Hematopoietic stem cell transplantation

MaaT Pharma Announces Publication of Results in eClinicalMedicine Journal Highlighting Clinical Benefit of MaaT013 in aGvHD

Retrieved on: 
Wednesday, July 26, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, Graft-versus-host disease, EAP, Hematology, Survival, Cancer, Microbiota, ARES, Patient, MET, Hospital, Execute Direct Access Program, Sorbonne University, Society, Hematopoietic stem cell transplantation, Pharmaceutical industry

The data includes results from 24 patients in a Phase 2 clinical trial and 52 patients enrolled in the Early Access Program (EAP) in France.

Key Points: 
  • The data includes results from 24 patients in a Phase 2 clinical trial and 52 patients enrolled in the Early Access Program (EAP) in France.
  • "Data show encouraging clinical outcomes and survival rates for very severe patients with acute GvHD, thereby opening new treatment avenues," said Pr.
  • "Based on this promising clinical data, including the good tolerability and safety profile, we eagerly anticipate the results of the ongoing evaluation of MaaT013 in Phase 3."
  • "The publication of our results in a peer-reviewed journal underlines the importance of the microbiome in the hematology-oncology field.

Nexcella Announces NXC-201 Multiple Myeloma Clinical Data Abstract Accepted for Presentation at the 20th International Myeloma Society Annual Meeting

Retrieved on: 
Tuesday, July 25, 2023
Multiple myeloma, Hadassah Medical Center, Hematopoietic stem cell transplantation, AL, Medical device, Immunotherapy

LOS ANGELES, July 25, 2023 (GLOBE NEWSWIRE) -- Nexcella, Inc. (“Nexcella”, “Company”, “We” or “Us”), today announced that updated NXC-201 relapsed/refractory multiple myeloma clinical data has been selected for presentation at the upcoming 20th International Myeloma Society Annual Meeting to be held in Athens, Greece, September 27-30, 2023.

Key Points: 
  • LOS ANGELES, July 25, 2023 (GLOBE NEWSWIRE) -- Nexcella, Inc. (“Nexcella”, “Company”, “We” or “Us”), today announced that updated NXC-201 relapsed/refractory multiple myeloma clinical data has been selected for presentation at the upcoming 20th International Myeloma Society Annual Meeting to be held in Athens, Greece, September 27-30, 2023.
  • “We are delighted to continue to see U.S. and international recognition of the progress we are making,” said Polina Stepensky, M.D., Director of the Hadassah Medical Organization’s Department of Bone Marrow Transplantation and Immunotherapy for Adults and Children, and NXC-201 principal study investigator.
  • “We are pleased to present clinical data in relapsed multiple myeloma at the upcoming International Myeloma Society Annual Meeting, an important international forum for discussion of novel treatments for multiple myeloma and AL Amyloidosis.”
    Event: 20th International Myeloma Society Annual Meeting, Athens, Greece

Immix Biopharma Subsidiary Nexcella Announces NXC-201 Multiple Myeloma Clinical Data Abstract Accepted for Presentation at the 20th International Myeloma Society Annual Meeting

Retrieved on: 
Tuesday, July 25, 2023
Multiple myeloma, Hadassah Medical Center, Hematopoietic stem cell transplantation, AL, Medical device, Immunotherapy

LOS ANGELES, July 25, 2023 (GLOBE NEWSWIRE) -- Nexcella, Inc., a subsidiary of Immix Biopharma, Inc. (“Nexcella”, “Company”, “We” or “Us”), today announced that updated NXC-201 relapsed/refractory multiple myeloma clinical data has been selected for presentation at the upcoming 20th International Myeloma Society Annual Meeting to be held in Athens, Greece, September 27-30, 2023.

Key Points: 
  • LOS ANGELES, July 25, 2023 (GLOBE NEWSWIRE) -- Nexcella, Inc., a subsidiary of Immix Biopharma, Inc. (“Nexcella”, “Company”, “We” or “Us”), today announced that updated NXC-201 relapsed/refractory multiple myeloma clinical data has been selected for presentation at the upcoming 20th International Myeloma Society Annual Meeting to be held in Athens, Greece, September 27-30, 2023.
  • “We are delighted to continue to see U.S. and international recognition of the progress we are making,” said Polina Stepensky, M.D., Director of the Hadassah Medical Organization’s Department of Bone Marrow Transplantation and Immunotherapy for Adults and Children, and NXC-201 principal study investigator.
  • “We are pleased to present clinical data in relapsed multiple myeloma at the upcoming International Myeloma Society Annual Meeting, an important international forum for discussion of novel treatments for multiple myeloma and AL Amyloidosis.”
    Event: 20th International Myeloma Society Annual Meeting, Athens, Greece

Akari Therapeutics Provides Updates on Development of Nomacopan in Pediatric and Adult HSCT-TMA

Retrieved on: 
Thursday, July 13, 2023
Consensus, Center for International Blood and Marrow Transplant Research, PRV, Blood, Priority review, Medical diagnosis, European Medicines Agency, Food and Drug Administration, NDA, EMA, Transplant, Orphan drug, Patient, Cincinnati Children's Hospital Medical Center, Akari, Diagnosis, Mortality, European Society for Medical Oncology, FDA, Therapy, Safety, BLA, Hematopoietic stem cell transplantation, Food, TMA, Pharmaceutical industry, Dentistry

NEW YORK and LONDON, July 13, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced updates in the development programs investigating nomacopan in pediatric and adult hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA).

