AUSTIN, Texas — PanTher Therapeutics has completed the dose-escalation portion of a Phase 1b clinical trial evaluating PTM-101, its implantable chemotherapy patch for non-metastatic pancreatic cancer, and has selected a 400 mg paclitaxel-containing implant as the recommended Phase 2 dose.
The clinical-stage company also appointed Tim Clackson, Ph.D., a life sciences executive with more than three decades of oncology experience, to its board of directors.
PTM-101 is designed to deliver sustained, high-dose chemotherapy directly to the tumor site while limiting systemic exposure. The implant is administered at the tumor surface during a standard staging laparoscopy shortly after diagnosis and is intended to work alongside standard neoadjuvant chemotherapy.
PanTher said the dose-escalation data support moving into a dose-expansion cohort. In the dose-finding portion of the trial, patients received 200 mg and 400 mg doses of paclitaxel with no systemic paclitaxel detected, no evidence of significant implant-related toxicities and no added toxicities when used with standard-of-care chemotherapy. Plasma pharmacokinetic data showed no evidence of systemic exposure, with levels below quantifiable limits.
The company said a study safety committee endorsed the 400 mg dose as the recommended Phase 2 dose based on data from 12 patients. PanTher said that dose represents four times the maximum tolerable dose of paclitaxel when delivered systemically.
The ongoing open-label, multicenter, single-arm Phase 1b study is evaluating the safety, tolerability, pharmacokinetics and anti-tumor activity of PTM-101 in patients with newly diagnosed, treatment-naïve, borderline resectable or locally advanced pancreatic ductal adenocarcinoma. The dose-expansion phase is now enrolling about 15 additional patients at sites across the United States.
PanTher said the study builds on a first-in-human trial that showed PTM-101 was safe at 100 mg and reported tumor shrinkage, including reductions in overall tumor volume of up to 70%.
About half of patients with pancreatic ductal adenocarcinoma are diagnosed with non-metastatic disease, when timely treatment and surgery may still offer a potential cure. PanTher said PTM-101 is designed to create an earlier treatment window by delivering chemotherapy directly to the tumor for about six weeks without systemic exposure.
“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 PanTher’s lead product candidate in a pipeline of implantable medicines aimed at hard-to-treat solid tumors. The company is also developing polymeric drug formulations for other solid tumors.
PanTher expects to report topline data from the Phase 1b study in the first half of 2027.
