Peptinovo Biopharma Receives Ethics Approval To Launch First Human Clinical Trials Of PALM™ Nanotechnology In Australia

Peptinovo Biopharma, an Ann Arbor–based biotechnology company developing targeted cancer therapies using its proprietary PALM™ nanotechnology, has received approval to begin its first human clinical trials in Australia. This milestone allows the company to start enrolling cancer patients in the coming months, with the goal of treating its first patient in the first quarter of 2026.

The approval comes after thorough scientific and safety reviews by the Human Research Ethics Committees (HRECs) that reviewed the trial. These committees serve as Australia’s equivalent of institutional review boards in the United States. With ethics approval in place, Peptinovo can now activate selected clinical sites across Australia and complete the final steps needed to start patient dosing.

“This is a defining moment for Peptinovo,” said CEO Steve Tokarz. “Receiving ethics approval to initiate human clinical trials confirms that our PALM™ nanotechnology has passed rigorous independent evaluation for both safety and scientific integrity. It marks the transition from years of laboratory and manufacturing development into the clinic, where our goal is to show real benefits for cancer patients.”

The clinical trial will test Peptinovo’s PALM™ (Peptide-Amphiphile Lipid Micelle) platform, which is designed to deliver existing chemotherapies directly into cancer cells while limiting exposure to healthy tissue. At the heart of the platform is a novel, patented vitamin-E-based prodrug linker, developed in collaboration with Italian pharmaceutical chemistry company Chemelectiva Srl.

This innovative linker temporarily inactivates the chemotherapy drug, allowing it to circulate safely in the body until it is taken up by tumor cells. Once inside the cancer cells, the linker is cleaved, reactivating the drug and releasing its full therapeutic potential. This targeted approach acts like a Trojan horse, aiming to maximize efficacy while reducing the side effects that limit conventional chemotherapy.

Peptinovo has already selected multiple clinical sites in Australia, whose principal investigators and ethics committees have approved the trial protocol. The company is now completing the operational steps needed to begin patient enrollment.

This clinical milestone follows several breakthroughs in manufacturing and formulation, announced in late 2025, including partnerships with Ardena for nanomedicine manufacturing and Alcami for lyophilization and global distribution. These collaborations have enabled Peptinovo to produce a stable, scalable supply of clinical-grade PALM™ drug product under current Good Manufacturing Practice (cGMP) standards. The company’s proprietary chemistry, including Chemelectiva’s semi-synthetic vitamin E compound and patented synthesis route, supports scalable, FDA-compliant production.

“With both ethics approval and cGMP manufacturing in place, we are entering the most critical phase of Peptinovo’s development,” said Ren Homan, inventor and co-founder. “From here on, every step is focused on translating our science into meaningful impact for patients.”

Peptinovo has raised $17.6 million to date through its Series A financing round to support the transition into clinical development. The company also plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration later this year to enable clinical trials in the United States.