Biocity receives IND approval from FDA for its FIC ADC BC3195

2023-02-13

Biocity Biopharma today announces that the U.S. Food and Drug Administration (FDA) has granted the company's Investigational New Drug (IND) application for the investigational drug BC3195 (CDH3 ADC). The approval enables Biocity Biopharma to conduct the phase 1 study of BC3195 in Patients with Locally Advanced or Metastatic Solid Tumors in the United States. This is the second US IND approval in the past few months, which is another important milestone for Biocity Biopharma in its effort to extend product development globally.

BC3195 is a novel ADC targeting CDH3/P-cadherin, a calcium-dependent cell-cell adhesion glycoprotein expressed in a variety of malignancies, including lung, breast, gastric, ovarian, colorectal, and pancreatic cancers.

CDH3 is highly expressed in malignant tumors with low or no expression in normal tissues, which makes it an ideal target to develop anticancer treatment, particularly for the development of ADCs.

In preclinical study, BC3195 binds to cell surface CDH3 and is efficiently internalized. In different animal models, BC3195 demonstrated good safety profile and strong antitumor activities with tumor growth inhibition reaching up to 100%.

BC3195 a first-in-class new generation ADC designed with a clinically validated linker and payload (MMAE) that has bystander effect.

Currently, BC3195 is the only ADC targeting CDH3 in clinical development globally.Biocity Biopharma believes that BC3195 may hold the promise of becoming a novel treatment for patients with advanced cancers where high unmet medical needs still exist.

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 chronic kidney diseases (CKD). The company has established a pipeline of more than 10 innovative drug candidates including small molecules, monoclonal and bispecific antibodies as well as antibody-drug conjugates (ADCs).

There are 5 oncology projects in phase 1 development targeting the DDR pathway with a WEE1 and an ATR inhibitor, or the immune system with a T cell engager (CD3XEGFR BsAb), an immune checkpoint inhibitor (TIM-3 mAb), and a T cell activator (4-1BB mAb). The novel CDH3-targeting ADC will initiate the first in human (FIH) trial in early 2023. In addition, an endothelin A(ETA)-receptor selective antagonist designed for CKD has completed the FIH study and is entering into phase 2 development.

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