SFG-03 / Otsuka, Benz Sciences - LARVOL DELTA

LSD1 inhibitor, TAS1440, disrupts INSM1-LSD1 complex activating tumor-suppressive pathways via transcriptional reprogramming in neuroendocrine SCLC. (PubMed, Nat Commun) - "Loss of LSD1 enzymatic activity or INSM1 knockout abrogated TAS1440 effects, defining its mode of action and chemoresistance. These findings support TAS1440 as a next-generation epigenetic therapy candidate for INSM1-high SCLC-A."

Journal • Gene Therapies • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • ASCL1 • SMAD2 • TGFB1

Taiho Pharmaceutical Out-Licenses LSD1 Inhibitor, TAS1440 to Benz Sciences (Taiho Press Release) - "Taiho Pharmaceutical...and Benz Sciences...announced today that the two companies have entered into a license agreement for TAS1440, a LSD1 (lysine-specific demethylase 1) inhibitor discovered by Taiho Pharmaceutical. Under the terms of agreement, Benz Sciences will obtain exclusive worldwide rights to develop, manufacture and commercialize TAS1440 (new development code SFG-03). Taiho Pharmaceutical will receive from Benz Sciences an upfront payment, milestone payments based on development progress and sales, and royalties....Benz Sciences will undertake preparations in the United States for the Phase 1b/2 trial of TAS1440 for the treatment of myeloproliferative neoplasms."

Licensing / partnership • Myeloproliferative Neoplasm

A Study of TAS1440 With ATRA in Subjects With r/r AML (clinicaltrials.gov) - P1 | N=52 | Terminated | Sponsor: Taiho Oncology, Inc. | N=80 ➔ 52 | Trial completion date: Dec 2025 ➔ Feb 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: Dec 2025 ➔ Feb 2024; The study was terminated due to the changing treatment landscape, difficulty in enrolling eligible participants, and little likelihood of providing meaningful clinical benefit for the participants.

Combination therapy • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

A Study of TAS1440 With ATRA in Subjects With r/r AML (clinicaltrials.gov) - P1 | N=80 | Active, not recruiting | Sponsor: Astex Pharmaceuticals, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

A Study of TAS1440 With ATRA in Subjects With r/r AML (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Astex Pharmaceuticals, Inc. | Trial completion date: Mar 2023 ➔ Dec 2025 | Trial primary completion date: Mar 2023 ➔ Dec 2025

Combination therapy • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

TAS1440, a novel reversible LSD1 inhibitor, modulates immunosuppressive population and potentiates the antitumor efficacy of anti-PD-1 antibody therapy (AACR-NCI-EORTC 2022) - "Combined treatment with TAS1440 and anti-PD-1 antibodies can serve as a new therapeutic strategy for overcoming immunotherapy resistance. No"

Clinical • IO biomarker • Oncology • CD8 • KDM1A • PRKDC

A Study of TAS1440 With ATRA in Subjects With r/r AML (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Astex Pharmaceuticals, Inc. | Trial completion date: Jul 2022 ➔ Mar 2023 | Trial primary completion date: Jul 2022 ➔ Mar 2023

Combination therapy • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

A Study of TAS1440 With ATRA in Subjects With r/r AML (clinicaltrials.gov) - P1; N=80; Recruiting; Sponsor: Astex Pharmaceuticals, Inc.; Enrolling by invitation ➔ Recruiting

Clinical • Combination therapy • Enrollment status • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

A Study of TAS1440 With ATRA in Subjects With r/r AML (clinicaltrials.gov) - P1; N=80; Enrolling by invitation; Sponsor: Astex Pharmaceuticals, Inc.; Not yet recruiting ➔ Enrolling by invitation

Clinical • Combination therapy • Enrollment open • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

A Study of TAS1440 With ATRA in Subjects With r/r AML (clinicaltrials.gov) - P1; N=80; Not yet recruiting; Sponsor: Astex Pharmaceuticals, Inc.

Clinical • Combination therapy • New P1 trial