Clarity Pharmaceuticals is ramping up its efforts in the breast cancer treatment space with the addition of 64/67Cu-SAR-trastuzumab to its Targeted Copper Theranostic (TCT) portfolio. The company recently published pre-clinical data on this novel asset and has secured a Supply Agreement with EirGenix, Inc. for clinical-grade trastuzumab, which will help drive the development of this cutting-edge radiopharmaceutical.
Why This Is Big
Clarity is focusing its attention on the breast cancer market, particularly the aggressive and difficult-to-treat HER2-positive breast cancer. This subtype is known for its poor prognosis, with up to 25% of patients relapsing within 10 years despite advances in early-stage treatments. By combining trastuzumab with Clarity’s proprietary SAR Technology, the company is creating a copper-67 (Cu-67) based radioimmunotherapy (RIT) aimed at improving survival rates for these patients.
What the Research Shows
In pre-clinical trials, 67Cu-SAR-trastuzumab demonstrated impressive results in reducing tumor size and extending survival in a HER2-positive tumor model. The therapy was found to inhibit tumor growth significantly and improve the survival of treated mice, highlighting its potential as a powerful treatment option.
Partnering for Success
To move this project forward, Clarity has partnered with EirGenix, Inc., which will provide the clinical-grade trastuzumab biosimilar needed for their trials. This partnership is essential for the development and eventual commercialization of 67Cu-SAR-trastuzumab. The collaboration aims to ensure a secure supply of trastuzumab and facilitate the next steps in Clarity’s radiopharmaceutical pipeline.
Looking Ahead
The company is gearing up for a Phase 1/2a theranostic study of 64/67Cu-SAR-trastuzumab in HER2-positive breast cancer patients. This study will focus on addressing the high unmet need for more effective treatments in this challenging area of oncology. Clarity is also committed to advancing its other products, such as SAR-Bombesin, SARTATE, and SAR-bisPSMA, in breast cancer treatment, complementing their ongoing focus on other cancers like prostate cancer and neuroendocrine tumors.
Clarity’s Vision
Clarity’s Executive Chairperson, Dr. Alan Taylor, emphasized that the company’s innovative approach to combining antibodies with SAR Technology has the potential to revolutionize treatment for HER2-positive cancers. He pointed out that while the antibody-drug conjugate (ADC) market has made strides, there’s still a lot of room for improvement, particularly with the use of radiation in radiopharmaceuticals, which Clarity aims to optimize. With abundant supply chains for copper-based isotopes and promising pre-clinical results, Clarity is well-positioned to push forward in the race to develop next-generation treatments for cancer.
The Bottom Line
Clarity Pharmaceuticals is making significant strides in breast cancer treatment with 64/67Cu-SAR-trastuzumab, and the recent publication of pre-clinical data, along with a solid supply agreement with EirGenix, marks a crucial step in moving these treatments toward clinical trials. With this innovation, Clarity is poised to address a critical gap in cancer care, offering new hope to patients with HER2-positive breast cancer.
