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DECEMBER 15, 2025

In the spotlight, astatine-211, an alpha-emitting radionuclide with high cytotoxic potential that will enable a major step forward in nuclear medicine, in the highly promising field of targeted radionuclide therapy (TRT).

A collaboration between Atonco and the Institut de Cancérologie de l’Ouest.

• ATONCO designs and develops targeted treatments for cancers resistant to conventional approaches, particularly using astatine-211.
• ICO has obtained authorization for the first Phase I clinical trial, PERSEVERANCE EU, using astatine-211 in the treatment of bladder cancer.

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PRESS RELEASE

A deep dive into cutting-edge medicine, with an ultra-targeted radiotherapeutic treatment.

The PERSEVERANCE EU clinical trial evaluating the safety, tolerability and response to ATO-101™ authorized: a first in France with astatine-211.

The Institut de Cancérologie de l’Ouest (ICO) has obtained authorization to launch the Phase I clinical trial PERSEVERANCE EU (NCT07260162), entitled A First In Human Phase I Trial Evaluating Safety, Tolerability and Response of [211At]At-Girentuximab (ATO-101™) in Patients With Non-Muscle-Invasive Bladder Cancer Refractory to Standard Treatment.

This trial aims to evaluate the safety, tolerability and response to ATO-101™ treatment in patients with non-muscle-invasive bladder cancers resistant to standard treatments. The study marks an important milestone in the development of innovative therapeutic treatments based on alpha emitters.

An innovative treatment using astatine-211

ATO-101™ ([²¹¹At]At-girentuximab), supplied by Atonco, is composed of an antibody directed against the CA-IX antigen (girentuximab) coupled with astatine-211, an alpha-emitting radionuclide with high cytotoxic potential. Its very short particle range should enable effective targeting of tumor cells while preserving surrounding healthy tissue.

“This trial follows on from the PERTINENCE study (NCT04897763), which validated the feasibility of imaging and safety of intravesical administration of a radiopharmaceutical (composed of the same antibody (girentuximab) but coupled with Zirconium-89) for both the patient and radiation protection of staff. This trial notably showed that the product remained only in the bladder, which is precisely what is sought in this type of non-metastatic cancer, suggesting minimal or even non-existent toxicity at the whole-body level in the PERSEVERANCE EU trial.”

Dr. Caroline Rousseau, ICO Coordinating Physician for the PERSEVERANCE EU study

“PERSEVERANCE EU fully illustrates Atonco’s medical ambition: to offer targeted treatments using alpha emitters for patients with limited therapeutic options. With ATO-101™, the objective is to demonstrate that astatine-211 can provide local tumor control while maximally preserving healthy tissue, thereby paving the way for a new generation of innovative radiotherapies in urothelial oncology.”

Dr. Jean-François Chatal, Medical Director, Atonco

The production of the investigational drug will be carried out by GIP Arronax and CHU de Nantes, two leading French institutions in the field of radiopharmacy and nuclear medicine research. Girentuximab is licensed to the Australian company Telix Pharmaceuticals, which will also supply the antibody for the study.

A clinical first in France

This is the first clinical trial in France involving astatine-211, paving the way for a new generation of targeted radiotherapeutic treatments. Enrollment of the first patients will begin at ICO Saint-Herblain as soon as all prerequisites are met.

“ATONCO is taking a decisive step by entrusting the promotion of this pioneering study to ICO. This collaboration marks a first for ICO’s Promotion Department! The enrolled patients will be the first to benefit from this therapeutic advancement, paving the way for a new era of innovative care.”

Nadia Allam and Laëtitia Himpe, ICO Project Managers for this project

“The authorization of the PERSEVERANCE EU trial confirms the potential of our targeted radiotherapy approaches and Atonco’s ability to bring its innovative radiopharmaceuticals to clinical trials. We are fully committed to ensuring that our developments such as ATO-101™ translate concretely into benefits for patients, with the highest standards of quality, safety and clinical evidence.”

