Debio 1562M / Debiopharm - LARVOL DELTA

A phase 1/2, first-in-human, multicenter, open-label trial evaluating the safety, tolerability, and antileukemic activity of Debio 1562M in patients with recurrent refractory acute myeloid leukemia (AML) (ASH 2025) - P1/2 | "The primary objective is to identify therecommended dose (RD) for future clinical development. The phase 2 consists of an open-label single-arm study aimed at evaluating the antileukemic activity of Debio 1562M monotherapy at the RD inpatients with R/R AML.Study results will provide insights into the clinical potential of Debio 1562M in patients with R/R AML forwhom no standard therapy of proven benefit is available.Accrual is currently ongoing over several sites in United States of America and Europe."

Clinical • First-in-human • P1/2 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • CD37 • TSPAN6

Debio 1562M, a Next Generation Antibody Drug Conjugate (ADC) Targeting CD37 for AML and MDS Treatment (ASH 2023) - "Furthermore, we evaluated the activity of Debio 1562M over venetoclax and azacytidine combination in the MV4-11 Luciferase xenografted mouse model. On-target toxicity profile couldn't be evaluated as Debio 1562M isn't cross reactive with mouse CD37, however 1st generation CD37 ADC has already demonstrated safety and tolerability in Phase 1 and 2 clinical trials.Overall, our data confirm the relevance of CD37 targeting for AML treatment. The excellent antitumor activity and tolerability of Debio 1562M in several pre-clinical models now pave the way for upcoming clinical development."

Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Myelodysplastic Syndrome • Oncology • CD37

A Study to Assess the Safety, Tolerability, and Antileukemic Activity of Debio 1562M in Participants With Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - P1/2 | N=134 | Recruiting | Sponsor: Debiopharm International SA | Not yet recruiting ➔ Recruiting

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

Debiopharm’s ADC Research Gains Momentum With Launch of First-in-human Trial Assessing Debio 1562M in Acute Myeloid Leukemia Patients (Businesswire) - "Debiopharm...announced that the first patient has been dosed in the first-in-human clinical trial evaluating the safety, tolerability, and antileukemic activity of Debio 1562M monotherapy in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML). This phase 1/2 trial (NCT06969430) will lay the groundwork for further development as it will allow the characterization of the safety and tolerability of the drug, dose optimization, and define the product’s activity."

Trial status • Acute Myelogenous Leukemia

A Study to Assess the Safety, Tolerability, and Antileukemic Activity of Debio 1562M in Participants With Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - P1/2 | N=134 | Not yet recruiting | Sponsor: Debiopharm International SA

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

Debio 1562M, a 2ndgeneration ADC targeting CD37, shows high potency against AML and MDS and safe toxicological profile for future clinical development (AACR 2025) - "Debio 1562M activity was benchmarked against several targeted therapies such as menin, FLT3, IDH1 and IDH2 inhibitors or gemtuzumab ozogamicin (GO) CD33-targeting ADC, in different in vivo models. In MOLM-13 xenografted mice, Debio 1562M induced tumor regression after a single injection similarly to GO, while the menin inhibitor revumenib achieved tumor stasis with twice daily administrations and the FLT3 inhibitor gilteritinib only achieved partial response after daily administrations. Similarly, in 4 patient-derived xenograft models bearing FLT3, IDH1 or IDH2 mutations, Debio 1562M led to greater circulating blast reduction compared to gilteritinib, ivosidenib IDH1 inhibitor and enasidenib IDH2 inhibitor...On-target toxicity profile of Debio 1562M could not be evaluated due to lack of cross-reactive species, however no significant toxicity on human PBMCs was observed in vitro. In conclusion, the promising antitumor activity and tolerability of Debio 1562M in..."

Clinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • CD33 • CD37 • FLT3 • IDH1

Debiopharm to Reveal Insights From Their ADC, DDR Inhibitor, and Antibody Conjugation Technology Research at the 2025 AACR Conference in Chicago (Businesswire) - "Comprehensive preclinical results will be presented for Debio 1562M, a next-generation Antibody-Drug Conjugate (ADC) targeting the cell surface glycoprotein CD37 soon to undergo first-in-human evaluation. Two preclinical data releases will be included in the poster display sessions for Debio 0123, a selective WEE1 kinase inhibitor disrupting the DNA-damage response (DDR) of cancer cells. The first data release shows how Debio 0123 can be used in combination with the PKMYT1 inhibitor lunresertib as a promising therapeutic strategy in ovarian and breast cancer....The company also announces joint poster presentation with new partner on the use of its AbYlink technology in preclinical setting."

Preclinical • Acute Myelogenous Leukemia • Breast Cancer • Myelodysplastic Syndrome • Ovarian Cancer

CD37 IS A RELEVANT TARGET FOR AML AND MDS TREATMENT BY DEBIO 1562M ANTIBODY DRUG CONJUGATE (ADC) (EHA 2024) - "Debio 1562Mantitumor activity was compared with venetoclax + azacytidine therapy in both CDX or PDX models. Overall, our data confirm that CD37 is a relevant and attractive target for AML and MDS treatment. Theexcellent antitumor activity and tolerability of Debio 1562M in several preclinical models pave the way forupcoming clinical trials."

Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Pain • CD37