Pipeline Strategy and Progress

Our differentiated pipeline strategy is to build a risk-controlled clinical stage pipeline with an exclusive focus on potentially first-in-class and best-in-class biologics. To achieve a delicate balance between exclusive positioning of our first-in-class and best-in-class potential with that inherent development risk, we have built a competitive biologics pipeline comprised of a China Portfolio and a Global Portfolio.


China Portfolio

Our China Portfolio consists of four core products that are positioned for sequential BLAs expected in 2021 and onwards in China. All four core products are ready for Phase 2 and Phase 3 clinical trials and have first-in-class and best-in-class potential. These products have desirable development characteristics. For example, they are at relatively advanced development stages and involve clinically validated drug targets. All products have successfully passed Phase 1 and Phase 2 clinical trials with excellent safety and preliminary efficacy data (Phase 2 assets) in Europe or elsewhere. As a result, the development risk of the products towards BLA is significantly reduced.

These products were licensed from reputable global pharmaceutical or biotech companies, and their efficacy, safety and clinical differentiation are supported by strong preclinical and clinical data packages. As a result, the prospects of our clinical development of such products are effectively enhanced. These “fast-to-market” assets, such as TJ202, represent the next generation of oncology therapeutics with the potential to change and upgrade the treatment paradigm of applicable indications.

KEY

  • PRE-CLINICAL :
  • PHASE 1:
  • PHASE 2:
  • PHASE 3:
  • PHASE 4:
Asset
Target
Molecular
Format
Therapeutic Area
Global Development
Phase
China Development
Phase
  • TJ101
    hGH
    hyFc fusion protein
    Pediatric growth
    hormone deficiency

    TJ101:A Phase III-ready potential best-in-class long-acting growth hormone

    TJ101 is a potential best-in-class long-acting recombinant human growth hormone (rhGH) with a novel molecular format of the hyFc-fusion technology. TJ101 is administered weekly and is superior to the existing daily injection of rhGH for convenience of usage and patient compliance and is a pegylated formulation for potentially better safety. These advantages have significant clinical relevance, as these agents are primarily used in pediatric patients with growth hormone deficiency. TJ101 has demonstrated safety and preliminary efficacy in three multi-regional clinical trials (Europe and Asia), including a recent Phase 2 trial in Europe. The asset is Phase 3 ready.

  • TJ202
    CD38
    mAb
    Oncology
    Auto-immune disease

    TJ202:A potential best-in-class CD38 antibody for multiple myeloma

    TJ202 is a potential global best-in-class CD38 antibody. Compared with daratumumab, TJ202 has demonstrated meaningful clinical differentiation with comparable efficacy, a significantly lower infusion-related reaction rate, and shorter infusion time. The asset is Phase 3 ready for relapsed/refractory multiple myeloma. We have agreement with CDE on our plan to initiate a registrational trial as monotherapy and a Phase 3 trial as combination therapy in China, and an IND application was submitted in July 2018. Product launch is expected in 2021. CD38 as a drug target is broadly implicated in various disease indications. Clinical development plans to evaluate TJ202 for autoimmune diseases, such as systemic lupus erythematosus, and solid tumors are being discussed

  • TJ301
    sgp 130
    Fc fusion protein
    Auto-immune disease

    TJ301:A potential best-in-class IL-6 trans-signaling blocker for inflammatory diseases

    TJ301 is a clinical-stage selective IL-6 inhibitor with best-in-class potential, owing to its novel mechanism of action on trans-signaling pathways. This differentiates TJ301 from other marketed IL-6 blockers in terms of potentially better safety, as shown in two Phase 1 clinical trials in Germany. TJ301 has a broad spectrum of autoimmune disease indications. We are conducting a Phase 2 clinical trial in ulcerative colitis as the first indication in Taiwan and South Korea, and have received the National Medical Product Administration (NMPA) approval and a Phase 2 clinical trial is on-going in China.

  • TJ107
    IL-7
    hyFc fusion protein
    Oncology

    TJ107:A potential first-in-class long-acting IL-7 for chemotherapy-induced lymphopenia and cancer immunotherapy

    As a long-acting recombinant IL-7, TJ107 is potentially a global first-in-class immuno-booster that activates T cells and enhances their cancer-fighting functions. TJ107 is positioned to treat all cancer patients with reduced T cells, a common condition called lymphopenia, which is typically induced by chemotherapy or radiation therapy. Lymphopenia in cancer patients further impairs patients’ immune systems to fight recurrent cancer. Currently there is no treatment approved for lymphopenia. TJ107 will also be evaluated in combination with other cancer therapies to potentially achieve superior treatment efficacy. TJ107 is safe and well-tolerated and its immuno-boosting properties have been demonstrated in pre-clinical studies and a Phase 1 clinical trial. Our IND application was approved in November 2018 and a clinical trial is about to start in cancer patients in China while our partner Genexine is conducting a Phase 2 clinical trial in South Korea. In addition, two clinical trials will soon be commenced in the United States.

