EBMT

Galapagos showcases innovative approach in hematological cancer care with clinical and translational data presentations at EBMT congress 2024

Retrieved on: 
Thursday, April 4, 2024
Symantec Endpoint Protection, CLL, Safety, RT, Patient, EBMT, NHL, Euronext, Efficacy, Abstract, CD19, Pharmaceutical industry

ATALANTA-1 and EUPLAGIA-1 are ongoing Phase 1/2 open-label, multi-center studies designed to assess the safety, efficacy and feasibility of point-of-care manufactured GLPG5101 and GLPG5201 in patients with relapsed/refractory NHL, and relapsed/refractory CLL and RT, respectively.

Key Points: 
  • ATALANTA-1 and EUPLAGIA-1 are ongoing Phase 1/2 open-label, multi-center studies designed to assess the safety, efficacy and feasibility of point-of-care manufactured GLPG5101 and GLPG5201 in patients with relapsed/refractory NHL, and relapsed/refractory CLL and RT, respectively.
  • The primary objective of the Phase 1 part of the studies is to evaluate the safety and preliminary efficacy to determine the recommended dose for the Phase 2 part of the study.
  • GLPG5101 and GLPG5201 are second generation anti-CD19/4-1BB CAR-T product candidates, administered as a single fixed intravenous dose.
  • “We are committed to accelerating breakthrough innovations to extend the reach of CAR-T therapies to patients with rapidly progressing cancers,” said Dr. Jeevan Shetty, M.D., Head of Clinical Development Oncology at Galapagos.

MaaT Pharma Announces 2023 Annual Results and Provides a Business Overview

Retrieved on: 
Thursday, March 28, 2024
Biotechnology, Pharmaceutical, Finance, Oncology, Health, FDA, Professional Services, Clinical Trials, AP-HP, Bone marrow, Survival, Immunotherapy, Patient, Innovation, IND, Ipilimumab, European Medicines Agency, Therapy, Artificial intelligence, Charcot disease, ASH, EMA, Head, MET, Investigational New Drug, Nivolumab, Safety, SITC, Microbiome, Food, ODD, Development, Acceleration, Maat, ARES, Cancer, AACR, DSMB, Haematopoietic system, Annual general meeting, OS, EUR, Physician, CIMON, CGMP, EAP, EBMT, ICI, Society, Randomized controlled trial, Symantec Endpoint Protection, Pharmaceutical industry

MaaT Pharma (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival of patients with cancer, today reported the full-year 2023 annual results and provided a business overview.

Key Points: 
  • MaaT Pharma (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival of patients with cancer, today reported the full-year 2023 annual results and provided a business overview.
  • In December 2023 , the Company presented positive results from the Early Access Program (EAP) in Europe involving 111 patients with aGvHD treated with MaaT013, at the 2023 American Society of Hematology (ASH) Annual Meeting.
  • In April 2023 , data from the Phase 1b study (CIMON) with MaaT033, previously communicated during the 64th annual ASH meeting, were also presented at the EBMT 2023 conference.
  • During 2023 and Q1 2024, MaaT Pharma reinforced its board of directors, executive team, and key functions:
    Karim Dabbagh as Chairman and Nadia Kamal as Director, both independent.

Galapagos announces full year 2023 results and outlook for 2024

Retrieved on: 
Thursday, February 22, 2024
Technology transfer, CD19, Filgotinib, Lupus, Multiple myeloma, DL2, Dermatomyositis, Acceleration, Baltic, BCMA, Mantle cell lymphoma, European Commission, Indolent lymphoma, JAK1, Safety, EBMT, RT, TYK2, CFO, PRAC, MAA, Richter's transformation, Euronext, Executive Committee, JAK, UC, Patient, SLE, Pharmaceutical industry

In addition, we entered into a strategic collaboration with BridGene Biosciences to advance our growing early-stage pipeline in precision oncology.

Key Points: 
  • In addition, we entered into a strategic collaboration with BridGene Biosciences to advance our growing early-stage pipeline in precision oncology.
  • Signed an agreement with Boston-based Landmark Bio and started the technology transfer for the decentralized production of Galapagos’ CAR-T cell therapy candidates.
  • Further streamlined our operations with a reduction of approximately 100 positions across the Galapagos organization to align with the Galapagos’ renewed focus on innovation.
  • Signed a strategic collaboration and license agreement with BridGene Biosciences to further strengthen Galapagos' growing early-stage oncology precision medicine pipeline.

Galapagos presents at EBMT-EHA annual meeting 2024

Retrieved on: 
Thursday, February 15, 2024
Blood, Galapagos NV, European, Safety, Richter's transformation, CD19, Euronext, Multiple myeloma, EHA, DL2, EBMT, RT, Patient, Efficacy

Mechelen, Belgium; 15 February 2024, 22:01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) to present new preliminary translational data and previously disclosed data at the European Society for Blood and Marrow Transplantation (EBMT)-European Hematology Association (EHA) 6th European CAR T-cell meeting taking place from 15–17 February 2024 in Valencia, Spain.

