The Phase II clinical data of KN046 combined with chemotherapy in the first-line treatment of esophageal squamous cell carcinoma will be announced on ASCO 2021

June 7, 2021, Suzhou, China-Corning Jereh Biopharmaceuticals (stock code: 9966.
HK) announced that it will announce PD-L1/CTLA in the form of a poster at the 2021 American Society of Clinical Oncology (ASCO 2021) annual meeting -4 Phase II clinical study data of the bispecific antibody KN046 combined with paclitaxel/cisplatin in the first-line treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) (study number: KN046-204)
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Esophageal cancer is one of the most common malignant tumors in the world.
According to data released by the International Agency for Research on Cancer of the World Health Organization in 2020, there are about 320,000 new cases of esophageal cancer in China each year, accounting for half of the global esophageal cancer cases, of which about 90 %-95% of esophageal cancer patients are diagnosed with squamous cell carcinoma
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The prognosis of esophageal cancer is poor.
The overall 5-year survival rate is only about 20%, and the 5-year survival rate of metastatic patients is only about 3.
5%.
More effective treatments are urgently needed
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KN046-204 is a phase II clinical study conducted in China to evaluate the efficacy and safety of KN046 monotherapy or combined chemotherapy in the treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma
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The clinical study results of one of the cohorts were published online on ASCO 2021 on June 4, Eastern Time, and the electronic poster can be viewed on the company's website:
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Topic: Efficacy and safety of KN046 combined with paclitaxel/cisplatin in the first-line treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) Poster number: 198655 Session title: Gastrointestinal tumors-gastroesophagus, pancreas, hepatobiliary section One author: Professor Xu Jianming, KN046-204 of the Chinese People's Liberation Army General Hospital includes 3 cohorts, one of which was enrolled in unresectable locally advanced, recurrence or metastasis confirmed by histology or cytology who had not received systemic treatment in the past Patients with sexual ESCC (ECOG PS 0-1 points)
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KN046 was treated with paclitaxel and cisplatin for 4 to 6 cycles, and then the patient received KN046 (5mpk, iv, q2W) maintenance treatment
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Tumor evaluation was performed according to RECIST 1.
1 every 6 weeks
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The primary study endpoint is the objective response rate (ORR) assessed by the investigator
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Secondary research endpoints include disease control rate (DCR), safety, pharmacokinetics (PK) and immunogenicity
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As of January 14, 2021, a total of 15 patients were enrolled in this cohort, all of whom were male, 52.
3% ≥ 60 years old, 64% ECOG PS scored 1, and 80% of patients had distant metastases at baseline
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The median exposure time of KN046 was 11.
4 weeks, and the average treatment period of KN046 was 2.
4 cycles
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Twelve subjects entered the efficacy analysis data set, and the objective response rate (ORR) was 58.
3%, and the disease control rate (DCR) was 91.
6%
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Seven patients (58.
3%) achieved partial remission (PR), and one subject achieved complete remission of the target lesion
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4 patients (33.
3%) achieved stable disease (SD), of which the target lesions of 3 patients were reduced by more than 20%
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Fifteen subjects entered the safety analysis data set.
The incidence of treatment-related adverse events (TRAE) was 80.
0%, and grade 3 and above accounted for 13.
3%
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The incidence of infusion reactions was 7.
8%, mostly grade 1-2
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The incidence of immunotherapy-related adverse reactions (irAE) was 53.
3%, and the most common irAE ≥ Grade 3 were nausea (n=1, 6.
7%) and skin rash (n=1, 6.
7%)
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The main investigator of the clinical trial, Professor Xu Jianming from the Chinese People’s Liberation Army General Hospital, said: “Esophageal cancer is a malignant tumor that originates from the epithelium of the esophageal mucosa.
The pathological types include squamous cell carcinoma and adenocarcinoma.
It is the most common malignant tumor in China.
One, about 90% of the pathological type of esophageal cancer is squamous cell carcinoma
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In recent years, immunotherapy has become the standard for second-line treatment of esophageal cancer, but the prognosis of advanced esophageal squamous cell carcinoma is still poor clinically
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In KN046-204 In the study, KN046 has achieved positive efficacy and safety data in the first-line treatment of patients with advanced esophageal squamous cell carcinoma, which indicates that this bispecific antibody is expected to become a better treatment option
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" said Dr.
Johannes Nippgen, Chief Medical Officer of Corning Jerry: " We are very pleased to see that in the cohort of patients with esophageal squamous cell carcinoma treated with KN046 combined with chemotherapy, the objective response rate and disease control rate reached 58.
3% and 91.
6%, respectively, and the safety was good
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Previously, in a KN046 combination initiated by the investigator The clinical studies of radiotherapy and chemotherapy for patients with esophageal squamous cell carcinoma also demonstrated an objective remission rate of 44.
4% and a disease control rate of 94.
4%
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It is
believed that these positive results will provide new solutions to the urgent clinical needs of the field of esophageal cancer
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"About KN046KN046 is a PD-L1/CTLA-4 bispecific antibody independently developed by Corning Jereh.
Its innovative design includes the fusion of CTLA-4 and PD-L1 single-domain antibodies with different mechanisms; it can be enriched in The tumor microenvironment with high PD-L1 expression and the elimination of Tregs that inhibit tumor immunity
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KN046 has been carried out in Australia and China to cover more than 10 types of tumors such as non-small cell lung cancer, triple negative breast cancer, esophageal squamous cell carcinoma, liver cancer, and pancreatic cancer.
20 clinical trials in different phases, and the trial results show that patients have the advantage of survival benefit
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Based on the clinical trial results obtained in Australia and China, the US FDA approved KN046 to directly enter the phase II clinical trial in the United States, and awarded KN046 in September 2020 Qualified as an orphan drug for the treatment of thymic epithelial tumors
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Four key registered clinical trials of KN046 are currently in progress
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About Kangning Jereh Kangning Jereh Biopharmaceuticals focuses on the research and development, production and commercialization of innovative anti-tumor drugs
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December 12, 2019 , the company listed on the Hong Kong stock Exchange, stock code: 9966
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Corning has a full Jerry biopharmaceutical industry chain bispecific antibody and protein engineering discovery, development and manufacturing platform
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the company's products include proprietary pipeline the height difference 15 kinds of anti-double-based antitumor drug candidates, and versatility of an antibody Covid-19, wherein the four products in China, the United States, Japan, Australia in clinical ⅰ ~ ⅲ
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En The marketing application for Wolizumab injection (KN035) has been formally accepted by the National Medical Products Administration (NMPA) and included in the priority review
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The company has a number of technical platforms with independent intellectual property rights such as heterodimers and hybrid antibodies, and large-scale production capabilities that meet the cGMP standards of China, the United States and the European Union, and have passed a complete quality system including multiple audits of the European Union QP.

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The company is committed to building an internationally leading, multi-dimensional drug development and industrialization platform, focusing on multifunctional biomacromolecule new drugs, benefiting patients in China and around the world
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Welcome to the company website
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