Another FDA clinical hold for Aprea

The US Food and Drug Administration has placed a clinical hold on US cancer focussed bioharma company Aprea Therapeutics’ (Nasdaq: APRE) clinical trial evaluating eprenetapopt with acalabrutinib or with venetoclax and rituximab in lymphoid malignancies.

No additional patients can be enrolled until the clinical hold is resolved, though patients on study deriving clinical benefit can continue to receive study treatment, noted the company, whose shares fell nearly 10% in premarket trading Thursday.

Subsequent to receiving notification of a partial clinical hold on its myeloid malignancies program, Aprea was informed by FDA of a clinical hold on its lymphoid malignancy study. The FDA’s concerns referred to the safety and efficacy data from the Phase III MDS clinical trial. One CLL patient is currently on study treatment receiving eprenetapopt in combination with venetoclax and rituximab and has achieved complete remission (CR). Aprea intends to work closely with the FDA to address the specific questions raised, and seek to resolve the clinical hold as soon as possible.