Key Points: 
  • Mechelen, Belgium; 15 February 2024, 22:01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) to present new preliminary translational data and previously disclosed data at the European Society for Blood and Marrow Transplantation (EBMT)-European Hematology Association (EHA) 6th European CAR T-cell meeting taking place from 15–17 February 2024 in Valencia, Spain.
  • Further, previously disclosed safety, efficacy and feasibility data from EUPLAGIA-1 and ATALANTA-1 support the potential of Galapagos’ innovative approach to CAR-T manufacturing and of the transformational impact on patients with severe hematologic cancers.
  • “At Galapagos, we are committed to accelerating transformative innovation to address the unmet needs of patients with advanced cancers, and the data we are presenting today demonstrates our positive momentum toward this goal,” said Dr Jeevan Shetty, M.D., Head of Clinical Development Oncology at Galapagos.
  • Moreover, the abundance of both CD4+ and CD8+ TN/SCM CAR-T cells in the final product correlated with CAR-T-cell exposure in patients.

ExCellThera Announces Positive Phase 2 Study Results from UM171 Cell Therapy in Patients with High-risk Leukemias and Myelodysplasias at American Society of Hematology (ASH) 2023 Annual Meeting

Retrieved on: 
Tuesday, December 12, 2023
Survival, TP53, Mortality, DSM-IV codes, Progression-free survival, Disease, Incidence, Society, Recurrence, Haematopoietic system, EBMT, ASH, Associate professor, Patient, Research fellow, Pharmaceutical industry

MONTREAL, Dec. 12, 2023 (GLOBE NEWSWIRE) -- ExCellThera Inc. (ExCellThera), a world leader in blood stem cell expansion and metabolic fitness, announced today positive results from 50 patients in two multi-center Phase 2 trials for UM171 cell therapy conducted at transplant centers in the U.S., Canada and Europe, building on prior strong data from a Phase 1/2 trial and comparative registry studies (CIBMTR and EBMT).

Key Points: 
  • “In these UM171 Phase 2 studies, about 70% of patients survived two years post-transplant without evidence of disease recurrence.
  • These outcomes are encouraging considering that 30% of the enrolled patients did not benefit from previous stem cell transplantation.
  • “We are very excited to share the positive Phase 2 results for UM171 cell therapy, building on strong data from our Phase 1/2 trial and comparative registry studies.
  • We believe this establishes UM171 cell therapy as a potential treatment options for high-risk leukemias and myelodysplasias based on its combined efficacy and safety profile.

Immix Biopharma Announces FDA Approval of IND Application for CAR-T NXC-201, Enabling U.S. Patient Dosing

Retrieved on: 
Tuesday, November 21, 2023
Exposition, Food, IND, Autoimmunity, CCR, FDA, Cell, IMS, Multiple myeloma, BCMA, MD, Gene, Society, Amyloidosis, EBMT, Investigational New Drug, AL amyloidosis, ASH, LOS, Clinical Cancer Research, Patient, Publication, Pharmaceutical industry

With this clearance, NEXICART-2 (NCT06097832) is to expand studies of NXC-201 in relapsed/refractory AL Amyloidosis to the United States.

Key Points: 
  • With this clearance, NEXICART-2 (NCT06097832) is to expand studies of NXC-201 in relapsed/refractory AL Amyloidosis to the United States.
  • “Building on encouraging NXC-201 clinical data to-date, we are thrilled that multiple leading U.S. sites are currently planning to enroll patients in the coming months,” said Ilya Rachman, MD PhD, Chief Executive Officer of Immix Biopharma.
  • “We credit our world-class cell-therapy expert team in achieving this IND clearance in-line with our previously communicated timelines,” said Gabriel Morris, Chief Financial Officer of Immix Biopharma.
  • “NXC-201’s favorable tolerability profile, including overcoming neurotoxicity, potentially enables expansion beyond AL Amyloidosis into autoimmune indications.”

Immix Biopharma Announces FDA Approval of IND Application for CAR-T NXC-201, Enabling U.S. Patient Dosing

Retrieved on: 
Tuesday, November 21, 2023
Exposition, Food, IND, Autoimmunity, CCR, FDA, Cell, IMS, Multiple myeloma, BCMA, MD, Gene, Society, Amyloidosis, EBMT, Investigational New Drug, AL amyloidosis, ASH, LOS, Clinical Cancer Research, Patient, Publication, Pharmaceutical industry

With this clearance, NEXICART-2 (NCT06097832) is to expand studies of NXC-201 in relapsed/refractory AL Amyloidosis to the United States.

