FDA Clears CytoDyn’s Leronlimab for Phase II Trial in Colorectal Cancer

CytoDyn Inc., a biotechnology company specializing in the development of leronlimab, a CCR5 antagonist with potential for multiple therapeutic indications, announced today that it has received FDA clearance to commence its Phase II oncology trial. This study will evaluate the efficacy of leronlimab in patients with relapsed or refractory microsatellite stable colorectal cancer. This milestone reflects the positive development of CytoDyn’s relationship with the FDA, following productive feedback sessions and the submission of a final study protocol in September 2024.

Publish Date: 04-11-2024 Source: CytoDyn Inc.

Colorectal cancer, commonly known as colon cancer, primarily arises in the colon or rectum; it is the third most prevalent form of cancer known for its slow progression over many years. Typically, it originates as a non-malignant polyp, an unusual tissue growth lining the colon. There are three main presentations of colorectal cancer: sporadic (70%), familial clustering (20%), and inherited syndrome (10%). Various risk factors are linked to the development of colon cancer, including age, environmental factors, diets high in animal fat, obesity, smoking, excessive alcohol consumption, genetic predisposition, and a history of inflammatory bowel disease. The most prevalent type of colon cancer diagnosed in patients is adenocarcinoma. Colorectal cancer development hinges on the adenoma-carcinoma sequence, characterized by a gradual accumulation of genetic alterations. In sporadic colorectal cancers, the gatekeeper pathway, governed by a gene that regulates growth, accounts for roughly 85% of cases and is the primary mechanism of carcinogenesis in individuals with familial adenomatous polyposis (FAP). A pivotal step in this process involves mutating the tumor-suppressor gene APC. Furthermore, several other tumor-suppressor genes (such as DCC, DPC4/Smad4, nm32, and p53) and oncogenes (e.g., c-myc, c-neu, c-src, c-erb-2, and K-ras) also play significant roles. Less common types of colon cancer include carcinoid tumors (which originate in hormone-producing cells in the intestines), gastrointestinal stromal tumors (a form of soft tissue sarcoma), and lymphoma (related to autoimmune conditions and capable of originating in the colon).

In 2023, it is anticipated that approximately 153,020 individuals in the United States will receive a colorectal cancer (CRC) diagnosis. Among this group, 19,550 individuals will be under the age of 50.

However, the current Relapsed or Refractory Colorectal Cancer treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (RGT-61159, Aplitabart (IGM-8444), 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 Relapsed or Refractory Colorectal Cancer treatment. The key companies in the advanced development stage are Rgenta Therapeutics Inc, IGM Biosciences, Inc., etc..

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Relapsed or Refractory Colorectal 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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