Federation of Clinical Immunology Societies

X4 Pharmaceuticals Announces Submission of New Drug Application (NDA) to U.S. FDA for Mavorixafor in WHIM Syndrome

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Tuesday, September 5, 2023
European Hematology Association, File, WHIM, Federation of Clinical Immunology Societies, NDA, CIS, WHIM syndrome, Immune system, EHA, Primary immunodeficiency, Wart, Ageing, Rare, FDA, Pharmaceutical industry, Infection, Myelokathexis, Hypogammaglobulinemia

“The submission of our first NDA is a significant milestone in X4's journey to transform the care of those living with rare immunodeficiencies,” said Paula Ragan, Ph.D., President and Chief Executive Officer of X4 Pharmaceuticals.

Key Points: 
  • “The submission of our first NDA is a significant milestone in X4's journey to transform the care of those living with rare immunodeficiencies,” said Paula Ragan, Ph.D., President and Chief Executive Officer of X4 Pharmaceuticals.
  • “We’re excited that this submission moves us one step closer to introducing what could be the first approved product in the U.S. for those with WHIM syndrome.
  • X4 has requested priority review for the application which, if granted, would provide a target FDA review period of six months from the application acceptance for filing date.
  • The NDA submission is supported by the results of the global, pivotal, 4WHIM Phase 3 clinical trial of once-daily, oral mavorixafor in individuals with WHIM syndrome.

SAB Biotherapeutics Provides Company Update for Q2 2023 Financial Results

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Monday, August 21, 2023
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SIOUX FALLS, S.D., Aug. 21, 2023 (GLOBE NEWSWIRE) -- SAB Biotherapeutics ( Nasdaq: SABS ), (SAB), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high-potency, fully-human immunoglobulins (hIgG), also known as fully-human polyclonal antibodies, without the need for human donors, today reported financial results for the second quarter ended June 30, 2023, and provided a company update.

Key Points: 
  • SIOUX FALLS, S.D., Aug. 21, 2023 (GLOBE NEWSWIRE) -- SAB Biotherapeutics ( Nasdaq: SABS ), (SAB), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high-potency, fully-human immunoglobulins (hIgG), also known as fully-human polyclonal antibodies, without the need for human donors, today reported financial results for the second quarter ended June 30, 2023, and provided a company update.
  • "We are pleased to share the significant progress achieved during the second quarter of 2023.
  • On August 21, 2023, we announced that EisnerAmper LLP was appointed as our independent registered public accounting firm for the fiscal year ending December 31, 2023, effective August 22, 2023.
  • The decrease was primarily due to discretionary cost reduction measures and increased efficiencies as we continue to mature as a publicly traded company.

X4 Pharmaceuticals Reports Second-Quarter 2023 Financial Results, Provides Corporate Updates, and Reports Emerging Data from Chronic Neutropenia Clinical Program

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Thursday, August 10, 2023
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Additional data from this ongoing Phase 2 trial are expected to be shared in the fourth quarter of 2023.

Key Points: 
  • Additional data from this ongoing Phase 2 trial are expected to be shared in the fourth quarter of 2023.
  • X4 is planning to initiate a Phase 3 clinical trial evaluating mavorixafor in certain chronic neutropenic disorders in the first half of 2024.
  • X4 will host a conference call and webcast today at 8:30 am ET to discuss these financial results and business highlights.
  • The live webcast and slide presentation can be accessed on the investor relations section of X4 Pharmaceuticals’ website at www.x4pharma.com .

AnaptysBio Announces Second Quarter 2023 Financial Results and Provides Business Update

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Monday, August 7, 2023
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Initiating a global Phase 2b trial for rosnilimab, a PD-1 agonist antibody, in rheumatoid arthritis (RA) later in Q3 2023 and a second Phase 2 trial, in an indication yet to be announced, by year-end 2023

Key Points: 
  • Initiating a global Phase 2b trial for rosnilimab, a PD-1 agonist antibody, in rheumatoid arthritis (RA) later in Q3 2023 and a second Phase 2 trial, in an indication yet to be announced, by year-end 2023
    SAN DIEGO, Aug. 07, 2023 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, today reported operating results for the second quarter ended June 30, 2023 and provided a business update.
  • She had extensive experience at Bristol-Meyers Squibb where she led teams that advanced more than 20 compounds into clinical development.
  • Among her prior roles includes serving as Principia’s chief medical officer from 2018 until the Sanofi acquisition in September 2020.
  • Cash, cash equivalents and investments totaled $488.7 million as of June 30, 2023, compared to $584.2 million as of December 31, 2022, for a decrease of $95.5 million.

