Autoimmunity

Century Therapeutics Presents Interim Results from Phase 1 ELiPSE-1 Study at ASCO 2024 Annual Meeting

Retrieved on: 
måndag, juni 3, 2024
CRS, ASCO, Relapse, Patient, Cell, IPSC, NHL, Ink, Autoimmunity, Society, Graft-versus-host disease, Safety, Pharmacokinetics, CD19, Therapy, Phase 1, Science, DNA, DLT, Histology, Schedule, Doctor of Philosophy, Nucleic acid thermodynamics, NK, Lymphoid leukemia, AUC, CRR, Development, Inflammation, Vaccine

PHILADELPHIA, June 03, 2024 (GLOBE NEWSWIRE) -- Century Therapeutics (NASDAQ: IPSC), an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology and autoimmune and inflammatory disease, today announced a poster presentation highlighting interim results from the ongoing Phase 1 ELiPSE-1 study evaluating CNTY-101 in relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) at the American Society of Clinical Oncology (ASCO) Annual Meeting being held May 31 – June 4, 2024 in Chicago, Illinois.

Key Points: 
  • ELiPSE-1 ( NCT05336409 ) is an ongoing Phase 1, multicenter, open-label clinical trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of CNTY-101 in patients with R/R, CD19-positive B-cell malignancies.
  • Further, the majority of these cycles have been administered in the outpatient setting, providing additional support for CNTY-101 as a new paradigm for allogeneic cell therapies.
  • In these low dose levels, CNTY-101 demonstrated encouraging early response signals, including two complete responses (CRs) and one partial response (PR).
  • The full poster will be available on the Scientific Resources page of Century’s website at the start of the poster presentation.

Zura Bio to Present Data Exploring the Expanded Potential of Tibulizumab (ZB-106) into Sjogren's Syndrome and Rheumatoid Arthritis at EULAR 2024

Retrieved on: 
måndag, juni 3, 2024
Health, Other Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Autoimmunity, IL-17A, EULAR, News, Sjögren syndrome, Inflammation, Rheumatoid arthritis, Poster, Translational medicine, BAFF

Zura Bio Limited (Nasdaq: ZURA) (“Zura Bio”), a clinical-stage immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases, today announced it will present data from its tibulizumab (ZB-106) program exploring the clinical potential of the dual-pathway antibody in Sjogren's syndrome and rheumatoid arthritis (RA) at EULAR 2024, June 12-15 in Vienna.

Key Points: 
  • Zura Bio Limited (Nasdaq: ZURA) (“Zura Bio”), a clinical-stage immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases, today announced it will present data from its tibulizumab (ZB-106) program exploring the clinical potential of the dual-pathway antibody in Sjogren's syndrome and rheumatoid arthritis (RA) at EULAR 2024, June 12-15 in Vienna.
  • “We believe that dual-pathway inhibition may warrant broad clinical exploration and help define the expanding potential of ZB-106 across a portfolio of autoimmune diseases.”
    Zura Bio will present results as detailed below.
  • The poster will be available on the Zura Bio website in the News and Events section and archived for at least 30 days following presentation.
  • Abstract, accepted for publication only, is available here on the EULAR 2024 website.

Tonix Pharmaceuticals Announces Two Poster Presentations of TNX-102 SL (Sublingual Cyclobenzaprine HCl) at the ASCP Annual Meeting

Retrieved on: 
torsdag, maj 30, 2024
NDA, FDA, Trauma, Reduction, PTSD, ASD, Week, COVID, ASCP, Therapy, Disability, Infection, Cocaine, Psychiatry, New Drug Application, Sleep, Sumatriptan, ASR, Autoimmunity, CNS, OASIS, Security (finance), Tonix Pharmaceuticals, Military personnel, Insomnia, Food, Safety, Long, Research, Cancer, Fatigue, Annual report, PROMIS, Society, Cognition, Failure, Science, Fibromyalgia, Patient, Risk, Government, Breakthrough therapy, CD40L, Health, Acute stress disorder, Observation, Veteran, Central nervous system, Disease, Annual general meeting, Pharmaceutical industry

CHATHAM, N.J., May 30, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced two poster presentations at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting being held May 28-31, 2024 in Miami Beach, Fla. Copies of the presentations are available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.

