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

The license 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 of Telix’s antibody portfolio for use with astatine-211, an alpha-emitting radioisotope, to treat bladder cancer that is no longer responsive to standard therapies.

Dr. Christian Behrenbruch, CEO of Telix, said astatine-211 emits alpha particles with a favorable emission profile that is well suited for bladder cancer because it delivers highly localized antitumor radiation with minimal impact on surrounding tissue.

Under the agreement, Telix may receive development milestone payments of approximately A$30 million, as well as royalties upon successful commercialization. Telix retains a right to reacquire the program if clinical data are conclusive.

This collaboration with ATONCO represents a new milestone for Telix, as it is the first time we have licensed our intellectual property to a third party,” said Dr. Behrenbruch. “While we maintain a disciplined focus on our prostate, kidney and brain cancer programs, this collaboration demonstrates the attractiveness of Telix’s technology to our customers, this collaboration demonstrates the attractiveness of our intellectual property to other companies and allows our assets to be developed for new cancer indications beyond Telix’s core focus areas, while giving us the opportunity to re-annex the program if promising clinical data warrant.”

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

“This is truly a clinical indication with currently unmet therapeutic efficacy that could benefit from a new treatment through the antibody-targeted features of 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 resulting from bladder cancer. ATONCO is a privately held French company that develops radiopharmaceuticals for oncology applications. A spin-off of the world-class radiochemistry cluster that includes Nantes University Hospital and the ARRONAX Public Interest Group (GIP), 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 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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