AB8939 / AB Science - LARVOL DELTA

Update on the AB8939 microtubule program and in particular on the ability of AB8939 to generate a response on MECOM rearrangement (GlobeNewswire) - "The intellectual property rights of AB8939 in AML are guaranteed until 2036 through a ‘composition of matter’ patent and potentially until 2044 in AML with chromosomal abnormalities, including the MECOM gene, through a ‘second medical use’ patent."

Patent • Acute Myelogenous Leukemia

AB Science announces that EMA granted orphan drug status to AB8939 for the treatment of acute myeloid leukemia (GlobeNewswire) - "AB Science SA...announces today that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) granted orphan drug status to AB8939 for the treatment of acute myeloid leukemia (AML)."

Orphan drug • Acute Myelogenous Leukemia

AB Science provides a summary of the webcast held on December 16, 2024 (GlobeNewswire) - "The objective of the phase 1 is to determine the maximum tolerated dose (MTD) for three different cycles of AB8939. The first step of the phase 1 has been completed with 28 patients enrolled...The second step of the phase 1 is close to completion and enrolled 10 patients...Preliminary activity in MECOM...AB8939 is a stem cell ALDH targeted therapy with potential use in AML with MECOM. ALDH gene expression is a marker of survival prognosis in AML. The higher the expression, the worse the prognosis; MECOM is associated with the worst prognosis in AML; The expression of ALDH1A1 is regulated by EVI1 and has an outstanding role in the formation and transformation of hematopoietic cells and in particular leukemia stem cells...AB8939 has shown activity on MECOM rearrangement, based on non-clinical data and early clinical data in relapsing/refractory line of treatment, with 50% response rate observed."

Clinical • Trial status • Acute Myelogenous Leukemia

AB Science provides a summary of the webcast held on December 16, 2024 (GlobeNewswire) - "AB Science SA...today provides an update on its AB8939 program in acute myeloid leukemia (AML)...AB8939 blocks proliferating leukemia cells through microtubules...AB8939 targets leukemia cancer stem cells though inhibition of ALDH...Non clinical pharmacology...i) AB8939 is active against chemotherapy naive or chemotherapy refractory/relapsing patient’s AML cancers cells ex vivo; ii) AB8939 eradicates blasts in Blood and Bone Marrow in 5-AraC-resistant (Cytarabine) PDX; iii) AB8939 increases survival and has an additive effect in combination with reference treatment Azacitidine and Venetoclax; iv) ALDHs expression is a hallmark of cancer stem cells (CSCs) and AB8939 is an inhibitor of ALDH1/2. Therefore, AB8939 is a targeted therapy for leukemia cancer stem cells; v) AB8939 eradicates Leukemia Cancer Stem Cells in a human PDX AML model."

Preclinical • Acute Myelogenous Leukemia

AB Science announces a capital increase of 5.0 million euros [Google translation] (GlobeNewswire) - "AB Science SA...announces today a capital increase of €5.0 million...through the issuance of 5,368,725 new ordinary shares, each of which is subject to share subscription warrants. This capital increase was subscribed by European qualified investors...'his fundraising is primarily intended to finance the phase 2 clinical development of the microtubule program (AB8939).'...The proceeds of the Capital Increase will provide AB Science with the additional resources needed to finance its activities over the next twelve months, including the clinical development of masitinib in amyotrophic lateral sclerosis and other orphan diseases, as well as the development of AB Science's microtubule destabilizer platform."

Financing • Amyotrophic Lateral Sclerosis • CNS Disorders • Oncology

AB Science provides an update on the microtubule program AB8939 and in particular the ability of AB8939 to generate response on MECOM rearrangement (GlobeNewswire) - P1/2 | N=78 | NCT05211570 | Sponsor: AB Science | "The phase 1 clinical trial of AB8939 completed its first step, consisting in determining the maximum tolerated dose following 3 consecutive days of AB8939 treatment, and was authorized to proceed with the next step, consisting in determining the maximum tolerated dose following 14 consecutive days of AB8939 treatment...In the phase 1 trial, 4 patients bore the MECOM rearrangement and 50% responded to AB8939 when used as a single agent. In phase 1, so far, AB8939 does not appear to be toxic to bone marrow, avoiding severe neutropenia and suggesting the possibility to use the drug for long-term treatment. A phase 2 with a limited sample size...would probably be convincing enough for an accelerated approval. This will be discussed with FDA in future regulatory milestone. This study could be implemented in 2025."

