New issued patents and fast-track status support development of the only locally administered drug treatment for TGCT

Positive proof-of-concept results lead to extension of phase 2 study to optimize dosing regimen for phase 3 design

REDWOOD CITY, Calif., Sept. 26, 2022 (GLOBE NEWSWIRE) — AmMax Bio, Inc. (“AmMax”), a private, clinical-stage biopharmaceutical company developing innovative therapeutics in oncology, including a focus on the colony- Stimulating Factor 1 Receptor (CSF1R), today announced a program update to AMB-05X, the only pharmacologic treatment delivered locally and directly to the tumor site for tenosynovial giant cell tumors (TGCT).

“Over the past few months, the AmMax Bio team has achieved a number of milestones advancing our potentially industry-leading therapy, AMB-05X, for the treatment of TGCT,” said Larry Hsu, Ph.D., Chief Executive Officer of AmMax Bio. “We have shown that local injection of AMB-05X directly at the tumor site achieves good clinical efficacy while minimizing the side effects of systemic treatments. Our primary market research indicates that physicians who generally do not prescribe systemic drugs, receive safety alerts, and patient monitoring requirements have a very strong interest in the potential of locally administered AMB-05X to improve the standard of care for TGCT and significantly reduce unacceptable side effects As we have expanded the AMB-05X program, we have also expanded our network of TGCT professionals and The feedback we continue to receive, particularly from orthopedic oncologists, reinforces our confidence that AMB-05X could become an important new treatment for this indication. “

“Now, with Fast Track status confirming the benefits of AMB-05X and newly issued patents protecting our novel formulation, AmMax is initiating the dose optimization phase of its Phase 2 program with a six-month treatment duration. Patients experienced positive and continuous clinical improvement through twelve weeks…