hold on the above-mentioned study on eprenetapopt. The stock has plunged 14.4% so far this year compared with the industry’s decrease of 19.6%.

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Aprea Therapeutics is developing eprenetapopt for treating hematologic malignancies and solid tumors.

Please note that in August 2021, the FDA placed a clinical hold on the lymphoid malignancy program owing to concerns over the safety and efficacy data from the phase III frontline study in myelodysplastic syndromes (“MDS”).

The same month, the FDA placed a partial clinical hold on several studies evaluating eprenetapopt in combination with Vidaza (azacitidine), including a phase III frontline MDS. All these studies were put on clinical hold due to concerns about the safety and efficacy data from the frontline MDS study.

The FDA has granted Orphan Drug and Fast Track designations to eprenetapopt for treating MDS as well as acute myeloid leukemia (“AML”). The European Commission has also granted Orphan Drug designation to eprenetapopt for MDS and AML.

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Aprea Therapeutics currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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Aprea (APRE) Reports FDA Removal of Clinical Hold on Study

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