Biositu/Yuhe Pharma Announces the Completion of the First Patient Dosing in the Australian Phase I Clinical Study of Its CD40 mAb YH003 Combined with CTLA-4 mAb YH001 and PD-1 mAb

Yimaike's recent hot reports ★Two "blockbusters", marketed ADC drugs are leading the way ★Biosetu/Youhe international clinical research has entered a new journey: 4-1BB monoclonal antibody completed the first administration of phase I in Australia 2022 April 7, 2020 / eMedClub News/--Today, April 7, 2022- Euho Pharma, a wholly-owned subsidiary of Biositu, announced today that its YH003 (CD40 monoclonal antibody) combined with YH001 (CTLA-4 monoclonal antibody) Anti-) and pembrolizumab (PD-1 mAb) Australian Phase I clinical study (number YH003005) completed the first patient dosing in Australia
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This study is an open-label, phase I dose escalation study of YH003 in combination with YH001 and pembrolizumab in patients with advanced solid tumors
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The primary objective is to evaluate the safety, tolerability and antitumor activity of YH003 in combination with YH001 and pembrolizumab in subjects with advanced solid tumors, and to evaluate the pharmacokinetics and immunogenicity of YH003
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In this regard, Dr.
Shen Yuelei, CEO of Biositu and Euho Medicine, said, "In preliminary clinical trials, we found that whether YH003 combined with PD-1 mAb, or YH001 combined with PD-1 mAb, is effective in patients with solid tumors.
All of them have shown good safety and preliminary efficacy
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The basis of the combination of CD40, PD-1 and CTLA-4 is that they have completely different but complementary biological mechanisms of action
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We hope that in clinical practice It can be seen that the combination of the three drugs can have better anti-tumor efficacy, thereby benefiting patients
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” About YH003YH003 is a humanized IgG2 agonistic antibody targeting CD40.
The activation of present cells positively regulates the effector activity of anti-tumor T cells
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Studies to date have shown that CD40 activation is a key regulatory point in tumor immunotherapy, which can effectively convert cold tumors lacking immune cell infiltration into hot tumors that respond well to tumor immunotherapy
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In the preclinical antibody screening stage, Euho Pharma made full use of the tumor model in CD40 humanized mice independently developed by Biocytos, and quickly screened in mice to completely inhibit tumor growth without side effects such as hepatotoxicity.
cloned antibodies
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Whether used alone or in combination with anti-PD-1 monoclonal antibodies, YH003 has demonstrated strong anti-tumor effects on a variety of tumor models in mice
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Pharmacodynamic studies in mice showed that YH003 significantly increased the proportion of anti-tumor T cells in tumor-infiltrating cells
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Importantly, YH003 showed good safety even at very high doses, both in mice and monkeys
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About YH001YH001 is an anti-CTLA-4 monoclonal antibody, which can treat various tumors by enhancing the body's own immune response against tumor cells and enhancing the removal of regulatory T cells (Treg) in the tumor microenvironment
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Enhancing the patient's immune response to tumors by blocking the inhibitory signals of the body's anti-tumor response is considered to be the most promising tumor immunotherapy currently
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CTLA-4 and PD-1 are considered to be two important checkpoints in the immune system.
Blocking them can affect different types of T cells and initiate anti-tumor immune attacks.
They are considered to be the cornerstone targets of tumor immunotherapy.

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About Euho Pharma As a wholly-owned subsidiary of Biositu, Euho Pharma undertakes the mission of clinical development for the R&D pipeline of Bioseda.
Relying on a strong clinical development team and its rich clinical development experience, Euho Pharma has provided patients in China and even around the world with the mission of clinical development.
Develop innovative medicines that meet clinical needs
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Biocyto focuses on tumor and non-tumor antibody drug therapy, and has built a strong R&D pipeline targeting more than ten targets
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At this stage, two products have started international multi-center (MRCT) phase II clinical research, and two products are in clinical phase
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For more information, please visit: About Biositu Bioseda is an international biopharmaceutical company with innovative technology-driven research and development of new drugs.
Health is our mission
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Based on the fully human antibody RenMiceTM platform (RenMab® and RenLite® mice) independently developed and owned by Biocytos, the monoclonal antibody RenMab® and double-antibody RenLite® development technology platform, animal in vivo efficacy screening platform, powerful Its clinical development capabilities are organically integrated to form a unique new drug development capability covering the entire drug development process
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Biositu is conducting large-scale drug development for more than 1,000 potential druggable targets (the "Qianmuwankang TM" plan).
14 companies including a number of MNCs have reached the authorization cooperation of the RenMiceTM platform
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The company has now established 12 core drug product pipelines, of which 2 products are in the phase II of the international multi-center (MRCT) clinical trial, and 2 are in the phase I of the clinical trial
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In the future, Biositu will continue to work with global partners to continuously produce many first-in-class and best-in-class antibody drugs to better benefit patients
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Headquartered in Beijing, Biositu has branches in Haimen, Jiangsu, Shanghai, Boston, USA and Heidelberg, Germany
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