Lupus Research Alliance Honors Carola Vinuesa, MD, PhD, for Discovering a Specific Gene Variant that Causes Lupus in Some Patients

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Thursday, June 22, 2023
Francis Crick Institute, Mouse, TLR7, Lupus Research Alliance, Weill Cornell Medicine, Guanosine, Toll-like receptor 7, Prevalence, Genetics, Federation of Clinical Immunology Societies, Attention deficit hyperactivity disorder predominantly inattentive, Australian Academy of Science, Medical Research Council, Mutation, Cas9, Research, SLE, Gottschalk Medal, Lupus, RNA, National Health and Medical Research Council, Doctor of Philosophy, Government, Autoimmunity, Assistant, FAA, The Prize, X chromosome, National Health, Patient, FRS, Immune system, Diagnosis, Bacteria, Royal Society, NHMRC, Genome, Autoantibody, Disease, Pharmaceutical industry, Vaccine, Science, MD

The Lupus Research Alliance awarded its 2023 Lupus Insight Prize to Carola Vinuesa, MD, PhD, of The Francis Crick Institute.

Key Points: 
  • The Lupus Research Alliance awarded its 2023 Lupus Insight Prize to Carola Vinuesa, MD, PhD, of The Francis Crick Institute.
  • Many lupus patients display increased TLR7 activity; however, disease-causing mutations in the TLR7 gene had not been identified.
  • "I am honored to receive this most prestigious award from the Lupus Research Alliance in recognition of our discovery of a genetic cause of lupus.
  • To determine whether the TLR7 mutation identified causes lupus, Dr. Vinuesa's team used a gene-editing tool, CRISPR/Cas9, to introduce the specific variant into mice.

NextCure Presents Non-Clinical Data Defining the Mechanism of NC525 at the 2023 Federation of Clinical Immunology Societies (FOCIS) Annual Meeting

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Wednesday, June 21, 2023
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“Our pre-clinical models showed that NC525 specifically eradicates leukemic stem cells (LSCs) and blast cells, while preserving healthy hematopoietic cells,” said Solomon Langermann, Ph.D., NextCure’s chief scientific officer.

Key Points: 
  • “Our pre-clinical models showed that NC525 specifically eradicates leukemic stem cells (LSCs) and blast cells, while preserving healthy hematopoietic cells,” said Solomon Langermann, Ph.D., NextCure’s chief scientific officer.
  • “The data presented in the poster define the mechanism that leads to specific induction of apoptosis in leukemic cells, but not in healthy immune cells.
  • High expression of LAIR-1 is seen on leukemic stem cells and blast cells, where it plays a role in survival of these cancer cells.
  • The current Phase 1 study is an open-label, non-randomized, dose escalation trial to determine safety and tolerability of NC525 in adult patients with relapsed or refractory AML.

SAB Biotherapeutics Presents Positive IND-Enabling GLP Toxicology Study for SAB-142, a Novel Immunotherapeutic for Type 1 Diabetes at FOCIS 2023

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Wednesday, June 21, 2023
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SIOUX FALLS, S.D., June 21, 2023 (GLOBE NEWSWIRE) -- SAB Biotherapeutics (Nasdaq: SABS), (SAB), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high-potency, fully-human multi-target immunoglobulin (hIgG) antibodies (fully-human polyclonal antibodies) without the need for human donors, today announced the presentation of positive safety and pharmacologic data from a GLP toxicology study for SAB-142, a first in class fully human immunotherapeutic being developed for delaying onset and progression of Type 1 Diabetes (T1D), at the Federation of Clinical Immunology Societies (FOCIS) in Boston. Results from the IND-enabling GLP tox study confirmed that SAB-142 affects the same subsets of immune cells associated with T1D as commercially available rabbit-derived anti-thymocyte globulin (rATG) in vivo.

