European Hematology Association

Disc Presents Positive Initial Data from Phase 2 BEACON Trial of Bitopertin in Patients with Erythropoietic Protoporphyria (EPP) at European Hematology Association (EHA) 2023 Congress

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Friday, June 9, 2023
EPIQ, Sodium- and chloride-dependent glycine transporter 1, Protoporphyrin IX, European Hematology Association, Metallicity, Disc, Week, EPP, Bitopertin, Quality of life, First grade, Pain, Congress, Sunlight, IRON, Patient, Erythropoietic protoporphyria, EHA, XLP, Photosensitivity, Poster, Safety, Disease, Pharmaceutical industry, Medical device, Sewage treatment, PPIX

The initial trial data demonstrated consistent decreases in PPIX, significant increases in reported sunlight tolerance and improvements in measures of patient quality of life.

Key Points: 
  • The initial trial data demonstrated consistent decreases in PPIX, significant increases in reported sunlight tolerance and improvements in measures of patient quality of life.
  • “We’re delighted to share these initial, positive data from BEACON, which provide the first clinical evidence supporting our therapeutic hypothesis of bitopertin in EPP.
  • Due to batch processing of samples, the data cutoff for PPIX data was April 7, 2023.
  • Management will host a call to review the presented data on Friday, June 9th at 7:30 am ET.

Editas Medicine Announces Positive Initial EDIT-301 Safety and Efficacy Data from the First Four Patients Treated in the RUBY Trial and the First Patient Treated in the EdiTHAL Trial

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Friday, June 9, 2023
Male, HBF, Blood, Senior, European Hematology Association, Life, Event, OH, Gene editing, SCD, Clinical trial, Aes, RAF Sullom Voe, Female, EDT, Editas Medicine, Șaeș, American Society of Pediatric Hematology/Oncology, Fetal hemoglobin, MD, Patient, Anemia, Busulfan, EHA, Sickle cell disease, Safety, Pharmaceutical industry, Nursing, Edith A. Perez

ET

Key Points: 
  • ET
    Company to host a virtual event on the RUBY and EdiTHAL data on Monday, June 12 at 8:00 a.m.
  • Editas Medicine will present the RUBY trial data and the EdiTHAL trial data on Monday, June 12, at 8 a.m.
  • All four treated patients in the RUBY trial are free from vaso-occlusive events since infusion with EDIT-301, with 2-10 months follow-up.
  • EDIT-301 is currently being investigated in clinical studies in patients with severe sickle cell disease (RUBY trial, NCT04853576) and transfusion-dependent beta thalassemia (EDITHAL trial, NCT05444894).

Successful Primary Engraftment of Trem-cel in First Five AML Patients Demonstrates Promise of Vor Bio’s Platform

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Friday, June 9, 2023
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“Based on this interim update of five patients treated, we remain confident in the potential of our approach to enable targeted therapies post-transplant.

Key Points: 
  • “Based on this interim update of five patients treated, we remain confident in the potential of our approach to enable targeted therapies post-transplant.
  • Investigator enthusiasm is strong and proposal of patients for enrollment in the study currently exceeds the enrollment stagger.
  • We look forward to sharing further engraftment and hematologic protection data from additional patients treated by year-end,” said Eyal Attar, MD, Vor Bio Chief Medical Officer.
  • Patients 4 and 5 achieved normal neutrophil engraftment and platelet recovery, providing further confidence in the Company’s platform and approach.

Kymera Therapeutics Presents Data Demonstrating Superior Efficacy of KT-253, a Potent and Selective Heterobifunctional MDM2 Degrader, Compared to Small Molecule Inhibitor in Preclinical Leukemia Models at the European Hematology Association Congress

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Friday, June 9, 2023
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The data will be presented at the European Hematology Association (EHA) Congress, taking place from June 8-15, 2023, in Frankfurt, Germany.

Key Points: 
  • The data will be presented at the European Hematology Association (EHA) Congress, taking place from June 8-15, 2023, in Frankfurt, Germany.
  • KT-253 targets MDM2, the crucial regulator of the most common tumor suppressor, p53.
  • p53 remains intact (wild type) in close to 50% of cancers, meaning that it retains its ability to modulate cancer cell growth.
  • Patients in the KT-253 Phase 1 dose escalation study will receive IV doses of KT-253 administered once every 3 weeks.

ADC Therapeutics Announces Updated LOTIS-2 Results Demonstrating Durable, Long-Term Responses of ZYNLONTA® in Relapsed/Refractory DLBCL

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Friday, June 9, 2023
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LAUSANNE, Switzerland, June 09, 2023 (GLOBE NEWSWIRE) -- ADC Therapeutics SA (NYSE: ADCT) today announced updated results from LOTIS-2, the pivotal Phase 2 clinical trial of ZYNLONTA® (loncastuximab tesirine-lpyl) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).

Key Points: 
  • LAUSANNE, Switzerland, June 09, 2023 (GLOBE NEWSWIRE) -- ADC Therapeutics SA (NYSE: ADCT) today announced updated results from LOTIS-2, the pivotal Phase 2 clinical trial of ZYNLONTA® (loncastuximab tesirine-lpyl) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).
  • “We’re pleased to be sharing updated LOTIS-2 results demonstrating the long‐term efficacy and safety of ZYNLONTA with the lymphoma community at EHA2023 and 17-ICML,” said Mohamed Zaki, MD, PhD, Chief Medical Officer of ADC Therapeutics.
  • The median (range) time to response was 41.0 (35 to 247) days for all responders and 42.0 (36 to 247) days for patients with a CR.
  • All-grade treatment‐emergent adverse events occurring in ≥30% of all patients were increased gamma-glutamyltransferase (42%), neutropenia (40%), and thrombocytopenia (33%).

