AbGn-168H

Neihulizumab

Therapeutic Area Indication

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, psoriatic arthritis and ulcerative colitis. 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: A phase I study in patients who develops steroid-refractory acute graft versus host disease (GVHD) after allogeneic hematopoietic cell transplantation (HCT), and also in the front-line setting of acute GVHD.
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 Ulcerative Colitis Steroid Refractory Acute Graft Versus Host Disease Acute Graft Versus Host Disease Solid Organ Transplantation

Psoriatic Arthritis

1

  • PRECLINICAL

  • 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

  • PRECLINICAL

  • 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.

Phase 2a anti-TNF α and/or anti-integrin refractory/intolerant Ulcerative Colitis trial completed with proof of clinical efficacy achieved; continued UC development planned with leiolizumab.

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Steroid Refractory Acute Graft Versus Host Disease

3

  • PRECLINICAL

  • 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 mounting a deleterious immune response against antigens found in the host. We believe AbGn-168H can effectively remove activated T-cells and thus has the potential to ameliorate the disease.
AbGn-168H is being studied in an ongoing phase 1b multi-dose trial in adults with steroid refractory acute GVHD. The FDA has granted Fast Track Designation to AbGn-168H in SR-aGVHD and Orphan Drug Designation in SR-aGVHD.

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Acute Graft Versus Host Disease

4

  • PRECLINICAL

  • 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 mounting a deleterious immune response against antigens found in the host. We believe AbGn-168H can effectively remove activated T-cells and thus has the potential to ameliorate the disease.
AbGn-168H is being studied in an ongoing investigator sponsored phase 1 study in front line acute GVHD to determine the maximum tolerated dose and safety of Neihulizumab for the treatment of Minnesota standard-risk aGVHD at the Medical College of Wisconsin.

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Solid Organ Transplantation

5

  • PRECLINICAL

    Preclinical

  • PHASE I

  • PHASE IIA

  • PHASE IIB

  • PHASE III

  • MARKET

Introduction

Solid organ transplantation is a potentially life-saving option for patients faced with terminal organ failure. However, immunosuppressive drugs are needed for prevention of rejection of transplanted organs and long-term administration of immunosuppressive medications has potential unfavorable consequences including increased susceptibility to opportunistic infections and malignancies.
Because of the unique MOA of AbGN-168H, we believe it has the potential for a durable response allowing patients to avoid long-term administration of immunosuppressive medications. We are currently studying the use of AbGn-168H in preclinical non-human primate renal transplantation models.