Abefolastat tesaroxetan

HIGHLIGHTS Another participant with metastatic castration-resistant prostate cancer (mCRPC) in the Cohort Expansion Phase (Phase II; 8 GBq of 67Cu-SAR-bisPSMA per cycle) of the SECuRE trial (NCT04868604)1 achieved undetectable disease as assessed by prostate-specific antigen (PSA) and prostate-specific membrane antigen (PSMA) positron emission tomography (PET). Undetectable disease by PSA was achieved after the first cycle, followed by a negative PSMA PET after the second cycle of 67Cu-SAR-bisPSMA. Participant was initially diagnosed with prostate cancer 15 years ago, had metastatic disease since 2020 and experienced progressive mCRPC in 2025. All related adverse events (AEs) were mild (Grade 1), most of which resolved after the treatment. No haematological or renal AEs were observed to date. This is the fifth patient to achieve undetectable disease by radiographic assessment following 67Cu-SAR-bisPSMA treatment. The previous participant in the same Cohort Expansion Phase who achieved undetectable PSA after three cycles of 8 GBq 67Cu-SAR-bisPSMA2 (announced on the 15 January 2026) continues to demonstrate undetectable disease on PSMA PET after the fourth cycle. The SECuRE trial will continue enrolment into the Cohort Expansion Phase with planned completion of recruitment in 2026. Phase III registrational trial planning is ongoing based on data generated to date. SYDNEY, Feb. 23, 2026 /PRNewswire/ -- Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, is pleased to announce that yet another participant with mCRPC in the Cohort Expansion Phase (Phase II) of the SECuRE trial achieved undetectable PSA and negative PSMA PET. The undetectable PSA was measured following the first cycle and the negative PSMA PET was reported following the second cycle of 67Cu-SAR-bisPSMA (8 GBq each cycle). Continue Reading Figure 1. Lesion uptake of 64Cu-SAR-bisPSMA PET at baseline (left images) and following two cycles of 67Cu-SAR-bisPSMA (8 GBq each; right images). PET images on the right were acquired 1 month after the second cycle and show no lesion uptake of 64Cu-SAR-bisPSMA compared to baseline. Red arrows indicate metastatic nodal lesions. Top images: maximum intensity projections. Bottom images: coronal sections of the corresponding insets. SUV: standardised uptake value. Figure 2. Lesion uptake of 64Cu-SAR-bisPSMA PET at baseline (left), following two cycles of 67Cu-SAR-bisPSMA (8 GBq each; centre) and following four cycles of 67Cu-SAR-bisPSMA (right). Coloured arrows indicate metastatic bone lesions within each region: red – skull; blue – ribs and sternum; orange – spine; green – pelvis. No detectable disease was observed on the post-treatment PET. Images are shown as maximum intensity projections. SUV: standardised uptake value. The participant is a 76-year-old man who was initially diagnosed with prostate cancer 15 years ago. He had radical prostatectomy to treat the primary disease and radiotherapy for local recurrence, having progressed to metastatic disease in 2020. Previous systemic anti-cancer treatments included an androgen receptor pathway inhibitor (ARPI) and androgen deprivation therapy (ADT). In 2025, the disease progressed further, and he was enrolled into the Cohort Expansion Phase of the SECuRE study with a baseline PSA of 3.25 ng/mL. Seven weeks after his first cycle of 67Cu-SAR-bisPSMA, this participant achieved undetectable PSA levels. He proceeded to receive one more cycle of 67Cu-SAR-bisPSMA, and no disease was observed on PSMA PET following the second dose (Figure 1). This participant exhibited mild (Grade 1) related AEs, including altered taste, dry eyes, eye pain, fatigue and salivary gland soreness (all resolved except fatigue). No haematological or renal AEs were observed to date. This new case represents the fifth participant to achieve undetectable disease by radiographic assessment following 67Cu-SAR-bisPSMA treatment in Clarity's SAR-bisPSMA theranostic program (3 participants who received up to four cycles of 8 GBq, and 2 participants who received up to three cycles of 12 GBq)2,3,4. Update on previously reported participant with no detectable disease following 67Cu-SAR-bisPSMA treatment Follow-up on the previously reported participant from the Cohort Expansion Phase (no detectable disease and absence of prior bone metastasis following three cycles of 8 GBq 67Cu-SAR-bisPSMA treatment)2, demonstrated that his PSA remains undetectable, with no disease identified on his latest PET conducted 1 month after the administration of the fourth cycle (Feb 2026; Figure 2). Following the first three cycles of 67Cu-SAR-bisPSMA, the participant exhibited mild (Grade 1) related AEs, most of which were gastrointestinal events, with no haematological or renal AEs2. Notably, no new