CS2011 / CStone Pharma - LARVOL DELTA

CS2011: A novel bispecific antibody targeting EGFR and HER3 that demonstrates promising antitumor activity in preclinical evaluation (AACR 2025) - "Approved anti-EGFR therapies, including cetuximab, pantitumumab, and necitumumab, are widely used in treating the aforementioned malignancies. Amivantamab, a bispecific antibody targeting EGFR and c-MET, has been approved for treating advanced NSCLC with EGFR mutations...Daiichi's HER3-ADC, U3-1402, has shown promising clinical results in advanced EGFR-mutant NSCLC, confirming HER3 as a valid therapeutic target... CS2011 is a promising bispecific antibody for the treatment of various advanced solid tumors. Current preclinical data support further IND-enabling development and clinical research on CS2011."

Preclinical • Colorectal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EGFR • ERBB3 • MET • NRG1

CStone Presents Preclinical Results of CS2011 (EGFR/HER3 bispecific antibody)…at 2025 AACR (PRNewswire) - "Key Highlights:...CS2011 shows superior in vivo and in vitro anti-tumor activity versus potential major competitors. (i) Compared to anti-EGFR, anti-HER3 and competing bispecific antibody, CS2011 induces faster and deeper internalization in tumor cells across varying EGFR & HER3 expression levels; (ii) CS2011 demonstrated potent inhibition of EGFR downstream signaling, comparable to anti-EGFR antibodies, and superior inhibition of HER3-mediated signaling compared to competitive bispecific antibody; (iii) CS2011 exhibited robust anti-proliferative activity in tumor cells with diverse EGFR and HER3 expression levels; (iv) In in vivo CDX tumor models, CS2011 demonstrated superior tumor-growth inhibition compared to anti-EGFR or anti-HER3 monoclonal antibodies alone and showed comparable efficacy to the combination treatment."

Preclinical • Solid Tumor

CS2011: A novel bispecific antibody targeting EGFR and HER3 that demonstrates promising antitumor activity in preclinical evaluation (PRNewswire) - "CStone to showcase...latest research achievements at AACR 2025....Abstract Number: 2927....Key Findings: CS2011 (an EGFR/HER3 bispecific antibody), composed of anti-EGFR and anti-HER3 arms with balanced affinity, effectively and synergistically inhibits EGFR/HER3 downstream signaling, leading to further inhibition of tumor growth. Its lead compound demonstrated favorable stability and a PK profile comparable to those of monoclonal antibodies."

Preclinical • Oncology

CStone Reports 2024 Interim Results and Recent Corporate Updates (PRNewswire) - "Anticipated near-term catalysts include:...(i) CS2009: IND submissions expected in 2024/2025; (ii) CS5006: IND submission expected in 2025; (iii) CS5005: IND submission expected in 2025; (iv) CS2011/CS5007: IND submission expected in 2025."

IND • Solid Tumor