Corning Jerry's HER2 dual-antibody KN026 Phase III clinical trial was officially accepted by CDE

On October 21, Corning Jereh Biopharmaceuticals and CSPC jointly announced that a phase III clinical trial application of recombinant humanized anti-HER2 bispecific antibody KN026 (study number: KN026-306) has been officially accepted by CDE and will start Combination chemotherapy is used in the registration clinical study of advanced gastric cancer/gastroesophageal junction adenocarcinoma with disease progression after first-line standard chemotherapy
.

Gastric cancer and gastroesophageal junction adenocarcinoma (GC/GEJ) is the fifth most common malignant tumor in the world and the third leading cause of tumor death
.

The latest global cancer burden data released by the World Health Organization in 2020 shows that there are 480,000 new cases of gastric cancer in China each year, and 370,000 deaths.
The number of new cases and deaths is close to half of the world, and the HER2 positive rate is 12 ~13%
.

KN026 is an anti-HER2 bispecific antibody developed by Corning Jereh using Fc heterodimer platform technology (CRIB) with independent intellectual property rights.
It can bind two non-overlapping epitopes of HER2 at the same time, resulting in HER2 signal blockade, which is better than Qu Touzumab or Pertuzumab is used alone to achieve the combined effect of trastuzumab and Pertuzumab, such as tumors that exhibit higher affinity and have superior efficacy in HER2-positive tumor cell lines Inhibition
.

At the same time, KN026 also has an inhibitory effect on HER2 low-expressing tumors and trastuzumab-resistant cell lines
.

According to the results of the Phase II study released at the ASCO annual meeting in 2021, KN026 has a good effect in patients with advanced HER2-positive gastric and gastroesophageal junction cancer, regardless of whether the patient has previously received trastuzumab treatment
.

Among patients with high HER2 expression, the objective response rate (ORR) was 55.
6%, the disease control rate (DCR) was 72.
2%, and the 9-month progression-free survival rate was 60.
4%; the objective response rate of patients who had previously received trastuzumab treatment (ORR) is 44.
4%, disease control rate (DCR) is 66.
7%
.

In August 2021, Corning Jerry and Shanghai Jinmante Biotechnology Co.
, Ltd.
(hereinafter referred to as "Jinmante Bio"), a wholly-owned subsidiary of CSPC, signed a development and commercialization license agreement for KN026 in Mainland China
.

According to the terms of the agreement, Jinmante Bio will obtain the exclusive development and exclusive commercialization license rights of KN026 for breast cancer and gastric cancer indications in Mainland China (excluding Hong Kong, Macau and Taiwan)
.

This IND application is the second registered clinical study carried out by KN026 after KN026 combined with KN046 for the treatment of HER2-positive solid tumors, and it is also the first phase III clinical study of KN026
.

This application reflects the seamless connection and efficient cooperation between the two parties.
We hope that through cooperation and collaboration, we will accelerate the clinical development and commercialization of KN026 in mainland China, and bring better treatment options to patients with gastric cancer as soon as possible
.

End Reference: [1]https://mp.
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