Key Points: 
  • NEW YORK and LONDON, July 13, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced updates in the development programs investigating nomacopan in pediatric and adult hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA).
  • Akari also is planning to move forward into a Phase 3 double-blind placebo-controlled clinical trial of nomacopan in adult HSCT-TMA and to open enrollment in 2024.
  • Akari is advancing into Phase 3 open-label single-arm study of nomacopan in pediatric HSCT-TMA and is planning to move into a Phase 3 double-blind placebo-controlled study of nomacopan in adult HSCT-TMA in 2023 and 2024, respectively.
  • Orphan Drug, Fast Track, and Rare Pediatric Disease designations have been granted by the FDA for nomacopan in pediatric HSCT-TMA.

Akari Therapeutics Receives Positive Opinion on Orphan Drug Designation from the European Medicines Agency for Nomacopan for Treatment in Hematopoietic Stem Cell Transplantation

Retrieved on: 
Thursday, July 6, 2023
Civil service commission, European Medicines Agency, COMP, Committee, EMA, Patient, Akari, Mortality, Therapy, EC, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Hematopoietic stem cell transplantation, Food, European Commission, Pharmaceutical industry

The application included nomacopan clinical data from the treatment of patients with pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA).

Key Points: 
  • The application included nomacopan clinical data from the treatment of patients with pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA).
  • Typically, the European Commission (EC) grants orphan drug designation 30 days after a positive opinion is issued.
  • The EMA designates orphan drug status for medicines treating rare, life-threatening, or chronically debilitating diseases that meet certain criteria.
  • The EMA orphan drug designation, if granted, will be an important addition to the Rare Pediatric Disease, Orphan Drug, and Fast Track designations already granted to nomacopan in pediatric HSCT-TMA by the U.S. Food and Drug Administration.

Ochsner Health and MD Anderson Announce Partnership to Create Fully Integrated Cancer Program in Louisiana

Retrieved on: 
Thursday, June 22, 2023
Partnership, Education, U.S. News & World Report Best Hospitals Rankings, Ochsner Health System, Commission, American Society of Clinical Oncology, Therapy, Cancer, Hope, Head, Research, Monroe Dunaway Anderson, Prostate, Neck, MD Anderson Cancer Center, Lung, U.S. News & World Report, Social, Organization, Nose, Adrian Dixon, Hospital, Estate (law), Patient, National Accreditation Program for Rectal Cancer, Physician, Anderson, Accreditation, FACS, Nutritionist, Diagnosis, American College, Health, Society, News, Hematopoietic stem cell transplantation, Pharmaceutical industry, Nursing, Ochsner

NEW ORLEANS and HOUSTON, June 22, 2023 /PRNewswire/ -- Ochsner Health and The University of Texas MD Anderson Cancer Center today announced a partnership to create Ochsner MD Anderson Cancer Center in southeastern Louisiana. Cancer patients in the region now have access to cancer treatments that are among the most advanced in the nation. Through this collaboration, Ochsner is the first and only provider in Louisiana with a fully integrated cancer program based on MD Anderson's standards and treatment plans.

Key Points: 
  • "As part of our ongoing commitment to providing world-renowned cancer care close to home, Ochsner is thrilled to join forces with MD Anderson to offer groundbreaking research and innovative therapies not found anywhere else in our region," said Brian Moore, M.D., FACS, medical director, Ochsner MD Anderson Cancer Center.
  • "Our patients can be confident that they will receive an enhanced level of comprehensive cancer care through this partnership.
  • Each member of our select team of cancer physicians has been certified by MD Anderson to clinically practice as part of the co-branded Ochsner MD Anderson cancer program, and appointed physicians will become adjunct members of MD Anderson faculty."
  • Ochsner MD Anderson is dedicated to improving the health of our communities and committed to the prevention and early detection of cancer.

GlycoMimetics Announces U.S. Food and Drug Administration Clears Addition of Time-based Final Analysis to Pivotal Phase 3 Study of Uproleselan in Relapsed/Refractory Acute Myeloid Leukemia

Retrieved on: 
Thursday, June 15, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, Inflammation, Survivor, Survival, Database, EFS, AML, Cancer, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Patient, Data, Hematopoietic stem cell transplantation, Food, HSCT, Pharmaceutical industry, Dentistry, Glycomimetic

With the addition of a time-based analysis, topline results are expected to be reported by the end Q2 2024.

