Grand Pharma’s Global Innovative Radionuclide-Drug Conjugate TLX250-CDx Overseas Phase III Clinical Trial Has Met Clinical Endpoints

Grand Pharma’s Global Innovative Radionuclide-Drug Conjugate TLX250-CDx Overseas Phase III Clinical Trial Has Met Clinical Endpoints

  • The sensitivity and specificity of TLX250-CDx in the diagnosis of ccRCC far exceeded the preset threshold required by the FDA, and successfully met primary and secondary endpoints;
  • These breakthrough clinical results demonstrate that TLX250-CDx is expected to provide a highly accurate and non-invasive diagnostic solution for ccRCC, and has the potential to become a new clinical diagnostic standard for ccRCC;
  • This clinical progress has provided positive data support for the follow-up clinical registration of TLX250-CDx in China and the potential expansion indications in CA9-overexpressing tumors other than renal cancer.

(November 10, 2022 - Hong Kong) Grand Pharmaceutical Group Limited (“Grand Pharma” or the “Company”, together with its subsidiaries, the “Group”, stock code: 00512) is pleased to announce that recently Telix Pharmaceuticals Limited (ASX: TLX, “Telix”), the Group’s key strategic partner in the field of radionuclide-drug conjugate (“RDC”), has announced positive topline results from the overseas Phase III clinical study of TLX250-CDx for the diagnosis of clear cell renal cell carcinoma (“ccRCC”). According to the study results, for the patients with renal masses suggested by computerized tomography (CT) or magnetic resonance imaging (MRI) but unable to determine whether it is ccRCC, the sensitivity and specificity of positron emission tomography (PET) imaging with TLX250-CDx in the diagnosis of ccRCC reached 86% and 87% respectively, which far exceeded the preset threshold required by the US Food and Drug Administration (“FDA”) (both sensitivity and specificity higher than or equal to 70%). Its positive predictive value has reached 93%, and successfully met primary and secondary endpoints. Moreover, for early ccRCC in stage T1a, which is currently difficult to diagnose (the tumor is confined to the kidney with the largest tumor diameter smaller than or equal to 4 cm), the sensitivity and specificity of TLX250-CDx diagnosis reached 85% and 89% respectively. These breakthrough clinical results demonstrate that TLX250-CDx is expected to provide a highly accurate and non-invasive diagnostic solution for ccRCC, and has the potential to become a new clinical diagnostic standard for ccRCC. Based on these positive clinical results, Telix announced that they intended to submit a Biologics License Application (BLA) for TLX250-CDx to the FDA. Meanwhile, this milestone progress will provide further data support for the product’s clinical registration in China.

TLX250-CDx is a globally innovative radionuclide conjugated drug for the diagnosis of ccRCC. Its target is carbonic anhydrase IX (“CA9”). CA9 is overexpressed in ccRCC and various cancer types. TLX250-CDx was granted Breakthrough Therapy Designation by the FDA in July 2020 based on its important breakthroughs in non-invasive diagnosis for the most common and aggressive type of kidney cancer - ccRCC as well as the patients’ follow-up treatment and management decisions. Its overseas Phase III clinical study has completed the recruitment of all 300 subjects in July 2022, and Phase I clinical trial and the confirmatory clinical trial in China has been approved in September 2022. The achievement of clinical endpoints in the Phase III clinical study of TLX250-CDx is a major milestone in the development and registration of the product. It not only provides a new non-invasive diagnostic solution for the clinical diagnosis of ccRCC, but also reveals the great potential of CA9 in the field of targeted therapy for malignant tumors. It has provided positive data support for the follow-up clinical registration of the product in China and the potential expansion indications in CA9-overexpressing tumors other than renal cancer.

By adhering to the treatment concept of integrated oncology diagnosis and treatment, the Group has reserved 13 innovative products in its nuclear medicine anti-tumor diagnosis and treatment segment, covering 6 nuclides including 68Ga, 177Lu, 131I, 90Y, 89Zr and 99mTc as well as 8 cancers including liver cancer, prostate cancer and brain cancer. In terms of product types. It covers two types of radionuclide drugs for diagnosis and treatment, providing patients with multi-indication treatment options, multi-method and integrated diagnosis and treatment of the world’s leading anti-tumor solutions. At the same time, the Group and Shandong University jointly established Grand Pharma - Shandong University Radiopharmaceutical Research Institute (遠大醫藥-山東大學放射藥物研究院) to jointly carry out the R&D of RDC drugs on the basis of radionuclide research by the Laboratory Nuclear Medicine Research Institute (實驗核醫學研究所) of Shandong University.

The nuclear medicine anti-tumor diagnosis and treatment platform is the Group’s high-end technology platform in the field of anti-tumor. The Group has achieved a comprehensive strategic plan in the fields of R&D, production, sales, regulatory qualifications and established a complete industrial chain. The Group, together with Sirtex Medical Pty Limited, cooperated with Telix and ITM Isotope Technologies Munich SE to establish a world-class tumor intervention R&D platform and a radionuclide-drug conjugate R&D platform. It has more than 400 employees, with approximately 35% of them holding master’s degrees and doctoral degrees, and is one of the most globalized segments of the Group. The Group has become a leading enterprise in nuclear medicine anti-tumor diagnosis and treatment in China. In the next 1 to 2 years, the Group will continue to strengthen the R&D and investment in the nuclear medicine anti-tumor diagnosis and treatment segment, enrich and improve the product pipeline and industrial layout, establish at least one production platform with Grade A qualification in China, realize the pipeline layout of more than twenty-five nuclear medicine anti-tumor diagnosis and treatment products, form a nuclear medicine anti-tumor diagnosis and treatment product cluster with the core of Yttrium-90 microsphere injections.

The Board of Grand Pharmaceutical Group Limited, commented, “In the future, the Group will continue to increase investment and development of global innovative products in the field of radionuclide diagnosis and treatment drugs for unmet clinical needs, enrich and improve product pipelines and industrial strategic plan, constantly enhance the Group’s global R&D strength in this field, make contribution to the development of radiopharmaceutical industry in China, and strive to build an internationally leading radiopharmaceutical diagnosis and treatment platform with a dual-system development path of local + global R&D and production.”