Max-40279 / Maxinovel - LARVOL DELTA

Determining sensitivity to FLT3 inhibitors prior to therapy in FLT3 mutant acute myelogenous leukemia (ASH 2025) - "For ex-vivo sensitivity assays, AML cells were treated with several dilutions of a FLT3i(Sorafenib, Midostaurin, Crenolanib, Quizartinib, Gilteritinib, Tuspetinib and MAX-40279 (a dualFLT3/FGFR inhibitor)) and cell viability was assessed with CellTiter-Glo® (Promega). Using our MS-based proteomics measurements and sensitivity results with our proprietary MLmodel, we processed both AML patient samples (N=57) and patient-derived cell lines (N=59), and wewere able to identify 7 distinct clusters. Previously we demonstrated that RPPA proteomics could discriminate FLT3i sensitive andresistant cases and here we present orthogonal confirmation by MS proteomics and ex-vivo sensitivityassays. Moreover, we show that the expression of only three proteins forms a robust biomarker topredict FLT3i sensitivity of FLT3-MUT AML patients prior to therapy. We also identified AML cell lines thatmimic both FLT3i resistance and sensitivity, and combined with deep proteomics data, these..."

Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • CD34 • FLT3 • PXN • SMARCA2

A Study of MAX-40279combined With KN046 in Patients With Advanced / Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=108 | Not yet recruiting | Sponsor: Maxinovel Pty., Ltd.

New P1/2 trial • Oncology • Solid Tumor

A Phase 2 Study to Evaluate the Safety and Efficacy of Max-40279-01 in Patients With Advanced Gastric Cancer or Gastroesophageal Junction Cancer (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Maxinovel Pty., Ltd.

New P2 trial • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • FGFR1OP2

A Study to Evaluate the Safety and Efficacy of Max-40279 and Toripalimab in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=28 | Recruiting | Sponsor: Maxinovel Pty., Ltd.

Combination therapy • New P1 trial • Oncology • Solid Tumor • FGFR1OP2

MAX-40279 in Subjects With Acute Myelogenous Leukemia (AML) (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: Maxinovel Pty., Ltd.; Trial completion date: Dec 2021 ➔ Dec 2022; Trial primary completion date: Nov 2021 ➔ Nov 2022

Clinical • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • FGFR • FLT3

MAX-40279-01 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: Maxinovel Pty., Ltd.; Trial completion date: Dec 2021 ➔ Dec 2022; Trial primary completion date: Nov 2021 ➔ Nov 2022

Clinical • Trial completion date • Trial primary completion date • Oncology • Solid Tumor • MRI

Study of MAX-40279 in Patients With Relapsed or Refractory Acute Myelogenous Leukemia (AML) (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: Maxinovel Pty., Ltd.; Trial completion date: Dec 2021 ➔ Dec 2022; Trial primary completion date: Dec 2021 ➔ Dec 2022

Clinical • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

A Clincal Study of Max-40279-01 in Patients With Advanced Colorectal Cancer (clinicaltrials.gov) - P2; N=130; Not yet recruiting; Sponsor: Maxinovel Pty., Ltd.; Trial completion date: Oct 2022 ➔ Oct 2023

Clinical • Trial completion date • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • MSI

A Phase 2 Study to Evaluate the Safety and Efficacy of Max-40279-01 in Patients With Advanced Colorectal Cancer (clinicaltrials.gov) - P2; N=130; Not yet recruiting; Sponsor: Maxinovel Pty., Ltd.

Clinical • New P2 trial • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • MSI

A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Max-40279-01 in Combination With Azacitidine (AZA) in Patients With Myelodysplastic Syndrome (MDS) or Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) (clinicaltrials.gov) - P1/2; N=100; Recruiting; Sponsor: Maxinovel Pty., Ltd.

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

MAX-40279 in Subjects With Acute Myelogenous Leukemia (AML) (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: Maxinovel Pty., Ltd.; Trial completion date: May 2021 ➔ Dec 2021; Trial primary completion date: Nov 2020 ➔ Nov 2021

Clinical • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • FGFR

Study of MAX-40279 in Patients With Relapsed or Refractory Acute Myelogenous Leukemia (AML) (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: Maxinovel Pty., Ltd.; Trial completion date: Feb 2021 ➔ Dec 2021; Trial primary completion date: Dec 2020 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

MAX-40279-01 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: Maxinovel Pty., Ltd.; Trial completion date: Feb 2021 ➔ Dec 2021; Trial primary completion date: Nov 2020 ➔ Nov 2021

Clinical • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Study of MAX-40279 in Patients With Relapsed or Refractory Acute Myelogenous Leukemia (AML) (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: Maxinovel Pty., Ltd.

Clinical • New P1 trial

MAX-40279-01 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: Maxinovel Pty., Ltd.

Clinical • New P1 trial

MAX-40279 in Subjects With Acute Myelogenous Leukemia (AML) (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: Maxinovel Pty., Ltd.; Trial completion date: Dec 2019 ➔ May 2021; Trial primary completion date: Jun 2019 ➔ Nov 2020

Clinical • Trial completion date • Trial primary completion date

MAX-40279 in Subjects With Acute Myelogenous Leukemia (AML) (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: Maxinovel Pty., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open