PanTher Completes Dose Escalation Phase in Non-Metastatic Pancreatic Cancer Phase 1b Trial and Appoints Tim Clackson to the Board of Directors

AUSTIN, Texas--(BUSINESS WIRE)--PanTher Therapeutics (“PanTher” or the “Company”), a clinical-stage company redefining early cancer treatment with therapeutic implants administered directly at the tumor site, today announced that it has concluded the dose escalation portion of its Phase 1b clinical trial of PTM-101 in pancreatic ductal adenocarcinoma (PDAC). PanTher has identified the PTM-101 400mg paclitaxel-containing implant as the recommended Phase 2 dose (RP2D) in combination with neoadjuvant standard of care chemotherapy. In addition, PanTher announced the appointment of senior life sciences executive Dr. Tim Clackson to its Board of Directors. This news reflects a pivotal stage in the company’s development to achieve the promise of the PTM-101 technology.

The ongoing Phase 1b study builds on PanTher’s first-in-human trial that demonstrated the safety of PTM-101 at 100 mg and reported promising tumor shrinkage, with reduction in overall tumor volume of up to 70%. The current trial is an open-label, multicenter, single-arm study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of PTM-101 in patients with newly diagnosed, treatment naïve, non-metastatic pancreatic cancer. In the dose-finding phase, subjects were treated at higher doses of paclitaxel (200 mg and 400 mg) with no systemic paclitaxel detected, no evidence of significant implant-related toxicities, and no additive toxicities with standard of care chemotherapy. Plasma pharmacokinetic data show no evidence of systemic exposure to paclitaxel with levels below quantifiable limits. Based on these data from a total of 12 patients, the Study Safety Committee endorsed the 400mg dose as the RP2D for further evaluation. This dose represents 4x the Maximum Tolerable Dose (MTD) of paclitaxel when delivered systemically, underscoring the potential benefit of localized therapy.

Approximately 50% of PDAC patients present with non-metastatic disease at diagnosis, when timely anti-tumor treatment and surgery still offer the potential for cure. Yet multi-agent systemic chemotherapy is often limited by toxicity. PTM-101 is a proprietary paclitaxel implant administered at the tumor surface during a standard tumor staging laparoscopy, immediately after diagnosis, providing ~6 weeks of sustained high-dose therapy directly to the tumor, with no systemic exposure. As an add-on therapy, PTM-101 integrates seamlessly with neoadjuvant standard of care FOLFIRINOX by adding a fourth chemotherapy agent while creating a new window for early intervention and improved outcomes.

The ongoing 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. PanTher is now enrolling patients in the dose expansion phase, which will enroll approximately 15 additional patients at sites across the United States to further characterize the safety and efficacy of PTM-101. For more information on the trial, please visit https://clinicaltrials.gov/study/NCT06673017

PanTher also announced today the appointment of Dr. Tim Clackson to its Board of Directors. Dr. Clackson brings more than three decades of experience building oncology companies to PanTher’s board, and his appointment reflects PanTher’s commitment to assembling a world-class team to support the advancement of PTM-101 and the Company's broader pipeline.

“We are thrilled to welcome Tim to PanTher’s Board of Directors,” said Laura Indolfi, Ph.D., Chief Executive Officer and Co-founder of PanTher Therapeutics. “His experience in developing and commercializing oncology therapies will be invaluable as we continue to build on the momentum of our Phase 1b clinical program and work to bring PTM-101 to patients in need.”

Laura continued, “For patients with localized pancreatic cancer, every treatment decision made at diagnosis can impact the future of that patient and the development of their diagnosis. PTM-101 offers the potential to integrate directly into the neoadjuvant standard treatment paradigm from the outset, delivering additional anti-tumor activity without compounding systemic side effects. It is our aim with PTM-101 to meaningfully improve clinical outcomes for patients, alongside the current standard of care, to drive deeper and longer treatment responses before a tumor has the opportunity to become metastatic.”

“PanTher is taking a highly differentiated and promising approach to tackling one of the most challenging cancers. By intervening right after diagnosis, with localized, high dose and sustained therapy, PTM-101 has the potential to transform PDAC outcomes before metastasis,” said Tim Clackson, Ph.D. “As a simple add-on therapy that integrates seamlessly with existing workflows and therapies, it has the potential for wide adoption. I look forward to working with Laura and the PanTher team to help bring PTM-101, and a broader pipeline of localized medicines, to patients in need.”

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.

The company expects to share topline data from the Phase 1b study of PTM-101 in the first half of 2027.

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-lasting, 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.