- Trial evaluating PTM-101, an absorbable, long-lasting, high-dose chemotherapy patch for non-metastatic pancreatic cancer -

- PTM-101 administration in the 200 mg cohort has been completed without dose-limiting toxicity -

- First subject enrolled in highest cohort of dose escalation phase, and enrollment ongoing across the U.S. -

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 it has concluded dosing in the first cohort of its Phase 1b clinical trial of PTM-101 in pancreatic ductal adenocarcinoma (PDAC). The rapid completion of this middle-dose cohort reflects vigorous engagement of the clinical oncology community with this new approach to cancer treatment.

The ongoing dose escalation and expansion study builds on findings from PanTher’s first-in-human trial that confirmed the safety of PTM-101 at 100 mg and reported promising tumor shrinkage. In the current U.S. Phase 1b trial, patients are being treated at escalating dose levels of 200 mg and 400 mg. Completion of the full cohort at the 200 mg dose level without evidence of toxicities further demonstrates PTM-101’s safety — even at a dose higher than what is typically used for IV infusion — and confirms its ability to be administered with well-established laparoscopic procedures. The Safety Committee has cleared advancement to the final anticipated cohort, and dosing at the 400 mg dose level has now begun, with the first patient treated.

“The swift execution of this first stage of our Phase 1b study underscores the momentum of our clinical strategy and the promise of PTM-101 as a new treatment paradigm for pancreatic cancer,” said Laura Indolfi, Ph.D., Chief Executive Officer and Co-founder of PanTher Therapeutics. “We are encouraged by the good safety profile observed so far and excited by the strong engagement from our clinical investigators. Medical and surgical oncologists are eager for better treatment options for their patients and have found that PTM-101 fits seamlessly into their existing neoadjuvant clinical treatments, creating an opportunity to reach patients at a critical point early in their journey.”

Intravenous chemotherapy is highly inefficient at permeating solid tumors and can cause debilitating side effects. PTM-101 is an investigational thin film formulation of the chemotherapy drug paclitaxel that is designed to overcome these limitations. It delivers a sustained (~6 weeks) high dose directly to the tumor site with little to no systemic exposure.

“From a surgical perspective, PTM-101 has been straightforward to place and has integrated seamlessly into minimally invasive staging laparoscopy and mediport placement. I favor a robotic-assisted approach, which allows for enhanced handling of the delicate tissue around the pancreas,” said principal investigator Danielle DePeralta, M.D., surgical director of the Pancreas Multidisciplinary Program at the Northwell Health Cancer Institute, Lake Success, NY. “Importantly, patch placement is incorporated into procedures that the patient would otherwise need prior to initiating standard systemic chemotherapy. My hope is that targeted local treatment with the patch, paired with standard chemotherapy, will make more patients with isolated pancreatic tumors candidates for surgical removal with the goal of long-term survival and cure. Because of the proximity of pancreatic tumors to major blood vessels, even minimal tumor shrinkage can make a big difference.”

The dose escalation and dose expansion Phase 1b study (NCT06673017) is assessing safety, tolerability, and anti-tumor activity of PTM-101 when combined with standard of care neoadjuvant chemotherapy (FOLFIRINOX) in subjects with borderline resectable or locally advanced PDAC. Dosing of patients has taken place at three clinical sites in the United States, with The University of Texas MD Anderson Cancer Center in Houston, Texas, recently joining the list of sites participating in the trial.

PTM-101 is the lead product candidate within PanTher’s pipeline of implantable medicines designed to directly address hard-to-treat solid tumors. 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 investigational 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 implantable medicines 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 directly to the tumor site, avoiding the dose-limiting side effects of off-target toxicity with systemic therapies, while preserving delivery of high doses locally. The company has offices in Austin, Texas, and Watertown, Massachusetts. For more information, visit www.panthertx.com.

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