Clarity Pharmaceuticals

Watch this insightful panel discussion "Theranostics in Focus: New Frontiers in Cancer Care" with Global Key Opinion Leaders, Professor Louise Emmett and Professor Oliver Sartor, and our Executive Chairperson, Dr Alan Taylor, as they discuss how this new area of theranostics is transforming cancer care, the pivotal role of industry-academic partnerships in shaping this change, as well as the unique benefits and challenges to be overcome, hosted by A/Prof Sophie Scott OAM at St Vincent's, Sydney.

The theranostic SECuRE trial progresses to the Cohort Expansion Phase at 8 GBq Cu-67 SAR-bisPSMA dose level following promising safety and efficacy assessment and the focus on earlier stage prostate cancer management.   Outstanding results were achieved in the pre-chemotherapy (metastatic castration-resistant) setting where 92% of participants had a PSA decrease greater than 35%, 61.5% of participants had a PSA drop greater than 50%, and reductions of 80% or more were achieved in almost half the participants, despite the heavy disease burden, heavy pre-treatment and the majority of participants only receiving single doses of Cu-67 SAR-bisPSMA.   Clarity looks forward to swiftly recruiting into the next phase of the SECuRE trial, moving towards a Phase III pivotal trial, with the goal of improving treatment outcomes for men with prostate cancer around the world.   #PSMA #theranostics #prostatecancer

Clarity is pleased to release its Interim Report and financial results for the half-year ended 31 December 2024. Click below to learn more about the milestones we achieved in the last half-year and our plans for the year ahead as we continue to move closer to our ultimate goal of improving treatment outcomes for children and adults with cancer. #TCT #biotech #radiopharmaceuticals  

Clarity has received its third Fast Track Designation (FTD) from the U.S. FDA for its optimised SAR-bisPSMA product. The latest FTD is for Cu-67 SAR-bisPSMA for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been previously treated with androgen receptor pathway inhibition (ARPI). The 3 FTDs received within the last 6 months indicate a high unmet need in the prostate cancer market and demonstrate the quality of the data generated with this novel, proprietary agent to date.   The FTDs will enable Clarity to accelerate the development of SAR-bisPSMA from initial diagnosis to late-stage prostate cancer treatment, with an opportunity to completely change the treatment landscape for this large market.   #PSMA #prostatecancer #biotech #radiopharmaceuticals

Clarity renews its focus on breast cancer with Cu-64/67 SAR-trastuzumab, as well as SAR-Bombesin, SARTATE and SAR-bisPSMA.   Pre-clinical data on SAR-trastuzumab to date is very exciting and Clarity intends to conduct a Phase 1/2a theranostic study with Cu-64/67 SAR-trastuzumab in HER2-positive breast cancer patients to address a significant unmet clinical need. To secure supply of clinical-grade GMP trastuzumab for future trials, Clarity signed a new Supply Agreement with EirGenix, Inc., enabling the Company to continue building a commanding pipeline of radiopharmaceuticals in order to reach its ultimate goal of better treating children and adults with cancer. #radiopharmaceuticals #breastcancer #biotech

Click below to learn more about the exciting milestones Clarity achieved in the last quarter and our plans for future development as we continue to move closer to our ultimate goal of improving treatment outcomes for children and adults with cancer. #biotech #radiopharmaceuticals #TCT

Clarity's COBRA and CLARIFY trials will be presented at the upcoming ASCO GU 2025 Conference and an abstract on the COBRA trial at the AUA Annual Meeting 2025, two world-leading conferences in oncology and urology.   The latest data from the COBRA trial showcases the improved efficacy of Cu-64 SAR-bisPSMA at detecting lesions compared to currently approved PSMA PET agents, with Cu-64 SAR-bisPSMA able to identify more lesions and visualising them months before detection by standard-of-care PSMA PET products. With investigators in this trial noting that they would change their intended treatment plan in approximately half of their patients due to the findings of Cu-64 SAR-bisPSMA PET, this product could be a game changer, transforming the diagnostic paradigm in prostate cancer. Meet the Clarity team at the upcoming ASCO GU conference February 13-15 in San Francisco, CA   #radiopharmaceuticals #biotech #prostatecancer #GU25 

Clarity received its second U.S. FDA Fast Track Designation (FTD) for the diagnostic Cu-64 SAR-bisPSMA product in patients with biochemical recurrence (BCR) of prostate cancer following definitive therapy. This milestone builds on Clarity’s earlier receipt of an FTD for Cu-64 SAR-bisPSMA in patients with suspected metastasis of prostate cancer who are candidates for initial definitive therapy. Together, these FTDs enable the Company to accelerate the development of its comprehensive diagnostic program with this product.   The FTD comes as Clarity is actively preparing to commence recruitment for its second registrational trial, AMPLIFY, in the coming months. The FTDs allow the Company to work closely with the FDA to expedite the development and regulatory review process, which will allow Clarity to bring what could become a best-in-class diagnostic to patients with prostate cancer sooner. #radiopharmaceuticals #biotech #PSMA  

Isotopes have been a big topic of discussion in radiopharmaceuticals. In targeted radiopharmaceutical therapies (TRT), the isotope is just one part of the product, and the TRT market is currently dominated by products utilising beta emitters. The alpha emitters have received a lot of hype, but to date have very limited clinical data, some of which already showing significant safety concerns for patients, and coupled with the current supply chain limitations, alphas still have a long road ahead.   Watch season 3 episode 3 below, featuring Clarity’s Executive Chairperson, Dr Alan Taylor, and Healthcare Analyst, Melissa Benson, as they discuss the benefits and limitations of alphas vs betas, the concept of the Goldilocks Zone, the need to focus on products that are safe and efficacious, and implications for cancer patients in need of novel treatment options. #radiopharmaceuticals #biotech #podcast

In the current radiopharmaceutical field, the limitations of one-hour time-point imaging and short half-life products present a significant challenge, especially when looking to identify and better treat cancer. Clarity rises above those issues as the Company continues developing optimised products that increase uptake and retention in cancer and offer the flexibility of anytime same-day or next-day imaging by utilising the perfect pairing of copper isotopes. Listen to Dr Luke Nordquist MD FACP, Principal Investigator (XCancer), discuss the ongoing registrational Phase III CLARIFY trial with Cu-64 SAR-bisPSMA in high-risk prostate cancer patients prior to undergoing radical prostatectomy. Dr Nordquist emphasises the need for improved imaging for better therapy and highlights how the unique capabilities of Cu-64 SAR-bisPSMA due to the optimised molecule and the longer half-life of copper-64 compared to traditional PSMA PET agents can improve the detection, and subsequently the treatment, of prostate cancer. Cu-64 SAR-bisPSMA is an unregistered product.