Tumor
Science & Technology
Advanced technology platforms fueling the research and development of drug candidates
Research Area
Adhering to the mission of "The Answer to Cancer"，YZYBIO is committed to developing innovative drugs. Current pipelines cover research area of tumor, age-related disease, and vaccines.
Tumor is one of the leading causes of human death. Tumor is a new organism formed when a cell in a local tissue loses its normal regulation of its growth at the genetic level under the action of various carcinogenic factors, resulting in its clonal abnormal proliferation. Currently, most evidence supports the idea that tumors are monoclonal, i.e., that all cancer cells in a tumor cell population proliferate from a single mutant cell. Tumors may be benign (not cancer) or malignant (cancer). Immuno-oncology, especially immune checkpoint inhibitor (including bispecific antibodies) and CAR-T therapy, are considered as a breakthrough to the treatment of cancer. Hence, YZYBIO devoted a significant amount of effort into the research and development of anti-tumor drugs. Our current pipelines include M701, Y101D, Y150, M802, and Y332.
Age-related Disease
Age-related disease is one of YZYBIO’s focus areas. Neurodegenerative diseases, degenerative Spine Conditions, degenerative joint and bone disease, age-related macular degeneration etc. are typical clinically geriatric diseases. Age-related macular degeneration (AMD) is a structural abnormal of the macula caused by aging. AMD is mostly observed in the cohort over 45 years old, and the prevalence of this disease is higher in older people，serving as the major reason for blindness and other visual impairments. Most of them are round lesions with normal appearance, blurred vision, deformed vision, and central shadow in the eye. According to fundus symptoms, they are divided into dry age macular degeneration (dAMD) (atrophic) and wet age macular degeneration (wAMD) (exudative ): mild pigmentation disorder in the macula in the early stage of dAMD, the foveal reflection is unclear or disappeared, scattered with drusen, and in the late stage, there may be gold foil-like changes, geographic pigment epithelium atrophy, cyst-like deformation or lamellar holes; in wAMD, macular pigmented epithelial disorders in the early stage, foveal reflection disappear or diffuse, drusen often merge, macular edema, hemorrhage and exudation, retinal serous or hemorrhagic detachment, neovascularization in the mid-stage, and formation of circular disc-shaped scars in the late-stage. YZYBIO has developed Y400 for wAMD, diabetic macular edema (DME) and other ocular neovascularization-related diseases.
Vaccine
Prophylactic vaccines are one of YZYBIO’s major research and development area. Vaccines are proteins that target pathogens or are essential for pathogenic infections (polypeptides, peptides), polysaccharides or nucleic acids, one or more components, directly or through vehicle immunization into the body and induce the body to produce specific humoral and/or cellular immunity, so that the body obtains immunity to prevent the disease. Currently, the application of vaccines has evolved from disease prevention to disease treatment, and there are prophylactic and therapeutic vaccines: prophylactic vaccines are autoimmune preparations made from pathogenic microorganisms (e.g. bacteria, viruses, etc.) and their metabolites, which are artificially attenuated, inactivated or genetically modified for the prevention of infectious diseases, and such vaccines retain the immunogenic properties of pathogens and can safely induce an immune response that confers protection against infection; Therapeutic vaccines refer to natural, synthetic or recombinant gene expression products or products expressed by genetic recombinant technology in organisms that have been infected with pathogenic microorganisms or already had certain diseases, by inducing specific immune responses to treat or prevent the progression of diseases. Currently, there are five major technical routes of vaccines against novel coronaviruses in the world: inactivated vaccine, recombinant protein vaccine, adenovirus vector vaccine, attenuated influenza virus vector vaccine, and nucleic acid vaccine. Y2019 is a new recombinant SARS-CoV-2 subunit protein vaccine developed by YZYBIO in cooperation with Wuhan Institute of Virology in response to the COVID-19 pandemic. YZYBIO has completed Phase Ia clinical trial for Y2019, and obtained approval from the ethic committee in July 2022 to commence a Phase IIa clinical trial of Y2019 in China.
Technology Platforms
Based on the advanced platform technologies and strong R&D capability, YZYBIO is at the forefront in discovering and developing drug candidates for the treatment of cancer and age-related diseases. YZYBIO has strategically developed four innovative platforms, including three bispecific antibody platforms, namely YBODY® platform, Check-BODY platform, Nano-YBODYTM platform and a vaccine platform, namely UVAX® platform.