Alexandra Paillard, Chief Operating Officer, Atonco

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ABOUT

ATONCO

Atonco is a French biotechnology company specializing in the development of innovative radiopharmaceutical therapies based on alpha emitters, particularly astatine-211.

In collaboration with research centers and hospital partners, Atonco designs and develops targeted treatments for cancers resistant to conventional approaches. Its mission is to offer new safe, effective and personalized therapeutic options for cancer patients.

For more information, please visit www.atonco-pharma.com
ClinicalTrials.gov – NCT07260162

Institut de Cancérologie de l’Ouest (ICO): An Expert Center

ICO is a Cancer Treatment Center, non-profit and without additional fees, fulfilling public hospital service missions. As an expert center for care pathway coordination, it aims to provide patients and partners with its expertise and specific skills in oncology. OECI-accredited in 2023, it received the High Quality of Care distinction from HAS in January 2024. Each year, ICO’s 1,600 professionals welcome nearly 48,000 patients across its two facilities in Angers and Saint-Herblain.

CUTTING-EDGE MEDICINE AT THE SERVICE OF PATIENTS

Specialized in oncology, ICO professionals support patients at every stage of their care journey, in a personalized, innovative and multidisciplinary manner. From rapid diagnosis to surgery, chemotherapy, radiotherapy, care also extends to supportive care, which is highly developed within the institution.

INTEGRATING CARE, RESEARCH AND INNOVATION

ICO’s research activity, a full-fledged mission, spans from fundamental research to clinical trials through translational research. It covers all oncology disciplines: medical oncology, radiotherapy, surgery, anesthesia, nuclear medicine, medical imaging, supportive care, and human sciences. Being treated at ICO means having privileged access to cutting-edge clinical trials in oncology.

Through its teaching mission and university expertise, the institution contributes to training tomorrow’s oncology professionals.

With its 4 missions — Prevention, Care, Research and Teaching — ICO offers cutting-edge and comprehensive expertise in the region, exclusively dedicated to oncology.

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CONTACT US

Press Contacts

Sylvain FANIER – ATONCO
President
Tel.: 06 07 59 01 67
Email: sylvain.fanier@atonco-pharma.com

Édith LEGRAND – Institut de Cancérologie de l’Ouest
Communications Project Manager
Tel.: 02 41 35 27 26 / 06 74 38 26 71
Email: edith.legrand@ico.unicancer.fr

Sophie NOBLET – Institut de Cancérologie de l’Ouest
Communications Director
Tel.: 02 40 67 98 68 / 06 82 20 81 48

Atonco Report: Overview of clinical developments in alpha-emitter radiotherapy

Atonco publishes its November 2025 report outlining the state of clinical research in alphatherapy worldwide. Compiled from ClinicalTrials.gov databases and recent scientific publications, this document maps all clinical trials conducted and ongoing with the three next-generation alpha-emitting radioisotopes: Actinium-225, Lead-212, and Astatine-211. This analysis identifies major players, their strategic choices regarding therapeutic targets and clinical indications, as well as industrial prospects for large-scale deployment of these promising technologies.

Current Status

Clinical alphatherapy is experiencing significant growth with 28 Phase 1 or 1/2 studies registered in 2025, involving both pharmaceutical giants (AstraZeneca, Bayer, BMS, J&J, Eli Lilly, Novartis) and numerous innovative biotechs. The three radioisotopes currently in development – Actinium-225 (14 studies), Lead-212 (6 studies), and Astatine-211 (8 studies) – share a decisive advantage: their linear energy transfer is 100 times higher than Lutetium-177, inducing irreparable double-strand DNA breaks in tumor cells. While Actinium-225 dominates clinical trials thanks to its 10-day half-life allowing long-distance transport, Astatine-211 stands out for its safe production in conventional cyclotrons and absence of long-lived toxic daughter nuclides. In this context, Atonco has demonstrated the clinical feasibility of intravesical instillation of anti-CAIX-labeled antibodies, confirming excellent bladder retention and superior radiocytotoxicity of Astatine-211.

