Corning Jerry will present the latest results of bispecific antibody products at the 2022 San Antonio Breast Cancer Congress

Corning Jerry Biopharmaceuticals (stock code: 9966.
HK) announced that the company's self-developed three clinical study data of HER2 bispecific antibody KN026 and PD-L1/CTLA-4 bispecific antibody KN046 will be published
in the form of a focus poster discussion and poster presentation at the 45th San Antonio Breast Cancer Congress (SABCS 2022) to be held from December 6 to 10 local time.

Breast cancer is one of the most common malignant tumors in women worldwide, and the World Health Organization reports that on average, 1 breast cancer patient is diagnosed
every 1.
8 seconds.
In China, the prevalence of breast cancer is increasing year by year, with 420,000 new cases and 120,000 deaths
in 2020.
With the advancement of science and technology, the survival of patients with early breast cancer has been significantly improved, but tumors such as HER2-positive breast cancer and triple-negative breast cancer are highly aggressive, heterogeneous, prone to recurrence and metastasis, and a considerable number of patients have disease progression or drug
resistance after first-line treatment.

Presentation format: Focus poster discussion

Poster topic: Efficacy, safety, and tolerability of PD-L1/CTLA-4 bispecific antibody KN046 in combination with albumin paclitaxel in the treatment of metastatic triple-negative breast cancer: final results of a phase II study

Poster number: PD11-10

Corresponding author: Professor Xu Binghe, Cancer Hospital, Chinese Academy of Medical Sciences

Published: December 8, 2022 at 7:00 AM (CST)

Presentation format: Focus poster discussion

Poster topic: Efficacy and safety results of HER2 bispecific antibody KN026 in combination with docetaxel first-line treatment of HER2-positive relapsed/metastatic breast cancer

Poster number: PD18-08

Corresponding author: Professor Zhang Qingyuan, Harbin Medical University Cancer Hospital

Published: December 9, 2022, 7:00- 8:15 a.
m.
(CST)

Display form: poster

Poster topic: KN026 in combination with docetaxel for neoadjuvant therapy for HER2-positive early or locally advanced breast cancer: a single-arm, multicenter, phase II study

Poster number: OT2-16-04

Corresponding author: Professor Wu Jiong, Cancer Hospital of Fudan University

Published: December 7, 2022, 5:00- 6:15pm (CST)

About KN046

KN046 is a PD-L1/CTLA-4 bispecific antibody developed by Corning Jerry, with independent intellectual property rights
.
The innovative design of KN046 includes: the fusion composition of CTLA-4 and PD-L1 single-domain antibodies with different mechanisms; It can target tumor microenvironment enriched in PD-L1 high expression and clear Treg
that inhibits tumor immunity.

KN046 has carried out more than 20 clinical trials in Australia, the United States and China covering more than 10 kinds of tumors such as non-small cell lung cancer, pancreatic cancer, thymic cancer, liver cancer, esophageal squamous cell carcinoma, triple-negative breast cancer, etc.
, and the trial results show that patients have the advantage of
survival benefit.
Based on the results of clinical trials in Australia and China, the US FDA approved KN046 to enter the phase II clinical trial in the United States, and in September 2020, it granted KN046 orphan drug designation
for the treatment of thymic epithelial tumors.
At present, four registered clinical trials of KN046 are underway, among which the interim analysis of the phase III clinical study of KN046 combined with chemotherapy for the first-line treatment of non-small cell lung cancer successfully reached the preset PFS endpoint
.

About KN026

KN026 is a HER2 bispecific antibody developed by Corning Jereh using Fc heterodimer platform technology (CRIB) with independent intellectual property rights, which can bind two non-overlapping epitopes of HER2 at the same time, resulting in HER2 signal blockade, which is better than the combination of trastuzumab and pertuzumab, such as showing higher affinity, and has a potent tumor suppressor effect in HER2-positive tumor cell lines
.
At the same time, KN026 also has inhibitory effect
on HER2 low-expression tumors and trastuzumab-resistant cell lines.

KN026 has been approved by the National Medical Products Administration (NMPA) and the US Food and Drug Administration (FDA) in 2018, and is currently conducting a number of clinical trials in different stages in China and the United States, including breast cancer, gastric cancer/gastroesophageal junction cancer, etc.
, KN026 combined with chemotherapy and KN026 combined with KN046 no chemotherapy for gastric cancer
。 The trial results showed that KN026 had good efficacy and safety, and still showed significant antitumor activity
in patients with HER2-positive breast cancer who progressed after multi-line anti-HER2 therapy.

In August 2021, Corning Jereh signed a Chinese mainland development and commercialization license agreement
with Shanghai Jinmante Biotechnology Co.
, Ltd.
(hereinafter referred to as "Jinmante Biotechnology"), a wholly-owned subsidiary of CSPC Pharmaceutical Group.
According to the terms of the agreement, Zimante Biotech will obtain the exclusive development and exclusive commercialization license of KN026 in Chinese mainland (excluding Hong Kong, Macau and Taiwan) for breast cancer and gastric cancer indications
.