-
YBODY® platform
-
Check-BODY platform
-
Nano-YBODYTM platform
-
UVAX® platform
YBODY® platform
YBODY® platform is the world’s first BsAb platform that focuses on the development of asymmetric IgG-like BsAbs with scFv-Fab-Fc structure, according to Frost & Sullivan. The BsAbs with scFv-Fab-Fc structure developed by the YBODY® platform have unique features, such as a favorable safety profile and a reduced toxicity of cytokine release syndrome due to their high affinity to the tumor-associated antigens (TAAs) and the reduced affinity to human immune cells, reaching a product purity of over 98%, minimizing mispairing of the heavy chain and light chain of a BsAb, favorable PK/PD profile and high stability. Based on YBODY® platform, YZYBIO has developed three T cell engager BsAbs, namely M701, M802 and Y150. According to Frost & Sullivan, M701 is the first EpCAM × CD3 BsAb to have entered into a Phase II clinical trial for the treatment of malignant ascites (MA) in China. M802 is the first domestically-developed BsAb in China, and also the first domestically-developed BsAb to have received IND approval in China. Y150 is the only CD38-targeting and T cell engager BsAb that has entered into clinical development in China as of the latest practicable date.
Check-BODY platform
Check-BODY platform is designed to develop innovative symmetric tetravalency BsAbs, with the structure of (Fab)2-(Fv)2-Fc. Both Fab and Fv moieties of a Check-BODY antibody show high affinity to the targets. Due to the symmetric structure, the purification process of Check-BODY antibodies is similar to that of IgG-like monoclonal antibodies. Multiple batches Check-BODY antibodies are produced in consistently high quality and could easily scale up the production. YZYBIO has discovered and developed Y101D, a PD-L1 × TGF-β BsAb, based on our Check-BODY platform.
Nano-YBODYTM platform
Nano-YBODYTM platform is designed to develop symmetric tetravalency BsAbs based on single-domain antibodies. The well-designed structure enables Nano-YBODYTM molecules to achieve higher binding affinity, better stability, lower immunogenicity and higher production yield rate than other BsAbs. YZYBIO has discovered and developed Y400 and Y332 based on the technologies of our Nano-YBODYTM platform. According to Frost & Sullivan,Y400 is one of the advanced BsAbs in terms of development stage in China for the treatment of wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and other ocular neovascularization related diseases. The Company has transferred the rights of Y400 to CMS Ophthalmology, which demonstrates the market recognition of the Company’s R&D capabilities.
UVAX® platform
YZYBIO’s UVAX® platform is a unique immunogen preparation platform for the development of recombinant protein vaccines, which is designed leveraging its proprietary BsAb engineering technologies. YZYBIO utilizes its UVAX® platform to form subunit dimers of coronavirus efficiently and produce immunogens of the vaccine through reliable, safe and high-yield CHO expression and antibody-like purification systems. The platform enables YZYBIO to make significant progress in the development of coronavirus vaccine Y2019The UVAX® platform is designed to develop RBD homodimeric proteins as immunogens for SARS-CoV-2 virus and its variant strains (VOCs) vaccines, which are based on YZYBIO's BsAb engineering technology to efficiently form viral subunit polymers, and generate immunogens through a reliable, safe, and efficient CHO expression and antibody-like purification system. Y2019, one of the recombinant subunit vaccines against SARS-CoV-2 developed on the UVAX® platform, has been approved by the ethic committee to proceed with a Phase IIa clinical trial started Phase IIa clinical trials in China. Moreover, based on our UVAX® platform, the vaccines to the variant of concern for SARS-CoV-2 can be rapidly prepared within three months.
Product Pipeline
- Core Product
- IND/Clinical Stage
- Pre-clinical Stage
-
Candidate1TargetTechnology PlatformIndicationPre-clinicalINDPhase IPhase Ia Phase IbPhase IIPhase III/PivotalCommercial RightsCurrent Status/Upcoming Milestone
-
M701EpCAM×CD3YBODY®Malignant ascitesMalignant pleural effusionGlobalGlobalPhase II commenced in Dec 2021; Expect to initiate the Phase III/Pivotal trial in 1H 2024
Phase Ib/II commenced in Nov 2022；
Expect to complete Phase Ib/II in 2H 2024
查看详情 -
Y101DPD-L1×TGF-βCheck-BODYSolid tumorPancreatic cancer
（with chemotherapy）Hepatocellular carcinoma
（with anti-angiogenesis therapy）GlobalGlobalGlobalPhase I commenced in Aug 2021；
Expect to complete Phase I in 2H 2023
Phase I commenced in Aug 2021；
Expect to complete Phase I in 2H 2023
Applying for IND approval for Phase Ib/II；
Expect to complete Phase Ib/II by the end of 2025
查看详情 -
Y150CD38×CD3YBODY®Relapse or refractory multiple myelomaGlobal
Phase I commenced in July 2021；
Expect to complete in 1H 2024
查看详情 -
Y2019²SARS CoV-2
RBD homodimer
(ancestral srtain)UVAX®COVID-19Global
Obtained the ethic committee approval for Phase IIa
查看详情 -
M802HER2×CD3YBODY®HER2-positive solid tumorGlobalCompleted Phase I查看详情
-
Y332VEGF×TGF-βNano-YBODYTMSolid tumorGlobal
Expect to file IND application in 1H 2023
查看详情 -
Y400VEGF×ANG2Nano-YBODYTMwAMD, DME and other ocular neovascularization related diseasesGlobal3Expect to file IND application by the end of 2022查看详情
-
Y229UndisclosedYBODY®UndisclosedGlobal查看详情
-
Y224UndisclosedUndisclosedUndisclosedGlobal查看详情
-
Y180UndisclosedUndisclosedUndisclosedGlobal查看详情
1.All drug candidates are inhouse developed.
