Discovery

Our innovative discovery engine is built upon a group of seasoned immunologists with extensive academic research and pharma R&D experience. The group embraces cutting-edge science to identify and create “points of innovation” or differentiation to develop novel molecules of first-in-class and best-in-class potential.


Target Biology to Create Molecules of First-in-Class and Best-in-Class Potential

We have world-class expertise in identifying biological targets and their immunological mechanisms involved in the two therapeutic areas we focus on. Our discovery capability in immunology is built upon a team of seasoned immunologists and drug developers who are passionate about and excel in developing potentially best-in-class monoclonal antibodies by creating clinically meaningful differentiated as well as bi-functional molecules of first-in-class potential by creating synergized biologic properties. More specifically, the demonstrated differentiation of TJC4 and TJD5 is engineered by design (de novo) from antibody screen through stepwise in vitro and in vivo validation processes. TJC4-CK and TJL1-CK are designed to position as bi-functional molecules to specifically treat solid tumors that otherwise may not respond to the CD47 antibody alone or tumors that respond poorly to standard PD-1 and PD-L1 treatment, respectively.

Our discovery team has deep expertise in functional assays across a wide range of immune cells, including T-cells, B-cells and macrophages. By designing high-throughput and robust assays, we can significantly increase screening efficiency and probability of finding the right molecules.

This discovery expertise, when combined with our “made-to-fit” antibody engineering technology platforms, becomes a powerful engine of innovation to create novel molecules of first-in-class and best-in-class potential.

Technology platforms

Make-to-Fit Technology to Create Novel Molecules

We utilize four antibody or molecular engineering platforms in our “made-to-fit toolbox” to engineer drug molecules that capture defined biologic properties.

  • Ig-cytokine

  • Bi-specific

  • Hy-Fc Protein

  • Monoclonal

CMC Development

Our CMC department is managed by a team of experts that covers a full spectrum of technical capabilities, including cell line development, cell culture and purification process development, analytical and formulation development, GMP manufacturing, quality control and assurance, as well as CMC regulatory support. With extensive experience in both international and local biopharmaceutical companies, our scientists have participated in a wide range of projects including monoclonal antibody and fusion protein, as well as challenging bi-specific or bi-functional molecule.

Our in-house CMC labs specialize in cell line development and analytical development. The team actively manages a number of global and domestic contract development and manufacturing organizations (CDMOs) to advance both early and late stage biologics for IND submission as well as clinical material supply for China and global trials. We combine these in-house core capabilities with CRO/CMO to effectively meet the quality, speed and cost-effectiveness of I-Mab’s biologics projects.

Our agile and comprehensive cell line development (CLD) lab aims to bridge in-house discovery and CMC out-sourcing and shorten the overall timeline from clinical candidate selection to IND filing. The CLD lab has established the following capabilities:

Evaluating developability

Developing cell lines from vector construction, clonal screening, top clone evaluation, and long-term stability studies

Producing test samples for difficult-to-express molecules

The analytical development lab supports early discovery, in-house cell line development, process development, and manufacturing. This lab has established the following capabilities:

Performing developability and characterization studies for molecule evaluation

Supporting development and transfer of special assays, trouble shooting, and method qualification

Providing the process development and manufacturing teams with fast turn-around analytical support

CMC Quality Assurance

CMC quality assurance leads the establishment and maintenance of CMC quality management system based on ICH Q10 guidelines. It provides the oversight of all relevant quality activities during CMC development phases and clinical material supply by CDMOs to ensure the compliance with the applicable regulations (e.g., NMPA GMP (2010), US regulations found in Title 21 of the CFR, EU guidelines to GMP for human use and their annexes, and ICH guidelines, etc.)

Manufacturing Facility Planning

The manufacturing facility is being planned to meet the demand of clinical trial material supply and future commercialization.

Pre-clinical Development

Preclinical Development team consists of seasoned scientists with both global and China experience in preclinical development of innovative drugs. We design and manage efficacy and safety studies using appropriate in vitro and in vivo models to support lead optimization and clinical development of new drugs based on the target biology and pharmacological mechanism of action.

We perform critical evaluation of preclinical data to make appropriate recommendations to the senior management regarding product in-licensing. We also provide technical support for product out-licensing to maximize the value of our assets.

Our preclinical team has rich experience in designing and managing preclinical development programs to support global IND and BLA filings. We have a successful track record in managing programs and communicating with regulatory agencies in China and other countries.

Clinical Development

Mainly based in Shanghai, our clinical development organization is highly skilled with many years of clinical development experience in both international and domestic pharma companies. The Clinical Development Organization includes a Medical Office (safety/pharmacovigilance/quality assurance/medical monitoring during clinical research) led by Yuan Meng, MD; Clinical Operations led by Michelle Yang, MS; Oncology Clinical Research led by Liping Wang, MD; Portfolio Management led by Chao Zhang, PhD; Regulatory Affairs led by Tiffany Liang, Head of the Beijing Site; and the US Site led by Claire Xu, MD, PhD and Biometrics function. Our integrated R&D management team has global pharma R&D expertise with extensive innovative drug development and managerial experience designing and executing clinical studies in their respective disciplines.

