ImPact Biotech receives FDA Orphan Drug Designation for Padeliporfin VTP in Pancreatic Cancer

  • Designation confers advantages including marketing exclusivity and tax credits 
  • Padeliporfin VTP Phase 1 trial in Pancreatic cancer to start by end Q4 2023

TEL AVIV, Israel, July 05, 2023 (GLOBE NEWSWIRE) — ImPact Biotech, the IMmune Photo Activated Cancer Treatment (IMPACT) specialist announces the U.S. Food and Drug Administration granted Orphan Drug Designation (ODD) to Padeliporfin Vascular Targeted Photodynamic therapy (VTP) for the treatment of patients with locally advanced pancreatic Cancer.

The Investigational New Drug (IND) application, allowing initiation of the Phase 1 clinical trial of Padeliporfin VTP in patients with locally advanced pancreatic ductal adenocarcinoma, will be submitted later this year and is expected to begin enrollment this year. Padeliporfin VTP has also previously received Fast Track designation and Orphan Drug Designation from the FDA for the treatment of adult patients with low-grade UTUC.

Orphan drug status confers a number of advantages for product development, including a tax credit for the cost of clinical trials undertaken in the US, marketing exclusivity for seven years, written recommendations from the FDA on clinical and preclinical studies needed for approval and a fast-track procedure for regulatory review.

Barak Palatchi, CEO of ImPact Biotech, said, “We are delighted to receive Orphan Drug Designation for Padeliporfin VTP in Pancreatic Cancer, further validating ImPact’s technology and the potential benefits our product could bring to patients with locally advanced Pancreatic Cancer. We continue to believe and follow our strategy, refocusing Padeliporfin VTP treatment on patients with limited treatment options. In Pancreatic Cancer, with limited treatment options for patients who have unresectable locally advanced disease our hope is that Padeliporfin VTP will offer a safe and effective treatment that will render the disease eligible for definitive treatment. Pancreatic Cancer is one of our priority indications within our ambitious plan. We are looking forward to exploring the possibility of offering Padeliporfin VTP to more patients coping with life threatening cancers.”

ImPact Biotech is focusing on the development of Padeliporfin VTP as a minimally invasive oncology platform for the treatment of solid tumors, with the potential to offer surgery-like efficacy, combined with healthy-tissue or organ preservation in solid tumors for high-risk surgical patients with unmet needs – either because surgery is not the preferred clinical option, or the risk of surgery is too high.

About Padeliporfin VTP

Padeliporfin VTP (Vascular Targeted Photodynamic therapy) is a minimally invasive oncology platform for the treatment of solid tumors. It offers surgery-like efficacy combined with healthy-tissue or organ preservation. VTP comprises the intravenous delivery of an inactive drug, Padeliporfin. Upon light activation, the drug rapidly triggers the constriction of the blood supply in the illuminated area only, resulting in targeted tumor necrosis that activates anti-tumor immunity which in-turn enhances cancer cell eradication.        

About Pancreatic Cancer

Pancreatic cancer is one of the most lethal cancers. In the US, it accounts for about 3% of all cancers but about 7% of all cancer deaths. Patients seldom exhibit symptoms until an advanced stage of the disease. Surgery remains the most effective treatment of pancreatic cancer to ensure extended survival and cure. Unfortunately, at time of diagnosis as many as two thirds of patients are ineligible for surgery because their cancer is already locally or distantly spread, and in many cases encases major blood vessels, such as the superior mesenteric artery. Padeliporfin VTP is currently being evaluated for this indication as a means to bridge more patients to be eligible for surgery.

About ImPact Biotech

ImPact Biotech is an Israeli biotech organization based on a spin-off from Steba Biotech, with operations in the EU, Israel and the US. ImPact biotech focuses on the development of a minimally invasive novel oncology platform to treat a range of solid tumors with Padeliporfin VTP (Vascular Targeted Photodynamic therapy). ImPact Biotech is implementing a bold strategy concentrating on a range of solid tumors with a high medical need such as UTUC, NSCLC and Pancreatic cancer.
ImPact Biotech’s strong relationships with The Weizmann Institute in Israel and Memorial Sloan Kettering Cancer Center in the US have produced exciting early results in a range of solid tumor types, including UTUC, esophageal, and lung and now Pancreatic Cancer. These programs are now being accelerated into the clinic, supported by the safety and efficacy profile already established during earlier research in low-risk prostate cancer.

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