Biocytogen/Eucure Biopharma's CTLA-4 and CD40 mAbs Approved for Phase II Clinical Trials by the FDA
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
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