AmMax Bio Announces First Patients Dosed in Phase 2b Study of AMB-05X for the Treatment of Tenosynovial Giant Cell Tumor (TGCT)
Study designed to optimize treatment regimen and evaluate efficacy over six-month dosing period
Initial results expected in second half of 2023
REDWOOD CITY, Calif., Jan. 30, 2023 (GLOBE NEWSWIRE) -- AmMax Bio, Inc. (“AmMax”), a private clinical-stage biopharmaceutical company developing innovative therapeutics in oncology, including a next-generation antibody-drug conjugate (ADC) and a mAb targeting colony-stimulating factor 1 receptor (CSF1R), today 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. (ClinicalTrials.gov Identifier: NCT05349643)
“The expansion of our TGCT program into this Phase 2b study builds on the strong proof-of-concept safety and efficacy data reported in 2022 which evaluated the treatment of AMB-05X in TGCT patients over a 12-week period,” said Larry Hsu, Ph.D., Chief Executive Officer of AmMax Bio. “Since announcing those results, both FDA Fast Track designation and EMA PRIME designation have been granted to AMB-05X, reflecting its significant potential to address the unmet medical need for this patient population with few treatment options. With six months of treatment, we believe patients will receive greater benefit with AMB-05X than any other pharmacological options, and we plan to use the data from this trial to finalize our Phase 3 study design.”
“Encouraged by the treatment experience with AMB-05X from the earlier POC study, our patients are excited to enroll in this Phase 2b trial,” stated the principal nvestigators, Hans Gelderblom, M.D., Ph.D., Chair of Medical Oncology, and Michiel van de Sande, M.D., Professor of Orthopedic Oncology at the Leiden University Medical Center in the Netherlands. “With AMB-05X already demonstrating positive safety and efficacy over a 12-week treatment period, this larger Phase 2b study, with a broader enrollment scope, will assess the treatment durability of this novel, locally administered therapy over a 24-week treatment period. If successful, AMB-05X would provide TGCT patients with a much-needed alternative to immediate surgical resection and the associated complications, long recovery times, and high rates of recurrence.”
About AmMax Bio Inc.
The Company’s core portfolio consists of AMB-101, a novel antibody-drug conjugate (ADC) with a proprietary next generation topoisomerase 1 inhibitor-based linker-payload that is expected to enter the clinic in 2023, and AMB-05X from the Company’s CSF1R platform as a potentially best-in-class locally administered treatment for TGCT. AmMax is currently leveraging positive clinical data and an improved safety profile to advance AMB-05X in an actively enrolling Phase 2 study.
For more information, please visit the company’s website at www.AmMaxBio.com.
AmMax Bio, Inc.