ANN ARBOR, Mich., Jan. 20, 2026 (GLOBE NEWSWIRE) -- Peptinovo Biopharma, an Ann Arbor–based biotechnology company pioneering targeted cancer therapies through its first-of-its-kind proprietary PALM™ nanotechnology, today announced it has received approval to initiate its first human clinical trials in Australia. The milestone clears the way for the company to begin enrolling cancer patients in the coming months.
After extensive scientific and safety reviews, Peptinovo received approval from both of the Human Research Ethics Committees (HRECs) to which the study was submitted. Ethics committees are the Australian equivalent of institutional review boards in the United States. The authorization allows Peptinovo to activate selected Australian clinical sites and proceed with the final steps required to start patient dosing. Peptinovo is targeting enrollment of its first patient in the first quarter of 2026.
“This is a defining moment for Peptinovo,” said CEO Steve Tokarz. “Receiving ethics approval to initiate human clinical trials means our PALM™ nanotechnology has passed rigorous independent review for safety and scientific integrity. It allows us to move from years of laboratory and manufacturing development into the clinic, where our goal is to begin demonstrating real benefit for cancer patients.”
The clinical trial will evaluate Peptinovo’s proprietary PALM™ (Peptide-Amphiphile Lipid Micelle) platform, which is designed to deliver established, approved chemotherapies directly into cancer cells while minimizing exposure to healthy tissue. At the core of the platform is a novel, patented vitamin-E-based prodrug linker developed through Peptinovo’s collaboration with Italian specialty pharmaceutical chemistry company Chemelectiva S.r.l.
This breakthrough chemistry enables PALM™ to exploit natural cellular uptake mechanisms that cancer cells use to fuel growth. By temporarily inactivating chemotherapy drugs using the proprietary vitamin-E-based linker, the PALM™ drug circulates safely through the body until it is taken up by tumor cells. Once inside, the linker is cleaved and the chemotherapy is reactivated — functioning like a Trojan horse that delivers the drug directly where it is needed, unleashing its full therapeutic potential while reducing the adverse effects that limit conventional chemotherapy.
Peptinovo has selected multiple clinical sites in Australia whose principal investigators have agreed to participate in the study and whose ethics committees have reviewed and approved the trial protocol. The company is now completing the remaining operational steps required to activate those sites.
This clinical milestone follows a series of manufacturing and formulation breakthroughs announced in late 2025, including Peptinovo’s partnerships with Ardena for nanomedicine manufacturing and Alcami for lyophilization (freeze-drying) and global drug-product distribution. Together, these partnerships established a stable, scalable supply of clinical-grade PALM™ drug product manufactured under current Good Manufacturing Practice (cGMP) standards. The company’s proprietary chemistry — enabled by Chemelectiva’s first-of-its-kind semi-synthetic vitamin E compound and patented synthetic route — makes commercial-scale, FDA-compliant production of the PALM™ prodrug possible, overcoming long-standing limitations of naturally sourced vitamin E derivatives.
“With both ethics approval and cGMP manufacturing in place, we are entering the most important phase of our company’s development,” said Ren Homan, inventor and co-founder of Peptinovo. “Every step from here forward is about translating our science into patient impact.”
To support its transition into clinical development, Peptinovo has raised $17.6 million to date as part of its open Series A financing round. Parties interested in learning more about the company or its financing may contact Peptinovo using the information below.
In parallel with the Australian study, Peptinovo plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration this year to support the launch of clinical sites in the United States.
About Peptinovo Biopharma
Peptinovo Biopharma is a privately held biotechnology company based in Ann Arbor, Michigan, developing next-generation targeted nanomedicines to enhance the treatment of cancer. Its proprietary PALM™ technology delivers proven chemotherapies directly to tumors while reducing toxicity to healthy tissues, aiming to improve outcomes and quality of life for patients. The company has raised $17.6M to date in its current Series A round to expand development of its platform. For more information, visit www.peptinovo.com.
Peptinovo Investor Contact
Steve Tokarz
steve.tokarz@peptinovo.com
Media Contact
Katie Merx
katie.merx@peptinovo.com
+1 313.510.5090
