AdvanCell Strengthens Executive Leadership to Accelerate U.S. Expansion and Scale its Global Targeted Alpha Therapy Platform

AdvanCell, a clinical-stage radiopharmaceutical company developing innovative targeted alpha therapies for cancer, today announced the appointment of Justyna Kelly as Chief Technology Officer (CTO) and François Gaudet as Chief Scientific Officer (CSO), expanding the company’s executive leadership team in the U.S. as it continues to scale its U.S. capabilities, and advance its growing pipeline of innovative targeted alpha therapies.

Justyna Kelly will lead AdvanCell’s global technical operations strategy, including CMC, GMP production and clinical supply, the company’s global manufacturing network, supply chain, and preparation for commercial readiness. Her focus will include further developing U.S. manufacturing capabilities to support the next phase of development for ADVC001. Ms. Kelly brings 16 years of radiopharmaceutical manufacturing and operations experience, most recently serving as Vice President and Site Head of Eli Lilly and Company’s Indianapolis radioligand therapy manufacturing site. She previously served as Chief Operating Officer at POINT Biopharma prior to its acquisition by Lilly and has held leadership roles of increasing responsibility, including Chief Executive Officer, at the Centre for Probe Development and Commercialization. She holds an MSc in Biochemistry from McMaster University.

“AdvanCell has built a differentiated Lead-212 platform with the potential to meaningfully impact patients with cancer,” said Justyna Kelly, CTO of AdvanCell. “I am excited to join the team and help execute a holistic strategy to scale our Lead-212 manufacturing infrastructure for Phase 3 and commercial readiness, while ensuring the quality, reliability, and operational excellence needed to deliver these therapies to patients.”

François Gaudet has commenced the role of CSO and will lead AdvanCell’s discovery and preclinical efforts, with a focus on accelerating the progression of new innovative Lead-212 targeted alpha therapies into clinical development. An accomplished drug hunter, Dr. Gaudet brings 25 years of experience across pharmaceutical and biotechnology companies, including leadership roles of increasing responsibility at Novartis, Johnson & Johnson, and Mnemo Therapeutics where he served as Chief Scientific Officer. He has led research teams responsible for the discovery and development of innovative therapeutic assets through commercialization, including TECVAYLI® and TALVEY®. He conducted his graduate work in cancer epigenetics at the Massachusetts Institute of Technology and holds a PhD in Biology from Ludwig Maximilians Universität.

“AdvanCell has built an innovative platform of Lead-212 targeted alpha therapies based on its commitment to advance new treatment options for patients in oncology. Lead-212 alpha therapy is a nascent field and ADVC001 represents a validation of the modality,” said François Gaudet, CSO at AdvanCell. “I’m excited to have joined the team to continue driving forward the pipeline development and help realize the full potential of the company’s differentiated approach.”

Simon Puttick has transitioned from Chief Scientific Officer to the role of Chief Isotope Development Officer. Having played a key role in establishing AdvanCell’s targeted alpha therapy platform, Dr. Puttick, in his new role, will have a dedicated mandate to advance the company’s next-generation isotope production technologies, driving radioisotope process development from concept through to scalable manufacturing, strengthening supply chain security, and further positioning AdvanCell as a leader in this strategically critical capability, supporting the company’s platform expansion. Dr. Puttick will continue to be based at the company’s Australian headquarters in Brisbane.

“These leadership appointments strengthen AdvanCell’s ability to build a category-defining targeted alpha therapy company, accelerating our U.S. expansion and scaling our targeted alpha therapy platform globally,” said Philina Lee, CEO of AdvanCell. “Justyna brings deep radiopharmaceutical manufacturing and operations expertise, François brings a proven track record of discovering and advancing innovative oncology therapeutics, and Simon’s dedicated focus on innovative methods for next-generation isotope production reinforces a core strategic advantage for AdvanCell: secure, scalable isotope supply and manufacturing.”

TECVAYLI® and TALVEY® are registered trademarks of Johnson & Johnson or its affiliated companies.

About 212Pb-ADVC001

212Pb-ADVC001 (ADVC001) is a proprietary and patented PSMA-targeting radioligand with optimized physicochemical properties and labelled with Lead-212 (212Pb), an alpha-emitting payload (radionuclide) with a high dose rate, 10.6-hour half-life and simple decay scheme. ADVC001 is designed to deliver radiation at a cellular level to effectively kill prostate cancer cells while minimizing toxicity.

About the TheraPb trial

The TheraPb trial (NCT05720130) is a prospective, open-label Phase 1/2 dose escalation and expansion study evaluating ADVC001 in metastatic prostate cancer. The completed Phase 1b dose escalation assessed the safety and tolerability of escalating doses of ADVC001 administered every 6, 4, 2 or 1 week(s) (see press release). The Phase 2 expansion is assessing the efficacy and safety of ADVC001 at two dose levels. The trial utilizes a randomized dose-response design and dose optimization elements to evaluate ADVC001 in PSMA-positive mCRPC and in mHSPC.

About AdvanCell

AdvanCell is a vertically integrated, clinical-stage radiopharmaceutical company dedicated to developing innovative cancer therapies that harness the power of targeted alpha-emitting radionuclides. By leveraging its proprietary Lead-212 platform, advanced and scalable manufacturing and world-class clinical development capabilities, AdvanCell aims to deliver novel treatments that improve outcomes for patients with cancer globally. For more information, visit www.advancell.com.au and follow us on LinkedIn.

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