SHANGHAI,Sept. 23,2024 -- On September 14,2024,BioCity presented interim clinical results on the safety and efficacy of its first-in-class antibody-drug conjugate (ADC) BC3195 targeting CDH3 (P-Cadherin) in a Phase I clinical trial at the European Society for Medical Oncology (ESMO) Congress 2024.

As of the data cut-off date (August 10,2024),BC3195 demonstrated impressive antitumor activity in patients with advanced non-small cell lung cancer (NSCLC) with an ORR of 36.4% (4 of 11 patients). TheORR was 80% (4 of 5 patients) in NSCLC with epidermal growth factor receptor mutations (EGFRmut). BC3195 demonstrated manageable safety and tolerability,as well as favorable pharmacokinetic characteristics. Dose optimization and further patient accrual in NSCLC,breast cancer,and other types of CDH3-expressing cancers are ongoing. Clinical trial information: NCT05957471.

Thirty-four patients (median age,59.5; male,64.7%) have been enrolled at the date of data cut-off,with 3 patients each enrolled at BC3195 dose levels of 0.3,0.6,1.2,and 1.8 mg/kg as an intravenous (IV) infusion every 3 weeks (Q3W),21 patients enrolled at the 2.4 mg/kg IV Q3W dose level,and 1 patient enrolled at the 1.2 mg/kg IV weekly dose level.

Notable safety findings include:

All patients in the dose escalation stage of the study were evaluable for dose-limiting toxicity (DLT). One patient had Grade 3 pharyngitis,considered a DLT,following treatment with BC3195 2.4 mg/kg IV Q3W.

Rash,stomatitis and liver function abnormalities were the main adverse events (AEs). Most episodes of rash and stomatitis occurred in the first cycle and were manageable.

Fourteen (41.2%) patients experienced Grade≥3 treatment-related adverse events (TRAEs). Grade ≥3 TRAEs experienced by more than 2 patients include stomatitis (23.5%),neutropenia (8.8%),and rash(8.8%).

Notable efficacy findings include：

Five patients,including 4 NSCLC patients and 1 breast cancer patient had confirmed PRs following treatment with BC3195 2.4 mg/kg IV Q3W.

Of 11 NSCLC patients treated at the 2.4mg/kg IV Q3W dose level,10 patients had reductions in tumor volume including 4 patients with confirmed PRs and 6 patients with stable disease (SD) as their best response. At 2.4 mg/kg IV,the ORR and disease control rate (DCR) were 36.4% and 90.9%,respectively.

Four of 5 (80%) patients with EGFRm NSCLC had confirmed PRs.

Among the 30 patients who were evaluable for tumor response,no complete response (CR) nor partial response (PR) were reported in BC3195 dose levels up to 1.8 mg/kg IV Q3W.

Based on the promising clinical results already achieved with BC3195,BioCity will continue to collaborate with global researchers to advance the clinical development of this first-in-class ADC.

About BC3195

BC3195 is currently the only ADC targeting CDH3(P-Cadherin) in clinical development globally. In preclinical studies,BC3195 binds to membrane CDH3 with strong affinity and is efficiently internalized. BC3195 is designed with a clinically validated,cleavable linker and payload (vc-MMAE) allowing for the destruction of targeted cancer cells,as well as surrounding cells,which is known as the bystander effect. In animal models,BC3195 demonstrated a favorable safety profile and robust antitumor activity with tumor growth inhibition ≥100% in some animals bearing well established cancers.

BC3195 is currently undergoing concurrent Phase I dose optimization and dose expansion in China and the US. BC3195 demonstrated a manageable safety profile and favorable PK characteristics,significantantitumor activity with confirmed PRs observed across multiple tumor types.

About BioCity

Founded inDecember 2017,BioCity is a clinical-stage biopharmaceutical company committed to developing novel and highly differentiated,modality-independent therapeutics for cancer and autoimmune disorders including CKD. BioCity has established a pipeline of more than 10 innovative drug candidates,including small molecules,monoclonal and bispecific antibodies,and antibody-drug conjugates (ADC).

Currently,BioCity has five core oncology assets in Phase 1/2 clinical development,including first-in-class CDH3-targeting ADC and GPC3-targeting ADCs,WEE1 and ATR inhibitors targeting the DNA damage response (DDR) pathway,and a monoclonal antibody targeting TIM-3 in collaboration with AstraZeneca. In addition,BioCity's SC0062,a highly selective ETA antagonist,is in phase 2 clinical development for CKD and a global phase 3 registration trial is being planned.

For more information,please visitwww.biocitypharma.com

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