Key Points: 
  • With this clearance, NEXICART-2 (NCT06097832) is to expand studies of NXC-201 in relapsed/refractory AL Amyloidosis to the United States.
  • “Building on encouraging NXC-201 clinical data to-date, we are thrilled that multiple leading U.S. sites are currently planning to enroll patients in the coming months,” said Ilya Rachman, MD PhD, Chief Executive Officer of Immix Biopharma.
  • “We credit our world-class cell-therapy expert team in achieving this IND clearance in-line with our previously communicated timelines,” said Gabriel Morris, Chief Financial Officer of Immix Biopharma.
  • “NXC-201’s favorable tolerability profile, including overcoming neurotoxicity, potentially enables expansion beyond AL Amyloidosis into autoimmune indications.”

Nexcella Announces FDA Approval of IND Application for CAR-T NXC-201, Enabling U.S. Patient Dosing

Retrieved on: 
Tuesday, November 21, 2023
Exposition, Food, IND, Autoimmunity, CCR, FDA, Cell, IMS, Multiple myeloma, BCMA, MD, Gene, Society, Amyloidosis, EBMT, Investigational New Drug, AL amyloidosis, ASH, LOS, Clinical Cancer Research, Patient, Publication, Pharmaceutical industry

LOS ANGELES, Nov. 21, 2023 (GLOBE NEWSWIRE) -- Nexcella, Inc. (“Nexcella”, “Company”, “We” or “Us”), a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for BCMA CAR-T NXC-201 (formerly HBI0101). With this clearance, NEXICART-2 (NCT06097832) is to expand studies of NXC-201 in relapsed/refractory AL Amyloidosis to the United States. Favorable tolerability enables potential expansion into autoimmune indications.

Key Points: 
  • With this clearance, NEXICART-2 (NCT06097832) is to expand studies of NXC-201 in relapsed/refractory AL Amyloidosis to the United States.
  • Favorable tolerability enables potential expansion into autoimmune indications.
  • “We credit our world-class cell-therapy expert team in achieving this IND clearance in-line with our previously communicated timelines,” said Gabriel Morris, President of Nexcella.
  • “NXC-201’s favorable tolerability profile, including overcoming neurotoxicity, potentially enables expansion beyond AL Amyloidosis into autoimmune indications.”

Autolus Therapeutics Reports Third Quarter 2023 Financial Results and Business Updates

Retrieved on: 
Thursday, November 2, 2023
SLE, Patient, FDA, EBMT, Medical Affairs Bureau, Trial of the century, Research, CAR, Multiple myeloma, Financial result, CD19, European Medicines Agency, Conference, UCL, Society, Program management, ASH, Senior, MHRA, MRD, Canadian Aviation Regulations, EMA, Nucleus, Autoimmune disease, Hand, European Society of Clinical Microbiology and Infectious Diseases, Conference call, Therapy, BCMA, Blackstone, ALL, BLA, Nature Medicine, GD2, Construction, Pharmaceutical industry, Nursing, Vaccine, Payment card, Cryptocurrency, EU, Blood

Patients continue to be enrolled and initial data will be presented at ASH in December 2023.

Key Points: 
  • Patients continue to be enrolled and initial data will be presented at ASH in December 2023.
  • Financial Results for the Third Quarter Ended September 30, 2023
    Cash and cash equivalents at September 30, 2023, totaled $256.4 million, as compared to $382.4 million at December 31, 2022.
  • Autolus estimates that its current cash and cash equivalents on hand and anticipated future milestone payment from Blackstone will extend the Company’s cash runway into 2025.
  • Unaudited Financial Results for the Third Quarter Ended September 30, 2023

IN8bio Completes Dose Escalation in Phase 1 Trial of INB-100, a Potential First-in-Class Gamma-Delta T Cell Therapy for the Treatment of Leukemias, and Initiates Enrollment for the Phase 2 Trial of INB-400 in Newly Diagnosed Glioblastoma

Retrieved on: 
Thursday, October 12, 2023
ASH, GBM, Glioblastoma, ORR, Cleveland Clinic, OS, Society, University of Louisville School of Medicine, Safety, University, HSCT, FDA, Brain, Clinical trial, Immune system, Leukemia, PFS, EBMT, TTP, Hematopoietic stem cell transplantation, European Society for Medical Oncology, Graft-versus-host disease, Progression-free survival, Patient, Pharmaceutical industry, Medical imaging

“Our novel, synergistic immunotherapy approach has demonstrated promising early clinical results in patients with unmet medical needs.

Key Points: 
  • “Our novel, synergistic immunotherapy approach has demonstrated promising early clinical results in patients with unmet medical needs.
  • The primary endpoints of this trial are safety and tolerability, and secondary endpoints include rates of graft versus host disease (GvHD), relapse rate and OS.
  • The University of Louisville and The Cleveland Clinic are the first clinical sites activated to enroll patients.
  • INB-400 was granted Orphan Drug Designation by the FDA in April 2023, marking the first genetically modified gamma-delta T cell therapy to receive this regulatory designation.