Jicheng Pharmaceutical (02616) submits clinical trial application for its flagship product CS2009 (PD-1/VEGF/CTLA-4 triple antibody) in Australia.

Cornerstone Pharmaceuticals (02616) announced today that its pipeline 2.0 blockbuster product CS2009 (PD-1/VEGF/CTLA-4 triple-specific antibody) for the treatment of various solid tumors has submitted a clinical trial application in Australia. The study has also been registered on the Clinicaltrials.gov website (registration number: NCT06741644) and made public. In addition, Cornerstone Pharmaceuticals plans to initiate the global multicenter, first-in-human study of CS2009 in Australia in early 2025, with future expansion to China and the United States. CS2009 is a triple-specific antibody with an innovative structural design that targets PD-1, VEGFA, and CTLA-4 simultaneously. CS2009 has a balanced affinity for both anti-PD-1 and anti-CTLA-4, selectively targeting and blocking PD-1 and CTLA-4 on double-positive tumor-infiltrating lymphocytes (TILs) without affecting CTLA-4 on single-positive cells, thus reducing potential systemic toxicity while ensuring efficacy. CS2009 can also induce efficient internalization, reducing the expression of the immune inhibitory molecules PD-1 and CTLA-4 on double-positive TILs cells. Furthermore, CS2009 retains its full anti-VEGF function, and preclinical data indicate a synergistic effect between its anti-VEGF and immune checkpoint inhibition activities - cross-linking with VEGFA significantly enhances the activity of anti-PD-1 and anti-CTLA-4. Cornerstone Pharmaceuticals presented preclinical data of CS2009 at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC). The preclinical data demonstrate that CS2009 has superior anti-tumor activity compared to potential competitors, with the potential to cover a wide range of tumor types, including non-small cell lung cancer, ovarian cancer, renal cell carcinoma, cervical cancer, liver cancer, stomach cancer, etc., making it a pioneering/optimal next-generation tumor immunotherapy product in its class. Dr. Yang Jianxin, CEO, Chief Scientific Officer, and Executive Director of Cornerstone Pharmaceuticals, stated: "We are pleased to see the timely submission of Phase I clinical trial application for CS2009, marking another significant milestone in Cornerstone Pharmaceuticals' pipeline 2.0. CS2009 is a new triple-specific antibody that we initiated in 2022 and independently developed from molecular design, with strong preclinical data support, aiming to replace existing PD-(L)1 therapy. Through close collaboration and efforts across departments, CS2009 smoothly entered the clinical development stage, and we will soon initiate its first human study in Australia, looking forward to seeing the benefits of CS2009 for cancer patients, especially those with low PD-(L)1 expression or who are non-responsive to PD-(L)1 therapy." CS2009 is a triple-specific molecule targeting PD-1, VEGFA, and CTLA-4, with the potential to be a pioneering/optimal triple-targeted antibody for large tumor types. Its differential molecular design combines three clinically verified targets, able to reinvigorate exhausted tumor-infiltrating T cells and possess VEGF neutralizing ability similar to original anti-VEGF antibodies. With a wide range of disease coverage, including non-small cell lung cancer, ovarian cancer, renal cell carcinoma, cervical cancer, liver cancer, stomach cancer, etc. In November 2024, Cornerstone Pharmaceuticals presented preclinical data of CS2009 at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC). The preclinical data demonstrate that CS2009 has superior anti-tumor activity compared to potential competitors, including PD-1/CTLA-4 dual antibodies, PD-1/VEGF dual antibodies, and anti-PD-1/anti-CTLA-4 combination therapy.