Clarity Pharmaceuticals Ltd (ASX: CU6) shares are having a strong start to the week.
At the time of writing on Monday, the ASX 300 stock is up 14% to $4.00.
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Why is this ASX 300 stock jumping?
Investors have been buying Clarity Pharmaceuticals shares after it announced another patient in its SECuRE Phase II trial achieved undetectable disease following treatment with its 67Cu-SAR-bisPSMA therapy.
According to the release, a 76-year-old participant with metastatic castration-resistant prostate cancer (mCRPC) achieved undetectable prostate-specific antigen (PSA) levels just seven weeks after the first treatment cycle. After the second cycle, a PSMA PET scan showed no detectable disease.
Importantly, the company noted that all related adverse events were mild (Grade 1), with no haematological or renal side effects observed to date.
This marks the fifth patient in Clarity's SAR-bisPSMA theranostic program to achieve undetectable disease by radiographic assessment.
Building momentum in SECuRE trial
Clarity also provided an update on a previously reported patient in the same Cohort Expansion Phase. That participant continues to show undetectable disease after four treatment cycles, with no new safety signals observed.
The SECuRE trial is a Phase I/IIa theranostic study evaluating 64Cu-SAR-bisPSMA for imaging and 67Cu-SAR-bisPSMA for therapy in patients with advanced prostate cancer. Recruitment into the Cohort Expansion Phase is ongoing, with completion expected in 2026.
Planning for a registrational Phase III trial is also underway based on data generated so far.
Management commentary
Commenting on the news, the ASX 300 stock's executive chair, Dr Alan Taylor, said:
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-SARbisPSMA 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.
Speaking about the "extraordinary" outcome, Taylor then adds:
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 treatments, 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.