  • TJM2
    GM-CSF
    mAb
    Auto-immune disease

    TJM2:A Potential First-in-Class anti-GM-CSF mAb for Rheumatoid Arthritis in China

    Granulocyte-macrophage colony-stimulating factor (GM-CSF) is an important cytokine that plays a critical role in tissue inflammation and destruction in autoimmune and inflammatory diseases. We discovered a number of neutralizing monoclonal antibodies against human GM-CSF. The lead candidate TJM2 is a humanized IgG1 that displays high affinity binding to GM-CSF and blocks its signaling and downstream effects, being developed for the treatment of autoimmune and inflammatory diseases, primarily RA and osteoarthritis. TJM2 is positioned to be the first anti-GM-CSF to enter clinical trial in China.


  • TJ210
    C5aR
    mAb
    Oncology
    Auto-immune disease

    TJ210:A Potential Best-in-Class Antibody for Immuno-oncology and Autoimmune Diseases

    TJ210 is a differentiated fully human antibody directed against C5aR. C5aR, the receptor of the complement factor C5a, is investigated as a new drug target in the field of immuno-oncology and autoimmune diseases. Tumors express high amounts of C5a which, by recruiting and activating myeloid-derived suppressor cells (MDSCs), is thought to contribute to an immuno-suppressive pro-tumorigenic microenvironment. TJ210 has the potential to be a best-in-class C5aR antibody with distinct binding epitope and superior functional properties. We will work jointly with MorphoSys for global studies towards proof-of-concert in oncology while exercising exclusive development and commercialization rights in Greater China and South Korea.


Global Portfolio

Relying on our internal discovery capability and integrated R&D platforms, we developed a portfolio of four globally competitive drug candidates that carry first-in-class or best-in-class potential. We own the intellectual property and full global rights of all assets in our Global Portfolio. These major pipeline assets take three different molecular formats: monoclonal antibody, antibody-cytokine fusion molecule (immunocytokine), and bi-specific antibody. They work through novel or differentiated mechanisms of action to potentially translate into innovative medicines for cancer treatment. These are expected to reach clinical development in the United States by 2019.

Both CD47 and CD73 antibodies are globally competitive and have huge potential to become the next generation of immuno-oncology agents. TJC4 and TJD5 in our Global Portfolio have attracted a high level of interest from global pharmaceutical companies and KOLs due to their clinical differentiation from competitor antibodies. This is a strong testament to our discovery capability in target biology, antibody engineering, translational medicine and antibody CMC. After discovering the four major pipeline assets in our Global Portfolio, our discovery group has been working actively on the next wave of novel molecules, which are mainly comprised of bi-specific antibodies for immuno-oncology and autoimmune disease to further enrich our Global Portfolio.

KEY

  • PRE-CLINICAL :
  • PHASE 1:
  • PHASE 2:
  • PHASE 3:
  • PHASE 4:
Asset
Target
Molecular Format
Therapeutic Area
Development Phase
  • TJC4
    CD47
    mAb
    Oncology

    TJC4:A Potential Best-in-Class CD47 Antibody for Immuno-Oncology

    TJC4 is a novel monoclonal antibody directed at a unique epitope on CD47, representing one of the most promising immuno-oncology targets to date. The current biologics targeting the CD47-SIRPa pathway have undesirable properties of binding to human red blood cells (RBC) or platelets. This unwanted binding property has been shown in preclinical and clinical settings to cause hematologic side-effects, e.g., anemia and thrombocytopenia, and the so-called “antigen sink effect” that affects pharmacokinetics. Unlike competitor molecules currently in clinical development, TJC4 was discovered through a screening cascade designed to select antibodies that do not bind to RBC. As such, TJC4 did not cause hematologic effects in a whole series of in vitro as well as non-human primate studies. This unique RBC-sparing property makes it a potentially best-in-class molecule. We expect to file an IND in December 2018 to start a Phase 1 trial in the United States.

  • TJD5
    CD73
    mAb
    Oncology

    TJD5:A Potential Best-in-Class CD73 Antibody for Immuno-Oncology

    TJD5 is a differentiated monoclonal antibody against another promising immuno-oncology target, CD73. It is expected to stimulate the immuno-suppressive tumor micro-environment and to work in concert with other cancer therapies such as PD-1 and PD-L1 antibodies. TJD5 acts through a unique intra-dimerization mechanism for anti-cancer activities. This unique mechanism of action ensures the molecule to work normally without a "hook effect" as evident in our preclinical studies. TJD5 is potentially a best-in-class CD73 antibody worldwide.

  • TJL1-CK
    PD-L1
    immunocytokine
    mAb-cytokine
    Oncology

    TJL1-CK:A Novel PDL-1-based Immunocytokine for Immuno-Oncology

    TJL1-CK is a novel bifunctional molecule consisting of PD-L1 antibody fused with an undisclosed cytokine. The molecule is designed to enhance the treatment effect of PD-L1 antibody by concentrating an immuno-boosting cytokine in the tumor environment to work synergistically. This novel mechanism of action by TJL1-CK has been demonstrated in our preclinical animal studies.

  • TJC4-CK
    CD47
    immunocytokine
    mAb-cytokine
    Oncology

    TJC4-CK:A Novel CD47-based Immunocytokine for Immuno-Oncology

    TJC4-CK is another novel bi-functional molecule consisting of CD47 monoclonal antibody fused with an undisclosed cytokine. This novel molecule is expected to have a superior property to treat solid tumors by activating tumor-residing macrophages to enhance the effect of CD47 antibody for various solid tumors.

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