AMB-05X / Amgen, AmMax - LARVOL DELTA

Evaluating the Role of AMB-05X in Modulating Key Fibrotic Markers in Human Precision-cut Lung Slices (ATS 2025) - "These findings suggest that AMB-05X effectively modulates the fibrotic response in human lung tissues, offering insights into its therapeutic potential for lung fibrosis and underscoring the importance of targeting CSF1R in fibrotic pathways."

Fibrosis • Inflammation • Pulmonary Disease • Respiratory Diseases • CCL2 • FN1 • TGFB1 • THBS2

Trial of AMB-05X for Patients With ctDNA(+) Colorectal Cancer After Curative-intent Treatment (clinicaltrials.gov) - P2 | N=15 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Not yet recruiting ➔ Recruiting

Enrollment open • Colorectal Cancer • Oncology • Solid Tumor

Trial of AMB-05X for Patients With ctDNA(+) Colorectal Cancer After Curative-intent Treatment (clinicaltrials.gov) - P2 | N=15 | Not yet recruiting | Sponsor: M.D. Anderson Cancer Center

New P2 trial • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

A Study to Evaluate Safety and Efficacy of AMB-05X Injections in Subjects With TGCT (clinicaltrials.gov) - P2 | N=20 | Completed | Sponsor: AmMax Bio, Inc. | Recruiting ➔ Completed | N=48 ➔ 20 | Trial completion date: Jan 2026 ➔ Jun 2024 | Trial primary completion date: Nov 2025 ➔ Jun 2024

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Giant Cell Tumor of Bone • Oncology • Tenosynovial Giant Cell Tumor

AMB-051-01: An Open-Label Study of Intra-articular AMB-05X Injections in Subjects With Tenosynovial Giant Cell Tumor of the Knee (clinicaltrials.gov) - P2 | N=11 | Completed | Sponsor: AmMax Bio, Inc. | Active, not recruiting ➔ Completed

Trial completion • Giant Cell Tumor of Bone • Oncology • Tenosynovial Giant Cell Tumor

A Phase 2 Study of Intravenous AMB-05X in Tenosynovial Giant Cell Tumor Patients (clinicaltrials.gov) - P2 | N=4 | Terminated | Sponsor: AmMax Bio, Inc. | Active, not recruiting ➔ Terminated; Further enrollment was halted in November 2021, enrolled subjects completed the study. Sponsor stopped further recruitment in this intravenous study to focus on intra-articular route of administration in subjects with tenosynovial giant cell tumor.

Trial termination • Giant Cell Tumor of Bone • Oncology • Tenosynovial Giant Cell Tumor

A phase 2, open-label, adaptive, dose-ranging study with long-term extension to evaluate the safety, tolerability, efficacy, and pharmacokinetics of intra-articular AMB-05X injections in patients with tenosynovial giant cell tumor. (ASCO 2023) - P2 | "Secondary outcome measures include ORR per modified RECIST and Tumor Volume Score, duration of response, time to response, PRO/QOL (including range of motion, stiffness, pain), pharmacodynamics and pharmacokinetics. Clinical trial information: NCT05349643."

Clinical • P2 data • PK/PD data • Giant Cell Tumor of Bone • Oncology • Pain • Tenosynovial Giant Cell Tumor

The synovial and systemic pharmacokinetics and pharmacodynamics of intra-articular administration of the CSF1 receptor antibody AMB-05X in a phase II proof-of-concept trial in tenosynovial giant cell tumor (ESMO 2022) - "CSF1 levels in both compartments achieved a plateau, indicative of full receptor engagement, early in the treatment period. Conclusions The AMB-05X PK and PD results support expansion of the clinical development of AMB-05X in TGCT with IA treatment at a comfortable interval of once-monthly or less."

P2 data • PK/PD data • Giant Cell Tumor of Bone • Oncology • Tenosynovial Giant Cell Tumor • CSF1R

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 (CTOS 2022) - No abstract available

Giant Cell Tumor of Bone • Immunology • Oncology • Tenosynovial Giant Cell Tumor • CSF1R

AmMax Bio Announces First Patients Dosed in Phase 2b Study of AMB-05X for the Treatment of Tenosynovial Giant Cell Tumor (TGCT) (GlobeNewswire) - "Initial results expected in second half of 2023....AmMax Bio, Inc...announced that the first patients have been dosed in the Company’s Phase 2b study evaluating AMB-05X for the treatment of tenosynovial giant cell tumor (TGCT). The AmMax phase 2b trial is an open-label, adaptive, dose-ranging study to evaluate the safety, efficacy and pharmacokinetics of intra-articular administration of AMB-05X in patients with TGCT after 24 weeks of treatment and an additional long-term extension period."

P2 data • Trial status • Giant Cell Tumor of Bone • Oncology • Solid Tumor • Tenosynovial Giant Cell Tumor

AmMax Bio’s AMB-05X Receives EMA PRIME Designation for the Treatment of Tenosynovial Giant Cell Tumor (TGCT) (GlobeNewswire) - "AmMax Bio, Inc...today announced that the European Medicine Agency (EMA) has granted AMB-05X Priority Medicines (PRIME) designation for the treatment of tenosynovial giant cell tumor (TGCT)....'The positive proof-of-concept data from our prior 12-week Phase 2 study of AMB-05X in TGCT provided the basis for our PRIME application,'...Initial Results from Phase 2b Trial Remains on Track for Second Half of 2023."

