GVHD

Affimed Reports 2023 Financial Results and Operational Progress

Retrieved on: 
Thursday, March 28, 2024
Research, EGFR, GVHD, NSCLC, Genentech, ASH, AML, PD, Disease, International, International Financial Reporting Standards, Patient, Webcast, EFS, EDT, CRS, Cancer, Record, Insurance, Trial of the century, Bank statement, Investment, Safety, Workforce, Roivant Sciences, PFS, IASB, Hodgkin lymphoma, Book, NK, HL, Cytokine release syndrome

MANNHEIM, Germany, March 28, 2024 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed” or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today reported financial results and provided an update on clinical and corporate progress for the year ended December 31, 2023.

Key Points: 
  • MANNHEIM, Germany, March 28, 2024 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed” or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today reported financial results and provided an update on clinical and corporate progress for the year ended December 31, 2023.
  • Based on the promising results, Affimed expanded enrollment in this cohort to 40 patients.
  • Affimed prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the IASB.
  • Affimed will host a conference call and webcast on March 28, 2024, at 8:30 a.m. EDT / 13:30 CET to discuss full year 2023 financial results and corporate developments.

Ironwood Pharmaceuticals Announces Positive Results from its Phase II Exploratory STARGAZE Trial of Apraglutide in Patients with Steroid-Refractory Gastrointestinal Acute Graft-versus-Host Disease (SR GI aGVHD)

Retrieved on: 
Thursday, March 28, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Principal, Disease, GVHD, Regeneration, Medication, Ironwood Pharmaceuticals, Patient, University, GI, Mortality, Standard of care, HSCT, Senior, NRM, Skin, Safety, MAGIC, Hematology, Liver, Phase II, Pharmaceutical industry

Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, today announced positive, primary results up to Day 91 for its Phase II exploratory STARGAZE trial evaluating apraglutide in patients with steroid-refractory gastrointestinal acute Graft-versus-Host Disease (SR GI aGVHD).

Key Points: 
  • Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, today announced positive, primary results up to Day 91 for its Phase II exploratory STARGAZE trial evaluating apraglutide in patients with steroid-refractory gastrointestinal acute Graft-versus-Host Disease (SR GI aGVHD).
  • This was a first-of-its-kind study combining a GLP-2 analog with immunosuppressive therapy in patients with SR GI aGVHD.
  • GI aGVHD, is a leading cause of morbidity and mortality following HSCT with approximately 70% of aGVHD cases having GI involvement.
  • The STARGAZE study will continue through its two-year endpoint, where apraglutide will be re-evaluated for safety and efficacy.

Lipella Pharmaceuticals Announces FDA Clearance of IND for LP-410 for Oral Graft-Versus-Host Disease, Advancing Clinical Pipeline

Retrieved on: 
Tuesday, March 5, 2024
Investigational New Drug, Toxicity, FDA, Food, Tacrolimus, GVHD, Patient, Graft-versus-host disease, Efficacy, Trial of the century, Pharmaceutical industry

Lipella’s clinical study, titled, A Multicenter, Dose-Ranging Trial Evaluating the Safety, Tolerability, and Efficacy of LP-410 in Subjects with Symptomatic Oral GVHD, is expected to commence in the second half of 2024.

Key Points: 
  • Lipella’s clinical study, titled, A Multicenter, Dose-Ranging Trial Evaluating the Safety, Tolerability, and Efficacy of LP-410 in Subjects with Symptomatic Oral GVHD, is expected to commence in the second half of 2024.
  • Dr. Jonathan Kaufman, CEO of Lipella, said, “We are extremely pleased to announce the approval of our IND application, and we look forward to initiating clinical testing in patients in 2024.
  • We believe that Lipella’s proprietary oral rinse formulation of liposomal tacrolimus has the potential to effectively treat oral GVHD, while minimizing systemic toxicity.
  • Lipella received FDA Orphan Drug Designation on tacrolimus for treatment of GVHD on November 8, 2023.

NMDP Announces Enrollment of First Patient in OPTIMIZE Clinical Trial

Retrieved on: 
Tuesday, February 20, 2024
Haematopoietic system, Incidence, Bone marrow, Senior, Infection, Toxicity, MMUD, HCT, Malignancy, Graft-versus-host disease, Quality of life, ACCESS, GVHD, Safety, NMDP, Health, Patient, OHSU, Survival, Clinical trial, Health equity, Research, Vaccine

The trial is sponsored by NMDP through the Center for International Blood and Marrow Transplant Research (CIBMTR®).

