APL-4098 / Apollo Therap - LARVOL DELTA

RESULTS FROM THE PHASE 1 MONOTHERAPY DOSE ESCALATION OF APL-4098, AN ORAL GCN2 INHIBITOR, IN RELAPSED/REFRACTORY ACUTE MYELOID LEUKEMIA (R/R AML) AND MYELODYSPLASTIC SYNDROMES (MDS)/AML PATIENTS (EHA 2026) - P1 | "APL-4098 has shown predictable, dose-proportionate PK supporting once daily oral dosing and has demonstrated exposure-driven PD activity. APL-4098 is currently being evaluated in combination studies with azacitidine and venetoclax / azacitidine in R/R AML and newly diagnosed AML patients."

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

A novel potent and selective GCN2 inhibitor, APL-4098, has anti-leukemic activity through dysregulation of mitochondrial function. (PubMed, Clin Cancer Res) - "APL-4098 is a novel, potent and selective GCN2 inhibitor with strong preclinical efficacy against AML cells, including LSCs. Our findings support APL-4098 as a promising candidate for AML treatment."

Journal • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology

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