safety signals have been observed during and since the administration of the fourth cycle to date. The interim data from this Phase II continues to confirm the favourable safety profile and promising efficacy seen in previous cohorts of SECuRE3 and supports the continuation of the trial with the aim to progress to a registrational Phase III study. Clarity's Executive Chairperson, Dr Alan Taylor, commented, "The momentum of data we are generating with our lead SAR-bisPSMA product in both theranostic and diagnostic trials is strong, with excellent results to date on all fronts. We are beyond excited to see yet another patient achieve undetectable disease following their 67Cu-SAR-bisPSMA treatments. What is particularly outstanding is that this new patient presented with undetectable PSA just 7 weeks after his first 8 GBq cycle, with a negative PSMA PET being reported after the second cycle. This result is particularly impressive given this participant has been battling prostate cancer for 15 years and is now free of any detectable disease based on PSA and PET assessments with only mild (Grade 1) AEs. "While this outcome is extraordinary, we now know this is not just luck or coincidence. Despite the number of participants in the SECuRE trial being relatively small, this is now the fifth time we have seen a patient present with undetectable disease following their 67Cu-SAR-bisPSMA treatments2,3,4, and study recruitment is still ongoing. We are also excited to see that the previous participant in the Cohort Expansion Phase of the SECuRE trial to achieve undetectable disease observed by anatomical and molecular imaging2 continues to show undetectable disease during his last follow up in February 2026, following the fourth 67Cu-SAR-bisPSMA cycle. This is especially encouraging as this participant had bone metastasis at study entry and now continues to report excellent quality of life after his treatment with 67Cu-SAR-bisPSMA." "Our methodical commitment to science and the highest standard of clinical development underpins our achievements to date. Combining the optimised bivalent "bis" structure with the benefits offered by the copper isotope pairing, enabled by the proprietary sarcophagine (SAR) chelating technology, is key to the benefits we are seeing from the SAR-bisPSMA products. The most recent data released from the Co-PSMA study clearly establishes that 64Cu-SAR-bisPSMA considerably outperforms its competitors in detecting prostate cancer recurrence and sheds light on the importance of the improved lesion detection, where the diagnostic benefits translate into enhanced patient management5. Our registrational diagnostic AMPLIFY6 and CLARIFY7 trials with 64Cu-SAR-bisPSMA are also nearing the end of recruitment, getting us closer to commercialisation. We now look forward to progressing the SECuRE trial recruitment and have already initiated the planning for a registrational Phase III trial, as we hope to see more people benefit from our unique theranostic product. Having three Fast Track Designations (FTDs) for SAR-bisPSMA gives us confidence to persevere harder than ever, and positive interactions with the US Food and Drug Administration (FDA) confirm that we are on the right track. Our team is motivated and driven to progress SAR-bisPSMA to the market through the entirety of the prostate cancer journey, from first detection to late-stage metastatic disease. As we continue to generate exceptional data, we believe SAR-bisPSMA is well positioned to fully exploit the current treatment and diagnostic challenges in radiopharmaceuticals and improve treatment outcomes for patients with cancer." About the SECuRE trial The SECuRE trial (NCT04868604)1 is a Phase I/IIa theranostic trial for identification and treatment of participants with PSMA-expressing mCRPC using 64Cu/67Cu-SAR-bisPSMA. 64Cu-SAR-bisPSMA is used to visualise PSMA-expressing lesions and select candidates for subsequent 67Cu-SAR-bisPSMA therapy. The trial is a multi-centre, single arm study, planning to enroll approximately 54 participants in the US. The overall aim of the trial is to determine the safety and efficacy of 67Cu-SAR-bisPSMA for the treatment of prostate cancer. The SECuRE trial consists of the Dose Escalation (Phase I) and Cohort Expansion (Phase II) Phases. Based on the data from the Dose Escalation Phase, which demonstrated a favourable safety profile and efficacy of 67Cu-SAR-bisPSMA, the SECuRE trial progressed to the Cohort Expansion at an 8 GBq dose level as per the Safety Review Committee (SRC) recommendation (up to 6 cycles per patient in total)3. Cohort 2 of the Dose Escalation phase of the trial, where participants were dosed with 8 GBq of 67Cu-SAR-bisPSMA, demonstrated a very low rate of related AEs while all three participants