CSF1

87.5% ORR | Abbisko presented two clinical updates of Pimicotinib at the 2023 CTOS Annual Meeting

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Tuesday, November 7, 2023
PD, US, BTD, TGCT, Priority, Human, European Medicines Agency, IDMC, Male, Liver injury, Hip, BIRC, Ankle, PRO, Pain, IRC, Completeness, Part Two, Response evaluation criteria in solid tumors, QD, 1.1, MRI, Itch, AST, US FDA, CSF1, Motion, Rash, Neoplasm, Independent Review Committee, PK, ORR, Part, Safety, Therapy, ALT, Patient, LDH, ASCO, PDGFR, Contraindication, Nilotinib, III, DOR, Imatinib, Breakthrough therapy, Clinical trial, Hepatotoxicity, Knee, FDA, Dyslipidemia, CPK, RES, SD, RECIST, Pharmaceutical industry, Nursing

SHANGHAI, Nov. 6, 2023 /PRNewswire/ -- Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics" hereafter) announced that two major clinical updates of its CSF-1R inhibitor pimicotinib（ABSK021）were presented at the 2023 Connective Tissue Oncology Society Annual Meeting, which is held in Ireland from November 1 to 4, 2023.

Key Points: 
  • SHANGHAI, Nov. 6, 2023 /PRNewswire/ -- Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics" hereafter) announced that two major clinical updates of its CSF-1R inhibitor pimicotinib（ABSK021）were presented at the 2023 Connective Tissue Oncology Society Annual Meeting, which is held in Ireland from November 1 to 4, 2023.
  • The two clinical updates include reporting the design of the pivotal global multi-center phase III clinical trial and the further update of the phase Ib clinical trial of pimicotinib.
  • In 2023, the U.S. FDA conferred Breakthrough Therapy Designation and the European Medicines Agency granted Priority Medicine Designation upon Pimicotinib treatment of TGCT.
  • Here, we report the phase 1b safety and efficacy results of Pimicotinib in TGCT patients over a 1-year follow-up.

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

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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.

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

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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).

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

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Thursday, September 15, 2022
Neuro, Therapy, Inflammation, Multiple sclerosis, Human, Nanomedicine, Microglia, HDS, Miami Beach Convention Center, Neurodegeneration, CSF1, Diabetic retinopathy, DME, HDT, Patient, PET, WMIC, Google Images, Ashvattha, Johns Hopkins University, Traffic barrier, Amyotrophic lateral sclerosis, Neurology, Stanford University, ALS, AMD, GLOBE, HD, Congress, Medical imaging, Ophthalmology

REDWOOD CITY, Calif., Sept. 15, 2022 (GLOBE NEWSWIRE) -- Ashvattha Therapeutics (“Ashvattha”), a clinical-stage company developing novel hydroxyl dendrimer therapeutics, today announced presentations of preclinical data on the selective uptake of its hydroxyl dendrimer-based PET tracer, [18F]OP-801, in the spines of a murine model of multiple sclerosis and a reduction in the PET signal after treatment with a hydroxyl dendrimer therapeutic (HDT) that inhibits CSF1 receptors. In addition, data on the synthesis of [18F]OP-801 suggests a reliable and high yielding method suitable for diagnostic imaging in humans. The data will be presented by scientific collaborators from Stanford University at the 2022 World Molecular Imaging Congress (WMIC), taking place at the Miami Beach Convention Center in Miami, FL, September 28 – October 1, 2022.

Key Points: 
  • In addition, data on the synthesis of [18F]OP-801 suggests a reliable and high yielding method suitable for diagnostic imaging in humans.
  • The data will be presented by scientific collaborators from Stanford University at the 2022 World Molecular Imaging Congress (WMIC), taking place at the Miami Beach Convention Center in Miami, FL, September 28 October 1, 2022.
  • Presentation details can be found below:
    [18F]OP-801 is a hydroxyl dendrimer (HD) imaging agent that provides information on uptake of HDs across tissue barriers including the blood-brain barrier.
  • 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 Announces Presentation of Phase 2 PK/PD Data of ABM-05X for the Treatment of Tenosynovial Giant Cell Tumor (TGCT) at ESMO Congress 2022

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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.

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.

AmMax Bio Announces the Appointment of Dorothy Nguyen, M.D. as Vice President of Clinical Development

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Monday, July 25, 2022
Giant, University of California, San Francisco, IPF, Stanford University, Genentech, University, GLOBE, Clinical, Drug, Transfusion medicine, Industry, Hematology, Health, University of California, Irvine Medical Center, Osteosarcoma, Incidence, Tenosynovial giant cell tumor, Risk, BS, Therapy, San Francisco, Board, TGCT, Cell, Quality of life, Outline of health sciences, UCI, Disability, CSF1R, MD, Assistant professor, Patient, IND, Pain, AstraZeneca, Oncology, Pathology, Idiopathic pulmonary fibrosis, Department, George Washington University School of Medicine & Health Sciences, Kaiser Permanente, Internal medicine, Infection, Macrophage, CSF1, Corcept Therapeutics, Pharmaceutical industry, Biology, Amgen

We are very pleased to welcome Dr. Nguyen to AmMax to lead our clinical programs, said Larry Hsu, Ph.D., Chairman of the Board and Chief Executive Officer of AmMax Bio.

Key Points: 
  • We are very pleased to welcome Dr. Nguyen to AmMax to lead our clinical programs, said Larry Hsu, Ph.D., Chairman of the Board and Chief Executive Officer of AmMax Bio.
  • "I am very excited to join AmMax Bio, a company which has already generated impressive Phase 2 data in TGCT with its lead drug candidate, AMB-05X, said Dorothy Nguyen, M.D.
  • AmMax is preparing to enroll patients in the next phase of its clinical development program for tenosynovial giant cell tumor (TGCT) in the third quarter of 2022.
  • Based on robust preclinical data and approved IND, AmMax is also prepared to initiate a Phase 2 clinical study in idiopathic pulmonary fibrosis (IPF).

