Unmet Need

therapeutics targeting cell adhesion

IDIOPATHIC PULMONARY FIBROSIS

Only two drugs are FDA-approved for treatment of idiopathic pulmonary fibrosis (IPF), which is the most common form of PF. They are nintedanib (Ofev®) and pirfenidone (Esbriet®). These medications decrease the rate of fibrosis or scarring in the lungs. The drugs are approved for patients with mild, moderate and severe IPF. Nintedanib inhibits receptor tyrosine kinases. It interferes with processes active in fibrosis such as fibroblast proliferation, migration and differentiation, as well as collagen secretion and extracellular matrix formation. Diverse action mechanisms have been suggested for pirfenidone. Among them, this drug has been shown to inhibit collagen synthesis and assembly. Throughout Europe and North America, the estimated incidence of IPF has been reported to range between 2.8 and 19 cases per 100,000 people per year. IPF is the most common of the idiopathic interstitial pneumonias and carries the worst prognosis, with median survival ranging from 2.5 to 3.5 years.

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Pancreatic Cancer UNMET NEED

Pancreatic cancer is a significant and increasing unmet medical need.

The mortality rate from pancreatic cancer is on an alarming upward trajectory with rising death rates in the United States and around the world. Pancreatic cancer is projected to become the second leading cause of cancer death by 2030. In 2020, approximately 57,600 people were diagnosed with pancreatic cancer in the USA.

Survival outcomes are poor for pancreatic cancer patients.

Pancreatic cancer is a highly lethal disease for which mortality closely parallels incidence. The five year survival rate of Stage IV patients is only 3%. No early screening tests are available as there are for many other cancers, and no standard program exists for screening patients at high risk. Often there are no symptoms until the disease reaches an advanced stage. The few symptoms that are common with pancreatic cancer are often vague and are easily attributed to other causes.

Five Year Survival Rates for Pancreatic Cancer

Stages Ia/Ib/IIa/IIb : 37%

Stage III: 12%

Stage IV: 3%

There is currently no adequate treatment for pancreatic cancer.

Pancreatic cancer is very difficult to treat. The major reason for the limited benefit of most pancreatic cancer therapies is thought to be drug resistance, both intrinsic and acquired.

Chemotherapy is often part of the treatment. Unfortunately, this cancer is particularly resistant to chemotherapy. Currently, the most common drugs used for adjuvant and neoadjuvant chemotherapy include Gemcitabine (Gemzar®), 5-fluorouracil (5-FU), Oxaliplatin (Eloxatin®), Albumin-bound paclitaxel (Abraxane®), Capecitabine (Xeloda®), Cisplatin, and Irinotecan (Camptosar®). None of them target N-cadherin, and they only extend life by approximately 6 months.

Newer treatments are drugs or other substances that block the growth and spread of cancer by interfering with the function of specific targets. These targets promote the growth, progression, and spread of cancer. Targeted therapies for pancreatic cancer include erlotinib (Tarceva®), which is used with chemotherapy, and olaparib (Lynparza®), which may be given after chemotherapy in a small number of patients with BRCA mutations (4-7%). Again, neither of these drugs target N-cadherin, and five-year survival rates remain poor.

New treatments for pancreatic cancer are urgently needed.

Despite the efforts to develop newer treatments, the mortality rates for pancreatic cancer remain high. Zonula’s approach to targeting cell adhesion represents a new approach to treating pancreatic cancer. Our novel small molecules kill a wide variety of cancer cells and their associated support cells.