2.The Company has completed a Phase Ia clinical trial for Y2019 in China in August 2022 which evaluates the safety and tolerability of Y2019 in healthy adults. This Phase Ia clinical trial of Y2019 is equivalent to a typical Phase I trial for healthy adults. The Company has obtained an approval from the ethic committee in July 2022 to commence a Phase IIa clinical trial of Y2019 for healthy adults in China. The Company may, depending on its business plan, conduct a Phase Ib clinical trial to expand the potential subject of Y2019 and evaluate the safety and tolerability of Y2019 in teenagers and children aged 17 years or younger in the future. This potential Phase Ib clinical trial is a different and independent clinical trial from the Phase Ia trial of Y2019, and will also be equivalent to a typical Phase I clinical trial for teenagers and children aged 17 years or younger.
3.The Company has transferred all the rights and assets of Y400 to CMS Ophthalmology. The Company is entitled to receive an upfront payment, milestone payments upon the occurrence of certain pre-agreed milestone events, and tiered royalties based on net sales.
Publication
Production Operation
-
Process Development and Production Platform
Process development and Production plays a critical role throughout biopharmaceutical candidate lifecycle from early discovery all the way to post-marketing surveillance, including target validation, genetic engineering, cell line development, cell culture/purification process development, formulation development and GMP-compliant manufacturing.
Cell line development: YZYBIO utilizes world-leading expression system (CHO GS-KO，etc.) to design and generate antibodies with different structures. As such, YZYBIO are able to produce stable cell lines with high expression level.
Upstream process development: Extensive experience in developing highly expressed and robust cell culture processes.
Downstream process development: Using our downstream purification platforms, YZYBIO is able to obtain high purity of drug substance. YZYBIO can achieve a robust, scalable and cost-effective purification process through yield optimization and product purity improvement.
Formulation development: YZYBIO is able to produce different types of drug products, such as liquid and lyophilized dosage forms. Through the formulation screening and optimization, the formulations are able to reach high concentration with low product viscosity and great stability.
GMP-compliant manufacturing: YZYBIO had a pilot manufacturing base with the scale of 500L in total to accommodate the manufacturing demands for our Phase I to Phase II clinical trials.
-
Quality System
YZYBIO has developed a comprehensive quality management system （QMS） in accordance with the regulations of NMPA and FDA, ICH Q8 and other biopharmaceutical regulations, including GMP and the standards of the Chinese and American Pharmacopoeia. YZYBIO’s QMS covers all aspects of operations, including product R&D, procurement, production, storage and transportation.
YZYBIO has established comprehensive QC and QA procedures to ensure that product operations meet relevant regulatory and internal quality requirements. We implement QC measures for the entire production process, mainly including control and inspection of raw materials, control of production process, inspection of intermediate and products, establishment of internationalized product release standards, research on product stability, and management of deviations, changes and risk evaluations during product development and manufacturing.
YZYBIO complies with all quality regulations in all major aspects and has passed all product release standards, developing more than 30 kinds of platform analytical methods, including physicochemical analysis, analysis of protein content, purity and impurity, and safety assessment, meeting the regulatory requirements of both NMPA and FDA.These platform assays can speed up our development progress. We also validate some of these methods for release testing and stability studies, and ensure the data integrity and product quality.
Adhering to the quality police of " Quality Is the First in Innovative Product Development", our QMS focuses on personnel training, data integrity, quality risk management, and continuous improvement for delivering high quality drug products.
Partnerships
YZYBIO actively seeks to form strategic collaborations with resourceful partners to support the development and maximize the commercial value of our drug candidates. These collaborations allow us to utilize clinical, financial, and commercial resources of our partners, and provide us with opportunities to explore innovative modalities and therapies that employ new mechanisms through cooperation with other innovative drug developers.
Phone：
027-82668988
E-Mail：info@yzybio.com
Address：Biolake, C2-1, No. 666 High-tech Avenue, Wuhan, Hubei, China
Share
