GM-CSF

Elicio Therapeutics to Present Updated Clinical T Cell and Antigen Spreading Response Data from the Ongoing AMPLIFY-201 Phase 1 Study of ELI-002 and Preclinical Data on ELI-007 and ELI-008 at the AACR Annual Meeting

Retrieved on: 
Friday, April 5, 2024
CD4, CD8, AMP, Development, Antigen, Immunotherapy, Colorectal cancer, Memory, Patient, Lung, GM-CSF, Biomarker, DNA, Epitope, Cancer, Granzyme B, BRAF, Lymph, IL2, Circulating tumor DNA, Phenotype, Neoplasm, Research and development, Immunization, Therapy, Vaccination, CRC, V600E, Immune system, Melanoma, Granzyme, Phase 1, Amphetamine, Nature Medicine, Annual general meeting, Vaccine

Preclinical data on vaccine candidates, ELI-007 and ELI-008, investigational peptide vaccines targeting BRAF and p53-driven cancers, respectively, will also be shared.

Key Points: 
  • Preclinical data on vaccine candidates, ELI-007 and ELI-008, investigational peptide vaccines targeting BRAF and p53-driven cancers, respectively, will also be shared.
  • A majority of patients who received the booster immunizations maintained or increased mKRAS-specific T cell responses relative to baseline.
  • The mKRAS-specific CD4 and CD8 T cells generated by ELI-002 exhibited increased cytotoxic function and development of favorable memory phenotype.
  • "Earlier data published in Nature Medicine demonstrate that our off-the-shelf lymph node-targeted cancer vaccine candidate, ELI-002, induces memory T cell responses.

Orphan designation: Genetically modified serotype 5/3 adenovirus coding for granulocyte macrophage colony-stimulating factor for the treatment of ovarian cancer Treatment of ovarian cancer, 29/04/2014 Withdrawn

Retrieved on: 
Tuesday, April 9, 2024
Eurostat, Diagnosis, Civil service commission, Ovarian cancer, GM, Gene, Survival, Disease, Patient, Committee, Knowledge, GM-CSF, Cancer, Female, Regulation, EMA, IRIS, Woman, European, Therapy, COMP, Sponsor, European Commission, Immune system, Safety, Marketing, Medicine, Pharmaceutical industry

Orphan designation: Genetically modified serotype 5/3 adenovirus coding for granulocyte macrophage colony-stimulating factor for the treatment of ovarian cancer Treatment of ovarian cancer, 29/04/2014 Withdrawn

Key Points: 


Orphan designation: Genetically modified serotype 5/3 adenovirus coding for granulocyte macrophage colony-stimulating factor for the treatment of ovarian cancer Treatment of ovarian cancer, 29/04/2014 Withdrawn

Greenwich LifeSciences Partners with GEICAM in Spain & Conducts First Site Initiation Visits in Europe

Retrieved on: 
Tuesday, March 12, 2024
Principal, GP2, Faculty, Breast cancer, Gregorio, Immunotherapy, Disease, Patient, Knowledge, GM-CSF, Research, Hospital, Observation, Pi, Cancer, Death, Teaching hospital, Baylor College of Medicine, ECIS, Complutense University of Madrid, Woman, Prognosis, Book, Vaccine, Map

The Company has partnered with GEICAM, the largest academic breast cancer research network in Spain, where 38 hospitals have agreed to participate in FLAMINGO-01.

Key Points: 
  • The Company has partnered with GEICAM, the largest academic breast cancer research network in Spain, where 38 hospitals have agreed to participate in FLAMINGO-01.
  • These sites were recently approved by Spanish authorities, which led to site initiation visits and training of the first sites this past week.
  • Founded in 1995, GEICAM is a not-for-profit organization leading academic breast cancer research in Spain.
  • Breast cancer is the leading cause of death in women between the ages 35-45 in Spain with 6,836 deaths in 2022.

Coya Therapeutics Provides a Corporate Update and Reports Fiscal 2023 Financial Results

Retrieved on: 
Tuesday, March 19, 2024
Mental Health, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, Research, Pharmacology, LD, Survival, Serum, ALS, Science, PD, Houston Methodist Hospital, Patient, Regulatory affairs, Granulocyte-macrophage colony-stimulating factor, FD, GM-CSF, Nebraska Medicine, COYA, University, IPO, Senior, Society, IND, Commerce, Viral disease, Therapy, Frontotemporal dementia, FDA, FTD, Pharmaceutical industry

Coya Therapeutics, Inc. (Nasdaq: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function, provides a corporate update and announces its financial results for the year ended December 31, 2023.