Download the full report (PDF): Status of Clinical Alphatherapy – November 2025

Atonco, an innovative company specializing in the development of next-generation radiopharmaceuticals based on astatine-211, today announces the promotion of Alexandra Paillard to the position of Chief Operating Officer (COO), effective October 1, 2025.

In addition to this appointment, Alexandra Paillard will also take on the role of Deputy Chief Executive Officer, overseeing all operations related to the technical and clinical development of radiopharmaceuticals under Atonco’s license.

A Doctor of Pharmacy and holder of a PhD in pharmaceutical technology, Alexandra Paillard brings extensive experience in managing complex projects in biotechnology and pharmaceutical development. Her mission will be to strengthen and accelerate Atonco’s operational strategy around its core focus: astatine-211-based radiopharmaceuticals, notably ATO-101™, developed within a next-generation alpha-immunotherapy approach.

This appointment marks an important milestone in Atonco’s organizational development and confirms the company’s ambition to become a global reference player in targeted alpha radiotherapy.

“Alexandra Paillard’s promotion reflects our confidence in her ability to lead our operations into a new phase of growth and industrial scale-up. Her leadership will be decisive in realizing the unique therapeutic potential of our astatine-211-based radiopharmaceuticals,” said Sylvain Fanier, Chairman of Atonco.

“It is an honor to take on the leadership of Atonco’s operations at such a strategic moment in its development. Astatine-211 represents a unique opportunity to transform the treatment of many cancer patients, and I am fully committed to bringing, together with our teams and partners, our radiopharmaceutical portfolio — notably ATO-101™ — to the next clinical and industrial milestones,” said Alexandra Paillard.

About Atonco

Atonco is an innovative biopharmaceutical company dedicated to the development of next-generation radiopharmaceuticals based on astatine-211, a promising alpha emitter for targeted cancer therapies. Its lead program, ATO-101™, is developed under an exclusive license of girentuximab from Telix Pharmaceuticals, as part of a high-precision therapeutic approach against cancers resistant to conventional treatments.

Atonco is proud to announce that the results of preclinical and clinical studies have been published in the journal Cancers (MDPI), highlighting the promising potential of its radiopharmaceutical ATO-101™ ([211At]At-girentuximab) in the treatment of non-muscle-invasive bladder cancer (NMIBC) refractory to standard therapies including BCG, using astatine-211 alpha-immunotherapy.

Non-muscle-invasive bladder cancer represents a major medical challenge, with a growing need for new therapeutic options. A promising approach in this field is radioimmunotherapy targeting the CA-IX antigen (Carbonic Anhydrase IX), particularly the use of alpha-particle-emitting radionuclides such as astatine-211. The aim of our preclinical and clinical studies was to evaluate the potential of ATO-101™ in treating patients who no longer respond to conventional therapies.

Preclinical studies showed that ATO-101™ binds extremely effectively to the CA-IX antigen, with high binding affinity, and induces significant targeted cytotoxicity compared to other treatments such as [177Lu]Lu-girentuximab. Additionally, biodistribution studies conducted in healthy mice revealed low systemic spread of radioactivity, demonstrating the safety of the treatment. After intravesical instillation of ATO-101™, no histological abnormalities were observed in the bladder wall, further supporting the safety of the approach.

Within the PERTINENCE study (NCT04897763), promoted by the Institut de Cancérologie de l’Ouest (ICO) in Nantes, PET/CT imaging with [89Zr]Zr-girentuximab (provided by Telix Pharmaceuticals) performed on 6 NMIBC patients showed no extravesical leakage, indicating that the approach is localized and effectively targeted. Radioactive foci in the bladder wall were associated with areas of recurrence or inflammatory reaction, suggesting that this treatment could effectively target tumor residues.

Furthermore, a dosimetric study suggested that intravesical astatine-211 alpha-immunotherapy with ATO-101™ could offer enhanced efficacy and safety for the treatment of NMIBC. Both clinical and preclinical data confirm the therapeutic potential of this approach and highlight its promising role in the management of NMIBC.

