Overview
Radiopharm Theranostics (ASX:RAD) is an innovative biopharmaceutical company specializing in the development of radiopharmaceutical products for both diagnostic and therapeutic applications. Founded with a mission to address significant unmet medical needs, particularly in oncology, the company has positioned itself at the forefront of the rapidly evolving field of precision medicine.
Lantheus’ investment in Radiopharm marks a pivotal moment for both companies and holds substantial implications for the field of theranostics. The funding will facilitate Radiopharm's research and development efforts, accelerating its product pipeline and market presence. Under the agreement, Radiopharm will transfer two early preclinical assets to Lantheus for a further AU$3 million, fostering a collaborative relationship focused on radiopharmaceutical development. The collaboration positions Radiopharm to capitalize on the increasing demand for theranostic solutions, aligning with trends in personalized medicine. Moreover, this financial backing will support clinical trials and operational needs, while also aiming for the commercialization of their products.
Radiopharm’s clinical stage development in the pipeline include:
- PD-L1 (non-small cell lung cancer indication) - currently in phase 1 in Australia;
- HER2 (breast/gastric cancer indication) - will begin phase 1 trials this year;
- Integrin VB6 (pancreatic cancer indication) - now in Phase I imaging in pancreatic cancer.
- Fatty Acid Synthase (brain METS indication) - preclinical has been completed and with IND approval for Phase IIb Imaging
The company recently received FDA approval for its investigational new drug application for 18-Pivalate (RAD 101). Labelled with the radioisotope F18, Pivalate is a small molecule that targets fatty acids synthase, which is overexpressed in brain tumours but not in normal cells.
Positive data from the company’s Phase 2 imaging trial of 17 patients with brain metastases has shown significant tumour uptake. Radiopharm holds an exclusive global license for the Pivalate platform.
Management Team
Paul Hopper – Executive Chairman
Paul Hopper is the founder of Radiopharm Theranostics. He has over 25 years of experience in the biotech, healthcare and life sciences. Focused on start-up and rapid-growth companies, he has served as the founder, chairman, non-executive director or CEO of more than 15 companies in the US, Australia and Asia. Previous and current boards include Imugene, Chimeric Therapeutics, Viralytics, Prescient Therapeutics and Polynoma. His experience covers extensive fund raising in US, Australia, Asia and Europe, and he has deep experience in corporate governance, risk management, and strategy.
Riccardo Canevari – Managing Director and Chief Executive Officer
Riccardo Canevari has broad and deep experience across specialty pharma, oncology and radiopharmaceuticals. He was most recently chief commercial officer of Novartis Advanced Accelerator Applications, one of the leading radiopharmaceutical and nuclear medicine companies, globally. He was responsible for global commercial strategy and country organizations in ~20 countries across North America, Europe and Asia. He was responsible for Lutathera’s in-market growth strategy and execution to build a blockbuster asset and for the pre-launch plan for Lu-PSMA 617 in metastatic prostate cancer. Prior to this, Canevari was senior vice-president and global head, breast cancer franchise for Novartis Oncology since 2017, overseeing the launch of major breast cancer products, including KISQALI and PIQRAY. He also held various management roles with Novartis Pharma and Ethicon/Johnson & Johnson.
Dr. Sherin Al-Safadi - Vice-president, Medical Affairs
Dr. Sherin Al-Safadi is an accomplished industry leader with many years of experience in pharmaceuticals and biotech. Most recently she was vice-president – medical affairs at POINT Biopharma, where she led the strategic and tactical planning for Phase III support and launch preparation of radiopharmaceuticals. She also provided strategic input and leadership for business development and licensing opportunities. She currently serves as co-founder and president at Foundation Amal (Canada-USA), overseeing an executive leadership team of 12 directors and members, who led the successful 2021 cross-border expansion into the USA and spearheaded the development of a successful branding and communication strategy. Al-Safadi holds a PhD in neurobiology from Concordia University, an MBA in entrepreneurship & management from the John Molson School of Business, and a MSc in pharmacology (oncology drug development) from McGill University.
Vimal Patel - Vice-president, CMC
Vimal Patel joins RAD from Orum Therapeutics where he was vice-president, head of CMC and supply chain. He was responsible for all CMC functions including process and analytical development, manufacturing, quality control, quality assurance, regulatory and supply chain. He led the successful manufacture of two ADCs and contributed to filing an IND leading to a Phase-I trial. Prior to Orum, Patel held roles of increasing responsibility in process development and manufacturing sciences at several companies, including Actinium Pharmaceuticals. Patel also held a position at Pfizer where he contributed to the refiling of Mylotarg and the filing of Besponsa BLAs. He also developed manufacturing processes for various ADCs. He also held roles at Daiichi Sankyo, Progenics Pharmaceuticals and SibTech in various capacities. Patel has MS in biotechnology from University of Connecticut and B.S. in chemical engineering from Sardar Patel University.
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