AmMax Bio Announces Positive Phase 2 Results Demonstrating Proof-of-Concept for the Novel Local Delivery of AMB-05X in Patients with Tenosynovial Giant Cell Tumor (TGCT)

Retrieved on: 
Wednesday, March 2, 2022
Giant, Risk, Tenosynovial giant cell tumor, Patient, Pharmacokinetics, Infection, Knee, Quality of life, Safety, Ohio State University, Macrophage, Principal, Program, Disability, CSF1R, ORR, TGCT, The James Cancer Hospital, Magnetic resonance imaging, Pain, Health, Cell, IPF, Idiopathic pulmonary fibrosis, MD, MRI, CSF1, Incidence, RECIST, GLOBE, Neoplasm, Therapy, Pharmaceutical industry, Medical imaging, Dentistry, Amgen

Data From the Phase 2 Study Support the Potential of AMB-05X as a Best-in-Class Therapy for Treatment of TGCT​REDWOOD CITY, Calif., March 02, 2022 (GLOBE NEWSWIRE) -- AmMax Bio, Inc. (“AmMax”), a private clinical-stage biopharmaceutical company developing innovative therapeutics targeting the colony-stimulating factor 1 receptor (CSF1R), today announced additional positive results from the first-of-its-kind local delivery Phase 2 study of AMB-05X via intra-articular (IA) injection for the treatment of tenosynovial giant cell tumor (TGCT).​“These longer-term, 12-week data from eight patients confirm the earlier positive interim results seen after 6 weeks of treatment with AMB-05X,” said Larry Hsu, Ph.D., Chief Executive Officer of AmMax Bio. “With these Phase 2 data, we have now demonstrated proof-of-concept for the intra-articular delivery of AMB-05X in patients with TGCT. Using our novel approach, we have the potential to truly transform TCGT therapy to ensure an optimal balance of efficacy and safety. Showing best-in-class potential, we look forward to further advancing this program into registration-enabling clinical studies.”

Key Points: 
  • With these Phase 2 data, we have now demonstrated proof-of-concept for the intra-articular delivery of AMB-05X in patients with TGCT.
  • Using our novel approach, we have the potential to truly transform TCGT therapy to ensure an optimal balance of efficacy and safety.
  • AmMax is enrolling patients in a Phase 2 clinical program for tenosynovial giant cell tumor (TGCT).
  • Based on robust preclinical proof-of-concept results, AmMax is also planning to initiate a Phase 2 clinical study in idiopathic pulmonary fibrosis (IPF).

AmMax Bio Announces the Appointment of Biotechnology Executive, Michael Kavanaugh, M.D., as Independent Board Member

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Thursday, February 24, 2022
Giant, GLOBE, Risk, Therapy, Board of directors, Tenosynovial giant cell tumor, Cell, Board, CSF1, Pain, IPF, Disability, University, Novartis, Industry, University of California, San Francisco, Drug development, TGCT, Signal transduction, Coronavirus Scientific Advisory Board (Turkey), CSF1R, Biotechnology, Independent Board for Presbyterian Foreign Missions, Patient, Quality of life, Macrophage, Idiopathic pulmonary fibrosis, Program, Incidence, Infection, Health, Pharmaceutical industry, Chiron, Amgen, Medicine

We are very pleased to welcome Dr. Kavanaugh to our Board of Directors, said Larry Hsu, Ph.D., Chairman of the Board and Chief Executive Officer of AmMax Bio.

Key Points: 
  • We are very pleased to welcome Dr. Kavanaugh to our Board of Directors, said Larry Hsu, Ph.D., Chairman of the Board and Chief Executive Officer of AmMax Bio.
  • We welcome Michael to our Board and look forward to benefiting from his future contributions.
  • "I am very happy to join the Board of AmMax Bio, said Michael Kavanaugh, M.D.
  • Based on robust preclinical proof-of-concept results, AmMax is also planning to initiate a Phase 2 clinical study in idiopathic pulmonary fibrosis (IPF).

Aurealis Therapeutics and Xbiome Enter into a License and Collaboration Agreement for Aurealis Four-in-One Diabetic Foot Ulcer and Inflammatory Disease Cell and Gene Therapy AUP-16 in Greater China

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Friday, January 28, 2022
Lynx, Aurealis, Growth, IND, CEO, Patient, Therapy, Graft-versus-host disease, FGF2, CSF1, GMO, FMT, Inflammation, Board, Human microbiome, Partnership, Granulation tissue, Prevalence, Growth factor, DFU, IL4, Company, Interleukin, Lactococcus lactis, Drug development, Blood, Mouth ulcer, Synthetic biology, LBP, Diabetic foot ulcer, Scholarship, Pharmaceutical industry, Vaccine

"At Aurealis we develop truly novel GMO cell and gene therapies to improve the lives of millions of patients worldwide.

Key Points: 
  • "At Aurealis we develop truly novel GMO cell and gene therapies to improve the lives of millions of patients worldwide.
  • We are extremely excited to collaborate with Aurealis to bring AUP-16 to DFU and other chronic wound patients in China.
  • Company's lead clinical asset is AUP-16, the first-in-class four-in-one cell and gene therapy drug for chronic wounds and other inflammatory degenerative diseases.
  • In June of 2021, Xbiome obtained IND approval in US for its lead program XBI-302, an orally administered FMT therapy for graft-versus-host disease (GvHD).