Immune reconstitution inflammatory syndrome

Gamida Cell Reports Third Quarter 2023 Financial Results and Provides Company Update

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Tuesday, November 14, 2023
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BOSTON, Nov. 14, 2023 (GLOBE NEWSWIRE) -- Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today reported financial results for the quarter ended September 30, 2023, and provided a business update.

Key Points: 
  • (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today reported financial results for the quarter ended September 30, 2023, and provided a business update.
  • “The third quarter marked the first patients receiving Omisirge following FDA approval and the point at which Gamida Cell truly transitioned to a commercial-stage company with our first revenue reported,” said Abbey Jenkins, President and Chief Executive Officer of Gamida Cell.
  • The company reported revenue for the delivery of two units of Omisirge in the third quarter of 2023 and projects revenue from a total of four to six units for full year 2023.
  • Annual shareholders meeting: Gamida Cell held its Annual General Meeting of Shareholders in New York City on October 19.

IN8bio Presents Biologic Correlative Data from the INB-200 Phase 1 Trial in Newly Diagnosed Glioblastoma at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting

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Monday, November 6, 2023
Pakistan Society of Neuro-Oncology, Survival, GBM, Temozolomide, NKG2D, DRI, Immune reconstitution inflammatory syndrome, SNO, American Society of Clinical Oncology, Glioblastoma, Society, SITC, Immunotherapy, Immune system, Annual general meeting, Deltex Medical Group, TMZ, Cancer, Patient, Abstract, ASCO, Vaccine, Medical imaging

A treated patient, with paired tissue biopsies, demonstrated infiltration of gamma-delta T cells 148 days following a single administration in Cohort 1.

Key Points: 
  • A treated patient, with paired tissue biopsies, demonstrated infiltration of gamma-delta T cells 148 days following a single administration in Cohort 1.
  • Updated patient, survival and enrollment data from the ongoing INB-200 study to be presented at the Society for Neuro-Oncology (SNO) Annual Meeting on November 17, 2023 from 7:30 PM – 9:30 PM PT (Abstract Number: CTIM-42).
  • In June 2023, IN8bio presented positive data from the Phase 1 study of INB-200 in an oral presentation at the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting.
  • The Company will present updated patient, survival and enrollment data from the study at the Society for Neuro-Oncology (SNO) Annual Meeting taking place November 15-19, 2023.

Gamida Cell Presents New Data on Allogeneic Stem Cell Therapy Omidubicel and Natural Killer (NK) Cell Therapy Candidate GDA-201 at Society for Immunotherapy of Cancer (SITC) Annual Meeting

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Saturday, November 4, 2023
Survival, UCB, NAM, Immune reconstitution inflammatory syndrome, Therapy, CD57, MD, Infection, Cell, SITC, Immunotherapy, B cell, Science, NF, Immunophenotyping, Annual general meeting, Kinetics, Culture, Society, Cancer, Patient, CF, Non-Hodgkin lymphoma, Fibroblast, Myelocyte, Pharmaceutical industry, Vaccine, NK

(Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today shared new data on the impact of the company’s proprietary nicotinamide (NAM) technology on its allogeneic stem cell therapy omidubicel and investigational natural killer (NK) cell therapy candidate GDA-201 at the Society for Immunotherapy of Cancer’s (SITC) Annual Meeting in San Diego, CA.

Key Points: 
  • (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today shared new data on the impact of the company’s proprietary nicotinamide (NAM) technology on its allogeneic stem cell therapy omidubicel and investigational natural killer (NK) cell therapy candidate GDA-201 at the Society for Immunotherapy of Cancer’s (SITC) Annual Meeting in San Diego, CA.
  • Both omidubicel and GDA-201 are powered by Gamida Cell’s proprietary NAM technology, which enhances and expands cells to create potentially curative cell therapies for patients with cancer.
  • Omidubicel was approved under the brand name Omisirge™ (omidubicel-onlv) by the U.S. FDA in April 2023 for allogeneic stem cell transplant; GDA-201 is in Phase 1 study for the treatment of non-Hodgkin lymphoma (NCT05296525).
  • Data on the first three cohorts of the Phase 1 study of GDA-201 were recently reported.

City of Hope appoints Marcel van den Brink, M.D., Ph.D., as president of City of Hope Los Angeles and National Medical Center, and chief physician executive

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Tuesday, August 29, 2023
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He will also be responsible for ensuring that the most leading-edge patient care is available across the City of Hope system.

