On August 11, 2021 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that the U.S. Food and Drug Administration (FDA) has granted LP-184 Orphan Drug Designation for the treatment of pancreatic cancer (Press release, Lantern Pharma, AUG 11, 2021, View Source [SID1234586348]). LP-184 is a small molecule drug candidate and next generation alkylating agent that preferentially damages DNA in cancer cells that over-express certain biomarkers or that harbor mutations in DNA repair pathways. LP-184 is being developed for several targeted indications in cancer, including pancreatic cancer.

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Pancreatic cancer is the fourth leading cause of cancer deaths in the United States with a five-year survival rate of 7.9% and a 10-year survival rate of just 1%. GLOBOCAN estimates that for pancreatic cancer there are approximately 490,000 thousand new cases of pancreatic cancer globally, with over 62,000 occurring in North America annually. Due to the late onset of symptoms, patients are often diagnosed after the cancer has progressed to locally advanced or metastatic stages of the disease. LP-184 is designed to target a specific subset of pancreatic cancer patients that are genetically defined, which has the potential to increase beneficial therapeutic options for patients and may ultimately improve survival for those with this cancer.

"Receipt of Orphan Drug Designation is an important accomplishment for the LP-184 program and for our company. This designation further validates our data-driven approach to oncology drug development as well as the groundbreaking collaborative R&D approach we are advancing with leading institutions such as Fox Chase Cancer Center," stated Panna Sharma, President & CEO of Lantern Pharma. "Orphan Drug Designation is designed to provide a number of benefits, including seven years of market exclusivity, which complements our growing portfolio of patents that provide us additional commercial and market protections."

"This orphan designation is one of many upcoming milestones that we expect to achieve for our LP-184 program in pancreatic cancer. We recently reported that LP-184 demonstrated significant and rapid pancreatic tumor shrinkage, by over 90%, within in-vivo mouse models over 8 weeks. In comparison, the tumors in the untreated mice grew by over eleven-fold in volume during the same 8-week period. We are excited to advance this groundbreaking research to help patients suffering from this devastating disease where the benefits of current treatment options are very limited."

Lantern has begun discussions on the design of first-in-human clinical studies for LP-184 in collaboration with Dr. Igor Astsaturov, an established, NCI -funded, physician scientist and co-leader of the Marvin & Conchetta Greenberg Pancreatic Cancer Institute at Fox Chase Cancer Center, as well as other key opinion leaders in the pancreatic cancer treatment landscape.

The FDA’s Office of Orphan Products Development grants orphan status to drugs intended for the safe and effective treatment, diagnosis or prevention of rare diseases or conditions affecting fewer than 200,000 people in the United States. Orphan Drug Designation is designed to provide drug developers with various benefits to support the development of novel drugs, including market exclusivity for seven years upon FDA approval, eligibility for tax credits for qualified clinical trials, waiver of marketing registration application fees, reduced annual product fees, clinical protocol assistance and qualification for expedited development programs.