Regulatory T cell

Xencor Presents Clinical Results from Phase 1a Study of XmAb®564 at the EULAR 2023 Congress

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Martedì, Maggio 30, 2023

Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies and cytokines for the treatment of patients with cancer and autoimmune diseases, today announced the presentation of results from its Phase 1a single-ascending dose study of XmAb®564 in healthy volunteers.

Key Points: 
  • Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies and cytokines for the treatment of patients with cancer and autoimmune diseases, today announced the presentation of results from its Phase 1a single-ascending dose study of XmAb®564 in healthy volunteers.
  • XmAb564 is a potency-tuned IL-2-Fc fusion protein, engineered to selectively activate and expand regulatory T cells (Tregs) for the potential treatment of patients with autoimmune diseases.
  • Results will be presented in a poster titled “XmAb564, a Novel Potency-Tuned IL-2 Fc-Fusion Protein Selectively Expands Regulatory T Cells: Results from a Single Ascending-Dose Study in Healthy Adult Volunteers” at the European Congress of Rheumatology (EULAR) being held May 31 to June 3 in Milan, Italy.
  • “We continue to enroll patients into the Phase 1b, multiple-ascending dose study in patients with atopic dermatitis and psoriasis, and we anticipate completing dose escalation in psoriasis cohorts in early 2024.”

Collaborators at the Keio and Osaka Universities Present Key Non-Clinical Data with Stable/Functional-Induced Regulatory T Cells (S/F-iTregs) in Autoimmune Disease Models

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Lunedì, Maggio 29, 2023

OSAKA, Japan, May 29, 2023 /PRNewswire/ -- RegCell collaborators from Keio University and Osaka University presented key data at ISID 2023 Tokyo Satellite Meeting.

Key Points: 
  • OSAKA, Japan, May 29, 2023 /PRNewswire/ -- RegCell collaborators from Keio University and Osaka University presented key data at ISID 2023 Tokyo Satellite Meeting.
  • Their presentation demonstrated that in a murine pemphigus model, S/F-iTregs significantly decreased clinical scores, circulating anti-Dsg3 IgG titers, and other autoimmune markers related to Pemphigus.
  • Collaborators also reported that S/F-iTregs generated from samples obtained from patients with Pemphigus also showed potent inhibition of autologous T cell proliferation in vitro.
  • Tregs play a central role in managing immune self-tolerance and depleted or dysfunctional Tregs are characteristic of many autoimmune disorders.

Collaborators at the Keio and Osaka Universities Present Key Non-Clinical Data with Stable/Functional-Induced Regulatory T Cells (S/F-iTregs) in Autoimmune Disease Models

Retrieved on: 
Lunedì, Maggio 29, 2023

OSAKA, Japan, May 29, 2023 /PRNewswire/ -- RegCell collaborators from Keio University and Osaka University presented key data at ISID 2023 Tokyo Satellite Meeting.

Key Points: 
  • OSAKA, Japan, May 29, 2023 /PRNewswire/ -- RegCell collaborators from Keio University and Osaka University presented key data at ISID 2023 Tokyo Satellite Meeting.
  • Their presentation demonstrated that in a murine pemphigus model, S/F-iTregs significantly decreased clinical scores, circulating anti-Dsg3 IgG titers, and other autoimmune markers related to Pemphigus.
  • Collaborators also reported that S/F-iTregs generated from samples obtained from patients with Pemphigus also showed potent inhibition of autologous T cell proliferation in vitro.
  • Tregs play a central role in managing immune self-tolerance and depleted or dysfunctional Tregs are characteristic of many autoimmune disorders.

