FDA Clears IND Application of Novel Paclitaxel Administration in Pancreatic Cancer

• The FDA has granted clearance to the investigational new drug (IND) application of PTM-101.
• A phase 1b study of PTM-101 in pancreatic ductal adenocarcinoma (PDAC) will proceed.
• PTM-101 is a proprietary flexible film that allows paclitaxel to be delivered directly to a peritumoral area.

The FDA has cleared the IND application of PTM-101, a flexible film allowing for direct paclitaxel delivery to a peritumoral area. A phase 1b study will evaluate the product in patients with PDAC.¹

“Receiving FDA clearance for our phase 1b study of PTM-101 marks a pivotal achievement for PanTher and represents a significant milestone in our mission to transform clinical outcomes for patients with challenging pancreatic cancer diagnoses,” said Laura Indolfi, PhD, chief executive officer and co-founder of PanTher Therapeutics, in a press release. “This study will build upon the company’s positive, early clinical data in patients with borderline resectable and locally advanced PDAC.

The phase 1b study will assess safety, tolerability, and antitumor activity of PTM-101 at 2 different dose levels. Patients with treatment naive, borderline resectable, and locally advanced PDAC will be included in the analysis.

First-in-human data of PTM-101 were presented at the 2024 American Association of Cancer Research Annual Meeting in April of this year.² PTM-101 led to tumor shrinkage in all patients (n = 3) during the 24 weeks of evaluation, and 2 patients had significant reductions in tumor volume of 40% and 70%. Regarding safety, the profile was favorable, and PTM-101 appeared to be well tolerated with no incidences of peritonitis, pancreatitis, infection, or hematologic toxicity reported. Further, paclitaxel was only detected locally in the pancreas and not systemically.

About PTM-101

PTM-101 is a flexible and absorbable film that allows continuous, high-dose chemotherapy to be delivered to a precise peritumoral area.¹ This minimizes off-target toxicity and adverse effects typically observed with systemic chemotherapy while maximizing antitumor activity.

“Use of PTM-101 to locally administer a highly potent drug, without the limitations from systemic safety and tolerability issues, offers the potential to facilitate significant improvement in patient outcomes, which is clearly needed in the treatment of pancreatic cancer,” said Charles Pilgrim, MD, PhD, associate professor of surgery at the Alfred Central Clinical School at Monash University, in a press release.² “The ability of PTM-101, in combination with standard of care chemotherapy, to shrink pancreatic tumors…is promising. The prognosis for patients with pancreatic cancer can be particularly devastating, as it is often detected at an advanced stage, at which point there are limited treatment options. Given the trajectory for this cancer, I am very encouraged by the results from the clinical trial of PTM-101 in locally advanced cases and the ease of integrating the treatment into current clinical practice and standard laparoscopic procedures.”

REFERENCES:

1. PanTher Therapeutics receives FDA clearance of IND application for phase 1b study of PTM-101 for the localized treatment of pancreatic cancer. News release. PanTher Therapeutics. August 13, 2024. Accessed August 13, 2024. https://tinyurl.com/2cypr2hv

2. PanTher Therapeutics presents positive first-in-human data for PTM-101 in pancreatic cancer at AACR Annual Meeting. News release. PanTher Therapeutics. April 8, 2024. Accessed August 13, 2024. https://tinyurl.com/wyzhp6zx