P1/2 data • Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1/2 | N=78 | Recruiting | Sponsor: AB Science | Trial completion date: Jun 2023 ➔ Dec 2024 | Trial primary completion date: Jun 2023 ➔ Dec 2024

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

AB Science reports a first complete bone marrow response in a relapsed refractory acute myeloid leukemia patient from the very low dose arm of its AB8939 Phase I/II clinical trial (AB18001) (Market Screener) - P1/2 | N=78 | NCT05211570 | Sponsor: AB Science | "AB Science SA...announces a case report from the initial stage of its Phase I/II study (AB18001) evaluating AB8939, a microtubule destabilizer, in patients with refractory and relapsed acute myeloid leukemia (AML)....One month after the first treatment cycle (i.e., three consecutive days of AB8939 treatment) there was a drastic reduction in bone marrow blast cells (i.e., leukemia cells), from a pretreatment level of 55% to 5% (i.e., a morphologic leukemia free state). Remarkably, this response was achieved at a very low dose of AB8939, corresponding to the second step of dose increment (out of 13 potential steps) in phase I. The patient also showed excellent tolerance to AB8939, having experienced no treatment-related toxicities....AB Science will host a live webcast on Thursday March 16, 2023, from 6pm to 7pm CET, to present in further detail the synthetic microtubule destabilizers platform and the on-going phase 1/2 with AB8939."

P1/2 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1/2 | N=78 | Recruiting | Sponsor: AB Science | Not yet recruiting ➔ Recruiting

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

AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1/2 | N=78 | Not yet recruiting | Sponsor: AB Science | Initiation date: Mar 2022 ➔ Jun 2022

Trial initiation date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1/2 | N=78 | Not yet recruiting | Sponsor: AB Science

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

AB Science received FDA authorization to initiate Phase 1/II trial of AB8939 in the treatment of acute myeloid leukemia (GlobeNewswire) - "AB Science SA...announces that its Phase I/II study (AB18001) evaluating AB8939 in patients with refractory and relapsed AML and refractory myelodysplastic syndrome (MDS) has received Investigational New Drug (IND) approval by the U.S. Food and Drug Administration (FDA)...Study AB18001 has also been approved in France and in Canada."

IND • New P1/2 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

AB Science granted authorization from the French Health Authority (ANSM) to initiate a study of AB8939 in the treatment of Acute Myeloid Leukemia (AML) (GlobeNewswire) - "AB Science SA...today announces that it has been authorized by the French Medicine Agency, ANSM, to initiate a Phase I/II study (AB18001) evaluating AB8939 in patients with refractory and relapsed AML and refractory myelodysplastic syndrome (MDS). This approval comes just a few weeks after receiving similar authorization from the Canadian Health Authority."

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

AB Science receives Health Canada approval letter to commence Phase I/II trial of AB8939 in the treatment of Acute Myeloid Leukemia (AML) (GlobeNewswire) - "AB Science SA...today announced that its clinical trial with AB8939 in adult patients with relapsed/refractory acute myeloid leukemia (AML) has been approved by Health Canada. The ‘No Objection Letter’ (NOL) received from Health Canada provides an acknowledgement of AB8939’s drug candidacy and the authority to proceed with a Phase I/II study (AB18001) in patients with refractory and relapsed AML and refractory myelodysplastic syndrome (MDS)."

Canadian regulatory • New P1/2 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

AB Science announces that results from AB8939 preclinical program in acute myeloid leukemia will be presented at the European Hematology Association 2020 Annual Congress (GlobeNewswire) - "AB Science SA...announces that an abstract reporting results from its AB8939 preclinical development program in acute myeloid leukemia (AML), is to be presented as an e-Poster at the European Hematology Association (EHA) 2020 Annual Congress....Entitled, ‘AB8939, a Novel Microtubule-Destabilizing Agent for the Treatment of Acute Myeloid Leukemia’, this e-Poster presentation will be made available on the on-demand Virtual Congress platform as of Friday, June 12 at 08:30 CEST and will be accessible until October 15, 2020."

Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Oncology

[VIRTUAL] AB8939, A NOVEL MICROTUBULE-DESTABILIZING AGENT FOR THE TREATMENT OF ACUTE MYELOID LEUKEMIA (EHA 2020) - "Methods For ex vivo studies, blasts isolated from AML pts were treated for 48 hours with various concentrations of AB8939 or cytarabine (Ara-C) and analyzed in a cell proliferation/viability assay. A similar dosing schedule study showed single agent AB8939 at 6mg/kg administered over 6 days (6 ON/1 OFF) was optimal with a median survival of 59 days, corresponding to a 100% improvement over control. Conclusion AB8939 is a highly potent (nanomolar concentrations) Pgp-independent, tubulin inhibitor for cancer therapy; in particular, difficult to treat AML pts."

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

Heat shock factor 5 is essential for spermatogenesis in mice: Detected by a new monoclonal antibody. (PubMed, Iran J Basic Med Sci) - "On the other hand, mAb10C3 could detect Hsf5 in spermatogonia and spermatocytes of adult testis in comparison with a known anti-Hsf5 antibody (ab98939) and an anti-PCNA antibody as a marker of spermatogonia cells. Taken together, these data indicated that generated anti-testis mAb10C3 was generated against anti-testis proteins, specifically to target Hsf5, and can be useful as a scientific tool to investigate the critical genes in the development and spermatogenesis."

Journal • Preclinical • PCNA

Newly added product (GlobeNewswire) - Preclinical, AML, Oncology

Pipeline update