AsiaNet 90512

BOSTON and BEIJING, July 7, 2021 /PRNewswire=KYODO JBN/ --

Eucure Biopharma, a wholly owned subsidiary of Biocytogen(

http://www.biocytogen.com/ ) dedicated to developing antibody drugs with

independent intellectual property rights, announced that the U.S. Food and Drug

Administration (FDA) has approved two phase II clinical trials for YH001

(anti-CTLA-4) and YH003 (anti-CD40) in the United States.

A phase II, non-randomized, multi-center clinical study will evaluate the use

of YH001 in combination with Junshi Biosciences' anti-PD-1 monoclonal antibody

(Toripalimab) for the treatment of advanced non-small cell lung cancer (NSCLC)

and hepatocellular carcinoma (HCC).  A phase II, open-label, multi-center study

will evaluate the safety and efficacy of YH003 combined with Toripalimab for

the treatment of PD-1-resistant unresectable/metastatic melanoma and pancreatic

ductal adenocarcinoma (PDAC). Both trials are multi-regional clinical trials,

and will be conducted in the United States, Australia and China. The YH003

phase II clinical trial in Australia was approved by the Australian regulatory

agency in May 2021 following a phase I dose-escalation study launched in May

2020.

Dr. Yuelei Shen, Chairman and CEO of Biocytogen and Eucure Biopharma, said that

the approvals signify "a milestone" for Eucure Biopharma. "In just one year,

both products advanced from Australian phase I clinical trials to the FDA

approvals of phase II trials. This is not only an affirmation of the clinical

safety and preliminary efficacy of these two products, but also an affirmation

of Biocytogen's drug discovery platform and in vivo drug efficacy screening

model. I am very pleased to see that the Eucure team was able to advance

clinical development so efficiently. We will continue to actively promote the

clinical trials of YH001 and YH003 in China and around the world. With our

RenMice HiTS Platform( https://renmab.com/about-hits-platform/ ), Eucure's

clinical pipeline will continue to expand with potentially novel best-in-class

and first-in-class mAbs for oncologic, viral and autoimmune diseases."

About YH001

YH001 is a humanized IgG1 monoclonal antibody targeting CTLA-4. YH001 enhances

the immune response against tumor cells and promotes removal of regulatory T

cells from the tumor microenvironment. In phase I first-in-human

dose-escalation studies in patients with advanced solid tumors conducted in

Australia and China, YH001 has shown best-in-class potential with an improved

safety profile compared to Ipilimumab (Yervoy®), and promising preliminary

efficacy when used in combination with Toripalimab.

About YH003

YH003 is a humanized IgG2 agonistic antibody targeting CD40, a receptor that

promotes the activation of antigen-presenting cells and the effector activity

of anti-tumor T cells. CD40 activation is a key regulatory point in tumor

immunotherapy, effectively transforming cold tumors lacking immune cell

infiltration into hot tumors that respond well to tumor immunotherapy. Whether

used as a single agent or in combination with anti-PD-1 monoclonal antibody

drugs, YH003 demonstrated strong anti-tumor effects against multiple tumor

models in Biocytogen's humanized CD40 mice. Pharmacodynamic studies in mice

indicates that YH003 significantly increased the infiltration of anti-tumor T

cells into tumors. Available clinical data from the YH003 phase I

dose-escalation trial indicates a desirable safety profile when combined with

Toripalimab, and a potential breakthrough treatment for PD-1-refractory

melanoma.

About Eucure Biopharma

Eucure Biopharma is a biopharmaceutical company focused on the development of

innovative immunotherapies to meet clinical needs of patients around the world.

Relying on a strong clinical development team with extensive experience, the

company has established a product pipeline for more than 10 targets.

Eucure Biopharma is a wholly owned subsidiary of Biocytogen(

http://www.biocytogen.com/ ), a biotechnology company focused on therapeutic

antibody discovery, antibody & biologic efficacy testing, and genetic

engineering for preclinical research.  

For more information, visit www.eucure.com and www.biocytogen.com.

SOURCE  Biocytogen