BioCity to Present Preliminary Phase I Results of BC3195 (CDH3 ADC) and Clinical Results from Two Trials of SC0245 (ATR Inhibitor) at 2024 ASCO Annual Meeting

Shanghai, China, May 20th, 2024 – BioCity Biopharma announced today that the preliminary Phase I data of BC3195 (CDH3 ADC) as a monotherapy for advanced solid tumors, and the data from two clinical studies of SC0245 (ATR inhibitor) will be exhibited at the American Society of Clinical Oncology (ASCO) Annual Meeting 2024. The ASCO Annual Meeting will be held in Chicago, USA, from May 31 to June 4, 2024.

Detailed information is as below:

(1)Abstract Title:

BC3195, a novel ADC targeting CDH3: Preliminary results of a first-in-human phase I study in patients with advanced solid malignancies.

Abstract #e15008

Session Type

Publication Only—Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

lt will be published on at 5:00 PM EDT on May 23,2024.

(2)Abstract Title:

An open-label, single-arm, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of the ATR inhibitor SC0245 in advanced solid malignancies.

Session Type

Publication Only—Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

Abstract #e15126

lt will be published on at 5:00 PM EDT on May 23,2024.

(3)Abstract Title:

An open-label, multicenter, phase Ib/II study of the ATR inhibitor SC0245 in combination with irinotecan in patients with relapsed and refractory extensive stage small cell lung cancer (ES-SCLC).

Session Type:

Poster SessionLung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Session date and time:

June 3,2024from 1:30 p.m.~4:30 p.m. (Central Daylight Time)

Poster Bd #364

About BC3195

BC3195 is currently the only ADC targeting CDH3/P-Cadherin in clinical development globally. In preclinical studies, BC3195 binds to cell surface 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 tumor cells as well as surrounding cells which is known as the bystander effect. In animal models, BC3195 demonstrated a favorable safety profile and strong antitumor activity with tumor growth inhibition of ≥100%.

BC3195 is in parallel clinical development in both China and the US. Prof. Yilong Wu from Guangdong Provincial People’s Hospital and Prof. Bob Li from MSK Cancer Center are leading the studies in these territories, respectively.

About SC0245

SC0245 is the first small molecule ATR Kinase inhibitor that entered clinical development stage in China and ranked in the top tier globally.

SC0245 exhibited strong ATR kinase inhibition potency in preclinical studies. In multiple animal models, SC0245 demonstrated favorable safety, tolerability, and pharmacokinetic profiles. SC0245 also exhibited strong antitumor activity as a single agent or in combination with other therapeutics in these models.

In a phase I clinical study led by Prof. Lin Shen at Beijing Cancer Hospital, SC0245 demonstrated favorable safety and tolerability profiles, and a high disease control rate.

SC0245 is now in a phase Ib/II clinical study in combination with irinotecan for the treatment of small cell lung cancer. This study is led by Prof. Shun Lu, oncology department director at Shanghai Chest Hospital.

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 ADCs.

Currently, BioCity Biopharma has 5 oncology assets in Phase 1 clinical development, including the first-in-class CDH3-targeting ADC and GPC3-targeting ADC, WEE1 and ATR inhibitors targeting the DNA damage response (DDR) pathway, and agents targeting the immune system, and an immune checkpoint inhibitor (TIM-3 mAb). In addition, an endothelin A (ETA)-receptor selective antagonist for CKD is in phase 2 clinical development.

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