Regulatory T cell

Medicenna Presents Updated Results of Single Agent MDNA11 Anti-tumor Activity from Dose Escalation and Ongoing Dose Expansion of the Phase 1/2 ABILITY-1 Study at the 2024 Annual Meeting of the American Association for Cancer Research (AACR)

Retrieved on: 
Tuesday, April 9, 2024
Toxicity, PR, Combination therapy, VLS, MSI-H, PD, LFT, RDE, Duodenal cancer, Patient, Hypertelorism, Radiation, MCC, MDNA, AACR, TSX, DLT, Pancreatic cancer, Safety, Regulatory T cell, Melanoma, Cancer, BCC, NK, Pharmaceutical industry

March 22, 2024) include:

Key Points: 
  • March 22, 2024) include:
    Acceptable safety profile: No dose limiting toxicity (DLT) reported and no evidence of vascular leak syndrome (VLS).
  • A new lymph node lesion developed during a 8-week MDNA11 treatment break (vacation) was treated with a single course of radiotherapy prior to resumption of MDNA11.
  • A new lymph node lesion developed at week 16 while baseline target and non-target lesions remained stable or decreased.
  • Monotherapy expansion is continuing to enroll patients with metastatic melanoma, non-melanoma skin cancers (cSCC, MCC, and BCC) and MSI-H/dMMR tumors.

Adagene Reports Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Friday, March 29, 2024
Head, Immunotherapy, HNSCC, Patient, Roche, Lead, Immunoglobulin G, Neoplasm, CRC, Audit committee, PD-1, Observation, Bioinformatics, Colorectal cancer, SAN, Information technology, Pembrolizumab, PRS, Safety, PD-L1, Compensated emancipation, Annual report, Apoptosis, Cervical cancer, Part, Merck, Senior, Bevacizumab, MSS, GAAP, ASCO, PFS, MTD, Liver disease, HCC, Therapeutic index, Endometrial cancer, Progression-free survival, ADS, Net, Regulatory T cell, Research and development, Liver, Pharmaceutical industry

SAN DIEGO and SUZHOU, China, March 29, 2024 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel antibody-based therapies, today reported financial results for the full year 2023 and provided corporate updates.

Key Points: 
  • Both confirmed PRs are sustained after more than one year with repeat dosing while maintaining robust safety profiles.
  • Observation of these clinical activities triggered further expansion into the second stage of the Simon’s 2-stage design for this dose level.
  • Net loss attributable to Adagene Inc.’s shareholders was US$18.9 million for the year ended December 31, 2023, compared to US$80.0 million in 2022.
  • The company encourages investors and others to review its financial information in its entirety and not rely on a single financial measure.

RegCell Appoints Leading T-Cell Therapy Expert Steven B. Kanner, Ph.D., to Board of Directors

Retrieved on: 
Wednesday, April 3, 2024
Cell, Rachel Haurwitz, Drug discovery, Genetics, Inflammation, Patient, Arrowhead Pharmaceuticals, Research, Bristol Myers Squibb, University, Publication, Reindeer, Microbiology, Regulatory T cell, RNA interference, Immune system, Therapy, Bangladesh Technical Education Board, Book, Astex Pharmaceuticals, Vaccine

"We are honored to have Steve Kanner join our Board of Directors," remarked Professor Shimon Sakaguchi, co-founder of RegCell.

Key Points: 
  • "We are honored to have Steve Kanner join our Board of Directors," remarked Professor Shimon Sakaguchi, co-founder of RegCell.
  • "Dr. Kanner's profound understanding of immunology comes at a pivotal juncture for RegCell as we advance our clinical development and expand our Precision Epigenetic Reprogramming Platform.
  • Backed by leading institutional and corporate investors hailing from Japan, RegCell emerges as the next-generation global life science enterprise at the forefront of regulatory T-cell therapies.
  • Central to RegCell's innovation is its 'Precision Epigenetic Reprogramming' platform, which entails the epigenetic reprogramming of CD4+ T-cells into regulatory T-cells.

Creative Medical Technology Holdings, Inc. Receives FDA Orphan Drug Designation for CELZ-101 in Key Transplantation Therapy

Retrieved on: 
Wednesday, March 6, 2024
Health, FDA, Diabetes, Other Science, Research, Science, Biotechnology, Urology, Regenerative medicine, Immunotherapy, Food, Regulatory T cell, Elective surgery, Gynaecology, Endocrinology, DNP, Transplant, Immunosuppression, CCRP, Patient, Autoimmunity, Drug, Pharmaceutical industry

Timothy Warbington, CEO of Creative Medical Technology Holdings, stated, "The FDA's Orphan Drug Designation for CELZ-101 underscores our commitment to developing groundbreaking therapies.

