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)

Intra-Articular Injection Strategy Shows Efficacy Across Multiple Clinical Endpoints and Favorable Safety Profile After 12 Weeks of Therapy  

Data From the Phase 2 Study Support the Potential of AMB-05X as a Best-in-Class Therapy for Treatment of TGCT

Excerpt from the Press Release:

REDWOOD CITY, Calif., March 02, 2022 (GLOBE NEWSWIRE) — AmMax Bio, Inc. (“AmMax”), a private clinical-stage biopharmaceutical company developing innovative therapeutics targeting the colony-stimulating factor 1 receptor (CSF1R), today 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 (TGCT).
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“These longer-term, 12-week data from eight patients confirm the earlier positive interim results seen after 6 weeks of treatment with AMB-05X,” said Larry Hsu, Ph.D., Chief Executive Officer of AmMax Bio. “With these Phase 2 data, we have now demonstrated proof-of-concept for the intra-articular delivery of AMB-05X in patients with TGCT. Using our novel approach, we have the potential to truly transform TCGT therapy to ensure an optimal balance of efficacy and safety. Showing best-in-class potential, we look forward to further advancing this program into registration-enabling clinical studies.”

The Phase 2 trial was designed as a 12-week adaptive, multi-center, open-label, proof-of-concept study to evaluate the safety, efficacy and pharmacokinetics of intra-articular injections of AMB-05X in patients with TGCT of the knee – the predominant joint affected by this tumor. (ClinicalTrials.gov Identifier: NCT04731675). Key study outcomes included objective response rate (ORR) via magnetic resonance imaging (MRI), improvements in pain, stiffness, range-of-motion, quality-of-life, pharmacokinetics measures and safety.

12-Week Results

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.

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