Radiopharm Theranostics (ASX:RAD) is a biopharmaceutical company that develops radiopharmaceutical products for diagnostic and therapeutic applications. With four licensed platform technologies – nanobody, peptide, small molecules and monoclonal antibodies (mAb), Radiopharm aims to commercialize its pipeline for possible licensing and distribution agreements seeking to develop for the diagnosis and treatment of certain cancers.
Radiopharm Theranostics represents a promising investment opportunity in the rapidly growing field of radiopharmaceuticals, leveraging its innovative technology platform and diverse clinical pipeline.
Radiopharm’s clinical stage development in the pipeline include:
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Radiopharm Theranostics represents a promising investment opportunity in the rapidly growing field of radiopharmaceuticals, leveraging its innovative technology platform and diverse clinical pipeline.
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.
Radiopharm Theranostics presents a compelling value proposition for investors, characterized by several key factors:
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 has four licensed platform technologies – nanobody, peptide, small molecules and monoclonal antibodies (mAb) – with diagnostic and therapeutic applications in both pre-clinical and clinical stages of development.
Radiopharm’s clinical stage development in the pipeline include:
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.
Radiopharm highlights that Pivalate is potentially a new target for radiopharmaceutical brain imaging agents, and its unique mechanism of action may offer eligible patients a better option in relation to current imaging technology, which has many limitations.
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 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 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 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.
Noel Donnelly brings more than 25 years of leadership experience in finance, strategy and operations within the biopharmaceutical and biotechnology industries. He has a distinguished track record of building and leading cross-functional teams, driving corporate governance and executing complex financial strategies that support rapid company. growth. Donnelly is current the chief financial officer of PepGen, where he oversaw the company's financial strategy through its successful IPO, raising U$120 million and leading subsequent financial efforts that secured an additional US$90 million. Donnelly was previously the CFO of EIP Pharma (now, CervoMed), where he led the company's IPO plannig phase. He had a 15-year tenure at Takeda/Shire PLC, in various senior roles, where he led critical R&D integrations and oversaw more than US$160 billion in integration planning and execution. He was instrumental in shaping the company's portfolio management strategy.
Developing innovative radiopharmaceuticals for a highly underserved oncology sector
Phase 1 1 First-In-Human study designed to assess safety  ,  tolerability  , right dose for Phase 2 and early signs of efficacy  of 177Lu-RAD20  2  in individuals with  advanced HER2-positive solid  tumors
Previous clinical proof-of concept data 2 for targeting HER-2 demonstrated the safety and biodistribution of 99mTc-RAD202 in humans
Radiopharm Theranostics (ASX:RAD, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced the dosing of the first patient in its Phase 1 ‘HEAT' clinical trial of RAD202, a proprietary nanobody that targets Human Epidermal Growth Factor Receptor 2 (HER2)-positive expression in a wide array of advanced solid tumors.
The open-label Phase 1 "HEAT' clinical trial is a dose escalation trial of 177Lu-RAD202 that is designed to determine the recommended Phase 2 dose and to evaluate the safety and preliminary clinical activity of this novel radiotherapeutic in individuals with HER2-expressing advanced cancers. The study is currently being conducted at clinical centers across Australia.
"Dosing patients in the HEAT clinical trial marks an important milestone in our transition to a clinical-stage company," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "Despite progressive improvements in the management of metastatic HER2-positive disease, the majority of patients experience disease progression on current standard of care and require further therapeutic options. The dosing of the first patient in the ‘HEAT' trial represents a significant step toward achieving RAD202's potential to address an unmet need for HER2-positive metastatic patients who are progressing or unable to tolerate current treatment options. With RAD202, we hope to provide an option that can meaningfully improve clinical outcomes for HER2-positive patients, while preserving their quality of life."
HER2 is overexpressed in breast cancer as well as several other solid tumors and represents a validated target in oncology. RAD202 is a proprietary single domain antibody that targets HER2. Ten HER2-positive breast cancer patients previously dosed in a Phase 1 diagnostic study of RAD202 demonstrated clinical proof-of concept as well as the safety and biodistribution of RAD202, validating its potential for the treatment of advanced HER2-expressing cancers 2 . Preclinical findings 3 examining the therapeutic effect in HER2-positive xenografts were also recently reported with 177Lu-RAD202. Collectively, these data further justify first in humans dose finding studies.