With this new targeted therapy, we are paving the way for a more selective, less toxic, and more effective treatment for patients with non-muscle-invasive bladder cancer, particularly those whose tumors are refractory to traditional treatments including BCG.

🔗 Learn more about this study: Link to the full study on MDPI

About ATONCO

ATONCO is a French private company developing targeted molecular radiation products for oncological applications. Originating from the world-renowned nuclear medicine centre in Nantes, ATONCO and its partners are committed to the clinical use of alpha-emitting radionuclides, particularly astatine-211 (211At).

For more information, please visit www.atonco-pharma.com

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Atonco and GIP ARRONAX (Saint-Herblain, France) are joining forces to take a new step forward in the implementation of alpha-immunotherapy against cancer. Their partnership aims to develop and validate the GMP (Good Manufacturing Practice) radiopharmaceutical production process for Atonco’s ATO-101 (Girentuximab radiolabelled with astatine-211), with a view to clinical intravesical instillation for the treatment of non-muscle-invasive bladder cancer. Through this collaboration, two key players in the Nantes radiopharmaceutical sector are combining their expertise: the development of innovative astatine-211-based radiopharmaceuticals (Atonco) and the production of radionuclides and radiopharmaceuticals for nuclear medicine research (GIP ARRONAX).

This collaboration represents a key milestone in the clinical translation of astatine-211, an alpha-particle-emitting radionuclide capable of selectively destroying targeted tumor cells. It builds on the astatine-211 production expertise developed at GIP ARRONAX and follows radiochemistry research conducted in Nantes by Team 2 of CRCI2NA, which led to the development of radiolabelling and quality control methods for astatine-211-labelled Girentuximab. Within this partnership, GIP ARRONAX plays a central role in the pharmaceutical development and GMP validation of manufacturing processes and control methods, in preparation for validation batches ahead of first-in-human clinical trials.

Laurette Fisson, CMC Director and Product Development at Atonco: “This collaboration reinforces Atonco’s position as a leader in the development of innovative astatine-211-based radiopharmaceuticals, contributing to the advancement of targeted therapeutic options for patients with cancers resistant to standard treatments. We are delighted to work with GIP ARRONAX, a longstanding partner with recognized expertise in radiopharmaceutical research and development.”

Férid Haddad, Director of GIP ARRONAX: “This collaboration with Atonco brings to fruition nearly 15 years of development work carried out by GIP ARRONAX on astatine-211, a promising alpha emitter. We are proud to contribute to the advancement of nuclear medicine, and particularly to the development of alpha radiotherapy, which represents a therapeutic solution of the future.”

About Atonco

Atonco is a private company developing targeted radiopharmaceutical products for oncological applications. Originating from the nuclear medicine centre in Nantes, Atonco and its partners are committed to the clinical use of alpha-emitting radionuclides, particularly astatine-211.

For more information, visit www.atonco-pharma.com

About GIP ARRONAX

ARRONAX is a Public Interest Group (GIP) carrying out public interest missions in the fields of research, economic development, and training. It operates a high-energy, high-intensity multi-particle cyclotron enabling the production of non-conventional radionuclides, including astatine-211, of which it is one of only two European producers. GIP ARRONAX manufactures radiopharmaceuticals to GMP standards to support early-phase clinical research.

For more information, visit https://www.arronax-nantes.fr/gip-arronax/

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Atonco, a French biotechnology company, and the University of Michigan today announced a collaboration agreement to conduct a targeted alpha-therapy Phase 1-2a clinical study evaluating Atonco’s ATO-101™ ([211At] anti-CA-IX antibody) in non-muscle-invasive bladder cancer (NMIBC).

Bladder cancer is one of the most prevalent cancers worldwide, ranking 10th overall and 6th among men. In 2020, it accounted for more than 573,000 new cases and approximately 212,000 deaths globally.

Although Bacillus Calmette-Guérin (BCG) therapy is the standard of care, it fails in approximately 40% of cases, leading to radical bladder removal procedures. While newer therapies such as immune checkpoint inhibitors have entered clinical trials, additional options are urgently needed.

