CSF1R

Deciphera Pharmaceuticals Announces Planned 2023 Corporate Milestones to Support Continued Evolution to Multi-Product Company

Retrieved on: 
Tuesday, January 3, 2023
Biotechnology, Pharmaceutical, Health, Oncology, Cancer, Gastrointestinal stromal tumor, INSIGHT, MEK, Research, Business, Pfizer, DNA, Binimetinib, Public expenditure, Tenosynovial giant cell tumor, Trial of the century, Colorectal cancer, Neoplasm, GIST, Patient, CSF1R, Cetuximab, Autophagy, TGCT, FDA, IND, Circulating tumor DNA, BRAF, KIT, International, Pharmaceutical industry, Medical device

The Company also announced plans to initiate the INSIGHT pivotal Phase 3 clinical study of QINLOCK versus sunitinib in this patient population in the second half of 2023.

Key Points: 
  • The Company also announced plans to initiate the INSIGHT pivotal Phase 3 clinical study of QINLOCK versus sunitinib in this patient population in the second half of 2023.
  • Continue European geographic expansion of QINLOCK in 2023, with planned commercial launches following conclusion of pricing and reimbursement negotiations in key European markets.
  • Nominate a new development candidate from Deciphera’s proprietary discovery engine of novel switch-control inhibitors in the first half of 2023.
  • Deciphera will host a conference call and webcast to discuss the ctDNA analysis results from the INTRIGUE Phase 3 clinical study, its planned 2023 corporate milestones and a general business update, today, January 3, 2023, at 5:00 PM ET.

Vigil Neuroscience Announces First Patient Dosed in the IGNITE Phase 2 Clinical Trial to Evaluate VGL101 in Patients with ALSP

Retrieved on: 
Wednesday, December 14, 2022
Genetic testing, Life expectancy, Diagnosis, Patient, Clinical trial, AD, Annual report, Autosome, Prevalence, Security (finance), FDA, Caregiver burden, Safety, ALSP, Magnetic resonance imaging, Physical, Pharmacokinetics, Microglia, IPO, Neurodegeneration, HIV disease progression rates, Disease, IND, Mutation, Biomarker, IGNITE, Brain, COVID-19, TREM2, CSF1R, Pharmaceutical industry, Vaccine

“Dosing the first ALSP patient in the IGNITE Phase 2 trial represents a significant clinical milestone for Vigil and for people living with this rare, rapidly progressing, fatal disease with a significant unmet need,” said Ivana Magovčević-Liebisch, Ph.D., J.D., President and Chief Executive Officer of Vigil.

Key Points: 
  • “Dosing the first ALSP patient in the IGNITE Phase 2 trial represents a significant clinical milestone for Vigil and for people living with this rare, rapidly progressing, fatal disease with a significant unmet need,” said Ivana Magovčević-Liebisch, Ph.D., J.D., President and Chief Executive Officer of Vigil.
  • Secondary outcome assessments include the effects of VGL101 on magnetic resonance imaging and biomarkers of neurodegeneration and target engagement.
  • Exploratory outcome assessments include the evaluation of clinical efficacy measures using standard cognitive, motor and functional assessments as well as assessment of the pharmacokinetics of VGL101 in patients with ALSP.
  • Patients enrolled in the trial will receive an intravenous (IV) infusion of 20 mg/kg of VGL101 approximately every four weeks, for a treatment duration of one year.

Gossamer Bio Announces Seralutinib Meets Primary Endpoint in Phase 2 TORREY Study in PAH

Retrieved on: 
Tuesday, December 6, 2022
Science, Cardiology, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, Therapy, III, PAH, Subdural hematoma, University of Giessen, Pulmonary hypertension, Peripheral edema, Patient, Entrepreneurship, Diarrhea, University Hospital (Newark, New Jersey), FC, Nausea, HIV disease progression rates, GOSS, Vomiting, Bio, Week, Resistance wire, SAE, Framingham Risk Score, Inflammation, Pulmonary artery, Hypertensive emergency, Teaching hospital, N-terminal prohormone of brain natriuretic peptide, Pharmaceutical industry, Medical device, CSF1R, Gossamer, Medicine, PVR

The Phase 2 TORREY study enrolled 86 patients with WHO Functional Class (FC) II or III PAH, with 42 randomized to the placebo arm and 44 randomized to the seralutinib arm.

Key Points: 
  • The Phase 2 TORREY study enrolled 86 patients with WHO Functional Class (FC) II or III PAH, with 42 randomized to the placebo arm and 44 randomized to the seralutinib arm.
  • The primary endpoint of the study was change from baseline to Week 24 in pulmonary vascular resistance (PVR).
  • An observed mean difference in 6MWD between placebo and seralutinib of 6.5 meters numerically favored the seralutinib arm.
  • Changes in PVR favored seralutinib across all pre-specified patient sub-group analyses, demonstrating consistency in the hemodynamic outcomes observed in the study.

Vigil Neuroscience to Host ALSP KOL Event on December 6, 2022

Retrieved on: 
Monday, November 28, 2022
Life expectancy, Doctor of Philosophy, National Hospital for Neurology and Neurosurgery, Physical, Diagnosis, UCL Institute of Ophthalmology, Prevalence, University, Mutation, Autosome, Brain, Patient, FAAP, NHS England, Microglia, Epidemiology, Disease, MRI, MSMS, Neurodegeneration, Pediatric Blood & Cancer, Genetic testing, KOL, Neurology, England, TREM2, ALSP, Caregiver burden, University of Minnesota, Medical imaging, Pharmaceutical industry, Illuminate, Excellence, CSF1R, MD

The event will provide further details on the ALSP disease background, epidemiology and patient journey.

Key Points: 
  • The event will provide further details on the ALSP disease background, epidemiology and patient journey.
  • To access a live webcast of this event, please visit Events & Presentations in the Investors section of the Vigil website at www.vigilneuro.com .
  • Vigil Neuroscience routinely posts information that may be important to investors in the Investors section of its website at https://www.vigilneuro.com .
  • The company encourages investors and potential investors to consult our website regularly for important information about Vigil Neuroscience.

AmMax Bio Announces Oral Presentation of Phase 2 Data of AMB-05X for the Treatment of Tenosynovial Giant Cell Tumor (TGCT) at the 2022 CTOS Annual Meeting

Retrieved on: 
Friday, November 18, 2022
Giant, Tenosynovial giant cell tumor, Incidence, Leiden University Medical Center, ORR, Infection, Macrophage, Degenerative disease, Cell, Risk, Pain, Safety, Knowledge, Health, Physician, Patient, CSF1R, Disability, TGCT, Fast Track, Endpoint security, Annual general meeting, CSF1, Kirin-Amgen Inc v Hoechst Marion Roussel Ltd, MRI, Neoplasm, Therapy, Quality of life, Biology, FDA, Pharmaceutical industry, Medical imaging

REDWOOD CITY, Calif., Nov. 18, 2022 (GLOBE NEWSWIRE) -- AmMax Bio, Inc. (“AmMax”), a private clinical-stage biopharmaceutical company developing innovative therapeutics in oncology, including targeting the colony-stimulating factor 1 receptor (CSF1R), today announced that Dr. Michiel van de Sande, Professor of Orthopedic Oncology at the Leiden University Medical Centre, will present Phase 2 efficacy data for the novel local administration of AMB-05X for the treatment of Tenosynovial Giant Cell Tumor (TGCT) on November 18th at the 2022 Connective Tissue Oncology Society (CTOS) Annual Meeting. Details of the presentation are provided below.

Key Points: 
  • Patient-reported clinical efficacy parameters such as worst pain and stiffness in the affected joint were also markedly improved.
  • AmMax Bio is initiating its Phase 2b program with a treatment duration of six months, in line with the common duration of systemic pharmacological interventions.
  • Under an exclusive worldwide license from Amgen, Inc., AmMax is leveraging positive proof-of-concept data and an improved safety profile to advance AMB-05X into the next phase of its clinical development program for tenosynovial giant cell tumor (TGCT).
  • AmMax actively seeks to in-license first-in-class and/or best-in-class oncology products in areas of significant unmet medical need.