Editas Medicine to Host Virtual Event to Discuss EDIT-301 Clinical Data from the RUBY Trial for Severe Sickle Cell Disease and the EDITHAL Trial for Transfusion-dependent Beta Thalassemia

Retrieved on: 
Tuesday, June 6, 2023
European Hematology Association, Event, Clinical trial, Sullom Voe Terminal, EDT, Fetal hemoglobin, Patient, EHA, Sickle cell disease, Safety, Pharmaceutical industry

ET to present clinical data from the RUBY trial of EDIT-301 for the treatment of severe sickle cell disease.

Key Points: 
  • ET to present clinical data from the RUBY trial of EDIT-301 for the treatment of severe sickle cell disease.
  • The Company will also present initial clinical data from the EDITHAL trial of EDIT-301 for the treatment of transfusion-dependent beta thalassemia.
  • The webinar follows the oral presentation of the RUBY clinical trial update at the European Hematology Association (EHA) Hybrid Congress in Frankfurt, Germany, and via live stream.
  • Initial safety data from one patient treated in the EDITHAL trial with 1.5 months follow-up, including neutrophil and platelet engraftment, and initial efficacy data covering total hemoglobin and fetal hemoglobin post-EDIT-301 infusion.

New Data Show Genentech’s Subcutaneously Administered Crovalimab Achieved Disease Control and Was Well-Tolerated in People With Paroxysmal Nocturnal Hemoglobinuria (PNH)

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Friday, June 9, 2023
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Crovalimab has been engineered to be recycled within the bloodstream, enabling sustained complement inhibition through low-dose, subcutaneous (SC) administration every four weeks.

Key Points: 
  • Crovalimab has been engineered to be recycled within the bloodstream, enabling sustained complement inhibition through low-dose, subcutaneous (SC) administration every four weeks.
  • Additionally, 65.7% (95% CI: 56.9, 73.5) achieved transfusion avoidance (TA) from baseline to week 25 with crovalimab and 68.1% (95% CI: 55.7, 78.5) with eculizumab.
  • The results from the COMMODORE 1 study indicate that crovalimab maintained disease control in people switching from currently approved complement inhibitors.
  • Global Phase III data from the COMMODORE 1 and 2 studies in PNH will be submitted to regulatory authorities around the world.

ImmunoGen Presents Updated Findings from CADENZA Trial of Pivekimab Sunirine in Blastic Plasmacytoid Dendritic Cell Neoplasm at EHA 2023 Congress

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Friday, June 9, 2023
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ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced updated data from an interim analysis of the Phase 2 CADENZA trial of pivekimab sunirine (pivekimab) in patients with frontline and relapsed/refractory (R/R) blastic plasmacytoid dendritic cell neoplasm (BPDCN).

Key Points: 
  • ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced updated data from an interim analysis of the Phase 2 CADENZA trial of pivekimab sunirine (pivekimab) in patients with frontline and relapsed/refractory (R/R) blastic plasmacytoid dendritic cell neoplasm (BPDCN).
  • The data will be presented in an oral session on Sunday, June 11 at the European Hematology Association (EHA) 2023 Congress in Frankfurt, Germany.
  • The CADENZA trial is enrolling frontline BPDCN patients, including those with de novo disease and those with a prior or concomitant hematologic malignancy (PCHM).
  • As of the May 19, 2023 data cutoff, data were available for 79 BPDCN patients (30 frontline, 49 R/R).

Wugen Presents Initial Data from First-in-Human Phase 1/2 Trial of WU-CART-007 at the European Hematology Association (EHA) 2023 Congress

Retrieved on: 
Friday, June 9, 2023
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“We are very encouraged by these initial safety and efficacy data from our ongoing Phase 1/2 trial of WU-CART-007 in patients with R/R T-ALL/LBL,” said Jan Davidson-Moncada, M.D., Ph.D., Chief Medical Officer of Wugen.

Key Points: 
  • “We are very encouraged by these initial safety and efficacy data from our ongoing Phase 1/2 trial of WU-CART-007 in patients with R/R T-ALL/LBL,” said Jan Davidson-Moncada, M.D., Ph.D., Chief Medical Officer of Wugen.
  • Many children and adults relapse after first line therapy and are left with very limited treatment options thereafter, often leading to high mortality.
  • Prior to enrollment, all patients had been heavily pretreated, with a median of 5 prior lines of therapy.
  • No cases of Graft versus Host Disease (GvHD), prolonged T-cell aplasia, or pancytopenia in the absence of disease were reported.

Immune-Onc Therapeutics Presents IO-202 Phase 1 Data in Patients with Relapsed or Refractory AML and CMML at the EHA Annual Meeting 2023

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Thursday, June 8, 2023
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Data from the dose escalation part of the Phase 1 study evaluating patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) and chronic myelomonocytic leukemia (CMML) will be presented during a poster session at the European Hematology Association (EHA) Annual Meeting in Frankfurt, Germany on June 9, 2023.

Key Points: 
  • Data from the dose escalation part of the Phase 1 study evaluating patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) and chronic myelomonocytic leukemia (CMML) will be presented during a poster session at the European Hematology Association (EHA) Annual Meeting in Frankfurt, Germany on June 9, 2023.
  • “AML is the most common form of acute leukemia in adults in the U.S. and is characterized by high rates of relapsed and refractory disease.
  • Monocytic AML is especially in need of break-through medicine as it is often resistant to standard-of-care treatment.
  • Poster presentation details are as follows:
    Title: A first-in-human Phase 1 study of IO-202 (anti-LILRB4 mAb) in Acute Myeloid Leukemia (AML) with monocytic differentiations and Chronic Myelomonocytic Leukemia (CMML) patients.