epratuzumab-cys-tesirine (ADCT-602) / Overland ADCT BioPharma - LARVOL DELTA

NCI-2018-02016: ADCT-602 in Treating Patients With Recurrent or Refractory B-cell Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P1/2 | N=37 | Terminated | Sponsor: M.D. Anderson Cancer Center | Active, not recruiting ➔ Terminated; <75% participation

Trial termination • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • CD22

NCI-2018-02016: ADCT-602 in Treating Patients With Recurrent or Refractory B-cell Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P1/2 | N=37 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Recruiting ➔ Active, not recruiting | N=57 ➔ 37

Enrollment change • Enrollment closed • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • CD22

ADC Therapeutics Reports First Quarter 2025 Financial Results and Provides Operational Update (PRNewswire) - "Abstract accepted for presentation of marginal zone lymphoma (MZL) data at ICML. A poster entitled, "Updated analysis of a phase 2 multicenter study of the loncastuximab in relapsed/refractory marginal zone lymphoma demonstrates high rate of complete responses" will be presented at ICML....Discontinuation of ADCT-602 trial. Based on the available clinical data, the Phase 1/2 ADCT-602 clinical trial, sponsored by The University of Texas MD Anderson Cancer Center, evaluating ADCT-602 in patients with r/r B-cell acute lymphoblastic leukemia will be discontinued....Product Revenues: ZYNLONTA generated net product revenues of $17.4 million for the first quarter of 2025 as compared to $17.8 million for the first quarter of 2024."

P2 data • Sales • Trial termination • B Acute Lymphoblastic Leukemia • Marginal Zone Lymphoma

ADC Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Updates (GlobeNewswire) - "ADCT-601 (targeting AXL): Additional data updates from the Phase 1 study in patients with sarcoma, pancreatic cancer and NSCLC in 2H 2024. ADCT-602 (targeting CD22): Additional data from the Phase 1 study in 2H 2024....Net product revenues were $17.8 million for the first quarter 2024, compared to $19.0 million for the first quarter 2023. Net product revenues are for U.S. sales of ZYNLONTA."

P1 data • Sales • B Acute Lymphoblastic Leukemia • Gastrointestinal Cancer • Hematological Malignancies • Leukemia • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Sarcoma • Solid Tumor

ADC Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Updates (GlobeNewswire) - "ADCT-602 (targeting CD22): Dose escalation and expansion in the Phase 1 study with relapsed or refractory acute lymphoblastic leukemia in collaboration with MD Anderson Cancer Center is progressing and additional clinical trial sites are being added to accelerate enrollment....ADCT-601 (targeting AXL): Additional data updates from the Phase 1 study in patients with sarcoma, pancreatic cancer and NSCLC in 2024. ADCT-602 (targeting CD22): Additional data from the Phase 1 study in 2024."

P1 data • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Sarcoma • Solid Tumor

ADCT-602, a novel PBD dimer-containing antibody-drug conjugate for treating CD22-positive hematological malignancies. (PubMed, Mol Cancer Ther) - P1/2 | "Combining ADCT-602 + pacritinib was beneficial in ADCT-602-resistant cells. Chidamide increased CD22 expression on B-cell tumor surfaces, increasing ADCT-602 activity. These data support clinical testing of ADCT-602 in R/R B-ALL (NCT03698552) and CD22-positive hematological cancers."

Journal • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Oncology • CD22 • IRAK1

ADC Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Updates (GlobeNewswire) - "ADCT-601 (targeting AXL): Initial data from Phase 1 study in 1H 2024; ADCT-901 (targeting KAAG1): Initial data from Phase 1 study in 1H 2024; ADCT-602 (targeting CD22): Additional data from Phase 1 study in 1H 2024."

P1 data • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Oncology • Solid Tumor

NCI-2018-02016: ADCT-602 in Treating Patients With Recurrent or Refractory B-cell Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P1/2 | N=65 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Dec 2023 ➔ Dec 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2025

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • CD22

ADC Therapeutics Reports Second Quarter 2023 Financial Results and Provides Business Updates (GlobeNewswire) - "ADCT-901 (targeting KAAG1): Initial data from Phase 1 study in 1H 2024. ADCT-601 (targeting AXL): Initial data from Phase 1 study in 1H 2024. ADCT-602 (targeting CD22): Additional data from Phase 1 study in 1H 2024....R&D expenses were $31.9 million for the quarter ended June 30, 2023, compared to $48.5 million for the same quarter in 2022. R&D expenses decreased due to less investment in Cami (camidanlumab tesirine) due to the completion of the Phase 2 study in 2022 and the Company’s decision to seek a partner to progress the program, as well as less investment in other development programs."