Ashvattha Therapeutics Announces Preclinical Data on Hydroxyl Dendrimer Based PET Tracer [18F]OP-801 Presented at the 2022 World Molecular Imaging Congress

Retrieved on: 
Thursday, September 29, 2022
Neuro, Plasma, Therapy, Inflammation, Multiple sclerosis, Spinal cord, Lists of diseases, Nanomedicine, QC, Microglia, Biomarker, HDS, Miami Beach Convention Center, Neurodegeneration, Quality control, Diabetic retinopathy, Macrophage, DME, HDT, Mouse, MS, Patient, PET, EAE, CEO, Ashvattha, Doctor of Philosophy, Johns Hopkins University, Traffic barrier, Autoradiograph, Neurology, Stanford University, ALS, AMD, GLOBE, HD, Neuroinflammation, Dosimetry, Disease, Radiology, Pharmaceutical industry, Medical imaging, Marketing, Trapping, Ophthalmology, CSF1R

REDWOOD CITY, Calif., Sept. 29, 2022 (GLOBE NEWSWIRE) -- Ashvattha Therapeutics (“Ashvattha”), a clinical-stage company developing novel hydroxyl dendrimer therapeutics, today announced preclinical data presented by collaborators from Stanford University demonstrating that its hydroxyl dendrimer (HD)-based PET tracer, [18F]OP-801, can detect activated macrophages and microglia with high sensitivity and specificity in an experimental autoimmune encephalomyelitis (EAE) murine model of multiple sclerosis (MS), in addition to being reproducibly synthesized and suitable for human use. The data were presented at the World Molecular Imaging Congress being held September 28th – October 1st, 2022, at the Miami Beach Convention Center in Miami, FL.

Key Points: 
  • The data were presented at the World Molecular Imaging Congress being held September 28th October 1st, 2022, at the Miami Beach Convention Center in Miami, FL.
  • PET imaging data was corroborated by autoradiography images, showing significantly higher signal in the lumbar spinal cord of untreated compared to treated EAE mice.
  • Human dosimetry estimates based on mouse imaging data are conducive to translation and clinical imaging of [18F]OP-801.
  • Ashvattha Therapeutics is a clinical-stage biotech company developing novel hydroxyl dendrimer therapeutics (HDTs) targeting unmet medical needs in ophthalmology, neurology, inflammation and neuro-oncology.

AmMax Bio Provides Update on AMB-05X Program for Tenosynovial Giant Cell Tumor (TGCT)

Retrieved on: 
Monday, September 26, 2022
Giant, Disability, Therapy, Safety, Infection, Incidence, Kirin-Amgen Inc v Hoechst Marion Roussel Ltd, FDA, TGCT, Risk, CSF1, Health, Macrophage, Program, Patient, Physician, Pain, Quality of life, Licensed practical nurse, Cell, Fast Track, Tenosynovial giant cell tumor, Â, Research, GLOBE, CSF1R, Initiate, ESMO, Osteosarcoma, Pharmaceutical industry

REDWOOD CITY, Calif., Sept. 26, 2022 (GLOBE NEWSWIRE) -- AmMax Bio, Inc. (“AmMax”), a private clinical-stage biopharmaceutical company developing innovative therapeutics in oncology, including targeting the colony-stimulating factor 1 receptor (CSF1R), today announced a program update on AMB-05X, the only pharmacological treatment administered locally and directly at the tumor site for tenosynovial giant cell tumor (TGCT).

Key Points: 
  • REDWOOD CITY, Calif., Sept. 26, 2022 (GLOBE NEWSWIRE) -- AmMax Bio, Inc. (AmMax), a private clinical-stage biopharmaceutical company developing innovative therapeutics in oncology, including targeting the colony-stimulating factor 1 receptor (CSF1R), today announced a program update on AMB-05X, the only pharmacological treatment administered locally and directly at the tumor site for tenosynovial giant cell tumor (TGCT).
  • In recent months, the AmMax Bio team achieved a number of milestones in advancing our potentially best-in-class therapy, AMB-05X, for the treatment of TGCT, said Larry Hsu, Ph.D., Chief Executive Officer of AmMax Bio.
  • Tenosynovial Giant Cell Tumor (TGCT), with a worldwide incidence of over 300,000, is a serious and debilitating locally aggressive tumor in which patients can experience severe pain, disability, and diminished quality of life.
  • Under an exclusive worldwide license from Amgen, Inc., AmMax is leveraging positive proof-of-concept data and an improved safety profile to advance AMB-05X into the next phase of its clinical development program for tenosynovial giant cell tumor (TGCT).

