Clarity Update: Complete response in first patient ever treated with 2 doses of Cu-67 SAR-bisPSMA at 8GBq

[God_Loves_Me]

Highlights

A complete response, based on Response Evaluation Criteria In Solid Tumours (RECIST v1.1) assessment, has been reported from the first patient with metastatic castrate-resistant prostate cancer (mCRPC) to ever receive two cycles of Clarity’s 67Cu-SAR-bisPSMA at the 8GBq dose level.

The patient remains with undetectable levels of Prostate Specific Antigen (PSA) for almost 6 months, following the administration of the second dose of 67Cu-SAR-bisPSMA. PSA is a marker used to assess clinical response to treatment and an indicator of the recurrence of prostate cancer.

The patient had no detectable lesions using positron emission tomography (PET) imaging with 64Cu-SAR-bisPSMA following the treatment.

The first cycle of 67Cu-SAR-bisPSMA was administered under the SECuRE trial protocol, and the second cycle under the US Food and Drug Administration’s (FDA) Expanded Access Program (EAP).

The participant was heavily pre-treated having failed multiple lines of therapy, including androgen deprivation therapy (ADT), androgen receptor pathway inhibitors (ARPIs), chemotherapy and a poly (ADP-ribose) polymerase (PARP) inhibitor.

No adverse events related to 64Cu-SAR-bisPSMA were observed. The safety profile of 67Cu-SAR-bisPSMA was favourable, with all adverse events related to the product showing improvement or resolution over time.

No dose limiting toxicities (DLTs) have been reported in any of the patients treated in the SECuRE trial to date. The recruitment is ongoing for cohort 4, the first multi-dose cohort, at the highest dose level of 12GBq.

Just got press release so sharing for Australian users. If you are in Australia, It can be your next treatment.

Phase |||

Already going on : clinicaltrials.gov/study/NC...

First patient dosed in Clarity's registrational Phase III prostate cancer trial with Cu-64 SAR-bisPSMA

OLD press release :

prnewswire.com/news-release...

[Scout4answers]

This one could be a game changer, if they can repeat the results in 100 men

[God_Loves_Me]

Just got press release so sharing for Australian users. If you are in Australia, It can be your next treatment.

[street-air in reply to God_Loves_Me]

it seems like the australian end was a pet psma alternative (scanning only) and that trial completed.

The other trial(s) are recruiting and they are US based, using the same stuff except made radioactive, for treatment. So its a pluvicto alternative.

[God_Loves_Me in reply to street-air]

🤞

[LakeT in reply to street-air]

I read it the same way. No trial in Australia for the 67Cu-SAR treatment side with those trials only in the USA.

[Slowdancing in reply to God_Loves_Me]

Apparently it's available in the US as well, but only if you're eligible under the Expanded access program:"second cycle under the US Food and Drug Administration’s (FDA) Expanded Access Program (EAP)."

[God_Loves_Me]

Do you have clinical trial URL ?

[KocoPr in reply to God_Loves_Me]

Here ya go

classic.clinicaltrials.gov/...

[Maxone73]

I love you too!!! 😂😂 I am not in Oz, but got friends there that keep telling me to go there for a long holiday, they would host me….well well

[Ovid]

Thank you for this information. Is Cu-67 SAR-bisPSMA at 8GBq treatment available in Europe?

[Big_Mcc]

Wonderful news. When will it be widely available and what will be the probable costs. What would be the cost to a private patient in Australia and is there a long waiting list. Important if this is a last chance treatment. Thankyou so much for letting us know about this.

[lokibear0803]

I’m a big fan of this stuff.

Cu-64 is used for imaging, and Cu-67 for the theranostics. Cu-67 is distinct from Lu-177 b/c it target the gastrin-releasing peptide receptor (GRPr) - this receptor is expressed even for PSMA-negative tumors.

One can imagine combination therapy with both Cu-67 and Lu-177 to target PSMA- and PSMA+. Here are some recent links and slideware from 2021:

urotoday.com/recent-abstrac...

isotopes.gov/sites/default/...

urotoday.com/recent-abstrac...

from the last link, dated March 2024:

— Although the last participants in cohort 3 only completed dosing in January 2024, 60% of participants across all cohorts so far showed reductions in prostate-specific antigen (PSA) levels of greater than 35% from a single dose of 67Cu-SAR-bisPSMA. Twenty-seven percent of participants showed reductions in PSA levels of greater than 80%.

— Among the participants from cohorts 2 and 3, almost 80% showed reductions in PSA levels of greater than 35% from a single dose of 67Cu-SAR-bisPSMA, and 44% showed reductions in PSA levels of greater than 80%.

“Given the outstanding data in the trial so far, what is most important for us now is the longevity of response, and the results we have seen from 2 case studies conducted under the EAP are extremely encouraging. Based on the clinical benefit seen in the SECuRE trial, clinicians have requested additional doses of 67Cu-SAR-bisPSMA under the EAP.2,3 These 2 patients received 1 or 3 additional doses of 67Cu-SAR-bisPSMA at 8GBq or 4GBq, respectively. They have failed multiple lines of therapy prior to being treated with 67Cu-SAR-bisPSMA and have had a dramatic response, with only few mild or moderate side effects from the treatment, also demonstrating great efficacy with the multi-dosing treatment. We look forward to replicating the case study results in the multi-dose phase of the trial at the higher dose of 12GBq. If we observe a similar response in larger patient numbers, 67Cu-SAR-bisPSMA may become the gold standard therapeutic agent for patients with mCRPC once approved.”

[Maxone73 in reply to lokibear0803]

So happy about this that I just bought another guitar to celebrate!!!

[God_Loves_Me in reply to Maxone73]

Bro - I will fly to you and give you big hug and listen to your guitar. I called nearest clinical hospital and they do not have access.

[Maxone73]

still phase one dammit! We must resist! How is it going with arx517?

[God_Loves_Me]

First patient dosed in Clarity's registrational Phase III prostate cancer trial with Cu-64 SAR-bisPSMA

prnewswire.com/news-release...

[God_Loves_Me in reply to God_Loves_Me]

PHASE ||| already going on : clinicaltrials.gov/study/NC...

[Maxone73 in reply to God_Loves_Me]

it's diagnostic but still great news!

[j-o-h-n]

Just for that I'm gonna watch the "The Sundowners" movie again for the umpteen time....

Good Luck, Good Health and Good Humor.

j-o-h-n

[Justfor_ in reply to j-o-h-n]

Their stock (CU6 ASX) tripled since YTD.

[j-o-h-n in reply to Justfor_]

That's me "just in" time to be too late.........

Good Luck, Good Health and Good Humor.

j-o-h-n