RAPT Therapeutics to Present Biomarker Data Corroborating Demonstrated Clinical Activity and Mechanism of Action of FLX475 in Advanced Cancers

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Giovedì, Maggio 25, 2023

SOUTH SAN FRANCISCO, Calif., May 25, 2023 (GLOBE NEWSWIRE) -- RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based therapeutics company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology, today announced biomarker data for FLX475 from its ongoing FLX475-02 Phase 1/2 clinical trial which corroborate the clinical activity of FLX475 reported in Epstein-Barr virus-positive (EBV+) lymphoma, EBV+ gastric cancer and non-small cell lung cancer (NSCLC), as well as the mechanism of this novel CCR4 antagonist. These data will be presented in a poster at the 2023 American Society of Clinical Oncology (ASCO) annual meeting taking place next week at the McCormick Place Convention Center in Chicago, IL.

Key Points: 
  • In December 2022 at ESMO-IO, a clinical update from the Phase 1/2 trial reported evidence of monotherapy and combination activity.
  • FLX475 monotherapy induced confirmed complete metabolic responses in two of the six evaluable patients with EBV+ NK/T cell lymphoma.
  • These data substantiate the mechanism of action and support the combination of FLX475 with pembrolizumab.
  • These data are consistent with and support the clinical activity we’ve seen with FLX475 as monotherapy and in combination therapy with pembrolizumab.”

Interim Results From Phase 1/2 Clinical Trial in Solid Tumor Cancers Demonstrate Aulos Bioscience’s AU-007 is Well Tolerated and Uniquely Reduces Regulatory T Cells

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Giovedì, Maggio 25, 2023

The data indicate that AU-007 is well tolerated in patients with unresectable locally advanced or metastatic cancer.

Key Points: 
  • The data indicate that AU-007 is well tolerated in patients with unresectable locally advanced or metastatic cancer.
  • AU-007 is a human IgG1 monoclonal antibody designed using artificial intelligence to harness the power of interleukin-2 (IL-2) to eradicate solid tumors.
  • This allows Teff and NK cells to expand and kill tumor cells.
  • In addition, all seven patients with available pharmacodynamic data demonstrate overall decreasing Tregs (percentage change and absolute) and eosinophils.

Outpace Bio to Present New Data on OutSmart™ IL-2/15, a CAR T Cell-Produced Designed Cytokine with Tumor-Localized Immune Cell Activity, at the 2023 Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT)

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Giovedì, Maggio 18, 2023

Pro-inflammatory cytokines could overcome the TME but pose a significant safety risk to patients when delivered systemically given their potency.

Key Points: 
  • Pro-inflammatory cytokines could overcome the TME but pose a significant safety risk to patients when delivered systemically given their potency.
  • Cell therapies engineered with OutSmart™ technology produce the right signals inside the tumor and keep them there.
  • With OutSmart™, the cell therapy bolsters its own activity while also recruiting helpful bystander cells to achieve efficacy without compromising safety.
  • Antigen targeting provides additional control by retaining the cytokine near the tumor and addressing activity to specific cell populations.

Orchard Therapeutics Presents Data from Research Programs at ASGCT Demonstrating the Ability of HSC Gene Therapy to Address Larger Indications

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Giovedì, Maggio 18, 2023

BOSTON and LONDON, May 18, 2023 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today presented new data from the company’s hematopoietic stem cell (HSC) gene therapy research pipeline targeting larger indications at the ongoing 26th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) in Los Angeles. Presentations include preclinical proof-of-concept data from OTL-104, the company’s investigational HSC gene therapy for the treatment of nucleotide-binding oligomerization domain containing protein 2 (NOD2) Crohn’s disease, as well as in vivo preclinical data demonstrating the development of functional CAR-Treg cells from genetically engineered HSCs. Both programs were designed and developed in Orchard’s own research laboratories utilizing the company’s proprietary HSC gene therapy platform.

Key Points: 
  • Both programs were designed and developed in Orchard’s own research laboratories utilizing the company’s proprietary HSC gene therapy platform.
  • “These data continue to demonstrate the power of our HSC gene therapy platform and its applicability beyond our rare neurometabolic franchise into diseases with larger patient populations,” said Fulvio Mavilio, Ph.D., chief scientific officer of Orchard Therapeutics.
  • The company will continue to advance its preclinical research activities aimed at further demonstrating the feasibility and applicability of its HSC CAR-Treg cell technology.
  • A replay of the webcast will be archived on the Orchard website following the presentation.

