APL-4098 / Apollo Therap - LARVOL DELTA

A Study to Investigate APL-4098 Alone and in Combination in Adults With AML or MDS (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: Apollo Therapeutics Ltd | Phase classification: P1/2 ➔ P1

Phase classification • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

First results from the Phase 1 study of APL-4098, an oral potent GCN2 inhibitor for the treatment of Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) and Myelodysplastic Syndromes (MDS)/AML (ASH 2025) - P1/2 | "APL-4098 is a potent, selective GCN2 inhibitor that has demonstrated excellent non-clinical potency, selectivity and efficacy properties. Dose escalation of APL-4098 in R/R AML and MDS/AML patients is ongoing with a good tolerability and safety profile. APL-4098 shows dose-proportionate PK supporting once daily oral dosing and demonstrated exposure-driven PD activity at the transcriptional level."

IO biomarker • P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • TP53

Nonclinical evaluation of APL-4098, a novel GCN2 kinase inhibitor, reveals potent anti-leukemic effects through mitochondrial stress induction and synergy with venetoclax, targeting AML blasts and LSCs (ASH 2025) - P1/2 | "APL-4098 is a novel, potent, selective, ATP-competitive GCN2 kinase inhibitor that disruptsmitochondrial processes and targets LCSs in nonclinical AML models as a monotherapy and incombination with venetoclax. A Phase 1/2 clinical study of APL-4098 in R/R AML and MDS/AML is ongoing(NCT06372717)."

Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • ANXA5 • CD34 • CD38 • EIF2A • EIF2S1

A Study to Investigate APL-4098 Alone and/or in Combination With Azacitidine in R/R AML and High-Risk MDS (clinicaltrials.gov) - P1/2 | N=112 | Recruiting | Sponsor: Apollo Therapeutics Ltd | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

A Study to Investigate APL-4098 Alone and/or in Combination With Azacitidine in R/R AML and High-Risk MDS (clinicaltrials.gov) - P1/2 | N=112 | Not yet recruiting | Sponsor: Apollo Therapeutics Ltd

Combination therapy • New P1/2 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology