Matthew Calleja
16th August 2024
FDA Green-lights PanTher Therapeutics for Phase 1b Study of PTM-101 in Localised Pancreatic Cancer
On Tuesday, PanTher Therapeutics announced the U.S. Food and Drug Administration (FDA) clearance of the Investigational New Drug (IND) application for the company’s lead program, PTM-101, to proceed in a phase 1b clinical study in patients with pancreatic ductal adenocarcinoma (PDAC).
Detoxifying Cancer Treatment
Traditional cancer treatments bombard the body with toxic drugs, yet less than 1% of these reach the tumour, leaving the rest to damage healthy organs.
Enter PanTher Therapeutics, a clinical-stage oncology company with a bold mission to change this reality. Led by their visionary CEO and Co-Founder, Dr. Laura Indolfi, PanTher is pioneering a targeted drug delivery system designed to eliminate the inefficiency and harmful side effects of conventional therapies.
This Tuesday, the company hit a milestone with FDA clearance for their leading product, PTM-101, to advance into a phase 1b clinical study for pancreatic ductal adenocarcinoma (PDAC). This achievement marks a significant leap forward in cancer treatment, signalling a future where therapies are not only more effective but also kinder to patients, sparing them from the ordeal of being poisoned as a byproduct of treatment.
The Full Picture
This phase 1b dose escalation and expansion study will be conducted across multiple sites, enrolling patients with treatment-naïve, borderline resectable, and locally advanced PDAC. The study offers hope for improved therapeutic responses in those with limited treatment options.
In the official press release, Dr. Indolfi described how receiving FDA clearance for their phase 1b study of PTM-101 is a pivotal achievement for PanTher and a significant milestone in their mission to transform clinical outcomes for patients facing challenging pancreatic cancer diagnoses.
“This study will build upon the company’s positive, early clinical data in patients with borderline resectable and locally advanced PDAC,”
explained Dr. Indolfi in more detail.
PTM-101, PanTher’s flagship clinical product, was developed using the innovative Sagittari™ drug development platform. This technology allows for continuous, high-concentration drug delivery directly at the tumour site over an extended period.
“This novel approach, which maximises killing of tumour cells, has not previously been possible with other technologies.”
Earlier this year, PanTher shared encouraging first-in-human data from a small phase 1 study involving three pancreatic cancer patients treated with PTM-101. Remarkably, two of the three patients who received the lowest dose of PTM-101, followed by standard chemotherapy, experienced a tumour volume reduction of over 40%.
The treatment demonstrated a favourable safety profile, with no cases of peritonitis, pancreatitis, infection, or haematological toxicity. Importantly, the chemotherapeutic agent remained localised within the pancreas in all patients, with no systemic paclitaxel detected at any point.
About PanTher Therapeutics
PanTher Therapeutics, a clinical-stage oncology company, is pioneering a game-changing approach to cancer treatment with its Sagittari™ platform.
This innovative technology delivers high-dose cancer therapies directly to the tumour site, ensuring continuous treatment over weeks or months while minimising harmful side effects. The platform’s versatility allows for treatment to be applied to the surface of cancerous organs or implanted directly into tumours. PanTher’s lead candidate, PTM-101, has shown promise in a Phase 1 trial for localised pancreatic cancer.
The company is now exploring the potential of its Sagittari™ platform in treating other solid tumours.
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