Redwood City, Calif.– Pheast Therapeutics has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its lead candidate PHST001, a novel investigational antibody aimed at treating advanced ovarian cancer. The designation applies to patients with platinum-resistant ovarian cancer and to those receiving PHST001 in combination with chemotherapy for platinum-sensitive disease.
PHST001 is a first-in-class anti-CD24 monoclonal antibody designed to enhance innate immune recognition of tumors by targeting a key “don’t eat me” signal used by cancer cells to evade macrophage attack. By blocking CD24, the therapy aims to stimulate the body’s natural immune response against solid tumors, including hard-to-treat ovarian cancers.
“Receiving Fast Track designation from the FDA reinforces the promise of CD24 as a next-generation immuno-oncology target,” said Dr. Raphaël Rousseau, Chief Medical Officer at Pheast Therapeutics. “It highlights the potential of PHST001 to address a critical unmet need for patients battling ovarian cancer. We are committed to moving this therapy forward with urgency.”
The FDA’s Fast Track program is intended to accelerate the development and review of therapies that treat serious conditions and address significant unmet medical needs. The designation provides companies with more frequent communication with the FDA and eligibility for expedited approval pathways.
PHST001 is currently being evaluated in a multicenter, open-label Phase 1 trial (ClinicalTrials.gov Identifier: NCT06840886), which is actively recruiting patients with relapsed or refractory solid tumors. The study will enroll up to 80 participants and is focused on determining the drug’s safety, tolerability, and optimal dosing for future studies. Secondary objectives include pharmacokinetic profiling and early assessments of anti-tumor activity.
The company sees the FDA’s decision as a validation of its macrophage-targeting approach and a meaningful step toward offering more effective treatment options to patients facing aggressive forms of cancer.
