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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ATONCO announces that the 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 the 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 investigator-led, open-label proof-of-concept study, is to evaluate the safety, biodistribution and dosing properties of 89Zr-DFO-girentuximab in patients with bladder cancer. The PERTINENCE study builds on the license 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 astatin-211 (²¹¹At) for targeted alpha therapy (TAT). TLX250-CDx (girentuximab) targets carbonic anhydrase IX (CA9), a receptor that is overexpressed in many solid tumors, including urologic malignancies.

The study is consistent with Telix’s focus on developing an alpha therapy as part of its future pipeline expansion 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 investigating CA9 as a therapeutic molecular target (MTR) in other tumor types, and provides a pathway to evaluate TLX250 with an alpha emitter isotope for the first time in humans.

Alpha emitters have the potential to deliver very large amounts of energy to cancerous tissue, while the short path length may reduce the risk of damage to surrounding healthy cells, thereby increasing the selectivity and power of radiation therapy. 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 in urothelial carcinoma or bladder cancer and triple-negative breast cancer, respectively. Other collaborative studies are in development for ovarian, colorectal, head and neck, lung and pancreatic cancers.

Dr. Caroline Rousseau, principal investigator of the ICO-promoted PERTINENCE study, said, “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 investigating the role of girentuximab as an alpha emitting radioisotope therapy.”

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

Dr. Colin Hayward, Chief Medical Officer of Telix, added, “We are pleased to continue our collaboration with ATONCO to explore girentuximab as a basis for therapy with the alpha-emitting radioisotope astatin-211 (²¹¹At), as well as to expand and accelerate development options to many types of cancer for which there is an unmet medical need. We would like 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 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 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 S.A.S. (‘ATONCO’) announced today that it has entered into a clinical research partnership agreement with the Institut de Cancérologie de l’Ouest (ICO Nantes Angers) regarding the clinical study of its CA-IX-binding antibody, ⁸⁹Zr-girentuximab, with PET imaging to document the absence of extravasation of radioactivity into the systemic circulation after intravesical instillation, and to visualize targeted papillary tumors.

This imaging and dosimetry study using ⁸⁹Zr-girentuximab is considered a “clinical proof of concept” prior to the subsequent therapeutic use of astatine-211 in a Phase I/II clinical development.

The clinical project will include 6 patients (3 men and 3 women), and is based on the license and development agreement between Telix and ATONCO for ATONCO to investigate the use of Telix’s Molecularly Targeted Radiation (MTR) intellectual property for the treatment of non-muscle-invasive bladder cancer resistant to standard therapies.

Under the agreement, ATONCO has a license to conduct R&D activities on girentuximab, radiolabeled with At-211, for the intravesical treatment of chemotherapy- or BCG-resistant bladder cancer, and subsequent commercialization of this product, if successful.

ATONCO will accelerate its therapeutic development targeting BCG-resistant bladder cancer. Dr. Caroline Rousseau, Head of Nuclear Medicine at the ICO (Institut de Cancérologie de l’Ouest) in Nantes, the clinical site and sponsor of the study, will lead the feasibility study as principal investigator.

Jean-François Chatal, ATONCO’s founder and medical director, said: “The unmet clinical need for non-muscle-invasive bladder cancer refractory to BCG or chemotherapy fits well with the radiophysical characteristics of astatine-211 with tumor targets rapidly accessible after intravesical instillation of girentuximab and consisting of thin superficial tumor layers corresponding to the short path length of the alpha particles. This alpha-immunotherapy should make it possible to avoid very uncomfortable radical cystectomies and thus prolong the life and improve the quality of life of our bladder cancer patients. We are confident that this is the first successful step in our partnership with ICO.”

Sylvain Fanier, President of ATONCO, said, “We are delighted to partner with ICO, one of the most respected clinical institutions in the field of oncology, and to develop with our local academic and preclinical CRO partners in Nantes an innovative Molecular Targeted Radiation (MTR) solution to improve the management of patients with non-muscle-invasive bladder cancer.”

In 2018, bladder cancer was the fifth most common cancer in the United States, with an estimated 82,501 new cases diagnosed and 17,755 deaths resulting from bladder cancer.

About ICO (Institut Cancérologie de l’Ouest) 

ICO is a 1,400 professional strong not-for-profit center fighting against cancer. It welcomes close to 48,000 patients per year, and conducts the mission and service of a public hospital. Strengthened by its 4 missions – Prevention, Care, Research and Teaching – ICO offers broad, state-of-the-art expertise that is exclusively dedicated to cancerology.

The integration of care, research and innovation is integral to ICO. Research activities, which are a specific mission at ICO, are undertaken from concept all the way through to clinical trials. Research is conducted in all disciplines of cancerology: medical oncology, radiotherapy, surgery, anaesthesia, nuclear medicine, medical imagery, support care, and human sciences. Patients who are cared for at ICO receive privileged access to cutting edge clinical trials in cancerology. The Innovation Centre, opened in 2021, is dedicated to accompanying innovation in oncology, and thus supports internal and external projects, from concept, all the way to operational deployment.

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

About ATONCO

ATONCO is a privately held French company that develops 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 announced today that Adrien Reymond, PharmD, B.Eng and EMBA candidate, will lead Regulatory Affairs and Quality.

Adrien, with 15 years of experience in the radiopharmaceutical industry (AAA, a Novartis company), PETNET Solutions (a Siemens company), Atlanpole Biotherapies and consulting for innovative radiopharmaceutical companies, will be in charge of Pharmaceutical and Regulatory Affairs and Quality Assurance to comply with Good Clinical Practices (GCP) and the preparation of the ISO 9001:2015 certification

The entire Atonco team is delighted to welcome Adrien Reymond to the company, both for his expertise and experience in the radiopharmaceutical industry and for his motivation to join the Atonco adventure.

About ATONCO

ATONCO is a privately held French company developing molecularly targeted radiopharmaceuticals for oncology applications. Stemming from the world-class nuclear medicine cluster in Nantes, 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 announces today that Sylvain Fanier, Msc. EMBA, will succeed Professor Jean-François Chatal as President as of March 16, 2020.

Sylvain Fanier has spent his career overseeing and leading the development of several global medical innovations in the healthcare sector. He brings to the company his leadership in strategy, global business perspective and financing, acquired over the past 30 years in large corporations such as Johnson and Johnson and CR Bard and in medical startups. Specialized in disruptive medical innovation, he has accompanied the success of innovative companies such as Lemerpax, Cardioinsight, Sonoscanner, Soundbite Medical Solutions, Surgivisio and Med-Innov through his consulting company, Novariver.

He holds a bachelor’s degree in biochemistry and a master’s degree in biology with a physiology option from Paul Sabatier University in Toulouse. He also holds an EMBA from ESSEC, Paris, France.

Sylvain is a member of the Board of Directors of Soundbite Medical Solutions Inc (Montreal, Canada), and of Ecential Robotics SAS (Grenoble, France).

Jean-Pierre Cabocel, Chairman of the Board of Directors, said: “I am delighted that Sylvain is taking on the position of President. I am confident that he will play a key role in the development and success of Atonco. I am also delighted that Jean-François Chatal will remain involved in our developments as co-founder and Medical Director.

“It is an honor to be named President of Atonco,” added Mr. Fanier. “With the support of the management team and talented and experienced advisors, we will optimize our development, strengthen our organization and partnerships to ensure the growth of Atonco.”

About ATONCO

ATONCO is a privately held French company developing molecularly targeted radiopharmaceuticals for oncology applications. Stemming from the world-class nuclear medicine cluster in Nantes, 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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