To advance our innovative products in both China and global portfolios, we have been carefully optimizing our infrastructure and processes to ensure the right strategies and programs are executed with high quality and efficiency. To that end, we have established development governance, standard operating procedures (SOPs), protocol review committees, safety steering committee and systematic vendor assessment and management processes.

We also play critical roles in collaborating with our global partners, conducting technical assessments of in-licensing/out-licensing compounds to support business development priorities.

While holding in-house core competencies in program strategies, regulatory affairs (both FDA and NMPA), study design, protocol development, KOL/PI engagement, we execute trials by leveraging CRO and other third-party vendors’ capabilities.

Medical Office

The I-Mab Medical Office delivers quality and safety commitments to our patients/clinical trial subjects. The Medical Office is responsible for supporting R&D by holistically and systematically managing quality across the organization to meet company quality objectives and ensure regulatory compliance. The Medical Office is accountable for patient/clinical trial subject safety monitoring and risk management throughout the product life cycle from first-in human trials through post-marketing. Our Medical Office footprint extends to Shanghai, Beijing and the United States to support the I-Mab global organization in the following areas:

a) Establish a quality-oriented organization to ensure sustainable compliance with the laws and regulations governing drug discovery and development;

b) Establish, maintain, monitor and continue improving a Quality management System covering all GxP activities;

c) Ensure the highest level of safety reporting compliance, signal detection, risk evaluation, and risk minimization measures, to ensure and maintain a favorable benefit/risk profile of I-Mab products;

d) Serve as the medical safety representative of I-Mab products and provide medical safety leadership for all clinical development programs and post-approval products;

e) Maintain efficient medical safety collaborations with business partners and contribute to the due diligence of potential partnerships as requested.

Clinical Operations

Clinical Operations encompass the integrated clinical trial management process, which requires expertise, quality and speed. Our Clinical Operations team is equipped with strong clinical trial execution skillset and rich industrial experiences in conducting China and global clinical trials. To advance I-Mab’s innovative drug development strategy, the team conducts either China only or multi-regional clinical trials (MRCT), following specific regulatory authorities’ requirements for China or respective countries. The team also collaborates closely with US clinical team for global development of I-Mab assets. To improve clinical trial efficiency, we expand our capabilities by working with clinical CROs and 3rd party vendors to support protocol design, supply chain strategy, site selection and patient enrollment, etc. To ensure the CRO and third-party vendor adherence to agreed timeline, quality and budget, we perform systematically vendor oversight according to established contractual terms and agreements.

Medical/Clinical Research

Medical/Clinical research is an essential function of clinical development, which comprises clinicians who have in-depth knowledge of the scientific nature of the compounds, development processes and requirements for registration of new drugs. We provide medical and scientific expertise in the context of the therapeutic areas in terms of study indication, study design and oversight, medical training & instruction, and oversight throughout the study execution to ensure quality, safety and data integrity. We can develop study protocols, assist with safety and efficacy data analysis and interpretation, and provide clinical study reports.

Dedicated to developing innovative and differentiated biologics, the team works closely and efficiently with internal stakeholders and external to bring first-in-class and best-in-class medicines to patients around the globe.

Biometrics

Our Biometrics group is composed of statistical, programming and data management teams. Highly specialized in technical skills and industry practices, the biometrics group works closely with the Medical/Clinical Research team for clinical trial design, data collection, data analysis and interpretation. We actively work with internal and external stakeholders to ensure the scientific rigor of the study design and data integrity.

Portfolio and Project Management Office (PMO)

Our R&D project team is structured as a cross-functional matrix that is responsible for product strategy planning and execution. Our Portfolio and Project Management Office consists of a group of portfolio and project management professionals who are the strategic and operational leads in the cross-functional team. PMO oversees the dynamics and progress of the I-Mab portfolio and provides governance support to ensure our portfolio is highly aligned with the I-Mab mission and vision. Meanwhile, PMO will implement program management principles and tools throughout the drug discovery and development processes to enable the R&D teams to deliver milestones in a timely and cost-efficient way. Cost, timeline and risk management are the three core values of PMO.

Regulatory Affairs

I-Mab’s regulatory team, located in Beijing and Shanghai, is responsible for all non-US regulatory activities. The team provides regulatory expertise and leadership for IND submissions, clinical development and eventually regulatory approval from the regulatory authorities. The team also serves as an effective channel between the company and regulatory authorities to guide the regulatory process from start to finish in the highly regulated and constantly evolving regulatory environment.

In addition, the team provides regulatory strategy and policy interpretation for I-Mab’s in-licensing, out-licensing and clinical trial activities outside China.

US Clinical Development Team

Located in Maryland, USA, the US clinical team works closely with other functions of the company in China to set up global trials for our key global assets. We also work closely with consultants, specialized CROs/vendors in the US for site selection, study design, regulatory interaction, and study execution to meet different regulatory requirements. In addition, we partner with business development team for licensing or partnerships with other companies or academic institutes in the US.

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