On November 11, 2024, Suzhou / PRNewswire / - Convergent Genomics BioPharma (Stock Code: 9966.HK) announced that the first human clinical trial results of the HER2 bispecific antibody-drug conjugate (ADC) and PD-L1 inhibitor high-concentration subcutaneous injection compound JSKN033 were selected for the latest breakthrough abstract of the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in 2024, to be first disclosed in the form of a poster during the conference.
The SITC Annual Meeting is one of the international grand events focusing on tumor immunotherapy, dedicated to exploring and analyzing the latest techniques and research outcomes in tumor immunotherapy, collectively driving scientific progress and enhancing patient prognosis. The 39th SITC Annual Meeting took place from November 6th to 10th, 2024, local time, in Houston, USA.
Theme: Innovative subcutaneous high-concentration compound JSKN033 of HER2 bispecific antibody-drug conjugate and PD-L1 inhibitor: for the treatment of advanced solid tumors
Abstract number: 1496
Display format: poster
Display time: November 9, 2024, local time in the USA
Clinical research results have shown that the combination of ADC and immunotherapy (IO) can improve treatment effectiveness and significantly prolong the survival of patients with malignant tumors. However, combination therapy usually means longer infusion and hospitalization times, while also increasing the risk of infusion reactions, impacting drug exposure and patient compliance with medication.
JSKN033 is the world's first high-concentration compound preparation of an ADC with a PD-L1 inhibitor for subcutaneous injection into the human body. Leveraging the stability and high solubility advantages of the world's first approved subcutaneous injection PD-L1 inhibitor, Envolid Monoclonal Antibody (KN035, trade name: Envita), it combines immunotherapy (KN035) with ADC (JSKN003) and enhances safety and convenience through optimized administration routes, aiming to provide patients with a safer, more effective, and more compliant treatment option. The Phase I/II clinical study of JSKN033 conducted in Australia (Study Number: JSKN033-101) completed the first patient dosing in March 2024 and is currently actively progressing.
Research method
JSKN033-101 (NCT06226766) is an open-label, multicenter, phase I/II clinical study for the first time in humans, enrolling patients with HER2-expressing advanced solid tumors (IHC≥ 1+) or HER2-mutant non-small cell lung cancer (NSCLC), aiming to evaluate the safety, tolerability, and preliminary efficacy of JSKN033 monotherapy.
Research Results
As of October 14, 2024, a total of 11 patients were enrolled in the phase I dose escalation stage study, with 5 dose groups receiving JSKN033 monotherapy once a week: 1 patient at 1.1mg/kg, 1 patient at 2.3mg/kg, 3 patients at 4.5mg/kg, 3 patients at 5.6mg/kg, and 3 patients at 6.7mg/kg.
The most common treatment-related adverse events (TRAEs) in terms of safety are injection site reactions, all of which are grade 1, and usually self-resolve within 2 weeks without the need for any treatment, or only after receiving antihistamines. No dose-limiting toxicity (DLT) was observed.
Among the 10 evaluable patients, 3 patients had partial responses (PR), 5 patients had stable disease (SD), and the disease control rate (DCR) reached 80%:
- JSKN033 showed anti-tumor activity at the dose level of 4.5mg/kg.
- All 3 PR patients achieved PR at the first baseline efficacy assessment. Two patients received treatment at the dose level of 5.6mg/kg: 1 patient with HR+/HER2- breast cancer who had received ≥4 lines of anti-tumor therapy in the past, and another patient with HER2-mutated NSCLC who had progressed after IO, chemotherapy, and HER2-TKI treatment; 1 patient received treatment at the dose level of 6.7mg/kg, who was a triple-negative breast cancer (TNBC) patient previously treated with albumin-bound paclitaxel and radiotherapy.
- As of the data cutoff date, 7 patients are still undergoing treatment.
Research conclusion
JSKN033 showed good safety profile and preliminary promising anti-tumor activity in patients with solid tumors after multiple-line treatment. This study further demonstrates the potential of ADC combined with immunotherapy and supports continued exploration of JSKN033.
About JSKN033
JSKN033 is the world's first high-concentration subcutaneous injection compound formulation of antibody drug conjugate and immune checkpoint inhibitor developed independently by Concorde Jerry, consisting of JSKN003 and Envalumab (KN035). JSKN003 is a HER2 bispecific antibody drug conjugate (ADC), consisting of three parts: bispecific antibodies targeting two non-overlapping epitopes of the HER2 extracellular domain, cleavable linker, and a topoisomerase I inhibitor; Envalumab is an Fc fusion protein composed of a humanized PD-L1 monovalent antibody and a human IgG1 Fc fragment, which was approved for marketing in China in November 2021 (trade name: Envida), the world's first subcutaneous injection PD-(L)1 inhibitor. JSKN033 combines immunotherapy with ADC to greatly enhance efficacy. Taking advantage of the stability and high solubility of Envalumab, ADC can be administered subcutaneously to improve safety and convenience. Currently, JSKN033 is undergoing Phase I/II clinical studies in Australia for the treatment of advanced or metastatic solid tumors with HER2 expression.
Concorde Jerry is an innovative biopharmaceutical company committed to discovering, developing, producing and commercializing world-class anti-tumor drugs to provide innovative biological therapies for patients. On December 12, 2019, the company was listed on the main board of the Hong Kong Stock Exchange (stock code: 9966.HK).
CanSino Biologics is an innovative biopharmaceutical company dedicated to the development, production and commercialization of world-class anti-tumor drugs, providing innovative biological therapies for patients. The Company was listed on the main board of the Hong Kong Stock Exchange on December 12, 2019 (stock code: 9966.HK).
Concorde Jerry has established a biologics drug research and production technology platform with independent intellectual property rights for protein/antibody engineering, antibody screening, and multi-module/multi-functional antibody modification. It has built a product pipeline with significant differentiation advantages and international competitiveness, covering monovalent antibodies, bispecific antibodies, and antibody-drug conjugates (ADCs) in anti-tumor innovative drugs: among them, one product KN035 (the world's first subcutaneous injection PD-(L)1 inhibitor, Envalumab injection, trade name: Envida) was approved for marketing in China in 2021, making a major breakthrough in the convenience and accessibility of cancer treatment; three new varieties of drugs are in Phase III or pivotal clinical studies, and several bispecific ADC new drugs are also in clinical stages. The company has entered into strategic partnerships with CSPC Pharma, Arrivent, Glenmark, and other collaborators on multiple products or technology platforms.
"We care for patients and strive for global wellness." CanSino Biologics is focused on unmet clinical needs, continuously developing safe and effective, cost-controlled, globally competitive anti-tumor drugs to benefit patients.
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