Corning Jereh PD-L1/OX40 double antibody and other clinical approvals

On February 9, the official website of the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of the People's Republic of China announced that Corning & Jereh has two Class 1 new drugs that have obtained an implied license for clinical trials
.

According to public information, the two new drugs are: 1) anti-PD-L1/OX40 bispecific antibody KN052 injection, which is planned to be developed for the treatment of patients with advanced solid tumors; 2) recombinant humanized PD-L1/CTLA-4 Bispecific single-domain antibody Fc fusion protein injection (KN046) is intended to be developed for the treatment of patients with advanced non-small cell lung cancer in combination with axitinib

Screenshot source: CDE official website

1.
KN052: Anti-PD-L1/OX40 double antibody

1.
KN052: Anti-PD-L1/OX40 double antibody

According to the public information of Corning Jereh, KN052 is an anti-PD-L1/OX40 bispecific antibody developed by the company using its Fc heterodimer platform technology, which is planned to be developed for the treatment of solid tumors
.

According to CDE's official website, this is the first time that the product has obtained an implied license for clinical trials

OX40 (also known as CD134) is an important class of T cell costimulatory molecules
.

The immunomodulatory effect of OX40 is to enhance immune activity by regulating the proliferation and survival of effector T cells on the one hand, and inhibit the activity and proliferation of regulatory T cells (Tregs) on the other hand

▲KN052 drug structure and drug characteristics (picture source: Reference [2])

According to the information previously disclosed by Corning Jereh, KN052 has the following drug characteristics: 1) PD-L1 antagonist and OX40 agonist produce activity in the same molecule; 2) Tandem structure is used for antigen binding domain arrangement to reduce anti-OX40 toxicity ; 3) Wild-type IgG1 Fc with complete Fc function
.

Previously, KN052 has shown synergistic antitumor activity in the MC38 tumor model

2.
KN046: PD-L1/CTLA-4 double antibody

2.
KN046: PD-L1/CTLA-4 double antibody

KN046 is a bispecific antibody independently developed by Corning Jereh that can simultaneously target PD-L1/CTLA-4
.

According to the public information of Corning Jereh, the innovative design of KN046 includes: the fusion of CTLA-4 and PD-L1 single-domain antibody with different mechanisms; it can target and enrich the tumor microenvironment with high PD-L1 expression and eliminate tumor immunity.

Previously, KN046 has obtained multiple implied licenses for clinical trials in China, and its approved indication this time is the treatment of patients with advanced non-small cell lung cancer (NSCLC) in combination with axitinib
.

According to public information, in April 2021, Corning Jereh announced a clinical trial cooperation with Pfizer to evaluate the efficacy and safety of KN046 in combination with a new generation of tyrosine kinase inhibitor axitinib for first-line treatment of NSCLC.

According to a recent (February 10) press release from Corning & Jeremy, KN046 has launched nearly 20 clinical trials at different stages covering more than ten types of tumors including NSCLC in Australia, the United States, and China
.

It currently has four registered clinical trials underway

References:

[1] CDE Official Website - Implied License for Clinical Trials.

[3] Corning Jereh’s PD-L1/CTLA-4 bispecific antibody KN046 and Pfizer’s Inlerda® (axitinib) jointly launched a phase II clinical trial.

[4] Phase II clinical study of KN026 combined with KN046 completed the enrollment of all patients.
Retrieved Jan 13, 2022.
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