Commercial • P1 data • Oncology • Solid Tumor

Adct-602, a CD22 Targeting Antibody Drug Conjugate Bound to PBD Toxin in Adult Patients with Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia: A Phase 1 Trial (ASH 2022) - P1/2 | "The median age was 39 years (range, 21-82) and pts had received a median of 5 (range, 2-9) prior therapies [inotuzumab ozogamicin 12/21 (57%); blinatumomab 18/21 (86%); venetoclax 12/21 (57%)]. In this phase 1 study in pts with very heavily pretreated R/R B-ALL with a median of 5 prior lines of therapy and high baseline bone marrow tumor burden, single-agent ADCT-602 was well tolerated with one pt with DLT noted at the 50µg/kg weekly dose level. Notably, all 3 pts treated at this dose level had evidence of clinical activity with 2/3 pts achieving MRD negative CR. Due to 1 pt with DLT at this dose level, this cohort is being expanded to treat 3 additional pts."

Clinical • IO biomarker • P1 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Disorders • Hematological Malignancies • Hepatology • Leukemia • Oncology • Thrombocytopenia • CD19 • CD22 • JAK2 • KRAS • PAX5 • TP53

ADC Therapeutics Reports First Quarter 2023 Financial Results and Provides Business and Strategy Update (Businesswire) - "ADCT-602 (targeting CD22): Additional data from Phase 1 study in 1H 2024....R&D expenses were $39.5 million for the quarter ended March 31, 2023, compared to $49.0 million for the same quarter in 2022. R&D expenses decreased due to less investment in Cami and other programs."

Commercial • P1 data • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

[VIRTUAL] Analysis of Adct-602 Pre-Clinical Activity in B-Cell Lymphoma Models and Identification of Potential Biomarkers for Its Activity (ASH 2020) - P1/2 | "ADCT-602 is an antibody drug conjugate (ADC) composed of Emab-C220, an engineered version of the anti-CD22 humanized IgG1 antibody epratuzumab, site-specifically conjugated to SG3249, which includes the DNA minor groove crosslinking pyrrolobenzodiazepine (PBD) dimer SG3199 linked to the antibody via a protease-cleavable linker (Zammarchi et al, ASH 2016). Expression signatures and other features (MZL or DHT DLBCL histology), but not the expression levels of its target, were associated with different sensitivity to the ADC. Our data supports the clinical evaluation of ADCT-602 in patients with B-cell lymphoma in addition to B-ALL."

IO Biomarker • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukaemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Immunology • Inflammation • Leukemia • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • BCL2 • IL2 • MYC • STAT5 • TGFB1 • TP53

ADC Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Updates (Businesswire) - "Upcoming Expected Milestones....ADCT-212 (targeting PSMA): Initiate Phase 1 study in 1H 2024. ADCT-602 (targeting CD22): Complete Phase 1 dose expansion study in 1H 2024. ADCT-701 (targeting DLK-1): Initiate Phase 1 study in 2H 2023."

New P1 trial • Trial status • Oncology

NCI-2018-02016: ADCT-602 in Treating Patients With Recurrent or Refractory B-cell Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P1/2 | N=65 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Dec 2022 ➔ Dec 2023 | Trial primary completion date: Dec 2022 ➔ Dec 2023

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • CD22

A Phase 1 Trial of Adct-602, a CD22 Targeting Antibody Drug Conjugate Bound to PBD Toxin in Adult Patients with Relapsed or Refractory CD22+ B-Cell Acute Lymphoblastic Leukemia (ASH 2021) - P1/2 | "The median age was 39.5 years (range, 22-82) and pts had received a median of 5 (range, 2-7) prior therapies [inotuzumab ozogamicin 10/14 (71%); blinatumomab 13/14 (93%); venetoclax 10/14 (71%); CD19 CAR 5/14 (36%)]. In this Phase 1 study in pts with very heavily pretreated R/R B-ALL with a median of 5 prior lines of therapy and high baseline bone marrow tumor burden, single-agent ADCT-602 was well tolerated with no DLTs noted. Two pts achieved MRD-negative remission. Dose escalation in the weekly schedule continues and 2 additional dose levels (40µg/kg weekly and 50µg/kg weekly) are planned."

Clinical • IO biomarker • P1 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Hepatology • Leukemia • Oncology • Thrombocytopenia • Transplantation • CD19 • CD22 • NRAS • POMP

NCI-2018-02016: ADCT-602 in Treating Patients With Recurrent or Refractory B-cell Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P1/2; N=65; Recruiting; Sponsor: M.D. Anderson Cancer Center; Trial completion date: Dec 2021 ➔ Dec 2022; Trial primary completion date: Dec 2021 ➔ Dec 2022

Clinical • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • CD22

ADC Therapeutics Announces Abstracts to be Presented at the 63rd ASH Annual Meeting (Businesswire) - "ADC Therapeutics...today announced abstracts for ZYNLONTA® and ADCT-602 have been accepted for presentations at the 63rd American Society of Hematology (ASH) Annual Meeting, which will be held virtually and in Atlanta, Georgia from December 11-14, 2021....'This will include presentations from investigators on subset data from our pivotal Phase 2 study and data on the use of ZYNLONTA post-CAR-T. We are also encouraged by the anti-tumor activity and manageable safety profile of ZYNLONTA in combination with ibrutinib. The Phase 2 protocol has recently been amended with a higher and more frequent dose of ZYNLONTA to potentially enhance the response and to investigate this combination in earlier lines of therapy.'"

