On July 28, 2021, biopharmaceutical company Thetis Pharmaceuticals (“Thetis”) shared that its small molecule Resolvin E1 (RvE1) therapy, TP-317, received Orphan Drug designation from the FDA. While TP-317 has been in development for acute respiratory distress syndrome (ARDS), the most recent designation is for the treatment of pancreatic cancer.

TP-317

Unfortunately, pancreatic cancer diagnoses come with a poor prognosis. The overall 5-year survival rate sits at just 9%. Thus, new and effective treatment options are needed to improve patient outcomes. Could TP-317 fit this need? According to Thetis:

Unlike steroids, immunomodulators and biologics that work by suppressing the immune response, RvE1 is an endogenous autacoid discovered by Professor Charles Serhan (Harvard Medical School) that activates multiple pathways to resolve inflammation and promote tissue repair without inhibiting host defense.

In patients with ARDS, TP-317 reduced tissue inflammation and improved tissue repair. For pancreatic cancer, researchers at the Panigrahy Lab wanted to understand the potential benefits of this treatment. In 2017, these researchers published an article regarding how resolvins, like RvE1, have numerous benefits for treating cancer. For example, TP-317 can reduce pro-tumor or pro-inflammatory cytokines; help clear tumor cell debris out of the body; and make the tumor microenvironment harsher to reduce tumor size and stop cancer progression.

Within this same lab, researchers determined that TP-317, as a monotherapy or in conjunction with other treatments, could show benefits for patients with pancreatic cancer. Moving forward, researchers hope to initiate clinical trials to further evaluate this therapy.

The Orphan Drug designation is granted by the FDA to expedite the development and review of drugs and biologics designed to treat rare conditions. In this case, “rare” is considered any condition affecting under 200,000 Americans. For receiving this designation, Thetis also receives increased regulatory assistance, tax credits, fee waivers, and 7 years of market exclusivity once approved.

Pancreatic Cancer

Pancreatic cancer accounts for an estimated 3.2% of all cancer diagnoses within the United States. As the name suggests, this cancer forms in the pancreas, which releases enzymes and hormones to aid in digestion and blood sugar management. Pancreatic cancer subtypes depend on where it forms. For example, exocrine pancreatic cancer develops in pancreatic ducts, while Islet cell tumors form in hormone-producing cells. Unfortunately, the prognosis for pancreatic cancer is poor, often due to diagnosis in later stages of the cancer. Risk factors include age (45+), being male, smoking tobacco, being obese, or having a family history of pancreatic cancer. When symptoms appear, these include:

• Jaundice (yellowing of the skin and eyes)
• Dark urine and pale stool
• Appetite loss
• Fatigue
• Diabetes
  • Note: This can be newly onset diabetes, or worsening of prior diabetes.
• Unintended weight loss
• Abdominal pain which radiates to the back
• Blood clots
• Obstructed bowel

Learn more about pancreatic cancer here.