Key Points: 
  • Timothy Warbington, CEO of Creative Medical Technology Holdings, stated, "The FDA's Orphan Drug Designation for CELZ-101 underscores our commitment to developing groundbreaking therapies.
  • “The Orphan Drug Designation by the FDA highlights CELZ-101's potential to meet a significant unmet need in the prevention of allograft rejection during pancreatic islet cell transplantation which was recently approved by the FDA.
  • Creative Medical Technology Holdings, Inc. (NASDAQ:CELZ) is dedicated to progressing CELZ-101 through the necessary regulatory pathways, with the goal of transforming the therapeutic landscape for patients in need of islet transplantation.
  • This achievement underscores the company's dedication to leveraging the natural regenerative capabilities of the human body to create lasting health solutions.

Re-engineering Immune Cells Opens Door to Promising Therapy for Lupus Kidney Inflammation

Retrieved on: 
Tuesday, February 6, 2024
Inflammation, Lupus Research Alliance, Steroid, Cell, Cytokine, Immune system, Proteinuria, Bacteria, Nature Communications, Research, Kidney, Patient, Virus, LRA, Antibody, Lupus nephritis, Protein, Disease, Urine, Smith, Infection, Regulatory T cell, Tissue, SLE, DSM-IV codes, Lupus, Vaccine

NEW YORK, Feb. 6, 2024 /PRNewswire/ -- Research featured in Nature Communications highlights a novel approach that re-engineers a person's own immune cells to suppress the overactive immune system that occurs in lupus nephritis, a serious and potentially life-threatening inflammation of the kidneys. With funding in part from the Lupus Research Alliance (LRA), associate professor Joshua Ooi, Ph.D. and his team at the Centre for Inflammatory Disease, Monash Health in Australia, developed an innovative method that could enable multiple targeted therapies not only for lupus but other autoimmune diseases as well.

Key Points: 
  • T cells direct the immune system's response to potential threats by identifying and attacking harmful invaders like viruses and bacteria.
  • In healthy individuals, a specific type of T cells called T regulatory cells (Tregs) prevent the immune system from continuing to react once an infection is cleared.
  • Earlier LRA funding allowed my team to pursue the idea that patients' immune cells could be engineered to correct immune dysfunction.
  • The Lupus Innovation Award then gave us the ability to test the effectiveness of these patient-derived engineered cells in a model of disease."

Domain Therapeutics Awarded Hospital-University Research in Health (RHU) SPRINT Consortium Grant to Progress Its Proprietary CCR8 Antibody Candidate to the Clinic

Retrieved on: 
Thursday, January 25, 2024
Technology, Biotechnology, Health, Biometrics, Other Health, Pharmaceutical, Artificial Intelligence, Oncology, Other Science, Research, Hospitals, Health Technology, Science, Clinical Trials, Patient, Therapy, G protein-coupled receptor, AP-HP, Multimedia, Fatigue, Intelligence, Medicen, Government, Cancer, Cutaneous T-cell lymphoma, Drug discovery, Quality of life, SPRINT, Survival rate, Regulatory T cell, National Cancer Institute, Disease, Study Group, Sarcoma, Hospital, GPCR, Pain, Gq alpha subunit, ANR, TME, RHU, Physician, Pharmaceutical industry

Domain Therapeutics (“Domain” or “the Company”), a clinical-stage global biopharmaceutical company developing innovative drug candidates in immuno-oncology targeting G Protein-Coupled Receptors (GPCRs), today announces it has been awarded a grant as part of the Hospital-University Research in Health (RHU) SPRINT consortium.

Key Points: 
  • Domain Therapeutics (“Domain” or “the Company”), a clinical-stage global biopharmaceutical company developing innovative drug candidates in immuno-oncology targeting G Protein-Coupled Receptors (GPCRs), today announces it has been awarded a grant as part of the Hospital-University Research in Health (RHU) SPRINT consortium.
  • View the full release here: https://www.businesswire.com/news/home/20240125583037/en/
    The SPRINT project aims to revolutionize the management of patients with CTCL and deliver a new cure paradigm as a standard-of-care.
  • The grant that we have been awarded by the RHU SPRINT consortium will support the progress of DT-7012, an anti-CCR8 monoclonal antibody which has incredible potential as a best-in-class therapeutic, into the clinic.
  • Domain was already awarded a first RHU grant, RHU CONDOR for Sarcoma, in the previous campaign, leveraging another proprietary asset.

