AdvanCell has dosed the first subject in its Phase I/II TheraPb clinical trial of ²¹²Pb-ADVC001 to treat PSMA-positive metastatic castration-resistant prostate cancer (mCRPC).
The open-label, multicentre trial will analyse the tolerability and safety and detect a recommended Phase II dose of the drug candidate as primary objectives.
Dosimetry measures, radiographic progression-free survival (rPFS), and prostatic-specific antigen (PSA) response will comprise the secondary objectives of the trial.
The company launched various study centres for the trial, which are now open for subject enrolment.
A targeted alpha therapy, ²¹²Pb-ADVC001 attaches to PSMA expressed in prostate cancer.
AdvanCell CEO Andrew Adamovich said: “The first patient dosed with an AdvanCell therapeutic candidate represents a major milestone for the company, our scientists, clinical trial sites, and our patients.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below formBy GlobalData
“We believe that ²¹²Pb is the ideal radioisotope to realise the full therapeutic power of targeted alpha therapy.
“This promise is strongly supported by preclinical results for ²¹²Pb-ADVC001, which demonstrate the potential for best-in-class safety and efficacy.”
Since 2020, the company developed the drug and entered a partnership with a radiopharmaceutical company on a supply chain for ²¹²Pb radioisotope and radioligand as well as a network for drug production.
AdvanCell also secured funding worth $13m from investors including Morningside and acquired a 35,000ft² manufacturing site.