Complicated Problem, Simple Solution

To eradicate disorders of the immune system by making multiple cytokine pathway modulation a technical and financial possibility.

About Us
Small peptide therapeutics with the unique functionality of selectively inhibiting subsets of cytokines that utilizing a common receptor. Such a capability allows us to selectively block desired parts of the immune system that have traditionally been difficult to modulate.
Being able to selectively deactivate pieces of the immune system is critical in treating immune-mediated diseases, in particular autoimmune disorders that are often driven by malfunctioning of cytokine (cell signaling molecule) pathways.
Because of cytokine redundancy. Cytokine pathways reinforce one another by functioning in parallel so the immune system won’t get interrupted if one is stopped.
There are monoclonal antibody (MAB) therapies that are effective in targeting single cytokine pathways. In some cases, such as Humira targeting the cytokine TNF-a, single target MABs have been a tremendous commercial and medical success. However, in many cases single MAB therapy is not fully effective. The reason for this is that there are multiple cytokines, often with redundant functions, that are disease drivers. To achieve full efficacy, all cytokines that are disease drivers should be inhibited.
While there is a scientific rationale for combining the MABs that target disease driving cytokines, it is not practical to do so. In addition to being very expensive, cocktail therapy would also be burdensome to patients and could only be given official therapeutic clearance by challenging regulatory pathways. Therefore, cocktail MAB therapies against multiple cytokines are not a practical solution.

Summary For Technical Readers

Bioniz Therapeutics leverages its proprietary platform technology to develop novel peptides that target functionally redundant cytokines with targeted specificity. While the technology is applicable for a variety of cytokine families, our initial focus is on the IL-2 or the gamma-c (gc) family of cytokines that consist of IL-2, IL-4, IL-7, IL-9, IL-15, & IL-21.

Each cytokine in this family has a unique receptor complex which consists of the common “g-chain” as well as a “private chain” specific to that cytokine. The formation of a complete receptor complex is required for fully functional cytokine signaling. As the first step, the free cytokine binds to its private receptor. This binding positions the cytokine in a proper conformational position to reach to the critical binding site of the common receptor, which triggers the downstream signaling cascade.

Bionz’s BNZ132-1 peptide binds to the common receptor and blocks the binding interface of some of the gc cytokines, but not all of them. For example, BNZ132-1 selectively inhibits IL-2, IL-9, and IL-15, but not IL-4, IL-7, and IL-21.

The problem of cytokine redundancy refers to the immune system’s strategy of relying on distinct cytokines with redundant functions, in order to prevent one cytokine pathway disruption from severely affecting the immune system as a whole. While this redundancy makes immune defenses robust, it limits the therapeutic efficacy of single anti-cytokine therapies. A highly targeted therapeutic solution that selectively inhibits redundant cytokine disease culprits is needed…

Diseases of the immune system are rarely the result of an isolated component malfunctioning. More often, the immune system’s own redundant failsafe mechanisms ensure that no pathology has occurred unless several safeguards have been breached. This means that in general, autoimmune diseases are typically driven by several of the immune system’s messenger pathways malfunctioning together.

Autoimmunity is currently targeted with global immune suppression, JAK Kinases prone to side effects, or antibodies mostly aimed at upstream targets…

Unfortunately, up until now, no single or combinatorial technologies have been available to specifically block the inappropriately activated parts of the immune system without shutting down the healthy parts of the immune system as well. Generally, the problem has been that therapies tend to be either damagingly broad or ineffectively narrow. Steroids and JAK inhibitors target larger systems in order to suppress the malfunctioning subsystems that we do not have the pharmaceuticals to specifically target. In general, this broader targeting causes unwanted side effects.

Steroids tend to work by globally suppressing immune function, and JAK kinases function by inhibiting the cellular signals that follow next in the pathways after cytokine activation. Since the JAK pathway is shared by many cytokine families, its blockade has broad effects on the immune system as a whole and therefore is associated with serious side effects.

Alternatively, monoclonal antibodies targeting individual cytokine pathways may lack efficacy since they don’t inhibit all of the other disease driving cytokines. Bioniz’s technology largely came about when NIH scientists became frustrated with the general ineffectiveness of the creation of targeted antibodies for cytokine blocking.

Bioniz can target multiple combinations of gamma chain cytokines using only one peptide…

Bioniz Therapeutics is tackling cytokine redundancy with a new and patented platform technology that creates intelligently designed peptide therapeutics in which one molecule can be designed to adhere to, and inhibit, many selected combinations of gamma-chain cytokines. The gamma chain family of cytokines and their receptors play vital roles in immune system regulation, without which our bodies have been shown to collapse into Severe Combined Immunodeficiency (SCID). The ability to inhibit only these cytokines in selected combinations allows for immune related diseases with known cytokine profiles to be modulated so that the healthy parts of the immune system are left intact, while those portions driven by these cytokine messengers can be turned off completely with only one molecule.

While the initial focus is on the gamma-c family of cytokines, the technology is applicable to other cytokine families including IL-6, IL-17, and TNF among others.

Bioniz’s platform technology is a robust tool for developing peptides that selectively inhibit the function of multiple cytokines that belong to a family. The process of developing peptide candidates is fast and cost effective and will result in the creation of a library of peptides, each single one with a unique cytokine inhibition profile…

This approach provides an advantage to conventional anti-cytokine therapies where one anti-cytokine MAB is tested in clinical trials for its efficacy, ignoring the other disease driving cytokines. By having access to a rationally created library of peptides, each inhibiting a specific set of cytokines, we greatly elevate our chances of producing effective therapeutics and reduce the time it takes to come up with and screen candidates for biological activity, safety, and efficacy.

Beyond providing a few new drugs, Bioniz is changing the way we think about immune disorder treatment by bringing an entirely new platform technology to bear on the problem of cytokine redundancy.

Bioniz’s ability to selectively design single small molecules to address multiple cytokines means that Bioniz is unleashing a new generation of therapeutics that will give new hope to the treatments of autoimmunity and cancer while decreasing healthcare burden by providing cheaper, more effective therapies with fewer side effects. Bioniz is already approaching two Investigative New Drug (IND) applications in 2016 and is estimated to have saved a capitalized development cost of over $90 million on the typical development pathway thanks to the broadly patented and wholly owned rational design platform.

Beyond providing a few new drugs, Bioniz is changing the way we think about immune disorder treatment by bringing an entirely new platform technology to bear on the problem of cytokine redundancy…

Bioniz’s ability to selectively design single small molecules to address multiple cytokines means that Bioniz is unleashing a new generation of therapeutics that will give new hope to the treatments of autoimmunity and immunogenic cancer while decreasing healthcare burden by providing cheaper, more effective therapies with fewer side effects. Bioniz is already approaching two Investigative New Drug (IND) applications in 2016 and is estimated to have saved a capitalized development cost of over $90 million on the typical development pathway thanks to the broadly patented and wholly owned rational design platform.