PanTher Therapeutics Gets FDA Nod for PTM-101 Phase 1b Pancreatic Cancer Study

PanTher Therapeutics, a clinical-stage oncology company based in Austin, Texas, has announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for its leading program, PTM-101. This clearance allows the company to proceed with a Phase 1b clinical study focused on treating patients with pancreatic ductal adenocarcinoma (PDAC).

The upcoming Phase 1b study will involve dose escalation and dose expansion across multiple sites. The study aims to enroll patients who are treatment-naïve, have borderline resectable, or locally advanced PDAC, in order to explore improved therapeutic responses for those with limited available treatment options.

Laura Indolfi, PhD, Chief Executive Officer and co-founder of PanTher Therapeutics, highlighted the importance of this development. She pointed out that receiving FDA clearance for the Phase 1b study of PTM-101 is a significant milestone for PanTher. The clinical study will build on the company’s earlier positive data in patients with borderline resectable and locally advanced PDAC. PTM-101 was developed using PanTher’s proprietary Sagittari™ drug development platform, which enables continuous delivery of high drug concentrations exclusively at the tumor site, maximizing the effectiveness of killing tumor cells.

Earlier this year, PanTher shared encouraging results from a small Phase 1 study involving three pancreatic cancer patients who were treated with PTM-101. Two of the three patients, who received the lowest dose of PTM-101 followed by standard chemotherapy, experienced a reduction of over 40% in overall tumor volume. The treatment demonstrated a favorable safety profile, showing good tolerability without incidents of peritonitis, pancreatitis, infection, or hematological toxicity. Moreover, the chemotherapeutic agent remained localized in the pancreas, with no systemic paclitaxel detected in any of the patients.

PanTher Therapeutics specializes in localized cancer treatment using its Sagittari™ platform to develop products that deliver high-dose oncology agents directly to the tumor site. This advanced technology allows for the formulation of therapeutic agents in various polymer-based dosage forms that can be administered directly to the surface of a cancerous organ or implanted within a tumor. The continuous drug delivery system aims to maintain therapeutic levels for weeks or months without causing dose-limiting side effects. PanTher’s lead clinical candidate, PTM-101, has shown promise in a Phase 1 clinical trial involving patients with treatment-naive, localized non-metastatic pancreatic cancer. The company is also exploring additional applications of the Sagittari™ platform for other solid tumor indications.

PTM-101, the company’s lead product, is an absorbable film designed to provide continuous, high-dose delivery of paclitaxel directly to the peritumoral area, thereby maximizing anti-tumor efficacy while minimizing side effects commonly associated with systemic paclitaxel administration. It has been designed to integrate seamlessly with existing laparoscopic procedures used for peritumoral placement. PTM-101 is currently being evaluated for the treatment of localized non-metastatic pancreatic cancer, following a successful Phase 1 study. The company is now preparing to initiate a Phase 1b trial to further assess the safety, tolerability, and anti-tumor activity of PTM-101 across two different dose levels.