"It is a privilege to be the first centre to administer 177Lu-RAD202, targeting HER2-positive tumors in this Phase 1 clinical trial (HEAT)." said Dr Aviral Singh, Clinical Head of Theranostics and Nuclear Medicine at St John of God Murdoch Hospital. "This opens the possibility of novel therapeutic avenues for patients with aggressive tumor types, including breast, ovarian, gastric, pancreatic, bladder, and several other cancers. With the trust put in us by Radiopharm, we look forward to a successful trial with beneficial outcomes for our patients."
About Radiopharm Theranostics
Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm is listed on ASX (RAD) and on NASDAQ (RADX). The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer. The clinical program includes one Phase 2 and three Phase 1 trials in a variety of solid tumor cancers including lung, breast, and brain metastases. Learn more at radiopharmtheranostics.com .
Authorised on behalf of the Radiopharm Theranostics board of directors by Chairman Paul Hopper.
For more information:
Riccardo Canevari
CEO & Managing Director
P: +1 862 309 0293
E: rc@radiopharmtheranostics.com
Anne Marie Fields
Precision AQ (Formerly Stern IR)
E: annemarie.fields@precisionaq.com
Paul Hopper
Executive Chairman
P: +61 406 671 515
E: paulhopper@lifescienceportfolio.com
Media
Matt Wright
NWR Communications
P: +61 451 896 420
E: matt@nwrcommunications.com.au
________________________________
1 clinicaltrials.gov/study/NCT06824155
2 Zhao et al, Molecular Pharmaceutics 2021 18 (9), 3616-3622
3 Altunay B. et al, EP-0136, Eur J Nucl Med Mol Imaging (2024) 51 (Suppl 1): S1–S1026. DOI: 10.1007/s00259-024-06838-z
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Supports plans to advance the RV01 program to first-in-human therapeutic basket study in solid tumour cancers
Data completes preclinical package for Investigational New Drug submission in mid-2025 with Phase 1 therapeutic study initiation expected in 4Q25
Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced that preclinical data from studies with the Lu177-B7H3-monoclonal antibody RV01 demonstrated favourable biodistribution and showed that RV01 maintained high tumour uptake. In addition, the Fc region modifications of the monoclonal antibody (mAb) confirm a shorter half-life, compared to traditional mAbs. The shorter half-life and other Fc modifications have the potential to limit off-target exposure to the isotope and mitigate toxicities associated with traditional monoclonal antibody therapies.
RV01 is the Company's B7-H3-targeted radiopharmaceutical therapy designed with strong affinity for the 4Ig isoform of B7H3 that is highly expressed in tumours and not in healthy tissues, which is being developed in partnership with MD Anderson Cancer Center. The B7-H3 targeting monoclonal antibody (mAb) is designed to target various solid tumours that express the B7-H3 protein. High expression of this target is associated with a poor prognosis in many cancer types.
"We are especially pleased with these new preclinical data as they further validate earlier preclinical work that showed strong affinity to the target without the extensive circulation time of other monoclonal antibodies. Our mAb has been purposefully modified in the Fc-region with the objective of maintaining the same targeting capabilities together with a reduced half-life. Most mAbs have a typical half-life of over one week, whereas RV01 peaks within one to two days," stated Dimitris Voliotis, M.D., Chief Medical Officer of Radiopharm Theranostics.
"The antibody shows faster liver excretion in the preclinical experiments, allowing the isotope enough time to effectively target the tumor potentially without the associated toxicities. Unlike peptides or small molecules, mAbs are excreted by the liver, the most radio-resistant organ. This, combined with the faster excretion due to the shortened half-life, potentially offers important advantages compared to excretion via the kidneys, where the elimination of radiopharmaceuticals can result in significant potential toxicities," added Dr. Voliotis.
The new preclinical data corroborate conclusions from earlier preclinical mouse studies that identified a high-affinity antibody highly selective to the cancer-specific 4Ig isoform of the B7-H3 receptor, demonstrated complete regression of established solid tumours with treatment and showed promising evidence of immune system stimulation and the ability to confer immune memory.
"This biodistribution study is the last preclinical work needed to complete the preclinical package for our Investigational New Drug Application (IND) with the U.S. Food and Drug Administration. These data allow us to confirm our guidance to file the IND-submission in mid-2025 and to initiate our first-in-human Phase 1 basket study by the end of this year," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics.
About Radiopharm Theranostics
Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm is listed on ASX (RAD) and on NASDAQ (RADX). The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer. The clinical program includes one Phase 2 and three Phase 1 trials in a variety of solid tumor cancers including lung, breast, and brain. Learn more at radiopharmtheranostics.com .
Authorized on behalf of the Radiopharm Theranostics Board of Directors by Executive Chairman Paul Hopper.