GigaGen Receives FDA Clearance of IND to Begin Phase 1 Trial of Oncology Drug Candidate, GIGA-564, in Solid Tumors

Retrieved on: 
Tuesday, December 12, 2023
Regulatory T cell, Partnership, Food, Tumor microenvironment, Biotechnology, IND, FDA, SAN, Head, Bangladesh Technical Education Board, Toxicity, Infection, NCI, Pharmaceutical industry

SAN CARLOS, Calif., Dec. 12, 2023 (GLOBE NEWSWIRE) -- GigaGen Inc., a biotechnology company advancing transformative antibody drugs for immune deficiencies, infectious diseases and checkpoint resistant cancers, and a subsidiary of Grifols, announced today that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to initiate a Phase 1 trial to evaluate the company’s oncology candidate, GIGA-564, for the treatment of solid tumors.

Key Points: 
  • “We are pleased to have reached this significant milestone, paving the way for our first oncology asset to enter clinical development,” said Carter Keller, senior vice president of Grifols and head of GigaGen.
  • “GIGA-564 introduces a novel approach to CTLA-4 targeting, with the promise of enhanced anti-tumor activity and lower side effects compared with existing anti-CTLA-4 agents.
  • The Phase 1a/1b dose escalation and dose-expansion trial will evaluate GIGA-564 for the treatment of advanced solid tumors.
  • The trial will be conducted by National Institutes of Health’s National Cancer Institute (NCI) researchers in close partnership with the GigaGen team.

Almirall Initiates First Phase I Clinical Study of ALM223, an Interleukin 2 Mutant Fusion Protein for Autoimmune Diseases

Retrieved on: 
Thursday, December 21, 2023
Science, Other Science, Biotechnology, Research, Pharmaceutical, Health, Clinical Trials, Other Health, Regulatory T cell, Simcere Pharmaceutical, Immune system, Multimedia, BME, Greater, Natural killer T cell, Human, Pharmacokinetics, Cell, Safety, ALM, Almirall, NK

View the full release here: https://www.businesswire.com/news/home/20231221296013/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20231221296013/en/
    Almirall HQ in Barcelona (Photo: Business Wire)
    ALM223 is a modified version of the protein IL-2 designed to selectively activate Regulatory T cells (Tregs).
  • It may therefore have potential to restore immune balance and prevent the immune cells from attacking the body’s own cells.
  • ALM223, previously referred to as SIM0278, had been developed by Simcere by utilizing their protein engineering platform.
  • Simcere also initiated the phase I development for the Chinese market in August 2023.

Mr. Wilbur L. Ross, Former United States Secretary of Commerce, Joins Board of Coya Therapeutics, Inc.

Retrieved on: 
Wednesday, December 20, 2023
Health, Neurology, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, Disease, Regulatory T cell, Regulation, Science, Bloomberg Markets, COYA, Commerce, Alzheimer's disease, Therapy, Inflammation, ALS, Pharmaceutical industry

Coya intends to leverage Secretary Ross’s extensive experience in both the business and investment community to help guide strategic partnering activities, capital markets initiatives and drug development programs.

Key Points: 
  • Coya intends to leverage Secretary Ross’s extensive experience in both the business and investment community to help guide strategic partnering activities, capital markets initiatives and drug development programs.
  • Secretary Ross explained, “I am excited to join the Board of Coya.
  • Secretary Ross has been chairman or lead director of more than 100 companies operating in more than 20 different countries.
  • “I am delighted that Secretary Ross will bring his long and noteworthy experience in capital markets and business operations to Coya.

Aulos Bioscience Advances AU-007 to Phase 2 Portion of Phase 1/2 Study Evaluating Computationally Designed IL-2 Antibody for Treatment of Solid Tumors

Retrieved on: 
Monday, December 18, 2023
Research, Technology, Clinical Trials, Health Technology, Biotechnology, Pharmaceutical, Health, Science, Oncology, Artificial Intelligence, Renal cell carcinoma, Safety, Annual general meeting, Immunoglobulin G, Karen Teff, Clinical trial, Patient, Regulatory T cell, Kidney, Artificial intelligence, Immunotherapy, Interleukin, Neoplasm, RCC, CD25, Therapy, Melanoma, SITC, Eosinophil, Skin, Cell, NK, Pharmaceutical industry, Vaccine

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.

Key Points: 
  • 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 is encouraging as the anti-tumor activity has been observed in heavily pre-treated patients whose tumors had progressed through checkpoint inhibitors.
  • Clinical data from the Phase 1/2 study were presented at the 38th Society for Immunotherapy of Cancer (SITC) Annual Meeting in November.
  • Created by Biolojic Design, AU-007 is the first computationally designed monoclonal antibody to be tested in a clinical trial.