GP (HK)’s Associate OncoSec Enters into A Collaboration Agreement with Merck to Conduct a Global Phase III Study in Advanced Metastatic Melanoma. The R&D of TAVO™ Records Landmark Progress, Continuing to Consolidate the Strategic Planning in Anti-Tumor Immunology Field
(July 8, 2021 - Hong Kong) China Grand Pharmaceutical and Healthcare Holdings Limited (“GP (HK)” or the “Company”, together with its subsidiaries, the “Group”, stock code: 00512) is pleased to announce that OncoSec Medical Incorporated (NASDAQ:ONCS) (“OncoSec”, an associate company of the Group), a research and development platform of the Group in the field of tumor immunity and DNA technology, announced that it has entered into clinical research cooperation agreement (“Cooperation Agreement”) with Merck (known as MSD outside the United States and Canada) (NYSE: MRK) to conduct a global phase III study of the interleukin-12 (IL-12) plasmid DNA drug TAVO™ in combination with the anti-PD-1 drug KEYTRUDA® (pembrolizumab) in advanced metastatic melanoma (“KEYNOTE-C87 Study”). The planned clinical trial will evaluate the overall survival of patients treated with the TAVOTM in combination with KEYTRUDA® versus standard of care in late-stage patients with metastatic melanoma who are refractory to immune checkpoint therapy.
Sticking to patients-centered and innovation-driven, the Group continue to expand its strategic planning in anti-tumor field and increase its investment in the world-class innovative products in the fields of radiopharmaceuticals and anti-tumor immunology. Through cooperating with the three global leading anti-tumor pharmaceutical companies which are invested by the Group, including US based OncoSec, Australia based Sirtex Medical Pty Ltd. and Telix Pharmaceuticals Limited (ASX: TLX), the Group will continue to introduce world-class innovative products for different cancer indications in response to unmet clinical needs and enrich product pipeline and improve supply chain, dedicating itself into building world-leading radiopharmaceuticals platform and anti-tumor immunology platform, and integrating diagnostics and treatment. The Group will continue to adopt the strategy of “global expansion and dual-cycle operation”, forming a new pattern of domestic and international cycles that synergize with each other.
According to the terms of the Cooperation Agreement, the KEYNOTE-C87 study is planned to be carried out in the United States, Canada, the European Union and Australia, and plans to recruit about 400 patients with stage III or IV unresectable metastatic melanoma who are ineffective for immune checkpoint therapy. The study aims to support the accelerated approval of TAVO™ by the FDA and is also as a pivotal study to support the full licensure of TAVO™ for marketing.
TAVO™, the core product of OncoSec, can continuously express IL-12 in tumors and its microenvironment based on the DNA encoding IL-12 to trigger the immune response of the body, enabling the immune system to target and attack tumor cells in order to inhibiting tumor cells growth. Its treatment method for drug-resistant metastatic melanoma was granted Orphan Drug status by the US Food and Drug Administration (FDA) in 2017. At present, TAVO™ has received Fast Track Designation from the FDA. With the development of its clinical combination with KEYTRUDA® or OPDIVO® (nivolumab), TAVO™ is expected to become a potential first-in-class drug in the world for the treatment of metastatic melanoma. The market prospect is very considerable.
The Board of China Grand Pharmaceutical and Healthcare Holdings Limited, commented, “the Group has been committed to the strategic planning in anti-tumor and other technological innovative fields. The Cooperation Agreement reached between OncoSec and Merck once again confirmed the Group’s accurate vision in strategic planning of global innovation. The KEYNOTE-C87 Study will not only advance the marketing process of TAVO™, it is also expected to make a breakthrough in the treatment of late-stage metastatic melanoma. Looking ahead, the Group will continue to make use of its domestic industrial advantages and research and development capabilities, to accelerate commercialization process for innovative products, provide cancer patients with more advanced and diverse treatment options in the world, as well as creating greater returns for shareholders.”