PanTher Completes PTM-101 Dose Escalation in Pancreatic Cancer Trial

PanTher Therapeutics announced it has concluded the dose escalation portion of its Phase 1b clinical trial of PTM-101 in pancreatic ductal adenocarcinoma (PDAC), identifying the PTM-101 400mg paclitaxel-containing implant as the recommended Phase 2 dose (RP2D) in combination with neoadjuvant standard of care chemotherapy.

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%. 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.

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. 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 with neoadjuvant standard of care FOLFIRINOX by adding a fourth chemotherapy agent.

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. Data from the expansion phase are expected in the first half of 2027.

PanTher also announced the appointment of a senior life sciences executive to its Board of Directors. The appointee brings more than three decades of experience building oncology companies. The Chief Executive Officer of PanTher stated that the executive's experience in developing and commercializing oncology therapies will be invaluable as the company builds on the momentum of its Phase 1b clinical program.

In other pancreatic cancer developments, the American Society of Clinical Oncology (ASCO) Annual Meeting 2026, held in Chicago, Illinois, featured Phase III RASolute 302 data and its potential impact in pancreatic cancer. Meanwhile, a study published in Nature identified NDRG1 (N-myc downstream-regulated gene 1) as a key mediator linking cancer-associated fibroblast-secreted extracellular matrix proteins to enhanced DNA repair in PDAC. NDRG1 was found to be highly expressed in PDAC tumours, and high expression correlates with poor disease-specific survival and poor response to chemotherapy. A separate case report described a 58-year-old man with a 15-cm pancreatic acinar cell carcinoma (ACC) treated by distal pancreatectomy and splenectomy, with complete resection achieved. Histopathology showed acinar architecture with Bcl-10 positivity and nuclear beta-catenin accumulation, consistent with Wnt pathway activation.