FDA Grants Orphan Drug Designation to Immuneering's IMM-1-104 for Pancreatic Cancer Treatment

Immuneering Corporation, a clinical-stage oncology company focused on developing universal RAS/RAF medicines for a broad range of cancer patients, has announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to IMM-1-104 for the treatment of pancreatic cancer. IMM-1-104 is currently in a Phase 2a clinical trial for patients with advanced solid tumors, including pancreatic cancer. Recent initial response data for first-line pancreatic cancer patients treated with IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel has been positive.

Publish Date: 15-10-2024 Source: Immuneering Corporation

Pancreatic cancer, specifically pancreatic ductal carcinoma, originates from the pancreatic duct cells. This type of cancer can manifest as adenocarcinoma, serous, seromucinous, or mucinous variations. Notable tumor markers associated with pancreatic cancer are CEA and CA 19-9. The predominant form of pancreatic cancer is adenocarcinoma, which initiates when the exocrine cells within the pancreas undergo uncontrolled growth. Exocrine cells constitute a significant portion of the pancreas, forming the exocrine glands and ducts. Patients with pancreatic cancer are categorized based on the stage of the disease: localized resectable (stages I and II), locally advanced unresectable (stage III), or distant metastatic (stage IV). The underlying causes of pancreatic cancer remain poorly understood. The sole therapy offering a potential cure for localized disease involves complete surgical cancer removal; curative treatment options are nonexistent for individuals with locally advanced or metastatic disease. The primary behavioral change widely acknowledged to reduce the risk of pancreatic cancer is quitting smoking. Additionally, risk factors for this cancer encompass a family history of the disease, chronic pancreatitis, long-standing type 2 diabetes, and obesity.

In 2023, it is estimated that 64,050 adults in the United States will receive a diagnosis of pancreatic cancer, with 33,130 men and 30,920 women affected.

However, the current Pancreatic cancer treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (Pamrevlumab, Gemcitabine, Irinotecan Liposomal, SNB-101, etc..) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for the Pancreatic cancer treatment. The key companies in the advanced development stage are FibroGen, NewLink Genetics Corporation, AB Science, Ipsen, etc..

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Pancreatic Cancer to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2023 to 2033.

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