suvemcitug (APX003)

P2, N=86, Terminated, Jiangsu Simcere Pharmaceutical Co., Ltd. | Trial completion date: Dec 2023 --> Jul 2023 | Recruiting --> Terminated; The study was terminated due to the sponsor's research and development strategy adjustment.

P3, N=421, Active, not recruiting, Jiangsu Simcere Pharmaceutical Co., Ltd. | Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Dec 2024

Envafolimab plus suvemcitug and docetaxel were administrated until disease progression or unacceptable toxicity...There was no grade 5 TRAE in either cohort. Conclusions This phase II clinical trial demonstrated antitumor activity and manageable safety profile of immunotherapy plus anti-angiogenic agent and chemotherapy in pts with NSCLC, who had failed at least one line of therapy.

Eligible pts had received at least one prior line of treatment for MSS/pMMR mCRC and were treated with envafolimab plus suvemcitug and FOLFIRI (Irinotecan, Leucovorin, and 5-Fluorouracil)...Conclusions To the best of our knowledge, this is the first study demonstrated promising antitumor activity and a manageable safety profile of immunotherapy plus anti-angiogenic agent and chemotherapy in pts with MSS/ pMMR mCRC who had failed at least one line of therapy. The results support further evaluation of the therapy in a larger population.

Research Sponsor: Shanghai Xianxiang Medical Technology Co., Ltd. and 3D Medicines Inc.

Suvemcitug has an acceptable toxicity profile and exhibits antitumor activities in pretreated patients with advanced solid tumors or metastatic colorectal cancer.

P2, N=110, Recruiting, Jiangsu Simcere Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting

P2, N=110, Not yet recruiting, Jiangsu Simcere Pharmaceutical Co., Ltd.

These data provide a solid rationale for combining antiangiogenic agents with immunotherapy for cancer treatment and support further clinical development of BD0801 in combination with ICIs.

In this study, we have revealed that BD0801 presents more potent activity than Bevacizumab in blockade of VEGF/VEGFR2 binding (IC50=275 ng/ml for BD0801; IC50=1451 ng/ml for Bevacizumab) and VEGFR2 activation in HUVEC assays...Our data demonstrated that the MOA of the anti-tumor synergy may involve enhanced T-cell mediated immunity, including increased tumor infiltration of CD8+ and CD4+ T cells and reduced double positive CD8+PD-1+ T cells, as well as improved vasculature normalization. Taken together, these data provide a foundation for combining BD0801 with immunotherapy for cancer treatment and support further clinical development plans for BD0801 toward this direction.