AmMax Bio's AMB-05X Receives EMA PRIME Designation for the Treatment of Tenosynovial Giant Cell Tumor (TGCT)
AMB-05X is the First and Only Investigational Drug Candidate to Receive PRIME Designation for the Treatment of TGCT
PRIME Designation Validates Unique Therapeutic Potential of AMB-05X as Demonstrated in Prior Phase 2 Study of TGCT
Initial Results from Phase 2b Trial Remains on Track for Second Half of 2023
REDWOOD CITY, Calif., Jan. 19, 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 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,” said Larry Hsu, Ph.D., Chief Executive Officer of AmMax Bio. “We appreciate EMA’s decision to award AMB-05X its PRIME designation, which validates the high potential therapeutic value of the program and the significant unmet medical need for patients impacted by TGCT.”
In November 2022, AmMax presented positive Phase 2 data for the novel local administration of AMB-05X in patients with TGCT at the Connective Tissue Oncology Society (CTOS) meeting. The significant efficacy data across multiple clinical endpoints and a favorable safety profile support the potential of AMB-05X as a best-in-class therapy for the treatment of TGCT, regardless of surgical resectability.
PRIME designation was launched by the EMA to enhance support for the development of medicines that target an unmet medical need. PRIME fosters the efficient development of medicines by enhancing interaction and early dialogue with developers of promising medicines, to optimize development plans and speed up evaluation so these medicines can reach patients earlier. Through PRIME, the EMA offers early and proactive support to medicine developers to optimize the generation of robust data on a medicne's benefits and risks and enable accelerated assessment of medicines applications. This will help patients to benefit as early as possible from therapies that may significantly improve their quality of life.1
In September 2022, AMB-05X was also granted Fast Track designation by the U.S. Food and Drug Administration (FDA).
About AmMax Bio Inc.
The Company’s core portfolio is a novel antibody-drug conjugate (ADC) with a proprietary next generation topoisomerase 1 inhibitor-based linker-payload (the TMALIN platform) that is expected to enter the clinic in 2023. Additionally, the Company’s CSF1R platform includes AMB-05X, 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.