Key Points: 
  • SAB-142's unique multi-target strategy can be directed at the multiple immunological cell subsets associated with T1D and other autoimmune diseases.
  • SAB will present a poster titled, “Safety and Pharmacodynamic Effects of Novel Fully Human Anti-Thymocyte Polyclonal IgG Antibodies in an IND Enabling GLP Toxicology Study.
  • In the in vivo study conducted under GLP conditions, SAB-142 was administered at three dose levels of 1, 5, and 10 mg/kg.
  • More information on SAB’s T1D candidate, SAB-142, can be found on the pipeline page of SAB’s website: SAB-142: Type 1 Diabetes .

AltruBio to Present at the Federation of Clinical Immunology Societies (FOCIS) 2023 Annual Meeting

Retrieved on: 
Thursday, June 15, 2023
2022–2023 monkeypox outbreak, Graft-versus-host disease, GVHD, NOAEL, Therapy, Federation of Clinical Immunology Societies, CD3, ICE, TT, Survival, Psoriasis, Inflammation, ELISA, P-selectin, DTH, Psoriatic arthritis, Patient, Ulcerative colitis, Tetanus, SAN, Toxicology, Mouse, NHP, Surface plasmon resonance, Research, Skin, Safety, Pharmaceutical industry, Vaccine

ALTB-268 is engineered to be a tetravalent version of its predecessor ALTB-168 and has a similar mechanism of action.

Key Points: 
  • ALTB-268 is engineered to be a tetravalent version of its predecessor ALTB-168 and has a similar mechanism of action.
  • ALTB-268, a tetravalent version of ALTB-168 demonstrated greater than 10-fold higher potency in in vitro T cell activation inhibition assays compared to ALTB-168.
  • The preclinical data will highlight a new role for PSGL-1 as a novel immune checkpoint regulator that modulates T cell homeostasis.
  • ALTB-168 has been clinically validated for safety, tolerability, and efficacy in treating inflammatory diseases including Psoriasis, Psoriatic Arthritis, Ulcerative Colitis and acute GVHD.

Cue Biopharma to Present at the Federation of Clinical Immunology Societies (FOCIS) 2023 Annual Meeting

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Wednesday, June 14, 2023
KRAS, Selective, De novo, Regulatory T cell, Malignancy, Federation, Translational medicine, Annual general meeting, HNSCC, HPV, WT1, Federation of Clinical Immunology Societies, Pembrolizumab, Autoimmunity, Inflammation, Vaccine

Proof of concept for this platform has been achieved with clinical data from CUE-101, the company’s lead candidate.

Key Points: 
  • Proof of concept for this platform has been achieved with clinical data from CUE-101, the company’s lead candidate.
  • Additionally, Dr. Quayle will discuss the modularity of the Immuno-STAT platform, which has enabled rapid generation of additional Immuno-STAT candidates targeting other tumor antigens, such as mutated KRAS or Wilms’ Tumor 1 (WT1).
  • This includes Cue Biopharma’s second CUE-100 series candidate, CUE-102, that is being evaluated in a Phase 1 trial for the treatment of WT1 positive malignancies.
  • Taken together, the clinical de-risking achieved with CUE-101 supports broad applications of the Immuno-STAT platform to target diverse cancers.

NexImmune Announces Poster Presentation at the 2023 FOCIS Annual Meeting

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Monday, May 22, 2023
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GAITHERSBURG, Md., May 22, 2023 (GLOBE NEWSWIRE) -- NexImmune, Inc. (Nasdaq: NEXI), a biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells in oncology, autoimmune and infectious diseases, today announced that it will be presenting a poster at the Federation of Clinical Immunology Societies (FOCIS) Annual Meeting, being held in Boston from June 20-23, 2023.

Key Points: 
  • GAITHERSBURG, Md., May 22, 2023 (GLOBE NEWSWIRE) -- NexImmune, Inc. (Nasdaq: NEXI), a biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells in oncology, autoimmune and infectious diseases, today announced that it will be presenting a poster at the Federation of Clinical Immunology Societies (FOCIS) Annual Meeting, being held in Boston from June 20-23, 2023.
  • This poster is a result of a collaboration between NexImmune and Dr. Steven Jacobsen at the NIH which is focused on two goals.
  • The second goal is to evaluate whether specific T cell defects can be circumvented as a potential development strategy to enable CD8+ specific killing of EBV+ cells that are believed to be a significant contributing factor to multiple sclerosis.
  • “We believe AIM products are uniquely positioned to deliver multi-antigen targeted approaches to address unmet need in these disease areas.”