Key Points: 
  • With the addition of a time-based analysis, topline results are expected to be reported by the end Q2 2024.
  • Based on blinded pooled data observed to date, a time-based final analysis in Q2 2024 is expected to yield a clinically mature dataset to evaluate uproleselan in R/R AML.
  • This dataset is expected to reflect a median follow-up of greater than three years, including at least two years of post-transplant data.
  • As a result, the company believes the capture rate of survival events for this study beyond Q2 2024 would provide limited additional value for the primary analysis.

Innate Pharma Highlights Increased Lacutamab Clinical Activity From Interim Results of Phase 2 TELLOMAK Study With Updated Olsen Criteria

Retrieved on: 
Friday, June 16, 2023
Biotechnology, Pharmaceutical, Health, Oncology, Peripheral T-cell lymphoma not otherwise specified, Hematopoietic stem cell transplantation, Lymphoma, Cutaneous T-cell lymphoma, KIR3DL2, MF, Bone marrow, Euronext Paris, Asilomar International Conference on Climate Intervention Technologies, IPH, Patient, Division, Lymph, IPHA, Node, Mycosis fungoides, Conference, ORR, Caregiver, Pharmaceutical industry, CTCL

Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that interim efficacy results from the TELLOMAK Phase 2 study in advanced Mycosis Fungoides (MF) according to updated lymph node classification confirms clinical activity and favorable safety profile of lacutamab, an anti-KIR3DL2 antibody.

Key Points: 
  • Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that interim efficacy results from the TELLOMAK Phase 2 study in advanced Mycosis Fungoides (MF) according to updated lymph node classification confirms clinical activity and favorable safety profile of lacutamab, an anti-KIR3DL2 antibody.
  • The data were presented at the 17th International Conference on Malignant Lymphoma, in Lugano, Switzerland.
  • Lymph Node assessment is an important component of staging and response assessment in CTCL (cutaneous T cell lymphomas).
  • We thank the investigators, clinical research coordinators, patients and caregivers involved in the ongoing TELLOMAK program.”

Innate Pharma to Present Updated Interim Phase 2 Efficacy Results of Lacutamab in Mycosis Fungoides at the International Conference on Malignant Lymphoma

Retrieved on: 
Monday, June 12, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Hematopoietic stem cell transplantation, Classification, Lymphoma, KILT, Bone marrow, Euronext Paris, International Conference on Nuclear Disarmament, Oslo, 2008, IPH, Division, IPHA, Fungal infection, Conference, Pharmaceutical industry

Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that interim efficacy results from the TELLOMAK Phase 2 study of lacutamab in advanced Mycosis Fungoides will be presented at the 17th International Conference on Malignant Lymphoma, being held in Lugano, June 13 – 17, 2023.

Key Points: 
  • Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that interim efficacy results from the TELLOMAK Phase 2 study of lacutamab in advanced Mycosis Fungoides will be presented at the 17th International Conference on Malignant Lymphoma, being held in Lugano, June 13 – 17, 2023.
  • Efficacy results will be presented according to updated lymph node classification.
  • Speaker: Dr. Pierluigi Porcu, Director, Division of Hematologic Malignancies and Hematopoietic Stem Cell Transplantation, Sidney Kimmel Cancer Center, Jefferson Health Philadelphia, US
    In addition, a Trial in Progress abstract of KILT, the Phase 2 study of lacutamab in peripheral T‑cell lymphoma led by The Lymphoma Study Association (LYSA) has been published in the 17‑ICML abstract book available online .

Cellectis Presents Updated Clinical and Translational Data on BALLI-01 at the European Hematology Association (EHA) 2023

Retrieved on: 
Friday, June 9, 2023
Graft-versus-host disease, Euronext Growth, Febrile neutropenia, ASH, CD19, European Hematology Association, ALC, CRS, Infection, Venetoclax, Clinical trial, Skin, Cyclophosphamide, FC, Acute promyelocytic leukemia, HSCT, Șaeș, MRD, CAR, Cytokine release syndrome, Patient, DLI, EHA, Alemtuzumab, Host, CRi, CR, FCA, Infrared spectroscopy correlation table, Society, Blinatumomab, Hematopoietic stem cell transplantation, Safety, Vaccine, Medical device, Medical imaging

NEW YORK, June 09, 2023 (GLOBE NEWSWIRE) -- Cellectis (the “Company”) (Euronext Growth: ALCLS - NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, presented today updated clinical and translational data on its clinical trial BALLI-01 (evaluating UCART22) at the European Hematology Association (EHA) 2023.

Key Points: 
  • NEW YORK, June 09, 2023 (GLOBE NEWSWIRE) -- Cellectis (the “Company”) (Euronext Growth: ALCLS - NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, presented today updated clinical and translational data on its clinical trial BALLI-01 (evaluating UCART22) at the European Hematology Association (EHA) 2023.
  • The data presented support the preliminary safety and efficacy of UCART22 in a heavily pretreated relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) population.
  • UCART22 cell expansion was detected in 9 of 13 patients in the FCA LD arm and associated with clinical activity.
  • Overall, these data support the preliminary safety and efficacy of UCART22 in this heavily pretreated r/r B-ALL population.