LP-184 for Pancreatic Cancer Granted Orphan Drug Designation

On August 11, 2021, biopharmaceutical company Lantern Pharma, Inc. (“Lantern”) shared the news that its small molecule drug candidate, LP-184 (hydroxyureamethylacylfulvene), received Orphan Drug designation from the FDA. This status was granted for the treatment of pancreatic cancer. Given to drugs or biologics intended to treat rare conditions (affecting under 200,000 Americans), Orphan Drug designation now grants Lantern a variety of benefits from fee waivers, tax credits, and increased regulatory assistance to 7 years market exclusivity once the drug is approved.


On the Lantern website, the company describes LP-184 as an alkylating agent and:

a promising member of a new generation of acylfulvenes, a family of naturally-derived anti-cancer drug candidates. In preclinical studies, LP-184 has shown significantly enhanced anti-tumor activity and substantially reduced toxicity as compared to earlier generation acylfulvenes.

The treatment works by targeting cancer cell DNA that over-expresses specific biomarkers. In mice models of pancreatic cancer, LP-184 treatment reduced pancreatic tumors by 90% over an 8-week (2 month) period. For untreated mice models, the tumors’ volume increased by up to 11x the size. Thus, researchers hope that the treatment can provide similar benefits for humans.

LP-184 was developed using Lantern’s proprietary RADR® artificial intelligence (AI) system. Through RADR, Lantern also developed:

a patient-specific biomarker test predictive of LP-184’s efficacy. We plan on using this test to facilitate patient selection in our planned Phase 1 clinical trial for LP-184.

In the future, Lantern hopes to work with Dr. Igor Astsaturov of the Marvin & Conchetta Greenberg Pancreatic Cancer Institute, as well as other stakeholders, to develop effective clinical trials.

Pancreatic Cancer

As the name suggests, pancreatic cancer forms in the pancreas, an organ which releases enzymes and hormones that aid in blood sugar management and digestion. Pancreatic cancer may manifest as Islet cell tumors, a rare form which occurs in neuroendocrine cells, or pancreatic adenocarcinoma, a more common form which begins in cells that line the pancreas. This difficult-to-detect cancer often is not diagnosed until later stages, making it more difficult to treat. Unfortunately, this leads to a poor prognosis: 7.9% 5-year and 1% 10-year survival rates. Thus, if you have a family history of pancreatic cancer, consider genetic counseling or other options to evaluate your risk. Additional risk factors include age (45+), obesity, being male, or smoking tobacco. Symptoms include:

  • Newly onset or worsening diabetes
  • Jaundice (yellowing of the skin and eyes)
  • Abdominal pain which radiates to the back
  • Dark urine or light stools
  • Unintended weight loss
  • Appetite loss
  • Obstructed bowel
  • Fatigue
  • Blood clots
  • Depression

Learn more about pancreatic cancer.

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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