Panther Therapeutics reports early signs of tumor response for localized pancreatic implant; clinical trial cleared by FDA

Panther Therapeutics, a clinical‑stage company developing localized cancer treatments, told the Cancer Prevention and Research Institute of Texas (CPRIT) oversight committee that its biodegradable, drug‑eluting peritumoral film produced antitumoral responses in an early study and that the company is preparing to begin a multi‑site U.S. trial.

The presentation by Dr. Laura Indolfi, co‑founder and chief executive officer of Panther Therapeutics, summarized two years of product development after the company relocated from Boston to Austin. The company’s lead product is a unidirectional, biodegradable film designed to be placed near pancreatic tumors via minimally invasive procedures and to elute chemotherapy directly toward the tumor while minimizing systemic exposure.

Why it matters: Pancreatic cancer has very low five‑year survival compared with other common cancers. Panther’s approach seeks to increase local drug exposure and reduce systemic toxicity by changing how the drug is delivered rather than changing the drug itself. If broadly effective and tolerable, the approach could change how some pancreatic tumors are treated and expand options for patients who are not immediate surgical candidates.

In her remarks, Indolfi said the device’s design keeps the drug local. “We have been able to demonstrate that we do not have drug into the bloodstream,” she said, describing imaging that shows the implant concentrates drug at the tumor site. “So we are forcing the drug to stay where it’s needed.”

Indolfi described the company’s first clinical experience: three patients were treated in an early Australian study at the lowest dose and, she said, placement produced no device‑related side effects. The company reported antitumoral responses at that dose and compared those results to published benchmarks for systemic neoadjuvant therapy: Panther cited a typical median tumor volume reduction of about 20 percent at 12 weeks in one MD Anderson study and reported larger reductions in individual patients in its experience, giving examples of 60 percent and 34 percent reductions in tumor volume at time points shown in their data slides. Indolfi emphasized that those examples are preliminary and described the initial trial as designed primarily to evaluate safety and integration into clinical care.

Regulatory and clinical plans: Indolfi said Panther submitted an IND and received full clearance from the U.S. Food and Drug Administration after pre‑IND meetings and that the company secured central IRB approval. The upcoming U.S. trial is planned as a study of up to 30 patients with five initial sites selected, including MD Anderson Cancer Center; three sites were expected to begin enrollment in March (timeline given in the presentation). The company said it manufactured clinical GMP lots at multiple doses and has produced hundreds of product units to support the next trial.

Manufacturing and operations: Panther said it now operates an approximately 8,000‑square‑foot facility in Austin that includes R&D and a clean room intended to support clinical manufacturing. Indolfi described manufacturing advances from small batch production to continuous film sheet production and said the company has automated portions of the manufacturing process to prepare for larger registrational studies and eventual commercial scale‑up.

Questions from oversight committee members covered the decision to run the first patients in Australia, imaging and biopsy plans to assess tumor viability, the risk of heterogeneous responses within tumors, and plans for combination approaches. Committee member Dr. Rosenfeld asked why the initial three patients were treated in Australia; Indolfi said Australian early‑phase data were accepted by the FDA and allowed a faster, more capital‑efficient development path. Dr. Raj Patel asked whether the product could include multiple layers with different agents; Indolfi said the manufacturing method is layer‑by‑layer and that future versions could include radiosensitizers, biologics or agents to alter the tumor microenvironment.

Oversight committee member and medical oncologist Dr. David Rice commented on the technology’s potential role within interventional oncology, saying it could expand options for patients with locally advanced disease.

What the company did not claim: Indolfi and committee members emphasized that the early study was small and primarily intended to test safety and feasibility. The company did not present evidence that the device cures pancreatic cancer, and speakers cautioned that longer follow‑up and larger trials are required to determine clinical benefit and survival impact.

Provenance: Excerpts of Dr. Indolfi’s presentation and committee questions were given during the grantee presentation segment of the oversight committee meeting. The presentation material and committee discussion are the source of the details above.

Ending note: Indolfi thanked CPRIT for its grant support and said Panther hopes the next trial will demonstrate clinical benefit sufficient to expand the technology’s use into other tumor sites after pancreatic cancer.