LAPIX Therapeutics Inc. Announces the Issuance of U.S. Patent for LPX-TI641, Its First-in-Class, Orally Administered Tim3/4 Agonist for Treg Expansion to Treat Autoimmune Diseases

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Mercoledì, Maggio 17, 2023

BOSTON, May 17, 2023 (GLOBE NEWSWIRE) -- LAPIX Therapeutics, Inc. (“LAPIX”), a biopharma company focused on developing novel, orally bioavailable immune system restoration therapies for autoimmune diseases and oncology, today announced the U.S. Patent & Trademark Office issued its U.S. Patent No.

Key Points: 
  • BOSTON, May 17, 2023 (GLOBE NEWSWIRE) -- LAPIX Therapeutics, Inc. (“LAPIX”), a biopharma company focused on developing novel, orally bioavailable immune system restoration therapies for autoimmune diseases and oncology, today announced the U.S. Patent & Trademark Office issued its U.S. Patent No.
  • 11,648,225, entitled “Compositions And Methods For Reducing Immune Intolerance And Treating Autoimmune Disorders.” The patent is directed to LPX-TI641, LAPIX’s novel, first-in-class, immune tolerance restoration small molecule.
  • LPX-TI641 has been purposefully designed to be a Tim3 and Tim4 agonist that can restore the regulatory T cell (Treg) population in an antigen-agnostic manner for treating autoimmune diseases.
  • “This is very promising for the treatment of autoimmune diseases in general and MS in particular.

Coya Therapeutics’ COYA 301 Increased Treg Function and Halted Cognitive Decline in an Open Label Study in Patients with Alzheimer’s Disease

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Martedì, Maggio 16, 2023

The study enrolled 8 patients with confirmed presence of brain amyloid pathology and baseline MMSE scores between 12 and 25.

Key Points: 
  • The study enrolled 8 patients with confirmed presence of brain amyloid pathology and baseline MMSE scores between 12 and 25.
  • The patients were treated with five-day-courses of COYA 301 for four monthly cycles and were followed for two months post-treatment.
  • Treg function and numbers, serum biomarkers of inflammation, and cognitive functioning as measured by the ADAS-Cog, CDR-SB and MMSE assessment tools were evaluated.
  • Mean (SD) Treg suppressive function was 46.61% (7.74) at baseline, and significantly increased to 79.5 % (20.55) at the end of treatment (p=0.003).

EQS-News: Andera Partners co-leads a €40 million Series A of Dualyx, a Belgian biotech developing novel Treg therapies for autoimmune diseases

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Lunedì, Maggio 15, 2023

Andera Partners co-leads a €40 million Series A of Dualyx, a Belgian biotech developing novel Treg therapies for autoimmune diseases

Key Points: 
  • Andera Partners co-leads a €40 million Series A of Dualyx, a Belgian biotech developing novel Treg therapies for autoimmune diseases
    The issuer is solely responsible for the content of this announcement.
  • Andera Partners co-leads a €40 million Series A of Dualyx, a Belgian biotech developing novel Treg therapies for autoimmune diseases
    Proceeds will enable the development of the Company’s lead autoimmune program DT-001, targeting TNFR2, as well as its pipeline of Treg-targeting candidates
    PARIS, FRANCE – MAY 15, 2023 – Andera Partners co-leads a €40 million Series A financing of Dualyx NV, a Ghent, Belgium based biotech developing next generation immune modulators.
  • Alongside Andera, Fountain Healthcare Partners and Forbion co-led the round, with support from existing investors V-Bio Ventures, BGV, PMV, VIB, HTGF, and GFF.
  • The funds raised will enable Dualyx to progress its lead autoimmune program DT-001, as well as its pipeline of Treg-targeting candidates.