On May 4, 2023 CRB091, a novel drug candidate developed by Cancer Research and Biotechnology AG (CRB), reported to have shown significant promise in reducing cancer cell proliferation in difficult-to-treat cancers such as colorectal and triple-negative breast cancers (Press release, Cancer Research and Biotechnology, MAY 4, 2023, View Source [SID1234631068]). The preclinical studies conducted by an independent research laboratory in the UK demonstrated a significant reduction in human cancer cell proliferation in vitro, with a synergistic effect between the product’s single ingredients.
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TNBC is the most aggressive type of breast cancer in women with a 5-years survival rate of 66% and a very low survival rate of 12% after metastasis. Conventional cancer treatments often come with severe side effects, limiting their use and efficacy. Furthermore, targeted therapies and new immunological treatments suit only a limited patient population, while drug resistance can develop rapidly. CRB091 offers a well-tolerable and effective therapy that could address the shortfalls of existing treatments.
CRB091’s active molecules have been proven safe for human use, and CRB anticipates initiating the first-in-human clinical trials in the US in 12 months. The FDA’s Pre-Investigational New Drug (Pre-IND) application advice is scheduled in Q3 2023, with the IND filing in Q3 2024.
As a preclinical oncology company, CRB is focused on developing drugs that address the metabolic disease that induces carcinogenesis. By providing a particularly effective and well-tolerated therapy, CRB091 has the potential to significantly improve the treatment of triple-negative breast cancer and other difficult-to-treat cancers.
With the meaningful efficacy demonstrated on human cancer cell lines, the Switzerland-based startup is poised to take a significant step towards human use of the novel treatment.