European regulatory • P2b data • Oncology • Solid Tumor • Tenosynovial Giant Cell Tumor

A Phase 2 Study to Evaluate Safety and Efficacy of AMB-05X in Subjects With Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: AmMax Bio, Inc. | N=36 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • CSF1

A Study to Evaluate Safety and Efficacy of AMB-05X Injections in Subjects With TGCT (clinicaltrials.gov) - P2 | N=48 | Recruiting | Sponsor: AmMax Bio, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Giant Cell Tumor of Bone • Immunology • Oncology • Tenosynovial Giant Cell Tumor

"AMB-05X - ab against CSF1R in tenosynovial giant cell tumor #TGCT - preliminary results presented at #CTOS2022 🔸significant improvement in almost all Quality of life measures @TGCTSupportorg #CTOSTweeTOS" (@pawel_sobczuk)

HEOR • Giant Cell Tumor of Bone • Immunology • Oncology • Tenosynovial Giant Cell Tumor • CSF1R

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 (GlobeNewswire) - P2a | N=11 | NCT04731675 | Sponsor: AmMax Bio, Inc. | "AmMax Bio, Inc....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....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."

P2a data • Giant Cell Tumor of Bone • Oncology • Solid Tumor • Tenosynovial Giant Cell Tumor

A Phase 2 Study to Evaluate Safety and Efficacy of AMB-05X in Subjects With Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - P2 | N=36 | Not yet recruiting | Sponsor: AmMax Bio, Inc. | Trial completion date: Jun 2024 ➔ Jun 2025 | Initiation date: Dec 2022 ➔ Mar 2023 | Trial primary completion date: Mar 2024 ➔ Mar 2025

Trial completion date • Trial initiation date • Trial primary completion date • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • CSF1

AmMax Bio Provides Update on AMB-05X Program for Tenosynovial Giant Cell Tumor (TGCT) (GlobeNewswire) - "AmMax Bio, Inc...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)....Significant Milestones and Development Plan to be Achieved Over the Next 12 Months: Initiate patient enrollment this quarter for Phase 2b study which will include a six-month initial treatment period with extension up to 2 years; Present final data from the earlier three-month proof-of-concept study at the Connective Tissue Oncology Society (CTOS) meeting in November 2022; Read-out initial results from six-month cohorts in the second half of 2023 and use Fast Track designation to increase communication with FDA on final Phase 3 design."

P2 data • Trial status • Giant Cell Tumor of Bone • Oncology • Solid Tumor • Tenosynovial Giant Cell Tumor

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 (GlobeNewswire) - P2 | N=11 | NCT04731675 | Sponsor: AmMax Bio, Inc. | "AmMax Bio...announced that Dr. Hans Gelderblom...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....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."

P2 data • PK/PD data • Giant Cell Tumor of Bone • Oncology • Solid Tumor • Tenosynovial Giant Cell Tumor

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

Fast track designation • Giant Cell Tumor of Bone • Oncology • Solid Tumor • Tenosynovial Giant Cell Tumor

A Phase 2 Study to Evaluate Safety and Efficacy of AMB-05X in Subjects With Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - P2 | N=36 | Not yet recruiting | Sponsor: AmMax Bio, Inc. | Trial completion date: Feb 2024 ➔ Jun 2024 | Initiation date: Jul 2022 ➔ Dec 2022 | Trial primary completion date: Nov 2023 ➔ Mar 2024

Trial completion date • Trial initiation date • Trial primary completion date • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • CSF1

A Phase 2 Study of Intravenous AMB-05X in Tenosynovial Giant Cell Tumor Patients (clinicaltrials.gov) - P2 | N=4 | Active, not recruiting | Sponsor: AmMax Bio, Inc. | Trial completion date: May 2022 ➔ Aug 2022

Trial completion date • Giant Cell Tumor of Bone • Immunology • Oncology • Tenosynovial Giant Cell Tumor

A Phase 2 Study to Evaluate Safety and Efficacy of AMB-05X in Subjects With Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - P2 | N=36 | Not yet recruiting | Sponsor: AmMax Bio, Inc.

New P2 trial • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • CSF1

A Phase 2 Study With LTE to Evaluate Safety and Efficacy of AMB-05X Injections in Subjects With TGCT (clinicaltrials.gov) - P2 | N=48 | Not yet recruiting | Sponsor: AmMax Bio, Inc.

New P2 trial • Giant Cell Tumor of Bone • Immunology • Oncology • Tenosynovial Giant Cell Tumor

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) (GlobeNewswire) - P2 | N=11 | NCT04731675 | Sponsor: AmMax Bio, Inc | "AmMax Bio, Inc...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....All 8 patients who completed 12 weeks of treatment with AMB-05X showed evidence of clinical benefit, including tumor reduction based on RECIST criteria and improvements across many clinically meaningful patient-reported functional outcomes including reduction of pain and stiffness, improvements in quality-of-life measures, and increased range-of-motion of the affected joint."

P2 data • Patient reported outcomes • Oncology • Solid Tumor • Tenosynovial Giant Cell Tumor

A Phase 2 Study of Intravenous AMB-05X in Tenosynovial Giant Cell Tumor Patients (clinicaltrials.gov) - P2 | N=4 | Active, not recruiting | Sponsor: AmMax Bio, Inc. | Recruiting ➔ Active, not recruiting | N=36 ➔ 4 | Trial completion date: Jan 2023 ➔ May 2022 | Trial primary completion date: Dec 2022 ➔ Mar 2022

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Giant Cell Tumor of Bone • Immunology • Oncology • Tenosynovial Giant Cell Tumor