AbGn-168H

Neihulizumab

Therapeutic Area

Product Overview
Neihulizumab/AbGn-168H is a humanized therapeutic antibody with a unique mechanism of action, which preferentially induces apoptosis of late-stage activated T cells. This novel activated-T cell apoptosis-inducing antibody effectively eliminates chronic pathogenic T cells while fully maintaining host defense. A long lasting drug-free remission and less concern of increasing infection/cancer risks are its substantial clinical benefits. These two characteristics, which have been well demonstrated in our proof of concept clinical studies, offer a sustainable competitive advantage over existing therapies.

Our lead candidate AbGn-168H/Neihulizumab has demonstrated the proof of clinical efficacy in Phase II clinical trials for T-cell mediated diseases such as psoriasis and psoriatic arthritis. This innovative drug candidate has the potential to bring game-changing benefits to the patients with many other T-cell mediated diseases. There are currently two ongoing clinical studies with it. One is a phase II trial in patients with TNF-inhibitor and/or Entyvio or JAK-inhibitor Refractory ulcerative colitis. The other is a phase I study in patients who develops steroid-refractory acute GvHD after allogeneic hematopoietic cell transplantation (HCT).
Competitive Advantage of Neihulizumab

01

Less concern of increasing the risk of infections and cancers

Cytokines inhibitors, the most popular bio-therapeutics on the market, can help the patient relieve the symptoms associated with inflammatory diseases. The increased risk of infection has often been noted in those inhibitors targeting immune-related cytokines such as TNF-alpha, IL-12/23, IL-6 and IL-17. However, accumulated clinical evidence demonstrated no signs of elevated infection risks post Neihulizumab treatment.

02

A long-lasting drug-free remission

By effectively eliminating chronic pathogenic T cells, Neihulizumab is likely to achieve a long-lasting remission. One of the limitations of TNF-alpha and IL-17 inhibitors is the lack of long-lasting drug-free remission. Although IL-12/23 inhibitors have longer remission terms of about 3 months, none of the current therapies could possibly achieve the goal of a long-lasting and drug-free remission.

03

Alternative therapy for the patients who either did not respond or lost response to existing therapies

Close to 50% of RA and PsA patients treated with existing cytokine inhibitors for at least 6 months failed to achieve the 50% (ACR50) improvement criteria. Furthermore, more than 50% of the patients with long-term treatment of TNF-alpha inhibitors lost response to the drugs. Therefore, an alternative therapeutic agent like Neihulizumab is warranted to treat those non-responsive or discontinued patients.

04

A potential standard of treatment for inflammatory diseases that have no effective treatments

Neihulizumab not only showed efficacy in psoriasis but also demonstrated an extraordinarily effectiveness with regards to pain reduction in PsA patients. Current biologics are poor or ineffective at treating diseases like PsA, GvHD, transplantation, inflammatory bowel disease, multiple sclerosis, type I diabetes and allergic diseases. Neihulizumab, however, has great potential to provide meaningful clinical benefits to those patients with unmet medical needs.

Indication

Psoriatic Arthritis

1

  • PRECLINAICAL

  • PHASE I

  • PHASE IIA

    Phase II

  • PHASE IIB

  • PHASE III

  • MARKET

Introduction

AbGn-168H (Neihulizumab) is a humanized therapeutic antibody with a unique mechanism of action (MOA), which preferentially induces apoptosis of late-stage activated T cells. As a consequence, the treatment of AbGn-168H can effectively eliminates chronic pathogenic T cells during onset of disease resulting in inhibition of multiple aspects of T-cell-driven autoimmunity and inflammation.

Indeed, a proof of concept/efficacy phase IIa study with AbGn-168H was completed in 2016. From 15 PsA patients completed with 7 courses of AbGn-168H treatment, significant improvement was seen in 8 patients at week-12 (primary endpoint), and some responders even have the significant efficacy maintained thru week-24.

These encouraging results will now need confirmation in appropriate Phase II trial with suitable target population and expanding number patients.

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Ulcerative Colitis

2

  • PRECLINAICAL

  • PHASE I

  • PHASE IIA

    Phase II

  • PHASE IIB

  • PHASE III

  • MARKET

Introduction

AbGn-168H (Neihulizumab) target specific parts of the immune system that is to abolish the activated T cells. Because of this unique MOA, we believe the presence of AbGn-168H can effectively eliminates pathogenic (activated) T cells during onset of ulcerative colitis (UC) resulting in inhibition of T-cell-driven inflammation and autoimmunity.

A phase II study to assess efficacy and safety of AbGn-168H in patients with TNF-inhibitor and/or Integrin-inhibitor refractory UC is just now starting recruitment. The completion of study is expected in Q1 2020.

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Acute Graft Versus Host Disease

3

  • PRECLINAICAL

  • PHASE I

    Phase I

  • PHASE IIA

  • PHASE IIB

  • PHASE III

  • MARKET

Introduction

Graft-versus-host disease (GvHD) is a multisystem disorder involving tissue inflammation that occurs after allogeneic hematopoietic cell transplant (HCT). It is known that the disease is initiated by donor T cells recognizing the host as foreign and mount a deleterious immune response against antigens found in the host. AbGn-168H (Neihulizumab) possess a unique MOA which preferentially leading activated T cells to death. We believe the presence of AbGn-168H can effectively remove activated T cells during onset of GvHD, as consequence in control the progress of inflammation in multisystem. AbGn-168H is being studied in an ongoing phase I trial in adults with steroid-refractory acute GvHD. The primary objective of the study is dose range finding and to evaluate the safety of AbGn-168H in patients with the disease, in the post-allogeneic transplantation setting. On top of that, in March 2018 the U.S. FDA granted orphan drug designation of AbGn-168H for the treatment of acute graft-versus-host disease.

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