achieved PSA declines of 80% or more (PSA80)3. The Dose Escalation Phase also showed high PSA response rates of the mCRPC in the pre-chemotherapy setting with a favourable safety profile: 92% of pre-chemotherapy participants (12/13) demonstrated PSA drops greater than 35%, 61.5% (8/13) of participants achieved PSA reductions greater than 50%, and 46.2% (6/13) of participants achieved PSA reductions of 80% or more3. These results supported the progress of the trial to its Cohort Expansion Phase using 8 GBq multi-dose in participants who had not received chemotherapy in the mCRPC setting. Recruitment is currently ongoing into the Cohort Expansion Phase which will include 24 participants. A subset of participants will be treated with the combination of 8 GBq of 67Cu-SAR-bisPSMA with enzalutamide (ARPI), in line with the positive results from the Enza-p trial8 and previous discussions with and advice from key global medical experts in the field of prostate cancer. About SAR-bisPSMA SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity's proprietary SAR technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy. 67Cu-SAR-bisPSMA and 64Cu-SAR-bisPSMA are unregistered products. The safety and efficacy of 67Cu-SAR-bisPSMA and 64Cu-SAR-bisPSMA have not been assessed by health authorities such as the US FDA or the Therapeutic Goods Administration (TGA). There is no guarantee that these products will become commercially available. About Prostate Cancer Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death in men worldwide9. Prostate cancer is the second-leading cause of cancer death in American men. The American Cancer Institute estimates there will be about 333,830 new cases of prostate cancer in the US in 2026 and around 36,320 deaths from the disease10. About Clarity Pharmaceuticals Clarity is a clinical-stage radiopharmaceutical company focused on the treatment of serious diseases. The Company is a leader in innovative radiopharmaceuticals, developing TCTs based on its SAR Technology Platform for the treatment of cancers. more information, please contact:Clarity Pharmaceuticals Dr Alan Taylor Lisa Sadetskaya Executive Chairperson Director, Corporate Communications [email protected] [email protected] This announcement has been authorised for release by the Executive Chairperson. SOURCE Clarity Pharmaceuticals 21% more press release views with Request a Demo

HIGHLIGHTS Abstract outlining key findings from the Co-PSMA Investigator-Initiated Trial (IIT) has been released. The study was led by Prof Louise Emmett at St Vincent's Hospital Sydney, and the abstract was accepted for oral presentation at the upcoming European Association of Urology (EAU) Congress 2026. Co-PSMA IIT evaluated the performance of Clarity's diagnostic product, 64Cu-SAR-bisPSMA, in a head-to-head comparison to standard-of-care (SOC) 68Ga-PSMA-11 in 50 patients with biochemical recurrence (BCR) of prostate cancer (with prostate-specific antigen [PSA] 0.2-0.75 ng/mL) following radical prostatectomy who were candidates for curative salvage therapy. 64Cu-SAR-bisPSMA positron emission tomography (PET) / computed tomography (CT) identified a statistically significant greater number of prostate cancer lesions per patient than 68Ga-PSMA-11 PET/CT (study primary endpoint). The mean per-patient lesion was 1.26 for 64Cu-SAR-bisPSMA vs. 0.48 for 68Ga-PSMA-11, with a difference of 0.78 (95% confidence interval [CI]: 0.52 – 1.04), ratio 2.63 (95%CI: 1.64 – 4.20) (p <0.0001). In total, 68Ga-PSMA-11 identified 24 lesions across all participants, while 64Cu-SAR-bisPSMA next-day imaging detected 63 lesions. At a per-patient level, 68Ga-PSMA-11 identified 36% (18/50) of trial participants as having a positive scan, while 64Cu-SAR-bisPSMA next-day imaging detected prostate cancer in 78% (39/50) of cases. Planned patient management changed following assessment of 64Cu-SAR-bisPSMA PET/CT in 22/50 (44%) trial participants. Further data outlining results from the Co-PSMA IIT will be presented at the EAU Congress 2026. SYDNEY, Feb. 16, 2026 /PRNewswire/ -- Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, is pleased to announce the release of an abstract on the Co-PSMA (NCT06907641)[1] IIT, accepted for oral presentation at the upcoming EAU Congress 2026, Europe's largest urological conference, to be held from 13 to 16 March 2026 in London, UK[2]. The abstract outlines key findings from the study. Co-PSMA ("Comparative performance of 64Copper [64Cu]-SAR-bisPSMA vs. 68Ga-PSMA-11 PET CT for the detection of prostate cancer recurrence in the setting of biochemical failure following radical prostatectomy") was led by Prof Louise Emmett at St Vincent's Hospital Sydney. This Phase II IIT evaluated the performance of Clarity's diagnostic product, 64Cu-SAR-bisPSMA, in