• The findings of JSKN003 during the dose escalation period (Ia) were reported at this AACR conference.
• The treatment of advanced HER2 expression/metastatic solid tumors with JSKN003 showed encouraging efficacy signals, with an ORR of 100% in patients with HER2-positive breast cancer. The tolerability and safety are good, DLT has not occurred, and MTD has not been achieved.

Suzhou, China, April 10, 2024/PRNewswire/ -- Corning Jerry Biopharmaceuticals (stock code: 9966.HK) announced that at the 2024 American Association for Cancer Research Annual Meeting (AACR 2024), the company announced the Phase I clinical study data of the HER2 double antibody conjugate drug JSKN003 for the treatment of advanced HER2-expressing solid tumors in Australia (Study ID: JSKN003-101).

Subject:Safety and efficacy of JSKN003 for the treatment of advanced/metastatic solid tumors: the first dose escalation and dose expansion, multicenter, open phase I study in humans
Summary ID:CT179
Exhibition location:Poster Section 48
Key Researchers:Claire Beecroft
Poster presentation time:April 9, 2024, 9:00 AM - 12:30 AM EST

JSKN003-101 is an open, multicenter, dose escalation and dose extension phase I clinical study conducted in Australia to evaluate the safety, tolerability, pharmacokinetics (PK) and initial efficacy of JSKN003 in treating advanced solid tumors, and to determine the recommended phase II dose (RP2D). Dose-escalation period (Ia) study data from this study were reported at this AACR conference.

A total of 32 patients were enrolled in the study and received JSKN003 monotherapy every 3 weeks in 7 dose groups (1.0 - 8.4 mg/kg) during the dose escalation period. Among them, the proportion of patients with an ECOG PS score of 0, 1, and 2 was 46.9%, 46.9%, and 6.3%, respectively. The proportion of patients with HER2 (IHC) 1+, 2+, and 3+ was 28.1%, 50.0%, and 21.9%, respectively. Patients were distributed by tumor type: breast cancer (46.9%), ovarian cancer (15.6%), bladder cancer (9.4%), lung cancer (6.3%), esophageal cancer (3.1%), stomach cancer (3.1%), head and neck tumors (3.1%), and other tumors (12.5%). 62.5% of patients have previously received 3-line or above systematic treatment.

Effectiveness:As of March 15, 2024, the objective response rate (ORR) and disease control rate (DCR) of 32 patients were 56.3% (95% CI: 37.7%, 73.6%) and 90.6% (95% CI: 75.0%, 98.0%), and the ORR for IHC 1+, 2+, and 3+ patients were 66.7% (6/9), 37.5% (6/16), and 85.7% (6/7), respectively. Among them, the ORR for HER2 positive breast cancer patients was 100% (5/5), and the ORR for breast cancer patients with low HER2 expression was 50% (5/10).

safety:Treatment-related adverse events (TREs) occurred in 27 cases (84.4%), grade 3 TRAE occurred in 4 patients (12.5%), and grade 2 interstitial pneumonia (7.3 mg/kg group) occurred in 1 patient (3.1%). Common TRAEs for all levels with an incidence greater than 10% were diarrhea (62.5%), nausea (53.1%), fatigue (21.9%), vomiting (21.9%), loss of appetite (18.8%), abdominal pain (12.5%), drowsiness (12.5%), and hair loss (12.5%). The incidence of hematologic toxicity is extremely low. No death or discontinuation of treatment due to TRAE. All patients completed the dose-limiting toxicity (DLT) observation period, no DLT events occurred, and the study did not reach the maximum tolerated dose (MTD).

PK: JSKN003 exposure increased with increasing dose, and the average half-life of 6.3 mg/kg was approximately 5 days. There is a certain accumulation after multiple doses, and the average accumulation ratio of JSKN003 at a dose of 6.3 mg/kg is about 1.3. The exposure of free toxins was significantly lower than JSKN003. Its Cmax of 6.3 mg/kg was 1.21 ng/mL, which suggests that JSKN003 is more stable in the internal circulation system.

Conclusions:JSKN003 is well tolerated and safe in patients with advanced/metastatic solid tumors previously treated with multi-line systems, and has shown encouraging initial anti-tumor activity. The incidence of hematologic toxicity and interstitial lung disease (ILD) is low (grade 2 ILD occurred in only 1 patient). As of the data cutoff date, all patients had completed the dose-limiting toxicity (DLT) observation period, no DLT events had occurred, and MTD had not been achieved.

regardingJSKN003

JSKN003 is a novel antibody conjugation drug (ADC) targeting the HER2 double epitope. It was independently developed by Corning Jerry using a unique glycos-based fixed-point conjugation platform. JSKN003 binds to HER2 on the surface of tumor cells and releases topoisomerase I inhibitors through HER2-mediated cellular endocytosis, thereby exerting an anti-tumor effect. Preclinical studies have shown that JSKN003 has better serum stability, stronger bystander killing effect, and similar tumor killing activity compared to similar drugs, effectively expanding the treatment window. Currently, JSKN003 is carrying out a number of clinical studies in Australia and China, and it has entered phase III clinical stage in China for breast cancer with low HER2 expression.

About Corning Jerry

Corning Jerry is an innovative biopharmaceutical company dedicated to the discovery, development, production and commercialization of world-class anti-tumor drugs to provide patients with innovative biologic therapies. On December 12, 2019, the company was listed on the main board of the Hong Kong Stock Exchange (stock code: 9966.HK).

Corning Jerry has created a biomacromolecular drug development and production technology platform with independent intellectual property rights, such as protein/antibody engineering, antibody screening, and multi-module/multifunctional antibody modification. A product pipeline with significant differentiation advantages and strong international competitiveness has been created, covering innovative anti-tumor drugs such as single-domain antibody/monoclonal antibodies, multi-functional antibodies and antibody conjugates: 1 product, KN035 (the world's first subcutaneous PD- (L) 1 inhibitor, Envolimab injection, product name: Enweida) was approved for marketing in China in 2021, making it a widely accessible drug for cancer patients; 3 products are in late clinical development; HER2 double antibody KN026 was recognized as a breakthrough therapy by China's NMPA. In addition, the company has a rich early development pipeline, and 2 new drug molecules have already entered the clinical research stage.

“Kangda patients, Regis family”. Corning Jerry has always focused on unmet clinical needs and continues to develop safe, affordable, and globally competitive anti-tumor drugs to benefit patients.