- First trial participant treated with PTM-101, an investigational thin film formulation of paclitaxel placed directly over the tumor for continuous localized drug exposure -

- Trial enrolling patients at multiple leading U.S. cancer centers, evaluating PTM-101 as part of first-line therapy for borderline resectable and locally advanced pancreatic cancer -

PanTher Therapeutics (“PanTher” or the “Company”), a clinical-stage company redefining cancer treatment with therapeutics administered continuously and exclusively at the tumor site, today announced that the first patient has been treated with PTM-101 in a Phase 1b clinical trial in pancreatic ductal adenocarcinoma (PDAC). PTM-101 is the most advanced product candidate within PanTher’s portfolio of innovative formulations for continuous, high-dose, localized drug administration directly to the site of the tumor.

“The start of this second clinical trial of PTM-101 is an exciting milestone in our journey to transcend the dosing limitations of today’s cancer treatments by reimagining how chemotherapy is delivered,” said Laura Indolfi, Ph.D., Chief Executive Officer and Co-founder of PanTher Therapeutics. “Powerful cancer drugs exist but their toxicity lowers maximum dose and limits dosing frequency — leaving too many opportunities for cancers to continue spreading while patients grapple with debilitating side effects. Our investigational formulations are designed to circumvent the toxic effects of systemic chemotherapy while retaining a much higher dose of the drug exclusively at the tumor, with the goal of shrinking difficult-to-treat tumors and extending patients’ lives.”

PTM-101 is a polymeric thin film formulation of paclitaxel, a well-established chemotherapy drug, designed to deliver a sustained (~6 weeks) high dose to the tumor site with little to no systemic exposure. A previous first-in-human Phase 1 study (ACTRN12621000881831) of PTM-101 at the 100 mg dose level, combined with standard of care chemotherapy in borderline resectable and locally advanced PDAC, reported promising tumor shrinkage and a favorable safety profile. No paclitaxel was detected systemically at any time. The study additionally demonstrated PTM-101’s ability to fit into current PDAC treatment protocols and deliver potential therapeutic benefit early in the clinical paradigm, beginning weeks before intravenous chemotherapy.

The ongoing dose escalation and expansion Phase 1b study (NCT06673017) is assessing safety, tolerability, and anti-tumor activity of PTM-101 at two higher dose levels when combined with standard of care neoadjuvant chemotherapy (FOLFIRINOX) in patients with borderline resectable or locally advanced PDAC. The first patient was dosed at Virginia Mason Medical Center in Seattle, Washington, under Drs. Vince Picozzi and William “Scott” Helton. In addition to Virginia Mason, trial enrollment is presently ongoing at Northwell Health Zuckerberg Cancer Center in Lake Success, New York; Hoag Memorial Hospital Presbyterian in Newport Beach, California; and the Barbara Ann Karmanos Cancer Institute in Detroit, Michigan. This non-randomized, open-label study plans to enroll approximately 30 treatment-naïve patients across multiple clinical sites in the U.S.

“PTM-101 is a novel, innovative approach to treating the primary pancreatic tumor,” said Vince Picozzi, M.D., a medical oncologist and a principal investigator of the Phase 1b clinical trial. “Doing so successfully is the first step towards curative therapy.”

Studies have shown that only about 1% of systemically delivered chemotherapy reaches the tumor, with the remaining 99% of drug producing toxic effects on off-target tissues — including neutropenia, hair loss, nausea and vomiting, and peripheral neuropathy. Additionally, pancreatic cancer is notoriously poorly vascularized, making it extremely difficult for systemic chemotherapy to reach therapeutic levels at the tumor site.

“Targeted cancer treatment is an area of immense interest for oncology,” said Scott Helton, M.D., a pancreatic surgeon in Seattle, Washington. “The ability of PTM-101 to integrate into our current PDAC care pathway is promising, offering the possibility of transforming a diagnostic step into the start of therapy, weeks before the patient can begin intravenous chemotherapy.”

PanTher is additionally developing polymeric drug formulations for the treatment of a range of other solid tumor types.

About PTM-101

PanTher’s most advanced product candidate, PTM-101, is an absorbable thin film formulation of paclitaxel for non-metastatic pancreatic cancer. PTM-101 is designed to deliver continuous, long-term, high-dose chemotherapy to the tumor with little to no systemic exposure. The product, laparoscopically implanted at the tumor site, easily integrates with common minimally-invasive procedures used in staging pancreatic cancer. PTM-101 is currently being evaluated in a Phase 1b clinical trial (NCT06673017) with support from the Cancer Prevention & Research Institute of Texas (CPRIT) DP220066.

About PanTher Therapeutics

PanTher Therapeutics is a clinical-stage oncology company leveraging combined expertise in drug formulation and materials science to develop and commercialize potent, localized therapeutic products that can improve outcomes for patients with solid tumors. PanTher’s Sagittari™ platform enables the formulation of anti-cancer medicines in a wide range of flexible, polymer-based dosage forms that can be administered to the surface of a cancerous organ or implanted directly into a tumor. The drug product is tunable and engineered to continuously deliver the drug for weeks or months at a desired dose level, avoiding dose-limiting side effects of off-target delivery. The company has offices in Austin, Texas, and Watertown, Massachusetts. For more information, visit www.panthertx.com.

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