a head-to-head comparison to SOC 68Ga-PSMA-11 in 50 prostate cancer patients with BCR who were candidates for curative salvage therapy. Eligible patients were required to have had radical prostatectomy with no salvage therapy and a PSA level between 0.2 and 0.75 ng/mL. 68Ga-PSMA-11 PET/CT was followed by 64Cu-SAR-bisPSMA PET/CT within 3 weeks (at 1 h and 24 h post-injection, same-day and next-day imaging, respectively), on the same digital PET camera. A standard of truth (SOT) was used to determine accuracy of the PET findings and included biopsy, response to targeted treatment without androgen deprivation therapy [ADT] or corroborative imaging. The primary endpoint of the Co-PSMA study was to assess the difference in mean per patient lesion number. 64Cu-SAR-bisPSMA PET/CT identified a statistically significant greater number of lesions per participant than 68Ga-PSMA-11 PET/CT, with a higher true positive rate also favouring 64Cu-SAR-bisPSMA. The mean per-patient lesion for 64Cu-SAR-bisPSMA was 1.26, compared to 0.48 for 68Ga-PSMA-11, with a difference of 0.78 (95%CI: 0.52 – 1.04), ratio 2.63 (95%CI: 1.64 – 4.20) (p <0.0001). In total, 68Ga-PSMA-11 identified 24 lesions across all participants, while 64Cu-SAR-bisPSMA next-day imaging detected 63 lesions. On a per patient level, 36% (18/50) of participants were positive on 68Ga-PSMA-11 PET/CT, compared to 78% (39/50) on the 64Cu-SAR-bisPSMA PET/CT (next-day imaging). Planned patient management changed following the assessment of the 64Cu-SAR-bisPSMA scans in 22/50 (44%) trial participants. Among the participants with an evaluable SOT, the true positive rate was 75% for 64Cu-SAR-bisPSMA (21/28) compared to 39% (11/28) for 68Ga-PSMA-11. These results further build on the growing body of evidence showing that 64Cu-SAR-bisPSMA improves the detection of prostate cancer, compared to the current SOC prostate-specific membrane antigen (PSMA) PET agents which are known to have low sensitivity, with limited ability to detect cancer, especially in patients with low PSA levels[3],[4],[5]. Further data outlining results from the Co-PSMA IIT will be announced in mid-March following their oral presentation at the EAU 2026. Clarity's Executive Chairperson, Dr Alan Taylor, commented, "The data from the Co-PSMA trial are nothing short of exceptional. We already knew of the significant benefits of the optimised bisPSMA molecule from the early days around 7 years ago, when it was purposely developed to overcome the many shortfalls of the current single-targeting SOC PSMA imaging agents. This innovative benchtop research of the dual-targeting bisPSMA agent quickly progressed to multiple clinical trials, including COBRA[6], PROPELLER[7] and SECuRE[8], which enabled us to secure three Fast Track Designations from the United States (US) Food and Drug Administration (FDA) and advance to two registrational trials, AMPLIFY[9] and CLARIFY[10], both of which are nearing completion of recruitment. "Importantly, in the COBRA trial, we also looked at the performance of 64Cu-SAR-bisPSMA in patients with BCR of prostate cancer following definitive therapy, but with participant selection criteria having no limitation on upper PSA levels (median 0.9 ng/mL, range 0.25 to 17.6). The Co-PSMA data we are seeing to date reinforces the COBRA trial findings where more lesions and patients with a positive scan were identified using 64Cu-SAR-bisPSMA compared to SOC PSMA PET products, including 68Ga-PSMA-11 and 18F-DCFPyL[6]. A subset of participants in the COBRA trial had a follow-up SOC PSMA PET. While 90% of these participants had a positive scan on the initial 64Cu-SAR-bisPSMA next-day imaging, only 60% were positive on SOC PSMA PET, despite median scan time from the first 64Cu-SAR-bisPSMA imaging to the follow-up scan being 73.5 days. The number of lesions across all participants (average sum of lesions across all readers) identified by 64Cu-SAR-bisPSMA on next-day imaging was >2.6 times higher than that detected by SOC PET agents (52.6 vs 20 lesions)[6]. "What we are learning today from the head-to-head Co-PSMA study is a valuable insight into how 64Cu-SAR-bisPSMA directly compares against 68Ga-PSMA-11, further bolstering the data seen to date. Similar to COBRA, Co-PSMA demonstrated that our product was able to identify more than 2.5 times total number of lesions on the next-day imaging in comparison to the SOC. Furthermore, 4 out of every 5 participants had a positive scan for prostate cancer using 64Cu-SAR-bisPSMA, compared to only 2 in 5 participants using 68Ga-PSMA-11, therefore making 64Cu-SAR-bisPSMA far more reliable than 68Ga-PSMA-11 in detecting the presence of cancer in these patients. These findings, coupled with the much higher true positive rate of 64Cu-SAR-bisPSMA (75% vs. 