TIM3

SHANGHAI, Oct. 14, 2024 /PRNewswire/ -- BioCity Biopharma announced that a late-breaking clinical trial abstract of its endothelin receptor type A (ETA) selective antagonist SC0062 has been selected for oral presentation at ASN Kidney Week 2024 which will take place from October 23 to 27 in San Diego, USA. The outstanding clinical data will be published simultaneously in JASN, the leading kidney journal in the world. The abstract titled "SC0062, a New Selective Endothelin Receptor Type A Antagonist in lgA Nephropathy" will be presented by Dr. Hiddo Lambers Heerspink from the University Medical Center Groningen. The details of presentation as below: Oral Abstract Session Session Title：Late-Breaking Science Orals -2 Session Date/Time：October 26,2024 from 4:30PM to 6:00 PM Session Room: Room 6C (Convention Center) Abstract Publication #：SA-OR103 Presentation Time: 5:30 PM to 5:40 PM SC0062 has been granted the Breakthrough Therapy Designation (BTD) by the Chinese regulatory agency National Medical Products Administration (NMPA) for the treatment of IgA Nephropathy (IgAN) with proteinuria. The randomized double-blind, placebo-controlled Phase 2 trial of SC0062 (2-SUCCEED) demonstrated a clinically meaningful and statistically significant reduction in proteinuria in IgAN with a clear dose-response relationship and good safety profile. The 2-SUCCEED study is ongoing for the diabetic kidney disease (DKD) cohort with results are expected in the near future. Currently, BioCity is planning Phase 3 clinical trials of SC0062 in China and worldwide intended for regulatory approval of SC0062 for IgAN as well as for the chronic kidney disease (CKD). About SC0062 SC0062 is a novel and highly unique ETA antagonist due to its high selectivity for ETA over endothelin receptor B (ETB). The high ETA selectivity suggests that it has a greater potential than non-selective ET antagonists for reducing progression of CKD while avoiding the safety risks associated with other nonselective molecules in the same class. Preclinical studies have shown that SC0062 improves pathological scores in models of acute kidney injury and CKD. In the completed Phase I study, SC0062 demonstrated a favorable safety profile, good tolerability, and predictable pharmacokinetic characteristics. Fluid retention, an adverse event associated with non-selective ET antagonists due to undesirable ETB blockade, was not observed in the phase 1 trial in healthy volunteers nor in the IgAN cohort of the Phase 2 study. SC0062 is potentially a best-in-class ETA selective antagonist. The ongoing Phase 2 clinical study is designed to evaluate the efficacy and safety of SC0062 in patients with CKD with proteinuria. It is a multi-center, randomized, double-blind, placebo-controlled study with two parallel cohorts (IgAN and DKD). The 2-SUCCEED study has fully enrolled all subjects in two cohorts. The primary endpoint in the IgAN cohort was met and based on this result SC0062 has granted BTD from NMPA and will be published in JASN, whereas the study is ongoing in the DKD cohort, and the results are expected in Q4 of this year. 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'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. In addition, 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. For more information, please visit Or LinkedIn BioCity Biopharma Contact: [email protected] [email protected] SOURCE BioCity Biopharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SHANGHAI, Sept. 26, 2024 /PRNewswire/ -- BioCity Biopharma (BioCity) announced its endothelin receptor type A (ETA) selective antagonist SC0062 has been granted the Breakthrough Therapy Designation (BTD) by National Medical Products Administration (NMPA) for the treatment of IgA nephropathy (IgAN) with proteinuria. The BTD for SC0062 was granted based on the outstanding results in subjects with IgAN and proteinuria participating in a randomized double-blind, placebo-controlled Phase 2 trial known as 2-SUCCEED. The main objective of the 2-SUCCEED trial was to evaluate the efficacy and safety of SC0062 in individuals with two types of chronic kidney disease (CKD), IgAN and diabetic kidney disease (DKD). Treatment of IgAN with SC0062 resulted in a clinically meaningful and statistically significant reduction in proteinuria with a clear dose-response relationship and good safety profile. Peripheral edema occurred at a much lower rate in SC0062-treated subjects compared to that in the placebo group. Additionally, for subjects who were receiving concurrent treatment with SGLT2 inhibitors, the combination of SC0062 and SGLT2 inhibitors resulted in a favorable safety profile. These results will be presented at an upcoming scientific conference. The study is still ongoing in the DKD cohort, and these results are expected in Q4 of this year. As one of the most common primary glomerular diseases worldwide, many individuals with IgAN will progress to end-stage renal disease (ESRD) within 10 to 20 years, requiring renal dialysis or kidney transplantation. While developing novel treatments for CKD, especially IgAN, has become a global focus, there remains an unmet medical need for more effective and tolerable therapeutics that can be administered safely for many years to reduce the risk of progression to ESRD. In recent years, several studies have demonstrated that endothelin receptor antagonists can improve renal blood flow, reduce proteinuria, and alleviate inflammatory and fibrotic processes, making them a promising therapeutic option for treating IgAN and other forms of CKD. SC0062 is a novel, highly selective ETA antagonist designed for CKD and the results from a Phase 1 study of SC0062 in healthy volunteers and subjects with IgAN in the 2-SUCCEED study have demonstrated its potential to be the "best-in-class" endothelin antagonist in the treatment of IgAN or CKD. Currently, BioCity is planning Phase 3 clinical trials of SC0062 in China and worldwide with the objective of registering and marketing the agent in IgAN, DKD and other types of CKD. About SC0062 SC0062 is a novel and highly unique ETA antagonist due to its high selectivity for ETA over endothelin receptor B (ETB). The high ETA selectivity suggests that it has a greater potential than non-selective ET antagonists for reducing progression of CKD while avoiding the safety risks associated with other nonselective molecules in the same class. Preclinical studies have shown that SC0062 improves pathological scores in models of acute kidney injury and CKD. In the completed Phase I study, SC0062 demonstrated a favorable safety profile, good tolerability, and predictable pharmacokinetic characteristics. Fluid retention, an adverse event associated with non-selective ET antagonists due to undesirable ETB blockade, was not observed in the phase 1 trial in healthy volunteers nor in the IgAN cohort of the Phase 2 study. SC0062 is potentially a best-in-class ETA selective antagonist. The ongoing Phase 2 clinical study is designed to evaluate the efficacy and safety of SC0062 in patients with CKD with proteinuria. It is a multi-center, randomized, double-blind, placebo-controlled study with two parallel cohorts (IgAN and DKD). The trial is led by Professor Jianghua Chen, Director of the Kidney Disease Center at the First Affiliated Hospital of Zhejiang University School of Medicine and former Chairman of the Chinese Medical Association Nephrology Branch. The study is being conducted at over 40 study sites nationwide. The 2-SUCCEED study has fully enrolled all subjects in two cohorts. The primary endpoint in the IgAN cohort was met and based on this result SC0062 has granted BTD from NMPA, whereas the study is ongoing in the DKD cohort, and the results are expected in Q4 of this year. 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'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. In addition, 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. For more information, please visit Or LinkedIn BioCity Biopharma Contact: [email protected] [email protected] SOURCE BioCity Biopharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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 Or LinkedIn BioCity Biopharma Contact: [email protected] [email protected] SOURCE BioCity Biopharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED