Propanc Biopharma signs MOU with Avance Clinical for Phase 1 trial
Propanc Biopharma, Inc. (Nasdaq: PPCB) announced it has signed a Memorandum of Understanding with Avance Clinical Pty Ltd to support the clinical delivery of a Phase 1b, First-In-Human trial for PRP, Propanc's lead investigational candidate targeting advanced solid tumors.
The MOU outlines the shared intent of both parties to collaborate on the design and execution of the trial, which is planned to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary clinical activity of PRP in patients with advanced cancer. The agreement also notes plans to transition into proof-of-concept and later-phase development as clinical data emerges.
Avance Clinical is an Australia-headquartered contract research organization with operations across North America, Asia Pacific, New Zealand, and Europe. The company specializes in early-phase and First-in-Human studies across more than 250 indications.
"It represents an important milestone in our journey from preclinical development to clinical evaluation," said James Nathanielsz, Propanc's Chief Executive Officer.
Dr. Gabriel Kremmidiotis, Chief Scientific Officer at Avance Clinical, said the organization will apply experience in adaptive dose-escalation strategies and integrated safety assessments, with attention to FDA Project Optimus expectations.
Propanc noted that its wholly owned subsidiary, Propanc Pty Ltd, has been based in Melbourne, Australia since 2007, positioning the company to access Australian R&D tax incentives and the country's regulatory framework for clinical trials. According to the press release, Australia offers up to a 43.5% R&D tax rebate.
Propanc describes PRP as designed to target cancer stem cells through proenzyme activation, with the goal of preventing cancer recurrence and metastasis. The company is listed on the Nasdaq exchange under the ticker PPCB.