Key Points: 
  • The trial is sponsored by NMDP through the Center for International Blood and Marrow Transplant Research (CIBMTR®).
  • The OPTIMIZE trial hypothesizes that a reduced PTCy dosage could reduce these risks while still effectively guarding against GvHD.
  • The OPTIMIZE trial’s goals include:
    Improve patient survival and quality of life by decreasing acute and long-term toxicities associated with standard dose PTCy.
  • This trial recently completed enrollment in its adult arms ahead of schedule and is continuing to enroll within its pediatric arm.

Incyte Announces U.S. Food and Drug Administration Grants Priority Review for Axatilimab for the Treatment of Chronic Graft-Versus-Host Disease

Retrieved on: 
Tuesday, February 27, 2024
FDA, Health, Stem Cells, Clinical Trials, Pharmaceutical, Biotechnology, Food, BLA, PDUFA, SNDX, GVHD, Safety, Society, Patient, Priority, Biologics license application, Priority review, Pharmaceutical industry

Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for axatilimab, an anti-CSF-1R antibody, for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy.

Key Points: 
  • Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for axatilimab, an anti-CSF-1R antibody, for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy.
  • The Prescription Drug User Fee Act (PDUFA) date for the FDA decision is August 28, 2024.
  • Axatilimab is being developed by Incyte and Syndax Pharmaceuticals (Nasdaq:SNDX) as part of an exclusive worldwide co-development and co-commercialization license agreement.
  • “Axatilimab’s novel mechanism offers a differentiated treatment approach which may help patients suffering from this devastating disease.

Appendix 4C Quarterly Activity Report for Quarter Ended December 31, 2023

Retrieved on: 
Wednesday, January 31, 2024
Congenital heart defect, FDA, Appendix, MSB, Journal, Bangladesh Technical Education Board, PRV, Survival, Randomized controlled trial, Biopharmaceutical, GVHD, Phases of clinical research, BLA, Hypoplastic left heart syndrome, RPD, HLHS, Growth, Patient, Blood, Inflammation, Priority review, Heart, NIH, Pain, Mesoblast, Ageing, BMT, Executive, MESO, Pharmaceutical industry

NEW YORK, Jan. 30, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an activity report for the second quarter ended December 31, 2023.

Key Points: 
  • NEW YORK, Jan. 30, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an activity report for the second quarter ended December 31, 2023.
  • Mesoblast will provide the Phase 3 trial protocol to FDA ahead of the upcoming meeting this quarter.
  • Mesoblast will meet with FDA this quarter to address potential pathways to approval for REVASCOR under our Regenerative Medicine Advanced Therapies (RMAT) designation.
  • Revenue from royalties on sales of TEMCELL® HS Inj.5 sold in Japan by our licensee for the quarter were US$1.5 million.

Incyte Highlights Growth Opportunities and Provides Business Updates at the 42nd Annual J.P. Morgan Healthcare Conference

Retrieved on: 
Monday, January 8, 2024
Biotechnology, Pharmaceutical, Health, CCNE1, Conference, Dermatology, CCNE, CDK2, BID, Ovarian cancer, Research, Graft-versus-host disease, Oncology, Q&A, Polycythemia, Week, GVHD, Growth, Inflammation, Patient, Safety, Pancreatic serous cystadenoma, Autoimmunity

Incyte (Nasdaq:INCY) will highlight growth opportunities and provide key updates across its investigational pipeline and commercial portfolio during a presentation today at 7:30 a.m. PT at the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco.

Key Points: 
  • Incyte (Nasdaq:INCY) will highlight growth opportunities and provide key updates across its investigational pipeline and commercial portfolio during a presentation today at 7:30 a.m. PT at the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco.
  • The overall safety profile of ruxolitinib cream is consistent with previous data, and no new safety signals were observed.
  • The Company intends to provide additional financial guidance and updates on key clinical programs during its 2023 fourth quarter and year-end earnings conference call.
  • The J.P. Morgan Healthcare Conference presentation and Q&A session can be accessed at investor.incyte.com .

