AUSTIN, Texas — 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.