Atonco’s ATO-101™ ([211At] anti-CA-IX antibody) is a targeted radiopharmaceutical composed of an alpha-emitting radionuclide, astatine-211 (211At), conjugated to the CAIX-specific monoclonal antibody Girentuximab (TLX250), designed to deliver the radioisotope directly to targeted cancer cells.

The study will be led by Professor Benjamin Viglianti, in collaboration with Professor Peter Scott.

“The disruptive potential of targeted radiopharmaceutical therapies in cancer treatment is considerable, as these therapies have the ability to deliver radiation directly and specifically to cancer cells, potentially reducing, in our study, the risk of complications associated with traditional BCG therapy,” noted Viglianti, Associate Professor of Clinical Radiology and Chief of the Division of Nuclear Medicine at the University of Michigan.

“We are delighted to partner with the University of Michigan and leverage their world-class expertise in clinical radiopharmaceutical research to uncover the safety and activity profile of ATO-101™. Atonco’s team will include Ms. Aurélie Moreau and Mr. Denis Bilodeau, a seasoned expert leading our clinical research team in the United States and Europe,” said Dr. Jean-François Chatal, founder and Chief Medical Officer of Atonco.

The Phase 1-2a study will be conducted at the University of Michigan and will involve a number of satellite sites. Enrollment of the first study patients is expected to begin in the coming months, pending FDA approval of the study plan.

About ATONCO

Atonco is a private company developing targeted radiopharmaceutical products for oncological applications. Originating from the nuclear medicine centre in Nantes, Atonco and its partners are committed to the clinical use of alpha-emitting radionuclides, particularly astatine-211.

For more information, visit www.atonco-pharma.com

About the UNIVERSITY OF MICHIGAN

The University of Michigan is a leading public research university committed to advancing knowledge and solving complex challenges. Its world-class faculty and state-of-the-art facilities make it a premier partner for medical research and clinical studies.

For more information, visit https://umich.edu

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ATONCO (Saint-Herblain, France) and Minerva Imaging (Oelstykke, Denmark) are pleased to announce a close collaboration to join forces in the fight against bladder cancer. Minerva Imaging will produce clinical doses for ATONCO’s planned Phase I clinical trial in Europe, using alpha-immunotherapy with 211At-Girentuximab (TLX250 licensed from Telix Pharmaceutical, radiolabelled with astatine-211).

This targeted radionuclide therapy is a precision medicine approach in which the radioactive substance is attached to a targeting moiety against Carbonic Anhydrase IX (CAIX). The use of alpha-particle-emitting radionuclides has attracted significant medical interest in oncology due to their short path length and high linear energy transfer, resulting in double-strand DNA breaks and high cytotoxicity. Astatine-211 possesses unique properties as an alpha-particle-emitting payload for targeted radionuclide therapies, thanks to its relatively short half-life, favorable decay chain, and scalable production.

Sylvain Fanier, President of ATONCO: “We are delighted to continue the global development of alpha-immunotherapy targeting non-muscle-invasive bladder cancers (NMIBC). Since our founding in 2019, ATONCO has focused on building a world-class team and establishing all the tools and technologies necessary to enable innovative precision medicine treatments based on astatine-211. We consider astatine-211 to be part of our DNA. ATONCO is fully committed to advancing the fight against cancer with a Phase I clinical trial involving our targeted alpha therapy using astatine-211.”

Carsten Haagen Nielsen, CEO of Minerva Imaging: “With the recent opening of our CDMO facility, we are able to manufacture radiopharmaceutical drugs in compliance with Good Manufacturing Practice (GMP). For the Phase I clinical trial using 211At-Girentuximab, we will source At-211 from Rigshospitalet. The proximity of Rigshospitalet and Minerva Imaging (less than 60 minutes by car) makes us the ideal European partner for ATONCO, and we look forward to contributing to the advancement of the clinical application of At-211-based targeted radionuclide therapies“.