Be The Match® Affirms Global Leadership in Life-saving Cell Therapies with New Name, Brand: NMDP℠

Retrieved on: 
Monday, January 8, 2024
NMDP, Marketing, Senior counsel, Ecosystem, Sickle cell disease, University, Physician, National Marrow Donor Program, Student, Research, Bone marrow, HLA, Long Way, MD, Society, Insurance, Volunteering, GVHD, Patient, All, Hematology, Disorder, Pharmaceutical industry

Over nearly four decades, the world has evolved, and so have we, expanding our global footprint, advancing research throughout the cell therapy ecosystem and impacting more people’s lives,” said Amy Ronneberg, CEO, NMDP.

Key Points: 
  • Over nearly four decades, the world has evolved, and so have we, expanding our global footprint, advancing research throughout the cell therapy ecosystem and impacting more people’s lives,” said Amy Ronneberg, CEO, NMDP.
  • Research advancements are driving the organization’s growth in enabling more patients than ever before to access cell therapy – a record 7,435 lives in 2023.
  • “These findings have helped more patients from a diverse range of ethnic backgrounds receive critical cell therapy.
  • Together, NMDP and its network strive to create a world where every patient can receive their life-saving cell therapy.

Coeptis Therapeutics President and CEO Issues Letter to Shareholders Highlighting 2023 Accomplishments and Outlook for 2024

Retrieved on: 
Thursday, January 4, 2024
Physician, CD34, Risk, Infection, Mesa, Letter, Cell, Cytokine release syndrome, Master of Science, Karolinska Institute, Research, MDS, Therapy, Cancer, Infrared spectroscopy correlation table, Ligand, University, GEAR, COVID-19, HSPC, Observation, Toxicity, Interim, GVHD, CRS, Growth, Patient, Safety, AML, NK, Pharmaceutical industry

WEXFORD, Pa., Jan. 4, 2024 /PRNewswire/ -- Coeptis Therapeutics Holdings, Inc. (NASDAQ: COEP) (the "Company" or "Coeptis"), a biopharmaceutical company developing innovative cell therapy platforms for cancer, today announced that Dave Mehalick, President and CEO of Coeptis Therapeutics Holdings, has issued a Letter to Shareholders providing a review of its 2023 achievements and anticipated milestones for 2024.

Key Points: 
  • WEXFORD, Pa., Jan. 4, 2024 /PRNewswire/ -- Coeptis Therapeutics Holdings, Inc. (NASDAQ: COEP) (the "Company" or "Coeptis"), a biopharmaceutical company developing innovative cell therapy platforms for cancer, today announced that Dave Mehalick, President and CEO of Coeptis Therapeutics Holdings, has issued a Letter to Shareholders providing a review of its 2023 achievements and anticipated milestones for 2024.
  • Our strategy is to leverage these innovative and complementary platforms to develop powerful, personalized cell-based treatments to improve outcomes for patients with cancer.
  • As we look to 2024, we see enormous potential to advance our pipeline and achieve meaningful growth milestones.
  • On behalf of the entire Coeptis team, I wish you all a happy and healthy 2024.

Lipella Pharmaceuticals Marks Successful First Year with Strategic Progress and Key Milestones Accomplished

Retrieved on: 
Wednesday, December 20, 2023
Hemorrhagic cystitis, Food, LIPO, IND, FDA, Type, OLP, IRB, Tacrolimus, HC, GVHD, Growth, Lichen planus, Pharmaceutical industry

PITTSBURGH, Dec. 20, 2023 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc., (Nasdaq: LIPO) ("Lipella," "our," "us" or the "Company"), a pioneering, clinical-stage pharmaceutical company, celebrates its first anniversary as a publicly traded entity.

Key Points: 
  • PITTSBURGH, Dec. 20, 2023 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc., (Nasdaq: LIPO) ("Lipella," "our," "us" or the "Company"), a pioneering, clinical-stage pharmaceutical company, celebrates its first anniversary as a publicly traded entity.
  • Based in Pittsburgh, PA, the Company has made substantial strides over the past year, achieving critical milestones and advancing its pipeline with three clinical indications and two orphan drug designations granted.
  • Additionally, Lipella's LP-310 has been granted orphan drug designation for the treatment of oral graft-versus-host disease (GVHD) with tacrolimus.
  • The Company is poised to submit a Phase 2a IND for this indication in the first quarter of 2024.