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ATONCO S.A.S. (‘ATONCO’) today announces that it has entered into a clinical research partnership agreement with the Institut de Cancérologie de l’Ouest (ICO Nantes Angers) for the clinical study of its CA-IX-binding antibody, ⁸⁹Zr-girentuximab, using PET imaging, to document the absence of radioactivity extravasation into the general 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 enroll 6 patients (3 men and 3 women), and builds on the licensing and development agreement between Telix and ATONCO, allowing ATONCO to study the use of Telix’s intellectual property, Molecularly Targeted Radiation (MTR), for the treatment of non-muscle-invasive bladder cancer resistant to standard therapies.

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

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

The unmet clinical need of non-muscle-invasive bladder cancer refractory to BCG or chemotherapy aligns well with the radiophysical characteristics of astatine-211, with tumor targets rapidly accessible after intravesical instillation of girentuximab, consisting of thin superficial tumor layers matching the short path length of alpha particles. This alpha-immunotherapy should help avoid highly discomforting radical cystectomies, thereby prolonging life and improving the quality of life of our bladder cancer patients. We are confident this is the first successful step in our partnership with the ICO.

Jean-François Chatal, Founder and Chief Medical Officer of ATONCO

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

Sylvain Fanier, Chairman of ATONCO

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 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, across all oncology disciplines: 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. The Innovation Centre, opened in 2021, supports 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 today announces that Adrien Reymond, PharmD, B.Eng and EMBA candidate, will lead regulatory affairs and quality.

Adrien brings 15 years of experience in the radiopharmaceutical industry, including at AAA (a Novartis company), PETNET Solutions (a Siemens company), Atlanpole Biotherapies, and as a consultant for innovative radiopharmaceutical companies. He will be responsible for pharmaceutical, regulatory, and quality assurance affairs, ensuring compliance with Good Clinical Practices (GCP) and overseeing preparation for 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 enthusiasm in joining the Atonco adventure.

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 today announces that Sylvain Fanier, MSc. EMBA, will succeed Professor Jean-François Chatal as Chairman effective March 16, 2020.

Sylvain Fanier has dedicated his career to overseeing and driving the development of several global medical innovations in the healthcare sector. He brings to the company strategic leadership and a global perspective on business and financing, acquired over 30 years at major corporations such as Johnson & Johnson and CR Bard, as well as in medical startups. Specializing in disruptive medical innovation, he has supported the success of innovative companies such as Lemerpax, Cardioinsight, Sonoscanner, Soundbite Medical Solutions, Surgivisio, and Med-Innov through his consulting firm, Novariver.

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

Sylvain serves on the board of directors of Soundbite Medical Solutions Inc. (Montreal, Canada) and Ecential Robotics SAS (Grenoble, France).

I am delighted that Sylvain is taking on the role of Chairman. I am certain he will play a decisive role in the development and success of Atonco. I am also pleased that Jean-François Chatal will remain engaged in our developments as co-founder and Chief Medical Officer.

Jean-Pierre Cabocel, Chairman of the Board of Directors

It is an honor to be appointed Chairman of Atonco. With the support of the management team and our talented and experienced advisors, we will optimize our development, strengthen our organization and partnerships to ensure Atonco’s continued growth.

Sylvain Fanier

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

Australian biopharmaceutical company Telix Pharmaceuticals Limited (ASX: TLX) has signed an agreement with French company ATONCO S.A.S. to study the use of Telix’s MTR (Molecularly Targeted Radiation) technology.

The licensing and development agreement will allow ATONCO to study the use of MTR technology for the treatment of non-muscle-invasive bladder cancer that is resistant to standard therapies.

Under the agreement, ATONCO will receive a license to select components from Telix’s antibody portfolio for use with astatine-211, an alpha-emitting radioisotope, with the aim of treating bladder cancer that no longer responds to standard therapies.

Dr Christian Behrenbruch, CEO of Telix, stated that astatine-211 emits alpha particles with a favorable emission profile well suited to bladder cancer, as it delivers highly localized anti-tumor radiation with minimal impact on surrounding tissues.

Under the agreement, Telix may receive development milestone payments of approximately AUD 30 million, as well as royalties in the event of successful commercialization. Telix retains a right to re-acquire the program in the event of compelling clinical data.

“This collaboration with ATONCO represents a new milestone for Telix,” said Dr Behrenbruch. “While we maintain a disciplined focus on our prostate, kidney, and brain cancer programs, this collaboration demonstrates the appeal of our intellectual property to other companies and allows our assets to be developed for new cancer indications beyond Telix’s primary areas of interest, while giving us the opportunity to re-annex the program if compelling clinical data warrants it.”

Professor Jean-François Chatal, CEO of ATONCO, stated that the collaboration with Telix Pharmaceuticals is driven by the clinical potential of alpha immunotherapy for refractory non-muscle-invasive bladder cancer.

“This is truly a clinical indication with currently unmet therapeutic efficacy that could benefit from a new treatment thanks to the characteristics of antibody-targeted astatine-211.”

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. ATONCO is a French private company developing radiopharmaceutical products for oncological applications. Originating from the world-class radiochemistry hub that includes the Nantes University Hospital and the Public Interest Group (GIP) ARRONAX, ATONCO and its academic collaborators are dedicated to the clinical use of astatine-211.

About Telix Pharmaceuticals Limited

Telix Pharmaceuticals Limited is a clinical-stage biopharmaceutical company focused on developing diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). 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