About Minerva Imaging

Minerva Imaging is a science-driven CRO and CDMO specializing in targeted radionuclide therapies. The company focuses on the use of advanced models in oncology, cardiovascular diseases, and in vivo molecular imaging for translational research and drug development. Minerva Imaging is committed to understanding its clients’ scientific questions and discussing how its methods and capabilities can address them. The Danish facility offers best-in-class, fully integrated radiopharmaceutical research, drug development, and manufacturing services.

For more information, please visit www.minervaimaging.com

About ATONCO

ATONCO is a French private company developing targeted molecular radiation products for oncological applications. Originating from the world-renowned nuclear medicine centre in Nantes, ATONCO and its partners are committed to the clinical use of alpha-emitting radionuclides, particularly astatine-211 (211At).

For more information, please visit www.atonco-pharma.com

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Telix (Melbourne, Australia) and Nantes-based company ATONCO S.A.S. (‘ATONCO’) today announced that the last patient has been treated in a Phase I study of TLX250-CDx in patients with non-muscle-invasive bladder cancer (NMIBC) at the Institut de Cancérologie de l’Ouest (ICO) in St Herblain, France.

The objective of “PERTINENCE” (NCT04897763), an open-label, investigator-led proof-of-concept study that has reached its recruitment target of six patients, is to evaluate the safety, biodistribution, and dosimetric properties of TLX250-CDx (⁸⁹Zr-DFO-girentuximab) administered directly into the bladder in NMIBC patients, and to establish CAIX as a potential therapeutic target in this disease. If the trial proves conclusive, the next step will be to initiate therapeutic studies with astatine-211 (²¹¹At) for targeted alpha therapy (TAT). This aligns with Telix’s strategy to both develop alpha therapies and expand the potential indications of radiolabelled girentuximab (TLX250), which targets Carbonic Anhydrase IX (CAIX), a cell surface protein highly expressed in several human cancers, including renal, bladder, lung, and oesophageal cancers.

Alpha emitters such as ²¹¹At have the ability to deliver very large amounts of energy to cancerous tissues, while their short path length can reduce the risk of damaging surrounding healthy cells, thereby increasing the selectivity and potency of radiotherapy. Alpha emitters may be complementary to beta emitters at different stages of the disease.

Lutetium-labelled TLX250 (177Lu-DOTA-girentuximab) is currently being evaluated in clear cell renal cell carcinoma (ccRCC) in Phase II therapeutic studies in combination with checkpoint inhibitors (STARLITE 1 and 2), and the company’s Phase III imaging pivotal study (ZIRCON) of TLX250-CDx (⁸⁹Zr-DFO-girentuximab), also in ccRCC, has recently completed enrolment.

Dr Caroline Rousseau, Principal Investigator of the ICO-sponsored PERTINENCE study: “We are pleased to have successfully completed recruitment in this proof-of-concept study, which we hope will improve our understanding of the imaging properties of TLX250-CDx in NMIBC and pave the way for studying astatine-211-labelled girentuximab as a targeted alpha therapy.”

Dr Colin Hayward, Chief Medical Officer of Telix: “We would like to congratulate Dr Caroline Rousseau and her clinical team at ICO for recruiting this trial ahead of schedule, and express our gratitude to all study participants for their commitment to exploring innovative treatment options for patients living with NMIBC. Subject to positive results, we look forward to Atonco progressing to therapeutic studies with astatine-211 and exploring targeted alpha therapy in bladder cancer, as part of Telix and Atonco’s ambition to establish leadership in urological oncology.”

About Telix Pharmaceuticals Limited

Telix Pharmaceuticals Limited is an Australian clinical-stage biopharmaceutical company focused on the development of diagnostic and therapeutic products using targeted molecular radiotherapy (TMR). The company is headquartered in Melbourne with international offices in Brussels (EU), Kyoto (JP), and Indianapolis (US). Telix is developing a portfolio of clinical-stage oncology products addressing significant unmet medical needs in prostate, kidney, and brain (glioblastoma) cancers. Telix is listed on the Australian Securities Exchange (ASX: TLX).

