SHANGHAI, Sept. 23,
2024 /PRNewswire/ -- 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). The ORR 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,
significant antitumor activity with confirmed PRs observed
across multiple tumor types.
About BioCity
Founded in December 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
visit www.biocitypharma.com
Or LinkedIn BioCity Biopharma
Contact:
BD@biocitypharma.com
IR@biocitypharma.com
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