Clinical data • P1 data • P2 data • B Acute Lymphoblastic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

ADCT-602 in Treating Patients With Recurrent or Refractory B-cell Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P1/2; N=65; Recruiting; Sponsor: M.D. Anderson Cancer Center; Trial completion date: Dec 2020 ➔ Dec 2021; Trial primary completion date: Dec 2020 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukaemia • Hematological Malignancies • Leukemia • Oncology

ADC Therapeutics and Overland Pharmaceuticals Announce Formation of Overland ADCT BioPharma to Develop and Commercialize Lonca and other ADCs for Hematologic and Solid Tumor Indications in Greater China and Singapore (Businesswire) - "ADC Therapeutics SA...and Overland Pharmaceuticals...today announced that they have jointly formed a new company, Overland ADCT BioPharma (CY) Limited, to develop and commercialize four of ADC Therapeutics’ antibody drug conjugate (ADC) product candidates for difficult-to-treat hematologic and solid tumors – loncastuximab tesirine (Lonca), ADCT-601, ADCT-602 and ADCT-901 – in greater China and Singapore...'As we prepare for the potential U.S. launch of Lonca in 2021...'"

Launch US • M&A • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Oncology • Solid Tumor

ADC Therapeutics Announces Eight Presentations on Data from its Next-Generation Antibody Drug Conjugates at the 62nd American Society of Hematology Annual Meeting (Businesswire) - "ADC Therapeutics SA...today announced that eight abstracts have been selected for presentation at the 62nd American Society of Hematology (ASH) Annual Meeting, which is being held virtually from December 5-8, 2020. Presentations will feature data on three of the Company’s pyrrolobenzodiazepine (PBD)-based ADCs – loncastuximab tesirine (Lonca), camidanlumab tesirine (Cami) and ADCT-602...we look forward to sharing subgroup data from the Lonca LOTIS 2 pivotal trial in relapsed or refractory diffuse large B-cell lymphoma, interim results from our LOTIS 3 trial evaluating Lonca in combination with ibrutinib in patients with advanced diffuse large B-cell lymphoma or mantle cell lymphoma, as well as preliminary results from our pivotal Phase 2 trial of Cami in patients with relapsed or refractory Hodgkin lymphoma"

Clinical data • P1/2 data • P2 data • Preclinical • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology

ADC Therapeutics Reports Second Quarter 2020 Financial Results and Provides Recent Business Highlights (Businesswire) - "Anticipated Upcoming Milestones: File a BLA with the FDA for Lonca for the treatment of relapsed or refractory DLBCL in the second half of 2020. Present data from the Phase 1b trial of Cami in selected advanced solid tumors at a scientific meeting in the second half of 2020. Initiate a pivotal Phase 2 trial of Lonca in follicular lymphoma (FL) in the first half of 2021. Report interim results from the pivotal Phase 2 trial of Cami in HL in the first half of 2021. Continue to accelerate the Company’s pipeline of ADC product candidates for the treatment of hematological cancers and solid tumors, including presenting Phase 1 data for ADCT-602 in acute lymphoblastic leukemia and ADCT-601 in solid tumors. Continue to advance our earlier-stage programs, ADCT-901 and ADCT-701, with IND-enabling studies."

BLA • IND • New P2 trial • P1 data • P2 data • Acute Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

ADC Therapeutics Announces Presentations at the 15th International Conference on Malignant Lymphoma (GlobeNewswire, ADC Therapeutics SA) - ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of antibody drug conjugates (ADCs), today announced that data on ADCT-402 (loncastuximab tesirine) and ADCT-301 (camidanlumab tesirine) have been selected for four presentations at the 15th International Conference on Malignant Lymphoma (15-ICML), which is being held June 18-22, 2019, in Lugano, Switzerland. Jay Feingold, MD, PhD, Chief Medical Officer and Senior Vice President of Clinical Development at ADC Therapeutics, said, “We are pleased to be presenting compelling data at 15-ICML from our 183-patient Phase I clinical trial of ADCT-402 in relapsed or refractory B-cell lymphoma (including 139 patients with diffuse large B-cell lymphoma), as well as our 128-patient Phase I clinical trial of ADCT-301 in relapsed or refractory Hodgkin and non-Hodgkin lymphoma (including 77 patients with Hodgkin lymphoma). we plan to commence a pivotal Phase II trial of ADCT-301 later this summer.

Clinical data • Preclinical