Laguna Announces FDA Clearance of IND Application for LGNA-100, a Novel γδ T Cell Activator for High-Risk Pediatric Leukemias
Excerpt from the Press Release:
SAN FRANCISCO, April 29, 2026 (GLOBE NEWSWIRE) — Laguna Biotherapeutics, Inc. (Laguna), a clinical-stage biotechnology company focused on novel live bacterial therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application, granting a “safe to proceed” for its lead clinical candidate from the QUAIL platform, LGNA-100.
LGNA-100 is a first-in-class, attenuated live bacterial immunotherapy designed to safely harness our immune system’s evolved response to Listeria; robustly and durably expanding and activating endogenous γδ T cells that can directly kill cancer cells while also improving existing immunotherapies. The Phase 1 first-in-human study will validate the QUAIL platform and evaluate LGNA-100 in patients with high-risk leukemia following hematopoietic stem cell transplantation (HSCT) to prevent leukemic relapse.
“The IND clearance of our first clinical study is a defining moment and transformative milestone for Laguna as we transition into a clinical-stage company,” said Jonathan Kotula, Ph.D., CEO of Laguna. “Our goal is to create systems-level therapies for complex diseases. With LGNA-100, and the QUAIL platform we are taking a fundamentally new approach to selectively stimulate innate T cells to improve long-term outcomes for pediatric patients with high-risk leukemia.”
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