PYX-201 Granted Orphan Drug Designation for the Treatment of Pancreatic Cancer

Pyxis Oncology is driven to improve the lives of people living with cancer through the development of innovative immunotherapy and antibody drug conjugate (ADJ) therapies. Their treatment PYX-201, a novel ADJ, targets extradomain-B fibronectin, a type of antigen that is present in many solid tumors. Since EDB fibronectin isn’t usually found in healthy tissue, it allows for more targeted and specific treatment. PYX-201 is in development for multiple indications such as breast, lung, thyroid, head and neck, ovarian, kidney, and pancreatic cancer. In fact, shares an article in OncLive, PYX-201 was just given Orphan Drug designation for pancreatic cancer. 

Orphan Drug designation is granted by the U.S. Food and Drug Administration to drugs or biologics that may prevent, diagnose, or treat a rare condition. In the United States, rare conditions affect fewer than 200,000 people. Incentives are also granted to the drug developer (in this case, Pyxis Oncology): fee waivers, more regulatory assistance, 7 years of market exclusivity upon approval. 

Currently, PYX-201 is being evaluated in a Phase 1 study in a variety of solid tumor indications. Within this dose escalation study, the research team will explore the therapy’s safety, efficacy, tolerability, pharmacodynamics, and pharmacokinetics. Data from the study should be available at some point next year. 

Pancreatic Cancer: The Basics

Your pancreas sits behind the lower part of your stomach and plays a role in different health functions. For example, releasing enzymes aids in digestion; hormone production regulates blood sugar. Pancreatic cancer occurs when cancer forms within this organ. Exocrine pancreatic cancer, or pancreatic adenocarcinoma, begins in the pancreatic ducts, while Islet cell tumors form in neuroendocrine cells. Unfortunately, pancreatic cancer can be hard to identify in early stages—and difficult to treat in later stages. Because of this, the 5-year survival rate sits at around 12%. However, new research and drug development has the potential to discover more targeted and effective treatments.

If you smoke cigarettes, are obese, are male, are older than 45, or have a family history of pancreatic cancer, you’re at a higher risk of developing it. When symptoms appear, you may notice:

  • Fatigue
  • Appetite loss
  • Upper abdominal pain that radiates to the back
  • Unintentional weight loss
  • Newly onset or worsening diabetes 
  • Jaundice (yellowing of the skin, eyes, and mucous membranes)
  • Blood clots
  • Dark urine and pale stool
  • Bowel obstructions 
  • Itchy skin
  • Nausea 
Jessica Lynn

Jessica Lynn

Jessica Lynn has an educational background in writing and marketing. She firmly believes in the power of writing in amplifying voices, and looks forward to doing so for the rare disease community.

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