AmMax Bio Announces Presentation of Phase 2 PK/PD Data of ABM-05X for the Treatment of Tenosynovial Giant Cell Tumor (TGCT) at ESMO Congress 2022

Retrieved on: 
Monday, September 12, 2022
Giant, Disability, Therapy, Safety, Infection, Incidence, Kirin-Amgen Inc v Hoechst Marion Roussel Ltd, Risk, FDA, TGCT, CSF1, Palliative care, Health, Macrophage, Patient, Cancer, Physician, Oncology, Pain, Quality of life, Licensed practical nurse, Cell, Tenosynovial giant cell tumor, Professor, Diagnosis, Fast Track, GLOBE, CSF1R, PD, Leiden University Medical Center, ESMO, Pharmaceutical industry, Vaccine

The favorable results confirmed high local concentrations and pharmacologic activity at the tumor site that were sustained beyond the dosing period.

Key Points: 
  • The favorable results confirmed high local concentrations and pharmacologic activity at the tumor site that were sustained beyond the dosing period.
  • AmMax Bio is scheduled to present final positive efficacy data from the study at a scientific conference later this fall.
  • Under an exclusive worldwide license from Amgen, Inc., AmMax is leveraging positive proof-of-concept data and an improved safety profile to advance AMB-05X into the next phase of its clinical development program for tenosynovial giant cell tumor (TGCT).
  • AmMax actively seeks to in-license potentially best-in-class oncology products in areas of significant unmet medical need.

Deciphera Pharmaceuticals, Inc. Presents Updated Phase 1/2 Data for Vimseltinib in TGCT at the European Society for Medical Oncology (ESMO) Congress 2022

Retrieved on: 
Sunday, September 11, 2022
Oncology, Health, FDA, General Health, Clinical Trials, Pharmaceutical, Biotechnology, U.S. Securities and Exchange Commission, Center, TGCT, HIV disease progression rates, Tenosynovial giant cell tumor, Cohort study, Cancer, ORR, ESMO, Safety, Neoplasm, Lipase, View, BPI, Disease, Feedback, LLC, Union, Private Securities Litigation Reform Act, SEC, Maintenance, Patient, GIST, COVID-19, Pharmacokinetics, NASDAQ, Director general, United Kingdom, Trial of the century, Pain, IRR, RECIST, Hypertension, LinkedIn, Pharmaceutical industry, Medical device, Phosphorus, Aluminium, Leather, Health insurance, Public relations, CSF1R, Twitter, Cohort

The updated data presented at ESMO underscore the best-in-class potential of vimseltinib for patients with TGCT.

Key Points: 
  • The updated data presented at ESMO underscore the best-in-class potential of vimseltinib for patients with TGCT.
  • These updated Phase 1/2 data demonstrate not only the strong clinical activity of vimseltinib, but also the favorable safety and tolerability profile that is essential for TGCT patients.
  • The Phase 1 data summarized below are based on the previously released abstract with a data cutoff date of February 18, 2022.
  • The Phase 1 poster presentation remains under embargo until tomorrow and will include updated data based on a May 6, 2022 data cutoff date.

AmMax Bio Announces AMB-05X Granted FDA Fast Track Designation for the Treatment of Tenosynovial Giant Cell Tumor (TGCT)

Retrieved on: 
Wednesday, September 7, 2022
Giant, Tenosynovial giant cell tumor, Neoplasm, Safety, Pain, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, CSF1R, Macrophage, CSF1, TGCT, Incidence, Food, Quality of life, Infection, Cell, Disability, Kirin-Amgen Inc v Hoechst Marion Roussel Ltd, Fast Track, GLOBE, Health, FDA, Therapy, Communication, Plasma protein binding, Risk, Drug development, Review, Patient, Pharmaceutical industry

REDWOOD CITY, Calif., Sept. 07, 2022 (GLOBE NEWSWIRE) -- AmMax Bio, Inc. (“AmMax”), a private clinical-stage biopharmaceutical company developing innovative therapeutics in oncology, including targeting the colony-stimulating factor 1 receptor (CSF1R), today announced that the U.S. Food and Drug Administration (FDA) has granted AMB-05X Fast Track designation for the treatment of tenosynovial giant cell tumor (TCGT).

Key Points: 
  • Physicians have shown tremendous enthusiasm for a locally injectable form of CSF1R inhibitor to address this localized disease in the joint.
  • The FDAs Fast Track designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and address significant unmet medical needs.
  • The benefits of Fast Track designation include but are not limited to early and frequent communication with the FDA throughout the entire drug development and review process.
  • In addition, a drug with Fast Track designation is eligible for rolling submission and priority review of its Biologics License Application and/or New Drug Application.