CPRIT grantee Panther Therapeutics describes implant that releases cancer drug near pancreatic tumors

Panther Therapeutics, a clinical‑stage company awarded a grant by the Cancer Prevention and Research Institute of Texas (CPRIT), told the CPRIT Oversight Committee that it has advanced a biodegradable, unidirectional drug‑eluting film designed to deliver chemotherapy directly to pancreatic tumors.

The company’s co‑founder and chief executive officer, Dr. Laura Indolfi, said the product — developed as part of the firm’s CPRIT‑funded work — is intended to place a flexible drug film near the tumor via minimally invasive surgery and release a high local dose of drug over weeks while minimizing systemic exposure. “It’s flexible; it can go through the laparoscopic trocar that are used for minimally invasive procedures,” Indolfi said during the presentation.

CPRIT’s grant funded early development and clinical proof‑of‑concept work. Indolfi told the committee the company’s product platform includes a peritumoral (around the tumor) biodegradable film and an intratumoral implant; the presentation focused on the peritumoral film developed for pancreatic cancer. She said the company’s lead drug product, known in presentation materials as PTM‑101, is in early clinical testing for pancreatic cancer and that an investigational new drug (IND) application submitted to the U.S. Food and Drug Administration was cleared after the agency’s 30‑day review.

Why this matters: pancreatic cancer has low long‑term survival and limited effective treatment options. Indolfi said systemic delivery often fails to reach pancreatic tumors because those tumors are poorly vascularized; the company’s approach aims to increase drug concentration at the tumor and reduce systemic toxicity. She argued that a localized, sustained delivery could increase the portion of patients who become eligible for surgery or have meaningful tumor shrinkage without adding systemic side effects.

Key details from the presentation: - Early human data: Panther treated three patients in an initial study in Australia at its lowest tested dose. Indolfi reported no procedure‑related infections or hematologic toxicities attributable to the implant before patients received standard systemic therapy. She said the three patients showed an antitumoral response at the dose intended to show safety. - Comparative tumor response: Indolfi compared the cohort’s imaging results against published MD Anderson volume‑reduction expectations (an average ~20% reduction at 12 weeks for systemic therapy responders) and reported a larger mean reduction in their early data (she cited a 34% reduction in volume at early time points in the study population), while stressing small numbers and the study’s early phase intent. - Regulatory and operational status: Indolfi said the IND is cleared, a central institutional review board (IRB) approval is in place, and clinical trial registration is active on ClinicalTrials.gov. She said Panther selected five U.S. sites for the upcoming trial, including MD Anderson, and expected three sites to begin enrollment in March; the planned study will enroll up to 30 patients. - Manufacturing and preclinical program: Panther reported scale‑up of manufacturing from small batches to continuous film production, completion of IND‑enabling studies including testing in over 36 pigs at multiple doses, and clinical GMP manufacturing campaigns. Indolfi said the company has produced several hundred devices across dose levels and has third‑party logistics in place to ship product to clinical sites. - Imaging and endpoints: The company plans to use CT volumetrics as the primary cross‑site imaging modality and is including PET‑MRI in the protocol where sites can provide it. Indolfi said routine biopsies for serial tissue sampling were limited by safety concerns; therefore, imaging will be the primary assessment tool in the initial U.S. trial.

Questions from committee members focused on safety, imaging endpoints and interpretation, and next steps. Committee members asked whether imaging captures viable tumor cells in the tumor core and whether PET‑MRI will be available across sites; Indolfi said CT will be used for consistent cross‑site comparisons and PET‑MRI will be included at sites able to perform it. She also described regulatory reasoning for conducting early patients in Australia to accelerate clinical proof‑of‑concept while continuing IND enabling work in the U.S.

The presentation highlighted that Panther relocated operations from Boston to Austin in 2022, established lab and clean‑room capacity in Texas, and is manufacturing product for the upcoming registrational‑intent trials. Indolfi thanked CPRIT for the grant support that enabled the accelerated timeline.

The Oversight Committee did not take a vote on the presentation. The committee asked follow‑up questions and heard the grantee’s description of clinical, manufacturing and regulatory progress.