Key Points: 
  • Coya Therapeutics, Inc. (Nasdaq: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function, provides a corporate update and announces its financial results for the year ended December 31, 2023.
  • COYA 302 is Coya’s combination of its proprietary LD IL-2 formulation with the immunomodulatory drug CTLA4-Ig.
  • “We believe that we have under-promised and over-delivered in executing on numerous deliverables in 2023 that have brought value to Coya,” commented Howard Berman, Ph.D., Chief Executive Officer of Coya.
  • Net loss was $8.0 million for the year ended December 31, 2023, compared to net loss of $12.2 million for the year ended December 31, 2022.

Partner Therapeutics' Leukine® (sargramostim) Receives Approval in Japan to Treat Autoimmune Pulmonary Alveolar Proteinosis (aPAP)

Retrieved on: 
Wednesday, April 3, 2024
Monocyte, GM, Serum, Disease, Partnership, Patient, GM-CSF, DNA, PTX, Doctor of Philosophy, Respiratory failure, Pleasure, Trade name, Granulocyte-macrophage colony-stimulating factor, Pulmonary fibrosis, APAP, Therapy, Niigata University, Pulmonary alveolar proteinosis, Division, Partner, PMDA, PAGE, CEA, WLL, Hospital

LEXINGTON, Mass., April 3, 2024 /PRNewswire/ -- Partner Therapeutics, Inc. (PTx) announced that its partner Nobelpharma received approval from the Japanese Pharmaceuticals and Medical Device Agency (PMDA) for the inhaled use of Leukine (sargramostim), branded in Japan as Sargmalin, to treat aPAP. PTx licensed rights for certain indications in Japan to Nobelpharma in 2022. Leukine is a glycosylated recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF) produced by recombinant DNA technology in yeast. Leukine is not approved outside Japan for aPAP or as an inhalation therapy. Partner Therapeutics will manufacture Sargmalin for Nobelpharma at its manufacturing facility in Lynnwood, WA.

Key Points: 
  • Leukine is not approved outside Japan for aPAP or as an inhalation therapy.
  • Partner Therapeutics will manufacture Sargmalin for Nobelpharma at its manufacturing facility in Lynnwood, WA.
  • Inhaled recombinant GM-CSF reduces the need for whole lung lavage and improves gas exchange in autoimmune pulmonary alveolar proteinosis patients.
  • Autoimmune pulmonary alveolar proteinosis.

Y-mAbs Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Corporate Developments

Retrieved on: 
Thursday, February 29, 2024
Acquisition, Research, Reiterate, Neoplasm, FDA, Cancer, Adium, Disassembler, International Society, NASDAQ Biotechnology Index, Interim, GM-CSF, Self-assembly, NBI, Therapy, Interest, Patient, HITS, Clinical trial, Congress, IND, Human, Cryptocurrency

On October 18, 2023, Y-mAbs announced that its Board of Directors appointed radiopharmaceutical industry veteran Mr. Rossi as President and Chief Executive Officer, effective November 6, 2023.

Key Points: 
  • On October 18, 2023, Y-mAbs announced that its Board of Directors appointed radiopharmaceutical industry veteran Mr. Rossi as President and Chief Executive Officer, effective November 6, 2023.
  • The DANYELZA net product revenues of $23.4 million in the fourth quarter of 2023, represented a favorable 17% increase compared to the third quarter of 2023, primarily driven by increased U.S. sales.
  • The Company did not have license revenues in the quarter ended December 31, 2023 and had license revenues of $0.5 million for the year ended December 31, 2023.
  • The net income for the quarter ended December 31, 2022, was after $15.0 million of license revenue recognized in the fourth quarter of 2022.

Therapeutic Solutions International Announces Landmark Finding Regarding Mechanism of Action of its JadiCell Stem Cell Product

Retrieved on: 
Thursday, February 29, 2024
Health, Stem Cells, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, FDA, TSOI, Standard of care, Cell, GM-CSF, Safety, COVID-19, Patent, Patient, Monocyte, Acute respiratory distress syndrome, Survival, Phase, Science, TGF, Brain, Pharmaceutical industry

Depletion of either of these cells significantly reduced therapeutic effects of JadiCells.