Key Points: 
  • Copies of the presentations are available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com .
  • TNX-102 SL was well tolerated with an adverse event profile comparable to prior studies and no new safety signals observed.
  • Previous trials of TNX-102 SL showed that it reduced military PTSD symptoms in as early as two weeks with favorable tolerability.
  • Randomized clinical trial of bedtime sublingual cyclobenzaprine (TNX-102 SL) in military-related PTSD and the role of sleep quality in treatment response.

Tonix Pharmaceuticals Announces Two Oral Presentations and One Poster Presentation Involving TNX-1500 (Fc-modified humanized anti-CD40L mAb) at the American Transplant Congress 2024

Retrieved on: 
onsdag, maj 29, 2024
Security (finance), Sumatriptan, Risk, Food, NDA, FDA, Autoimmunity, Government, Breakthrough therapy, Long, CD40L, Research, Cancer, Fibromyalgia, CNS, Annual report, Therapy, Infection, Failure, Central nervous system, Cocaine, Disease, Pharmaceutical industry

TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID.

Key Points: 
  • TNX-102 SL is also being developed to treat acute stress reaction as well as fibromyalgia-type Long COVID.
  • Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has Breakthrough Therapy designation.
  • Tonix also has product candidates in development in the areas of rare disease and infectious disease.
  • All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements.

Atara Biotherapeutics Presents Preclinical Data on ATA3219, an Allogeneic CD19-Targeted CAR T Therapy for the Treatment of B-Cell Driven Autoimmune Diseases, at the ISCT 2024 Annual Meeting

Retrieved on: 
onsdag, maj 29, 2024
Research, Clinical Trials, Stem Cells, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, EBV, Patient, Cell, Epstein–Barr virus, Phenotype, ISCT, Toxicity, SLE, Cytokine, CD19, International Society, ATRA, Cancer, Autoimmunity, PDT, IL-6, NHL, Inflammation, Lupus nephritis, Annual general meeting, Vaccine

Findings demonstrate that ATA3219 maintains comparable cytotoxic function and potency while inducing lower levels of pro-inflammatory cytokines compared to autologous benchmark CD19 CAR T cells.

Key Points: 
  • Findings demonstrate that ATA3219 maintains comparable cytotoxic function and potency while inducing lower levels of pro-inflammatory cytokines compared to autologous benchmark CD19 CAR T cells.
  • The data will be presented in a poster session at the International Society for Cell & Gene Therapy (ISCT) 2024 Annual Meeting taking place May 29 to June 1, 2024, in Vancouver, Canada.
  • ATA3219 consists of allogeneic CD19-directed CAR EBV T cells that have been optimized to offer a potential best-in-class profile and off-the-shelf availability.
  • “We are pleased to share promising preclinical data that shows ATA3219 mediates robust B-cell depletion against SLE and multiple sclerosis patient derived immune cells.

Zura Bio Announces Participation in June Investor Conferences

Retrieved on: 
onsdag, maj 29, 2024
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Inflammation, Autoimmunity, Dermatology, Translational medicine

Zura Bio Limited (Nasdaq: ZURA) (“Zura Bio”), a clinical-stage immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases, today announced that members of senior management will participate in two investor conferences in June.

Key Points: 
  • Zura Bio Limited (Nasdaq: ZURA) (“Zura Bio”), a clinical-stage immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases, today announced that members of senior management will participate in two investor conferences in June.
  • Details: Michael Howell, Ph.D., Chief Scientific Officer and Head of Translational Medicine, will participate in one-on-one meetings on Thursday, June 6, 2024, in New York, NY.
  • Details: Robert Lisicki, Chief Executive Officer, will participate in a “Novel Immunological Mechanisms for Dermatological Disorders” panel discussion and one-on-one meetings on Monday, June 24, 2024, in New York, NY.

JJP Biologics Announces Positive Decision to Execute a First-in-Human Clinical Trial of Anti-Inflammatory mAb JJP-1212 (anti-CD89)

Retrieved on: 
onsdag, maj 29, 2024
Biotechnology, General Health, Health, Pharmaceutical, Clinical Trials, JJP, Patient, EudraCT, Biology, Blister, Immunoglobulin G, European Medicines Agency, Clinical trial, Linear IgA bullous dermatosis, Doctor of Philosophy, Immunoglobulin M, Trial of the century, Autoimmunity, Disease, Safety, Henoch–Schönlein purpura, Autoantibody, Fatty liver disease, IgA nephropathy, Trust, Civil service commission, European Commission, Idiopathic pulmonary fibrosis, Cancer, CSO, Axial spondyloarthritis, Lupus, Biomarker, Incidence, Chronic obstructive pulmonary disease, Volunteering, Cystic fibrosis, Hidradenitis suppurativa, Linearity, European, Paratriathlon, Rheumatoid arthritis, Immunoglobulin A, Pharmaceutical industry

Up to date, JJP Biologics is the first Polish company to receive approval to perform the First-in-Human clinical trial with a novel therapeutic monoclonal antibody.