For more information:
Investors:
Riccardo Canevari
CEO & Managing Director
P: +1 862 309 0293
E: rc@radiopharmtheranostics.com
Anne Marie Fields
Precision AQ (formerly Stern IR)
E: annemarie.fields@precisionaq.com
Media:
Matt Wright
NWR Communications
P: +61 451 896 420
E: matt@nwrcommunications.com.au
Follow Radiopharm Theranostics:
Website – https://radiopharmtheranostics.com/
X – https://x.com/TeamRadiopharm
LinkedIn – https://www.linkedin.com/company/radiopharm-theranostics/
InvestorHub – https://investorhub.radiopharmtheranostics.com/
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ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, and Radiopharm Theranostics (ASX:RAD; NASDAQ: RADX "Radiopharm"), a developer of a world-class platform of radiopharmaceutical products for both diagnostic and therapeutic uses, today announced the signing of a supply agreement that will provide Radiopharm with ITM's medical radioisotope, non-carrier-added Lutetium-177 (n.c.a. 177 Lu), to enable its usage in the clinical and potential future commercial development of the 177 Lu-based molecules in Radiopharm's development pipeline.
Under the terms of the agreement, Radiopharm will use ITM's n.c.a. 177 Lu across its clinical pipeline, including in key programs such as RAD 204 (PD-L1-targeting nanobody, Phase 1), RAD 202 (HER2-targeting nanobody, Phase 1), and RV01 (B7-H3-targeting monoclonal antibody, preclinical), for the treatment of solid tumors. Coupled with the targeting molecules that are designed to deliver ITM's n.c.a. 177 Lu directly to tumor sites, the radioisotope emits therapeutic beta radiation with the aim to destroy malignant cells in a highly precise and localized manner.
" Ensuring supply of key isotopes continues to be a priority for our team, allowing us to accelerate our clinical programs ," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics . " Lutetium-177 is required for three of our more advanced assets and this supply agreement with a radiopharmaceutical leader like ITM is another important step to ensure quality, reliability, and redundancy in our clinical development plans ."
ITM's n.c.a. 177 Lu is a market-approved, highly pure form of the beta-emitting radioisotope, Lutetium-177, that can be linked to tumor-specific targeting molecules for the treatment of various cancers and has been successfully used in numerous clinical and commercial radiopharmaceutical cancer treatments. ITM holds a U.S. Drug Master File (DMF) with the Food and Drug Administration (FDA) for n.c.a. 177 Lu and has marketing authorization in the EU (brand name EndolucinBeta ® ).
" As the leading global manufacturer of non-carrier-added Lutetium-177, we are just as committed to supplying our global partners with high-quality medical radioisotopes as we are to supplying our own pipeline ," said Andrew Cavey, CEO of ITM . " Supporting Radiopharm in the advancement of their therapeutic candidates reflects our shared dedication to delivering improved treatment options to people living with cancer ."
About ITM Isotope Technologies Munich SE
ITM, a leading radiopharmaceutical biotech company, is dedicated to providing a new generation of radiopharmaceutical therapeutics and diagnostics for hard-to-treat tumors. We aim to meet the needs of cancer patients, clinicians and our partners through excellence in development, production and global supply. With improved patient benefit as the driving principle for all we do, ITM advances a broad precision oncology pipeline, including multiple phase 3 studies, combining the company's high-quality radioisotopes with a range of targeting molecules. By leveraging our two decades of pioneering radiopharma expertise, central industry position and established global network, ITM strives to provide patients with more effective targeted treatment to improve clinical outcome and quality of life. www.itm-radiopharma.com
About Radiopharm Theranostics
Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm is listed on ASX (RAD) and on NASDAQ (RADX). The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer. The clinical program includes one Phase 2 and three Phase 1 trials in a variety of solid tumor cancers including lung, breast, and brain. Learn more at radiopharmtheranostics.com .
Authorised on behalf of the Radiopharm Theranostics board of directors by Chairman Paul Hopper.
For more information:
Riccardo Canevari
CEO & Managing Director
P: +1 862 309 0293
E: rc@radiopharmtheranostics.com
Paul Hopper
Executive Chairman
P: +61 406 671 515
E: paulhopper@lifescienceportfolio.com
Media
Matt Wright
NWR Communications
P: +61 451 896 420
E: matt@nwrcommunications.com.au
ITM Contact
Corporate Communications
Kathleen Noonan/Julia Westermeir
Phone: +49 89 329 8986 1500
Email: communications@itm-radiopharma.com
Investor Relations
Ben Orzelek
Phone: +49 89 329 8986 1009
Email: investors@itm-radiopharma.com
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