AdvanCell Announces First Patient Dosed in Phase I/II TheraPb Clinical Trial of 212Pb-ADVC001 in Metastatic Prostate Cancer

“The first patient dosed with an AdvanCell therapeutic candidate represents a major milestone for the Company, our scientists, clinical trial sites, and our patients,” said Andrew Adamovich, CEO of AdvanCell. “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.”

“Patients with metastatic prostate cancer continue to benefit from advances in radiopharmaceutical treatment options,” said Ken Herrmann, MD, AdvanCell Advisory Board member and Chair of the Department of Nuclear Medicine at the Universitätsklinikum Essen in Germany. “We are excited to be moving this ²¹²Pb-based therapy forward in the TheraPb clinical study.”

Since November 2020, AdvanCell has:

• Developed the world’s first ²¹²Pb-based Targeted Alpha Therapy to enter clinical trials in metastatic prostate cancer.
• Invented proprietary platform technology that enables scalable manufacture of ²¹²Pb, the ideal radioisotope to treat cancer.
• Signed a letter of intent with a world-class radiopharmaceutical company to collaborate on a global ²¹²Pb radioisotope and radioligand supply chain and drug manufacturing network.
• Developed a proprietary target discovery and ligand development program encompassing a robust pipeline of Targeted Alpha Therapies to treat cancer.
• Raised US $13M from world-class investors including Morningside and awarded $10M in non-dilutive grant funding,
• Participated in the Cancer Lethality Lead Collaboration, which was awarded $10M from the Prostate Cancer Foundation’s TACTICAL Awards program, in collaboration with the Peter MacCallum Cancer Centre, Uniklinik Essen, University of California Los Angeles, and University of California San Francisco.

• Built a 25-person world-class team across Australia and the United States and secured a 35,000-square-foot flagship manufacturing facility with plans to expand globally.

About ²¹²Pb-ADVC001
²¹²Pb-ADVC001 was designed to bind to PSMA, a clinically validated cell surface target highly expressed in prostate cancer. The proprietary drug candidate has been optimised for safety and efficacy and has demonstrated potential best-in-class attributes in preclinical studies.

About TheraPb Clinical Trial
The Phase I/II trial of ²¹²Pb-ADVC001 is a multicentre, open-label study evaluating safety and efficacy in patients with PSMA-positive mCRPC. The trial’s primary objectives are to assess safety and tolerability and identify a recommended Phase II dose. Secondary objectives include measures of dosimetry, rPFS by RECIST and PSMA PET-CT, and PSA response. Multiple sites for the Phase I/II clinical trial of ADVC001 are now open for enrolment. For more information, visit clinicaltrials.gov (NCT05720130).

About AdvanCell
AdvanCell is a clinical-stage radiopharmaceutical company developing an innovative pipeline of ²¹²Pb-based Targeted Alpha Therapies for cancer patients. AdvanCell’s platform technology addresses the most significant challenge in targeted alpha therapy – the reliable and scalable supply of isotope. AdvanCell’s novel drug discovery, preclinical processes, and state-of-the-art facilities leverage daily access to ²¹²Pb, the ideal isotope for Targeted Alpha Therapy. For more information, please visit www.advancell.com.au.

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