AUSTIN, Texas | May 30, 2026
PanTher Therapeutics announced the completion of the dose-escalation portion of its Phase 1b clinical trial evaluating PTM-101, an absorbable paclitaxel-containing implant designed for patients with newly diagnosed non-metastatic pancreatic ductal adenocarcinoma (PDAC). Based on safety, tolerability, and pharmacokinetic findings, the company selected the 400 mg PTM-101 implant as the recommended Phase 2 dose (RP2D) for use alongside standard neoadjuvant chemotherapy. The study marks an important milestone in the development of PanTher’s localized cancer treatment platform, which aims to deliver high-dose chemotherapy directly to tumors while minimizing systemic exposure.
Phase 1b Data Support Advancement to Expansion Cohort
PanTher Therapeutics reported that patients treated during the dose-finding phase received PTM-101 implants containing either 200 mg or 400 mg of paclitaxel in combination with standard-of-care FOLFIRINOX chemotherapy. Across the 12 patients enrolled, investigators observed no detectable systemic exposure to paclitaxel, no significant implant-related toxicities, and no additional safety concerns when combined with chemotherapy.
The Study Safety Committee endorsed the 400 mg implant dose for further clinical evaluation, noting that this localized delivery approach provides approximately four times the maximum tolerated systemic dose of paclitaxel while avoiding the toxicities commonly associated with intravenous administration.
PTM-101 Designed to Improve Early Intervention in Pancreatic Cancer
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PTM-101 is a proprietary implantable thin-film formulation of paclitaxel designed to provide sustained chemotherapy directly at the tumor site for approximately six weeks following implantation. Administered during a routine staging laparoscopy immediately after diagnosis, the therapy is intended to complement existing treatment regimens by adding localized anti-tumor activity without increasing systemic side effects.
Approximately half of pancreatic cancer patients are diagnosed before metastatic spread occurs, creating a critical treatment window where therapies like PTM-101 could potentially improve tumor control, increase surgical eligibility, and enhance long-term outcomes. The ongoing Phase 1b study is evaluating PTM-101 in patients with borderline resectable or locally advanced pancreatic cancer.
Board Strengthened with Appointment of Oncology Veteran Tim Clackson
PanTher Therapeutics also announced the appointment of Dr. Tim Clackson to its Board of Directors. Dr. Clackson brings more than three decades of experience in oncology drug development and company leadership, strengthening the company’s strategic and clinical expertise as PTM-101 advances toward later-stage development.
Chief Executive Officer and Co-founder Laura Indolfi, Ph.D., stated that his experience in developing and commercializing innovative oncology therapies will help accelerate PanTher’s mission to improve outcomes for patients with difficult-to-treat solid tumors. The company is currently enrolling approximately 15 additional patients into the expansion phase of the trial and expects to report topline Phase 1b results during the first half of 2027.
Source: PanTher Therapeutics press release
