LAVA Therapeutics Gets FDA Orphan Designation for LAVA-051

By Colin Kellaher

LAVA Therapeutics N.V. on Friday said the U.S. Food and Drug Administration granted orphan-drug designation to LAVA-051, the most advanced product candidate from its Gammabody platform, for the treatment of chronic lymphocytic leukemia.

The Utrecht, Netherlands, clinical-stage biotechnology company said enrollment is underway in a Phase 1/2a clinical trial of LAVA-051 for the treatment of relapsed and/or refractory chronic lymphocytic leukemia, multiple myeloma and acute myeloid leukemia.

The FDA's orphan-drug program gives special status to drugs and biologics for diseases and disorders that affect fewer than 200,000 people in the U.S. and provides for an extended marketing-exclusivity period against competition.

LAVA said it expects data from the Phase 1 dose escalation phase of the study in the first half of 2022, with top-line clinical data from the Phase 2a expansion cohorts expected in the second half.

Shares of LAVA, which closed Thursday at $7.63, rose 7.6% in premarket trading Friday.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

10-15-21 0748ET