Atonco and GIP ARRONAX (Saint Herblain, France) have joined forces to take the next step in the implementation of alpha-immunotherapy for cancer. Their partnership aims to develop and validate the radiopharmaceutical production process under GMP (Good Manufacturing Practice) conditions for Atonco’s ATO-101 (Girentuximab radiolabeled with astatine-211), with a view to clinical intravesical instillation for the treatment of non-musculo-invasive bladder cancer. Through this collaboration, two players in Nantes’ radiopharmaceutical industry are combining their expertise: the development of innovative radiopharmaceuticals using astatine-211 (Atonco) and the production of radionuclides and radiopharmaceuticals for nuclear medicine research (GIP ARRONAX).

This collaboration represents a key step in the transfer to the clinic of astatine-211, an alpha particle emitting radionuclide enabling the selective destruction of targeted tumor cells. It builds on the astatine-211 production expertise developed within GIP ARRONAX, and follows on from the radiochemistry research work carried out in Nantes by CRCI²NA team 2, which led to the development of radiolabeling and control methods for astatine-211-labeled Girentuximab. As part of this partnership with Atonco, GIP ARRONAX plays a key role in the pharmaceutical development and validation of manufacturing processes and control methods under GMP conditions, in preparation for the production of validation batches with a view to the first human clinical trials.

Laurette Fisson, Atonco’s CMC and Product Development Director: “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 therapies. We are delighted to collaborate with GIP ARRONAX, a long-standing partner with recognized expertise in radiopharmaceutical research and development.”

Férid Haddad, Director of GIP ARRONAX: “This collaboration with Atonco is the culmination of nearly 15 years’ work by GIP ARRONAX on astatine-211, a promising alpha emitter. We are proud to contribute to the progress of nuclear medicine, and particularly to the development of alpha radiotherapy, a therapeutic solution with a future.”

About Atonco:

Atonco is a private company developing targeted radiopharmaceuticals for oncology applications. Atonco and its partners, who have emerged from the nuclear medicine cluster in Nantes, are committed to the clinical use of alpha-emitting radionuclides, in particular astatine-211.

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

About GIP ARRONAX :

ARRONAX is a grouping of several public and private-sector members carrying out public-interest missions in the fields of research, economic development and training. It has a high-energy, high-intensity multi-particle cyclotron for the production of non-conventional radionuclides, including astatine-211, of which it is one of two European producers. GIP ARRONAX manufactures radiopharmaceuticals to GMP/GMP standards to support early-stage clinical research.

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

Contacts :

• Tony Prézeau, Director Technology Transfer and Partnerships, GIP ARRONAX
  prezeau@arronax-nantes.fr
• Sylvain Fanier, President, Atonco
  fanier@atonco-pharma.com

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

Bladder cancer ranks among the most prevalent cancers globally, standing at the 10th position overall and the 6th most common in men. In 2020, it accounted for over 573,000 incident cases and approximately 212,000 deaths around the world.

While Bacillus Calmette-Guérin (BCG) therapy is the standard of care, it fails in approximately 40% of cases leading to consequential radical bladder ablation procedures and while more recent therapies, such as immune checkpoint inhibitors, have entered the clinic realm, more options are needed.

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

The study will be led by Benjamin Viglianti, MD, PhD in collaboration with Peter Scott, PhD.  “The transformative potential of targeted radiopharmaceutical therapies in the field of cancer treatment is substantial as these therapies have the ability to deliver radiation directly and specifically to cancer cells, potentially reducing the risk of complications as compared to traditional BCG therapy in our clinical study” notes Viglianti, Nuclear Medicine Clinical Service Chief at University of Michigan.

“We are thrilled to partner with the University of Michigan and leverage their world-class expertise in radiopharmaceutical clinical research towards discovering the safety and activity profile of ATO-101™. Atonco’s team will include Mrs. Aurélie Moreau and Mr. Denis Bilodeau, a seasoned clinical research expert who is guiding our clinical team for North America and Europe.” said Jean-François Chatal, MD, founder and Chief Medical Officer of Atonco.

The Phase 1-2a trial will be conducted at the University of Michigan and will involve a number of satellite sites. The study is expected to begin enrollment in the coming months once the FDA has cleared the study design.

About ATONCO

Atonco is a privately held French company developing molecularly targeted radiopharmaceuticals for oncology applications. The company is dedicated to the clinical use of astatine-211, an alpha-emitting radionuclide, to treat cancer.

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

About UNIVERSITY OF MICHIGAN

University of Michigan is a leading public research university committed to advancing knowledge and solving complex challenges. The university’s world-class faculty and state-of-the-art facilities make it a premier destination for cutting-edge medical research and clinical trials.

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

1. Bladder cancer statistics: World cancer research fund international. WCRF International. (2022, April 14). https://www.wcrf.org/cancer-trends/bladder-cancer-statistics/

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ATONCO (Saint Herblain, France) and Minerva Imaging (Oelstykke, Denmark), are pleased to announce a close collaboration to combine their strengths to fight bladder cancer. Minerva Imaging will produce clinical doses for the planned European ATONCO Phase I alpha-immunotherapy clinical trial using ²¹¹At-Girentuximab (TLX250 licenced fromTelix Pharmaceutical radiolabeled with Astatine-211).

