With Kangfang Biopharma's successful challenge to PD-1 monoclonal antibody with Ivoside, tumor immunotherapy (IO) has rapidly evolved to the 2.0 era. PD-(L)1/VEGF bispecific antibodies have been snapped up by MNCs, and PD-(L)1/VEGF trispecific antibodies have gradually become a research and development trend, indicating that tumor treatment is accelerating towards multi-target synergy.

Recently, CStone Pharmaceuticals announced the latest clinical progress of its independently developed potential first-in-class/best-in-class CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody).

The drug has balanced monovalent PD-1 and CTLA-4 binding arms and bivalent VEGFA binding arms, which can produce strong multi-target synergistic effects and preferentially target tumor tissues to reduce systemic toxicity.

The global multi-center Phase I/II clinical study of CS2009 is actively recruiting patients in Australia and China, and plans to expand to the United States for Phase II enrollment. Currently, the trial enrollment is very rapid, and the number of patients is expected to exceed 100 by the end of the year.

The Phase Ia dose-escalation study has completed four dose levels in patients with multi-line-pretreated advanced solid tumors and is currently enrolling patients at the fifth dose level (30 mg/kg every three weeks). The Phase Ib/Phase II dose-expansion/pivotal extension study is expected to initiate in the second half of 2025.

To date, CS2009 has shown good tolerability at all dose levels evaluated, and anti-tumor activity has been observed in low-dose groups of "cold tumors" and PD-(L)1-experienced patients.

Phase Ia clinical data (including safety, PK, PD and anti-tumor activity) are expected to be released at an international academic conference in the fourth quarter of 2025.

In addition to CS2009 from CStone Pharmaceuticals, Shanghai Hongcheng Pharmaceuticals has also developed a PD-1/CTLA-4/VEGF trispecific antibody HC010. A multicenter, open-label, dose-escalation and dose-expansion Phase I clinical study is currently underway to evaluate the safety, pharmacokinetics and anti-tumor activity of HC010 in the treatment of patients with advanced solid tumors.

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