Key Points: 
  • He will also be responsible for ensuring that the most leading-edge patient care is available across the City of Hope system.
  • Van den Brink joins City of Hope after serving 24 years at Memorial Sloan Kettering Cancer Center, most recently as the head of its Division of Hematologic Malignancies.
  • Dr. van den Brink has had many other leadership roles, including vice-chairman of the board of the Deutsche Knochenmark Stiftung (DKMS).
  • Current City of Hope National Medical Center President Michael Caligiuri, M.D., will remain at City of Hope and transition to focus full time on his laboratory research.

Helocyte Announces $3.22 Million Grant from the National Cancer Institute for Triplex Phase 2 Clinical Trial Program

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Thursday, June 15, 2023
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MIAMI, June 15, 2023 (GLOBE NEWSWIRE) -- Helocyte, Inc. (“Helocyte”), a subsidiary company of Fortress Biotech, Inc. (Nasdaq: FBIO), today announced that the National Cancer Institute (“NCI”) has awarded a $3.22 million grant to City of Hope for clinical studies of Triplex, a cytomegalovirus (“CMV”) vaccine being developed by Helocyte and City of Hope. This competitive award will fund two planned multicenter, placebo-controlled, randomized Phase 2 studies to evaluate the potential safety and immunological response of Triplex and its ability to enhance CMV-specific T cell immunity in stem cell donors to reduce the risk of CMV events in recipients of allogeneic hematopoietic cell transplant (“HCT”). Triplex was initially developed by City of Hope, one of the largest cancer research and treatment organizations in the United States, and exclusively licensed to Helocyte in 2015.

Key Points: 
  • Triplex was initially developed by City of Hope , one of the largest cancer research and treatment organizations in the United States, and exclusively licensed to Helocyte in 2015.
  • Diamond and his team developed Triplex and he serves as a consultant to Helocyte.
  • The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
  • Helocyte will provide clinical materials to support the trial.

IN8bio Presents Positive, New INB-100 Data Showing Long-term Complete Remissions and Elevated Gamma-Delta T Cells in 100% of Evaluable Treated Leukemia Patients at EBMT 2023

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Monday, April 24, 2023
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ET today to discuss the latest clinical updates and data.

Key Points: 
  • ET today to discuss the latest clinical updates and data.
  • Elevations in CD4+, CD8+ T cells, NK cells and B cells have also been observed, indicating a broad positive immune response.
  • Additional treated patients have remained progression free for 33.9, 22.2, 7.8, 5.8, 5.6 and 2.6 months, respectively.
  • ET to review the updated data from the EBMT presentation, as well as recent clinical updates.

Smart Immune receives $5 million investment to further its thymus-empowered ProTcell therapy platform

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Monday, April 17, 2023
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PARIS, France, 17 April, 2023 – Smart Immune SAS, a clinical-stage biotechnology company developing ProTcell, a thymus-empowered T-cell therapy platform to fully and rapidly re-arm the immune system, announced today that it has received an equity investment of $5 million from the Bill & Melinda Gates Foundation to accelerate the development of ProTcell, a proprietary T-cell therapy platform to treat cancer and infectious disease.

Key Points: 
  • PARIS, France, 17 April, 2023 – Smart Immune SAS, a clinical-stage biotechnology company developing ProTcell, a thymus-empowered T-cell therapy platform to fully and rapidly re-arm the immune system, announced today that it has received an equity investment of $5 million from the Bill & Melinda Gates Foundation to accelerate the development of ProTcell, a proprietary T-cell therapy platform to treat cancer and infectious disease.
  • Smart Immune’s ProTcell platform has been developed to ensure early immune reconstitution post allogeneic hematopoietic stem cell transplantation (allo-HSCT) and to reverse thymic involution through its proprietary T-cell progenitor-based therapy.
  • The science is ground-breaking, but it is the team driving Smart Immune, now 35 strong, that make it truly special.
  • This investment from Gates is a testament to the hard work of everyone at Smart Immune as well as the broad potential of the ProTcell platform.

Jasper Therapeutics Announces Positive Follow-up Clinical Data from Investigator-Sponsored Study of Briquilimab Conditioning in Fanconi Anemia Patients at the 2023 Transplantation & Cellular Therapy Meetings of the ASTCT and CIBMTR

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Friday, February 17, 2023
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The study is a Phase 1/2 clinical trial ( NCT04784052 ) utilizing briquilimab to treat FA patients in bone marrow failure requiring allogeneic transplant with non-sibling donors.