For more information, visit www.telixpharma.com

About the Institut de Cancérologie de l’Ouest (ICO)

The ICO is a non-profit cancer centre with 1,400 professionals dedicated to fighting cancer. It welcomes nearly 48,000 patients per year and fulfils the mission and service of a public hospital. With its four missions – Prevention, Care, Research, and Education – the ICO offers broad and specialized expertise exclusively dedicated to oncology.

The integration of care, research, and innovation is an integral part of the ICO. Research activities, which constitute a specific mission of the ICO, are undertaken from concept through to clinical trials. Research is conducted across all disciplines of oncology: medical oncology, radiotherapy, surgery, anaesthesia, nuclear medicine, medical imaging, supportive care, and human sciences. Patients treated at the ICO benefit from privileged access to cutting-edge clinical trials in oncology. The Innovation Centre, opened in 2021, is dedicated to supporting innovation in oncology, backing both internal and external projects from concept through to operational deployment.

For more information, visit www.institut-cancerologie-ouest.com

About ATONCO

ATONCO is a French private company developing molecularly targeted radiopharmaceutical products for oncological applications. Originating from the world-class nuclear medicine centre in Nantes, ATONCO and its partners are committed to the clinical use of alpha-emitting radionuclides, particularly astatine-211 (²¹¹At).

For more information, visit www.atonco-pharma.com

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Atonco (Nantes-Saint Herblain, France) and Ionetix (Lansing, MI, USA) have signed a partnership agreement to ensure GMP manufacturing and supply of the radiopharmaceutical product required for the success of Atonco’s clinical studies and commercialization in the United States.

Atonco, a clinical-stage radiopharmaceutical company, aims to demonstrate through its clinical research program the relevance of a groundbreaking therapeutic treatment — alpha immunotherapy — targeting non-muscle-invasive bladder cancer.

IONETIX Corporation operates a GMP-compliant North American manufacturing and supply chain for alpha-emitting radiopharmaceuticals. Through this agreement, Ionetix will make available its astatine-211 radioisotope production capabilities and its network of radiopharmacies to manufacture patient doses in accordance with Good Manufacturing Practice (GMP).

The agreement covers the supply of the astatine-211 radioisotope, GMP manufacturing of injectable doses, and specifies the terms of the FDA agent agreement signed in August 2021.

IONETIX is pioneering the first commercial-scale supply of astatine-211 in North America from its cyclotron production facility in Lansing, MI.

David Eve, Vice President of Medical Affairs: “We are very excited about the partnership with Atonco, which will allow us to actively collaborate in its clinical development program and commercialization in the United States, subject to approval of Atonco’s drug candidates.”

Sylvain Fanier, Chairman of Atonco: “This partnership agreement is a key milestone in Atonco’s development. We are convinced that Ionetix is the most reliable and advanced partner to ensure optimal supply for our clinical development and commercialization in North America. Thanks to their expertise and experience in radiopharmaceutical manufacturing and FDA discussions, Ionetix will greatly contribute to our shared success in offering bladder cancer patients a highly promising therapeutic alternative.”

About IONETIX

IONETIX leverages its growing network of radiopharmaceutical manufacturing sites to support the development and commercialization of targeted alpha therapy (TAT). TAT is an emerging cancer treatment using alpha-emitting radionuclides that delivers high-energy alpha particles to cancer cells and the tumor microenvironment to treat cancer while sparing healthy tissues.

For more information, visit www.ionetix.com

About ATONCO

ATONCO is a French private company developing targeted molecular radiation products for oncological applications. Originating from the world-class nuclear medicine centre in Nantes, ATONCO and its partners are committed to the clinical use of alpha-emitting radionuclides, particularly astatine-211 (211At).

For more information, visit www.atonco-pharma.com

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Atonco announces that a first patient has been dosed in the Phase I ‘PERTINENCE’ study of TLX250-CDx in patients with non-muscle-invasive bladder cancer.

Telix Pharmaceuticals and ATONCO are pleased to announce that a first patient has been treated in the PERTINENCE feasibility study in patients with non-muscle-invasive bladder cancer (NMIBC) at the Institut de Cancérologie de l’Ouest (ICO) in St Herblain, France.

