PHST001 / Pheast Therap - LARVOL DELTA

Phase 1 study of PHST001, a humanized anti-CD24 monoclonal antibody, in adult patients with advanced relapsed and/or refractory solid tumors (AACR-NCI-EORTC 2025) - P1 | "Other endpoints include exploring antitumor activity, pharmacokinetics/pharmacodynamics correlation (target occupancy, cytokine profiling, ctDNA and immune cell frequency) and immunogenicity of PHST001. The study is currently enrolling, and the first patient was treated in April 2025."

Clinical • Late-breaking abstract • Metastases • P1 data • Biliary Cancer • Cholangiocarcinoma • Colorectal Cancer • Endometrial Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CD24

Pheast Therapeutics Receives FDA Fast Track Designation for PHST001 for the Treatment of Ovarian Cancer (Businesswire) - "Pheast Therapeutics...announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to PHST001 for the treatment of patients with advanced platinum-resistant ovarian cancer or in combination with chemotherapy in platinum-sensitive ovarian cancer. PHST001 is an investigational anti-CD24 monoclonal antibody designed to enhance innate immune recognition and anti-tumor activity in solid tumors....The multicenter, open-label Phase 1 clinical study of PHST001 is actively recruiting patients and will enroll up to 80 patients with advanced relapsed and/or refractory solid tumors (ClinicalTrials.gov Identifier: NCT06840886)."

Fast track • Platinum resistant • Platinum sensitive • Trial status • Ovarian Cancer

A Study of PHST001 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=155 | Recruiting | Sponsor: Pheast Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

Pheast Therapeutics Announces First Patient Treated in Phase 1 Clinical Trial of PHST001 for Patients with Advanced Solid Tumors (Businesswire) - "Pheast Therapeutics...announced that the first patient has been treated in its Phase 1 clinical trial evaluating PHST001, an anti-CD24 macrophage checkpoint inhibitor, in patients with advanced solid tumors...The multicenter, open-label Phase 1 study will enroll up to 80 patients with advanced relapsed and/or refractory solid tumors (ClinicalTrials.gov Identifier: NCT06840886). The study’s primary objectives include evaluating safety and tolerability of PHST001 and establishing the recommended Phase 2 dose, with secondary endpoints assessing pharmacokinetics and early signs of anti-tumor activity."

Trial status • Solid Tumor

A Study of PHST001 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=155 | Not yet recruiting | Sponsor: Pheast Therapeutics

New P1 trial • Oncology • Solid Tumor

PHST001, a humanized anti-CD24 antibody, induces phagocytosis of human tumor cells in vitro and tumor clearance in vivo (SITC 2024) - "PHST001 does not induce cytokine release in vitro and detects CD24 in human tissues. A clinical study to investigate the safety and efficacy of PHST001 in cancer patients is being developed.Download figure Open in new tab Download powerpoint Abstract 513 Figure 1 Download figure Open in new tab Download powerpoint Abstract 513 Figure 2 Download figure Open in new tab Download powerpoint Abstract 513 Figure 3 Download figure Open in new tab Download powerpoint Abstract 513 Figure 4 Download figure Open in new tab Download powerpoint Abstract 513 Figure 5 Download figure Open in new tab Download powerpoint Abstract 513 Figure 6"

Preclinical • Tumor cell • Breast Cancer • Colorectal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Triple Negative Breast Cancer • CD24 • HER-2 • IFNG • IL2 • IL6 • ITGAM • SIGLEC10 • TNFA

Pheast Presents New Preclinical Data for PHST001, an Anti-CD24 Macrophage Checkpoint Inhibitor, at SITC 2024 (Businesswire) - "The presented data show that PHST001, through potent CD24 binding, promotes macrophage-induced phagocytosis in a number of cancer cells and significantly shrinks tumors in vivo. In addition, PHST001 has a favorable PK profile in non-human primates and does not induce immune-mediated toxicity in vitro....Pheast is on track to initiate clinical trials with PHST001 in the first half of 2025."

New trial • Preclinical • Solid Tumor

Pheast partners with Lonza to produce cancer-gobbling CD24 drug (BioProcess International) - "The company has partnered with contract development and manufacturing organization (CDMO) Lonza to manufacture its drug substance (DS) and drug product (DP), with the cell-line development and DS work done in Visp and the DP work done in Basel, both in Switzerland. That partnership has enabled Pheast to attain the supply needed of its lead drug candidate, PHST001, for first-in-human clinical trials. The drug was developed as a therapeutic against cluster of cell differentiation (CD) 24, a known 'don’t eat me' signal that is highly expressed in ovarian and breast cancers."

Commercial • Breast Cancer • Ovarian Cancer

Pheast Unveils First Preclinical Data for PHST001, an Anti-CD24 Macrophage Checkpoint Inhibitor (Businesswire) - "Pheast Therapeutics...today announced the first presentation of preclinical data for PHST001, an anti-CD24 antibody drug candidate that is designed to block a key macrophage 'don’t eat me' signal on cancer cells. The data to be presented at the 20th Annual PEGS Boston Summit demonstrate that PHST001 can powerfully induce an anti-cancer immune response and drive therapeutic efficacy in in vivo models...'The Pheast team is making rapid progress to support filing an investigational new drug application with the goal to enter the clinic in patients in the first half of next year.'...Pheast scientists have demonstrated that blocking CD24 with PHST001 induces macrophage phagocytosis of multiple cancer subtypes in vitro, and have shown potent efficacy for PHST001 in vivo....Dr. Burg will present these data on Monday, May 13, 2024, at 1:15 pm ET in a talk..."

New trial • Preclinical • Oncology • Solid Tumor