Biocytogen/Eucure Biopharma Announce the Completion of First Patient Dosing for Phase II Clinical Trial of YH003 in Australia
Beijing, China, December 8, 2021 – Eucure
Biopharma, a wholly owned subsidiary of Biocytogen, announced the first patient
dosing for a phase II clinical trial of YH003 (anti-CD40 monoclonal antibody,
mAb) (No. YH003004) in Australia.
The open-label, multi-regional clinical
trial (MRCT) will evaluate the efficacy and safety of YH003 in combination with
Toripalimab (anti-PD-1 mAb) for the treatment of patients with PD-(L)1
resistant unresectable/metastatic melanoma or pancreatic ductal adenocarcinoma
(PDAC). The trial will be conducted in Australia, the United States, China and
other countries or regions. Each subject will receive 0.3 mg/kg YH003 and 240
mg Toripalimab every-three-week
to evaluate the antitumor efficiacy and safety in three
parallel cohorts. The first two cohorts will consist of subjects with
unresectable/metastatic melanoma that failed PD-1/PD-L1 treatment, or subjects
with unresectable/metastatic PDAC who failed first-line treatment, respectively.
The third cohort will evaluate YH003/Toripalimab plus standard chemotherapy (Nab
palitaxel + Gemcitabine) as first-line treatment in subjects with
unresectable/metastatic PDAC. The study adopts Simon’s two-stage optimization
design. The evaluation will be made when each cohort has recruited 18 subjects.
The study marks the first phase II clinical
trial for Biocytogen. Dr. Yuelei Shen, Chairman and CEO of Biocytogen and
Eucure Biopharma, said that the company will continue making rapid progress to
develop safe and effective innovative medicines to benefit patients worldwide.
YH003 is a humanized IgG2 agonistic CD40 antibody.
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, without exhibiting hepatotoxicity
or other toxicities. Pharmacodynamic studies in mice indicates that YH003
significantly increased the infiltration of anti-tumor T cells into tumors. Phase
I dose-escalation data indicates a desirable safety profile of YH003/Toripalimab.
Eucure Biopharma develops innovative antibody
drugs for Biocytogen’s R&D pipelines in oncology and other indications. Relying
on a strong team with extensive clinical development experience, the company‘s pipeline
includes more than 10 targets. At present, four products have received clinical
trial approvals in the US and China including two products that have obtained
phase II clinical approvals from both the FDA and NMPA, two products that have
entered phase I clinical trials in China, and four in phase I clinical trials
Biocytogen Pharmaceuticals (Beijing) Co.,
Ltd. is a global biotech company that drives the research and development of
new drugs with innovative technologies. Using RenMabTM and RenLiteTM mice for fully human antibody production, Biocytogen has integrated its
monoclonal and bispecific antibody development platforms, in vivo drug efficacy
screening platforms and strong clinical development ability to streamline the
entire drug development process. Biocytogen is undertaking a large-scale
project to develop antibody drugs in collaboration with global partners for
more than 1000 druggable targets, known as the RenMiceTM HiTS
Platform. Headquartered in Beijing, Biocytogen has branches in Haimen Jiangsu,
Shanghai, and Boston, USA.