Key Points: 
  • Depletion of either of these cells significantly reduced therapeutic effects of JadiCells.
  • Additionally, transfer of monocytes and T cells from JadiCell treated mice was able to protect naïve mice from lung injury.
  • The therapeutic effect of JadiCells was amplified by administration of Leukine (GM-CSF), which is known to increase circulating monocytes.
  • We are dedicated to curing this terrible disease1 and making our cells the new standard of care.”

Coya Therapeutics Issues Letter to Stockholders Highlighting Expansion of COYA 302 into Alzheimer’s Disease and Coya’s Pathway to a “Pipeline in a Product”

Retrieved on: 
Wednesday, February 21, 2024
Mental Health, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, Cancer, Coya, CD4, PD, Immune system, Houston Methodist Hospital, Frontotemporal dementia, Research, LD, Inflammation, Neuroinflammation, COYA, Animal, Letter, FTD, GM-CSF, Safety, University, Biomarker, Therapy, Patient, Survival, Oxidative stress, IND, Protein aggregation, Partnership, Pharmaceutical industry

Today, we announce that we are further expanding the pipeline for COYA 302, adding Alzheimer’s disease (AD) to its growing list of indications expected to be validated in the clinic.

Key Points: 
  • Today, we announce that we are further expanding the pipeline for COYA 302, adding Alzheimer’s disease (AD) to its growing list of indications expected to be validated in the clinic.
  • Beyond COYA 302, our therapeutic platform includes additional drug product combinations using COYA 301 (our proprietary LD IL-2) as their backbone.
  • 2 investigator-initiated trial with COYA 301 in AD that we expect will support the development of COYA 302 in that same indication.
  • I look forward to providing investors with additional periodic updates on our research, clinical, corporate, and commercial progress.

Coya Therapeutics Licenses Intellectual Property Rights for Use of Next Generation Immune Modulatory Biologics in Combination with COYA 301 to Enhance Regulatory T Cells (Tregs) in Inflammatory Diseases

Retrieved on: 
Tuesday, February 13, 2024
Research, Neurology, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Other Science, Science, Transfer, Spleen, Coya, Inflammation, COYA, Nebraska Medicine, Technology transfer, GM-CSF, University, Therapy, Phenotype, Patent, Patient, Gendelman, CD39, Mouse, Immune system, Pharmaceutical industry

Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing multiple therapeutic programs intended to enhance regulatory T cell (Treg) function, has expanded and strengthened its patent estate beyond COYA 302, which is a combination of COYA 301 with CTLA-4 Ig.

Key Points: 
  • Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing multiple therapeutic programs intended to enhance regulatory T cell (Treg) function, has expanded and strengthened its patent estate beyond COYA 302, which is a combination of COYA 301 with CTLA-4 Ig.
  • UNeMed will receive payments upon achievement of certain milestones and will be eligible to receive tiered low single-digit royalty on net sales.
  • This included a 4-to-6-fold higher expression of Tregs in mice treated with the combination compared to treatments with either cytokine alone.
  • Coya’s foundation and progress in low-dose IL-2 research makes them an ideal company to leverage our findings to date.”

Comprehensive Review Highlights Importance of Leukine® in Combination with Anti-GD2 Immunotherapy for Treatment of High-Risk Pediatric Neuroblastoma

Retrieved on: 
Wednesday, January 17, 2024
Lazarus, Neutrophil, Macrophage, Therapy, Canadian International Council, Hook effect, Hematology, G-CSF, Sant Joan, Safety, Hospital, MHC, FDA, PTX, INT, GM-CSF, ADCC, B cell, Vaccine

LEXINGTON, Mass., Jan. 17, 2024 /PRNewswire/ -- Partner Therapeutics, Inc. (PTx) announced today the publication of a comprehensive review by Mora et al.

Key Points: 
  • LEXINGTON, Mass., Jan. 17, 2024 /PRNewswire/ -- Partner Therapeutics, Inc. (PTx) announced today the publication of a comprehensive review by Mora et al.
  • It also describes why the authors believe it is suboptimal to replace with Leukine with G-CSF in this regimen for mechanistic reasons.
  • Leukine has been studied extensively in combination with dinutuximab and naxitamab leading to improved patient outcomes.
  • As a result, all clinical trials supporting the FDA-approval of dinutuximab and naxitamab included Leukine and both products are labeled for use in combination with GM-CSF.