Using local administration for a local disease, positive clinical results suggest AMB-05X could become best-in-class treatment for the diverse population of TGCT patients
Positive Proof-of-Concept Results Lead to Initiation of Phase 2b Study to Optimize Dosing Regimen for Phase 3 Design
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.
Session 7: GIST & Other Sarcomas with Actionable Targets
Title: Intra-Articular Injections of AMB-05X, a Potent, Selective, Human Monoclonal Antibody Against Colony Stimulating Factor 1 Receptor for the Treatment of Tenosynovial Giant Cell Tumor
Presenter: Michiel van de Sande, M.D., Ph.D.
Time: 11:29am Pacific Time
Location: Vancouver Convention Centre, Vancouver, BC, Canada
Abstract number: 1298214
Conference link: Click here
Dr. van de Sande will present clinical efficacy and safety data including Objective Response Rate (ORR) for tumor reduction via MRI from a 3-month proof-of-concept Phase 2a trial of AMB-05X that uses a novel therapeutic approach via intra-articular (IA) injection for the treatment of TGCT, a locally invasive disease. After only 12 weeks of treatment, the study achieved the ORR targets and showed trends for continuing tumor shrinkage beyond the dosing period, with minimal systemic exposure and significantly fewer adverse events than reported in other TGCT trials. Patient-reported clinical efficacy parameters such as worst pain and stiffness in the affected joint were also markedly improved.
(ClinicalTrials.gov Identifier: NCT04731675).
These data suggest that treatment with AMB-05X directly administered to the tumor site via intra-articular injection could offer physicians and patients a more convenient and potentially much safer treatment option compared to systemically administered pharmacotherapeutics for this condition.
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.
The Connective Tissue Oncology Society (CTOS) is an international group comprised of physicians and scientists with a primary interest in the tumors of connective tissues. The goal of the society is to advance the care of patients with connective tissue tumors and to increase knowledge of all aspects of the biology of these tumors, including basic and clinical research.
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.
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 first-in-class and/or 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.
AmMax Bio, Inc.
Andrew Sauter, CFO
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