Key Points: 
  • The study is a Phase 1/2 clinical trial ( NCT04784052 ) utilizing briquilimab to treat FA patients in bone marrow failure requiring allogeneic transplant with non-sibling donors.
  • In the follow-up data series presented, 100% total donor chimerism was achieved through six months for the first patient and at three months for the second patient.
  • Briquilimab was cleared by day 9 after dosing in both patients and no treatment-related adverse events or toxicities were observed.
  • It is also the only proven treatment for the bone marrow failure that occurs in a majority of patients with FA.

Helocyte, Inc. Announces Positive Data from Stem Cell Transplant Donor Vaccination Trial to be Presented at the 2023 Tandem Meetings: Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR

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Thursday, February 16, 2023
B cell, City, Immune reconstitution inflammatory syndrome, Fortress Biotech, City of Hope, HCT, Vaccination, Safety, Haematopoietic system, American Journal, Patient, Mortality, Risk, Triplex, Toxic epidermal necrolysis, Antigen, Cytomegalovirus, Transplant, IE1, IE2, American Journal of Hematology, CMV, Vaccine, Hematology

MIAMI, Feb. 16, 2023 (GLOBE NEWSWIRE) -- Helocyte, Inc., (“Helocyte”) a subsidiary company of Fortress Biotech, Inc. (Nasdaq: FBIO), announced today that data from a Phase 1 pilot trial (see NCT03560752) evaluating the potential safety, immunological response and efficacy of the cytomegalovirus (“CMV”) vaccine Triplex to enhance CMV protective immunity in immunosuppressed recipients of allogeneic hematopoietic cell transplants (“HCT”) will be presented at the 2023 Tandem Meetings: Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR (“Tandem Meetings”), taking place February 15-19, 2023, in Orlando, Florida. Triplex was developed by City of Hope, one of the largest cancer research and treatment organizations in the United States, and exclusively licensed to Helocyte in 2015.

Key Points: 
  • City of Hope researchers led a pilot trial to explore the vaccination of immunocompetent HCT donors with Triplex to enhance CMV protective immunity in recipients of an allogeneic HCT.
  • “CMV is still the most common infectious complication in allogeneic HCT and remains of fundamental clinical concern.
  • Triplex was generally well-tolerated in stem cell donors who participated in the study with no serious adverse events reported.
  • All HCT recipients were fully engrafted with stem cells of donor origin without delay.

Study Published in American Journal of Hematology Demonstrates First Reported Evidence of Safe and Successful Boosting of Cytomegalovirus Vaccine-Specific T Cell Immunity in a Stem Cell Transplant Recipient Via Vaccination of a Donor with Triplex

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Wednesday, February 15, 2023
City, Immune reconstitution inflammatory syndrome, Fortress Biotech, City of Hope, Memory, Post-transplant lymphoproliferative disorder, Transplant, HCT, Immunodeficiency, Vaccination, Safety, MRD, Haematopoietic system, American Journal, Disease, Mortality, HIV, Cytomegalovirus, Hematology, American Journal of Hematology, CMV, Pharmaceutical industry, Vaccine, Triplex

MIAMI, Feb. 15, 2023 (GLOBE NEWSWIRE) -- Helocyte, Inc., (“Helocyte”) a subsidiary company of Fortress Biotech, Inc. (Nasdaq: FBIO), announced today that data from a Phase 1 pilot study published in the American Journal of Hematology demonstrated the feasibility, safety, immunological response and potential efficacy associated with vaccination of a hematopoietic cell transplant (“HCT”) donor with the cytomegalovirus (“CMV”) vaccine Triplex to enhance protective CMV-specific T cells in immunosuppressed recipients of allogeneic HCT.

Key Points: 
  • The investigator-initiated trial conducted at City of Hope analyzed the results of 17 CMV-seropositive recipients who received an HCT from a matched related donor (“MRD”) vaccinated with Triplex prior to stem cell harvest and transplant.
  • Triplex was well tolerated with limited adverse events in donors and recipients, all of whom experienced successful engraftment.
  • This strategy has been shown to significantly enhance protective T and B cell responses and enhanced the immunogenicity associated with vaccination post-HSCT.
  • CMV reactivation requiring preemptive therapy in recipients with Triplex vaccinated donors (18%) was observed to be lower than those in similar cohorts prophylactically treated with letermovir (37%).