39% for 68Ga-PSMA-11), will enable clinicians to treat prostate cancer more effectively and with a greater level of confidence based on the accurate detection of disease. These results speak for themselves, clearly illustrating that 64Cu-SAR-bisPSMA considerably outperforms its competitors in detecting prostate cancer recurrence. Moreover, this sheds light on the importance of the improved lesion detection, where the diagnostic benefits translate into enhanced patient management: almost half of the Co-PSMA and COBRA study participants had a change of their planned disease management as a result of the 64Cu-SAR-bisPSMA findings[6], which could be absolutely game-changing for clinicians and their patients. This is the difference between allowing prostate cancer lesions to grow or having a clear diagnosis and an active and highly targeted treatment plan. Earlier intervention in BCR can prevent cancer growth and spread, avoid side effects from systemic therapies and considerably improve patient outcomes. "The current market for PSMA PET imaging in the US alone is around US$2 billion per year, and this is expected to further grow to over US$3 billion by 2029. Unfortunately, this blockbuster market is dominated by 68Ga-PSMA-11 and 18F-DCFPyL, both of which have low sensitivity[4],[5]. The development pipeline of new products, excluding 64Cu-SAR-bisPSMA, offers no significant differentiation from the existing agents, with some new entrants commercialising the unpatented 68Ga-PSMA-11 agent, which has been capitalised on by three separate groups already. Time and time again we are seeing significant clinical and logistical benefits offered by 64Cu-SAR-bisPSMA through our trials. We strongly believe this product could not only become the new SOC in PSMA PET but also grow the market opportunity further by substantially improving the diagnosis of prostate cancer in many stages of the disease, from its early phases pre-definitive therapy, through to better identification of lesions in the BCR setting, including in patients with oligometastatic disease. "While the AMPLIFY and CLARIFY trials are key to getting 64Cu-SAR-bisPSMA towards commercialisation, Co-PSMA provides further evidence of its benefits to clinicians and prostate cancer patients. This makes the paradigm shift towards improved diagnostics a no-brainer due to our relentless focus on rigorous clinical development and commitment to strong science to change the lives of people living with cancer. The acceptance of the Co-PSMA data by a world-leading urology conference as an oral presentation is a testament to the strength and quality of the data, generated by Prof Emmett, a global key opinion leader in the field." Prof Louise Emmett (St Vincent's Hospital Sydney), Principal Investigator in the Co-PSMA trial, commented, "While approved PSMA PET agents are highly specific, their low sensitivity at low PSA levels means that many patients with early rising PSA show no detectable disease, making treatment planning challenging. More sensitive diagnostics that remain highly specific are needed for effective early intervention in BCR. Our research demonstrates that 64Cu-SAR-bisPSMA PET/CT offers a significant advancement in the detection of recurrent prostate cancer. Compared to 68Ga-PSMA-11, the 24-hour 64Cu-SAR-bisPSMA images identified the site of disease recurrence in a higher proportion of patients, directly informing tailored treatment decisions for men in BCR. These findings highlight the potential for 64Cu-SAR-bisPSMA to improve patient outcomes." About SAR-bisPSMA SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity's proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy. Disclaimer 64Cu-SAR-bisPSMA is an unregistered product. The safety and efficacy of 64Cu-SAR-bisPSMA have not been assessed by health authorities such as the US FDA or the Therapeutic Goods Administration (TGA). There is no guarantee that this product will become commercially available. About Prostate Cancer Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death in men worldwide[11]. Prostate cancer is the second-leading cause of cancer death in American men. The American Cancer Institute estimates there will be about 333,830 new cases of prostate cancer in the US in 2026 and around 36,320 deaths from the disease[12]. About Clarity Pharmaceuticals Clarity is a clinical stage radiopharmaceutical company focused on the treatment of serious diseases. The Company is a leader in innovative radiopharmaceuticals, developing Targeted Copper Theranostics based on its SAR Technology Platform for the treatment of cancers. References This announcement has been authorised for release by the Executive Chairperson. SOURCE Clarity Pharmaceuticals 21% more press release views with Request a Demo