Key Points: 
  • Up to date, JJP Biologics is the first Polish company to receive approval to perform the First-in-Human clinical trial with a novel therapeutic monoclonal antibody.
  • According to Paweł Szczepański, COO and Management Board Member at JJP Biologics - “This is a historically unprecedented approval of a first-in-human clinical trial for a novel large molecule therapy from Poland.
  • JJP Biologics is exploring the development of companion diagnostics in various indications using serum IgA autoantibodies as biomarkers for personalized treatment with JJP-1212.
  • JJP Biologics pursues the development of its product candidates as well as projects executed in cooperation with scientific partners.

selectION Announces Initiation of Phase 1b Clinical Trial Evaluating si-544 in Patients with Psoriasis Vulgaris or Psoriatic Arthritis

Retrieved on: 
tisdag, maj 28, 2024
Psoriatic arthritis, Patient, Doctor of Philosophy, PD, KCNA3, Atopic dermatitis, Autoimmunity, Trial of the century, Safety, Psoriasis, Selection

This new clinical study is designed as a multicenter, Phase 1b, double-blind, placebo-controlled trial in adults with mild to severe Ps or PsA.

Key Points: 
  • This new clinical study is designed as a multicenter, Phase 1b, double-blind, placebo-controlled trial in adults with mild to severe Ps or PsA.
  • The Company anticipates enrolling up to 40 patients with Ps, of which up to 16 patients may also have PsA.
  • This psoriasis study follows the recent completion of the Company’s first-in-human Phase 1b trial in atopic dermatitis patients, in which the Company observed safety and tolerability of si-544 in adult patients with mild to severe atopic dermatitis.
  • The current Phase 1b trial design in patients with Ps or PsA should also allow for the evaluation of efficacy signals.

Trinity Biotech Announces Q1 2024 Financial Results and Reiterates Guidance

Retrieved on: 
torsdag, maj 23, 2024
VTM, Infection, COVID-19, Automation, HIV, Waveform, Glycated hemoglobin, FX, Autoimmunity, POC, Movement, Acquisition, Operating cost, Research, Pharmaceutical industry

DUBLIN, Ireland, May 23, 2024 (GLOBE NEWSWIRE) -- Trinity Biotech plc (Nasdaq: TRIB), a commercial stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors, today announced the Company’s results for the quarter ended March 31, 2024.

Key Points: 
  • Our clinical laboratory revenues were $11.7m in Q1, 2024, a decrease of $1.0m or 7.6% compared to $12.7m in Q1, 2023.
  • Gross margin for Q1, 2024 was 37.6%, which was the same as the gross margin in Q1, 2023.
  • Net financial expenses in Q1, 2024 were $0.2m compared to $2.4m in Q1, 2023, a decrease of $2.2m.
  • The movement in the derivative financial asset led to financial income of $0.1m in Q1, 2024.

Hornet Therapeutics emerges from stealth with data published in Science demonstrating the first potential drug intervention for Epstein-Barr Virus (EBV) driven disease

Retrieved on: 
torsdag, maj 23, 2024
Human services, EBV, Patient, Infection, Survival, University, GSK plc, Kyowa Kirin, Risk, Malignancy, Infectious mononucleosis, Pathology, Autoimmunity, Therapy, PTLD, Disease, Transplant, Medical research, Lymphoma, DRS, Multiple sclerosis, NAD, Pharmaceutical industry

Targeting this pathway with an IDO-1 inhibitor hinders B cell transformation and EBV-driven pathogenesis in vitro and in animal models in vivo.

Key Points: 
  • Targeting this pathway with an IDO-1 inhibitor hinders B cell transformation and EBV-driven pathogenesis in vitro and in animal models in vivo.
  • The groundbraking findings reported in Science point at IDO-1 inhibition as a potential treatment mechanism for pathologies related to EBV latency.
  • Professor Christoph Hess, founder and Chief Scientific Officer at Hornet Therapeutics added: “In a landmark paper published 60 years ago, Drs.
  • Our data demonstrate that HTX-201 has the potential to hinder EBV latency in its primary host cells, the B cells.