Unique, intra-articular administration of AMB-05X yielded sustained, high synovial concentrations with low systemic exposures and positive clinical efficacy
REDWOOD CITY, CA, USA I September 12, 2022 I 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. Hans Gelderblom, Professor and Head of Medical Oncology at the Leiden University Medical Centre, will present Phase 2 Pharmacokinetic (PK) and Pharmacodynamic Data (PD) for the novel local administration of ABM-05X for the treatment of Tenosynovial Giant Cell Tumor (TGCT) on September 12th at the ESMO Congress 2022. Details of the presentation are provided below:
Session: Mini Oral session: Sarcoma
Title: The Synovial and Systemic Pharmacokinetics and Pharmacodynamics of Intra-articular Administration of the CSF1 Receptor Antibody AMB-05X in a Phase 2 Proof-of-Concept Trial in Tenosynovial Giant Cell Tumor
Presenter: Hans Gelderblom, M.D., Ph.D.
Time: 2:55pm Central European Time
Location: Urval Auditorium, Paris Expo Porte de Versailles, Paris France
Presentation number: 1486MO
Conference link: Click here
Dr. Gelderblom will present PK/PD data from a 3-month proof-of-concept Phase 2 trial of AMB-05X that uses a novel therapeutic approach via intra-articular (IA) injection for the treatment of TGCT, a locally invasive disease. The favorable results confirmed high local concentrations and pharmacologic activity at the tumor site that were sustained beyond the dosing period. The results also demonstrated minimal systemic exposure and fewer adverse events in the TGCT patients treated, and could offer physicians a promising new option with a better safety profile than systemic pharmacotherapeutics for this condition.
(ClinicalTrials.gov Identifier: NCT04731675).
AmMax Bio is scheduled to present final positive efficacy data from the study at a scientific conference later this fall.
About ESMO
ESMO is the leading professional organization for medical oncology. With more than 25,000 members representing oncology professionals from over 160 countries worldwide, ESMO is the society of reference for oncology education and information. ESMO’s core mission is to improve the quality of cancer care, from prevention and diagnosis all the way to palliative care and patient follow-up. It is to educate – doctors, cancer patients and the general public – on the best practices and latest advances in oncology. And it is to promote equal access to optimal cancer care for all patients.
About TGCT
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. Surgical resection, the primary standard of care for TGCT, carries significant risk to patients, including complications from infections and prolonged postoperative care, and frequent relapse. A safe and efficacious pharmacological therapy that can be used alongside surgery remains a significant unmet need. AmMax is uniquely positioned to address this need for patients with TGCT by leveraging the target selectivity and enhanced safety profile of AMB-05X via local intra-articular administration, while creating a sizable commercial opportunity from improved patient care.
About AMB-05X
A potent monoclonal antibody against CSF1R and granted Fast Track designation by the FDA for TGCT, AMB-05X represents a therapeutic platform targeting serious macrophage-driven inflammatory, fibrotic and neovascular diseases. CSF1R, via its binding to two regulatory cytokines, CSF1 and IL-34, is critically involved in the regulation of macrophages and related cells in multiple biological processes across many organ systems, making it an attractive target with broad therapeutic applications.
About AmMax Bio Inc.
AmMax is a private biotechnology company focused on the clinical development of innovative oncology products. 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.
For more information, please visit the company’s website at www.AmMaxBio.com.
SOURCE: AmMax Bio
Post Views: 55
Unique, intra-articular administration of AMB-05X yielded sustained, high synovial concentrations with low systemic exposures and positive clinical efficacy
REDWOOD CITY, CA, USA I September 12, 2022 I 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. Hans Gelderblom, Professor and Head of Medical Oncology at the Leiden University Medical Centre, will present Phase 2 Pharmacokinetic (PK) and Pharmacodynamic Data (PD) for the novel local administration of ABM-05X for the treatment of Tenosynovial Giant Cell Tumor (TGCT) on September 12th at the ESMO Congress 2022. Details of the presentation are provided below:
Session: Mini Oral session: Sarcoma
Title: The Synovial and Systemic Pharmacokinetics and Pharmacodynamics of Intra-articular Administration of the CSF1 Receptor Antibody AMB-05X in a Phase 2 Proof-of-Concept Trial in Tenosynovial Giant Cell Tumor
Presenter: Hans Gelderblom, M.D., Ph.D.
Time: 2:55pm Central European Time
Location: Urval Auditorium, Paris Expo Porte de Versailles, Paris France
Presentation number: 1486MO
Conference link: Click here
Dr. Gelderblom will present PK/PD data from a 3-month proof-of-concept Phase 2 trial of AMB-05X that uses a novel therapeutic approach via intra-articular (IA) injection for the treatment of TGCT, a locally invasive disease. The favorable results confirmed high local concentrations and pharmacologic activity at the tumor site that were sustained beyond the dosing period. The results also demonstrated minimal systemic exposure and fewer adverse events in the TGCT patients treated, and could offer physicians a promising new option with a better safety profile than systemic pharmacotherapeutics for this condition.
(ClinicalTrials.gov Identifier: NCT04731675).
AmMax Bio is scheduled to present final positive efficacy data from the study at a scientific conference later this fall.
About ESMO
ESMO is the leading professional organization for medical oncology. With more than 25,000 members representing oncology professionals from over 160 countries worldwide, ESMO is the society of reference for oncology education and information. ESMO’s core mission is to improve the quality of cancer care, from prevention and diagnosis all the way to palliative care and patient follow-up. It is to educate – doctors, cancer patients and the general public – on the best practices and latest advances in oncology. And it is to promote equal access to optimal cancer care for all patients.
About TGCT
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. Surgical resection, the primary standard of care for TGCT, carries significant risk to patients, including complications from infections and prolonged postoperative care, and frequent relapse. A safe and efficacious pharmacological therapy that can be used alongside surgery remains a significant unmet need. AmMax is uniquely positioned to address this need for patients with TGCT by leveraging the target selectivity and enhanced safety profile of AMB-05X via local intra-articular administration, while creating a sizable commercial opportunity from improved patient care.
About AMB-05X
A potent monoclonal antibody against CSF1R and granted Fast Track designation by the FDA for TGCT, AMB-05X represents a therapeutic platform targeting serious macrophage-driven inflammatory, fibrotic and neovascular diseases. CSF1R, via its binding to two regulatory cytokines, CSF1 and IL-34, is critically involved in the regulation of macrophages and related cells in multiple biological processes across many organ systems, making it an attractive target with broad therapeutic applications.
About AmMax Bio Inc.
AmMax is a private biotechnology company focused on the clinical development of innovative oncology products. 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.
For more information, please visit the company’s website at www.AmMaxBio.com.
SOURCE: AmMax Bio
Post Views: 55