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

Sylvain Fanier, President of ATONCO, states: “We are excited to pursue the worldwide development of alpha-immunotherapy targeting non-muscle invasive bladder cancers (NMIBC). Since our foundation in 2019 ATONCO has focussed on building a world-class team and establishing all the required tools and technologies to enable novel 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, emphasizes the importance of the collaboration:“With the recent opening of our CDMO facility we are able to manufacture radiopharmaceutical drugs in compliance with Good Manufacturing Practice (GMP). For the ²¹¹At-Girentuximab phase I clinical trial we will be sourcing At-211 from Rigshospitalet. With the close proximity of Rigshospitalet and Minerva Imaging (less than 60 minutes by car) we are the ideal European collaboration partner for ATONCO and we look forward to being part of advancing the clinical application of At-211-based targeted radionuclide therapies.”

About Minerva Imaging:

Minerva Imaging is a scientifically driven CRO and CDMO specialized in targeted radionuclide therapies. The company focusses on the use of advanced models within oncology, cardiovascular diseases and in vivo molecular imaging for translational research and drug development. Minerva Imaging engages with its clients to understand their scientific questions and discuss how its methods and capabilities can provide answers. The facility located in Denmark offers best–in–industry, fully integrated radiopharmaceutical research, drug development and manufacturing services.

For more information, please visit www.minervaimaging.com

About Atonco:

ATONCO is a privately-owned French company that develops targeted molecular radiation products for oncological applications. Stemming from Nantes’ world-class nuclear medicine hub, 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 ATONCO S.A.S. (‘ATONCO’) today announced that the final patient has been dosed 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 investigator-led, open-label, proof of concept study, which has reached target enrolment of six patients, is to evaluate safety, biodistribution and dosing properties of TLX250-CDx (⁸⁹Zr-DFO-girentuximab) given directly into the bladder in patients with NMIBC and establish CAIX as a potential therapeutic target in this condition. Should the trial prove successful, the next stage will be to commence therapeutic studies with astatine-211 (²¹¹At) for targeted alpha therapy (TAT). This is aligned with Telix’s strategy to both develop alpha therapeutics and expand potential indications for radiolabelled girentuximab (TLX250), targeting carbonic anhydrase IX (CAIX), a cell surface protein that is highly expressed in several human cancers including renal, bladder, lung and oesophageal cancers.

Alpha emitters such as ²¹¹At have the potential to deliver very high amounts of energy to cancer tissue whilst the short path length can decrease the risk of damage to surrounding healthy cells, increasing the selectivity and potency of the radiation treatment. Alpha emitters have the potential to be complementary to beta-emitters in different stages of 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 pivotal Phase III imaging study (ZIRCON) of TLX250-CDx (⁸⁹Zr-DFO-girentuximab) also in ccRCC, has recently completed enrolment.

Principal Investigator for the PERTINENCE study, sponsored by ICO, Dr. Caroline Rousseau said, “We are pleased to have successfully completed enrolment 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-labelled girentuximab as a targeted alpha therapy.”

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

About Telix Pharmaceuticals Limited

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

For more information, visit www.telixpharma.com

About ICO (Institut de Cancérologie de l’Ouest)

The ICO is a non-profit center of 1,400 professionals that fights cancer. It welcomes nearly 48,000 patients per year and provides the mission and service of a public hospital. With its four missions – Prevention, Care, Research and Education – the ICO offers a wide range of specialized expertise exclusively dedicated to cancer.

The integration of care, research and innovation is an integral part of the ICO. Research activities, which are a specific mission of the ICO, are undertaken from concept to clinical trials. Research is conducted in all cancer disciplines: medical oncology, radiotherapy, surgery, anesthesia, 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 Center, which will open in 2021, is dedicated to supporting innovation in oncology, and thus supports internal and external projects, from concept to operational deployment.

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

About ATONCO

ATONCO is a privately held French company developing molecularly targeted radiopharmaceuticals for oncology applications. Originating from the world-class nuclear medicine cluster in Nantes, France, ATONCO and its partners are committed to the clinical use of alpha-emitting radionuclides, in particular 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 the manufacturing and GMP supply of the radiopharmaceutical product required for the successful completion 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 revolutionary therapeutic treatment, alpha immunotherapy, targeting non-musculo-invasive bladder cancer.

IONETIX Corporation operates a North American GMP manufacturing and supply chain for alpha emitting radiopharmaceuticals. Through this agreement, Ionetix will provide its production capabilities for the radioisotope, astatine-211, and its network of radiopharmacies to manufacture patient doses in accordance with good pharmaceutical manufacturing practices (GMP).

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

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

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

“This partnership agreement is a key step in the development of Atonco,” said Sylvain Fanier, President of Atonco. 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. With their expertise and experience in radiopharmaceutical manufacturing and FDA discussions, Ionetix will greatly contribute to our joint success in providing bladder cancer patients with a very promising therapeutic alternative.

About IONETIX

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

For more information, visit www.ionetix.com

About ATONCO

ATONCO is a privately-held French company that develops targeted molecular radiation products for oncology applications. Originating from the world-class nuclear medicine cluster in Nantes, France, ATONCO and its partners are committed to the clinical use of alpha-emitting radionuclides, in particular astatine-211 (211At).

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

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