The objective of the PERTINENCE study, an open-label, investigator-led proof-of-concept study, is to evaluate the safety, biodistribution, and dosimetric properties of 89Zr-DFO-girentuximab in patients with bladder cancer. The PERTINENCE study builds on the licensing and development agreement between Telix and ATONCO announced in December 2019, and will be led by Dr Caroline Rousseau at the ICO. It will enroll 6 patients over 12 months, with a positive outcome leading to therapeutic studies with astatine-211 (²¹¹At) for targeted alpha therapy (TAT). TLX250-CDx (girentuximab) targets Carbonic Anhydrase IX (CA9), a receptor that is overexpressed in many solid tumors, particularly urological malignancies.

The study is consistent with Telix’s focus on developing alpha therapy as part of the future expansion of its pipeline and its strategy to seek additional indications for the CA9 target, a key pipeline asset currently being evaluated in clear cell renal cell carcinoma (ccRCC) in the company’s Phase III imaging study (ZIRCON) and Phase II therapeutic studies (STARLITE 1 and 2).

PERTINENCE is the third in a comprehensive series of studies evaluating CA9 as a therapeutic molecular radiation (TMR) target in other tumor types, and provides a pathway to evaluate TLX250 with an alpha-emitting isotope for the first time in humans.

Alpha emitters have the potential to deliver very large amounts of energy to cancerous tissues, while their short path length can reduce the risk of damage to surrounding healthy cells, thereby increasing the selectivity and potency of radiotherapy. Alpha emitters may be complementary to beta emitters at different stages of the disease.

The other two studies evaluating CA9 (ZiP-UP and OPALESCENCE) have been initiated for urothelial carcinoma or bladder cancer, and triple-negative breast cancer, respectively. Additional collaborative studies are under development for ovarian, colorectal, head and neck, lung, and pancreatic cancers.

Dr Caroline Rousseau, Principal Investigator of the PERTINENCE study: “CA9 is a very interesting target that is highly expressed in many hypoxic solid tumors. This study builds on the clinical work we are already doing with CA9 in the OPALESCENCE study and will help us generate a better understanding of the imaging properties of TLX250-CDx in NMIBC as a precursor to studying the role of girentuximab as a therapy with an alpha-emitting radioisotope.”

Sylvain Fanier, Chairman of ATONCO: “We are delighted to extend our partnership with Telix, one of the most respected companies in nuclear medicine, and to develop an innovative TMR solution with our local academic and industrial partners in Nantes, in order to improve therapeutic options for patients with non-muscle-invasive bladder cancer (NMIBC).”

Dr Colin Hayward, Chief Medical Officer of Telix: “We are pleased to continue our collaboration with ATONCO to explore girentuximab as a basis for therapy with the alpha-emitting radioisotope astatine-211 (²¹¹At), as well as to expand and accelerate development options across many cancer types for which there is an unmet medical need. We wish to express our gratitude to Dr Caroline Rousseau and her clinical team at the ICO, as well as to the patients who will contribute to this groundbreaking study.”

About Telix Pharmaceuticals Limited

Telix Pharmaceuticals Limited is a clinical-stage biopharmaceutical company focused on developing diagnostic and therapeutic products using targeted molecular radiation (TMR). The company is headquartered in Melbourne with international offices in Brussels (EU), Kyoto (JP), and Indianapolis (US). Telix is developing a portfolio of clinical-stage oncology products addressing significant unmet medical needs in prostate, kidney, and brain (glioblastoma) cancers. Telix is listed on the Australian Securities Exchange (ASX: TLX).

For more information, visit www.telixpharma.com

About ATONCO

ATONCO is a French private company developing molecularly targeted radiopharmaceutical products for oncological applications. Originating from the world-class nuclear medicine centre in Nantes, ATONCO and its partners are committed to the clinical use of alpha-emitting radionuclides, particularly astatine-211 (²¹¹At).

For more information, visit www.atonco-pharma.com

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