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