Differences in female biology impact drug development, driving us to innovate in drug science through R&D that takes a female-centered perspective.

~50
Million

Number of Americans who
have an autoimmune disease¹

80%

Of all autoimmune patients
are female²

19:1

The ratio of female to male patients
with Sjögren’s Syndrome³

Our Science

Novel Bispecific Soluble Receptor Therapeutics

Bispecific basics

Bispecific soluble receptor fusions are engineered proteins designed to simultaneously recognize and bind to two different molecules, typically cytokines. These receptors are soluble, meaning they are not anchored to cell membranes but instead float freely in the bloodstream or interstitial fluids to capture cytokines, preventing them from signaling through the cell membrane.

Our approach

Fab’s technology is a dual-targeting soluble receptor drug platform that binds extracellular ligands.

The platform consists of:

Soluble receptors made up of the extracellular domains of membrane-bound receptors found on key immune cell types including B cells and T cells.

Cytokine targets chosen for their emerging importance in Sjögren's and other T cell + B cell autoimmune diseases.

Molecules that typically bind extracellular ligands while leaving membrane-bound receptors and their immune cells intact and functional.⁹

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Fab Biopharma has detailed operational knowledge for generating preclinical data which will support IND submissions

for initiation of clinical studies on bispecific receptor fusion drugs in separate disease indications.

Our potential

We will optimize patient dosing with our drugs to counteract the hyperactive immune response and reduce the immune system’s activity to normal levels without damaging its natural protective function against foreign pathogens. This approach leads to increased safety and efficacy and a wider therapeutic window for a greater number of patients. Maintaining the body’s adaptive immunity is especially important in an autoimmune disease such as Sjögren’s, which is both T and B cell-dependent, as these cells are key producers of lymphocytes.

Because this novel drug class reduces activation of both B and T cells simultaneously without compromising innate immunity, there is significant potential for complete remission of the indicated autoimmune conditions of Sjögren’s and Lupus—a radical advancement for this space.

Indications

Taking on Pervasive, Debilitating Autoimmune Disorders

Taming the rogue adaptive immune response

Our adaptive immune system, which evolved in each of us to recognize and rapidly respond to pathogens, features two main lymphocyte types: T and B cells. These cells work in concert to produce our adaptive immune response, both becoming activated by and producing cytokines—proteins that are crucial to the growth and function of immune and blood cells. An overproduction of cytokines can lead to the overactivation of the immune system, causing T and B cell lymphocytes to mount an immune and inflammatory response misdirected to healthy tissues, causing the chronic debilitating symptoms common to autoimmune diseases like Sjögren’s and Lupus.

Targeted Indication

Sjögren’s Syndrome

Disease Description

Sjögren’s is a multi-system autoimmune exocrine gland and organ disorder that overlaps with lupus and several other immune disorders. Sjögren’s occurs predominantly in women and exhibits as extreme dryness of mucous membranes and glands, with dry mouth and tear ducts or “sicca” presenting as hallmark symptoms. Many systems are affected, including the eyes, mouth, genital, skin, nerves, oints, organs, and overall immune system. 40% of patients will suffer from organ failure and 15% will develop B cell lymphoma, a potentially deadly cancer.

Unmet Need

The current standard of care for Sjögren’s is poor, primarily consisting of symptom amelioration with eye drops, glucocorticosteroids, and drinking more water. As the disease progresses systemically to the joints, kidneys, lungs, nerves, and blood vessels, patients are given toxic immunosuppressive therapies such as methotrexate, TNF antagonists, or rituximab. There is no efficacious treatment, nor is there an approved biologic drug for Sjögren’s.

Targeted Indication

Lupus Erythematosus

Disease Description

Lupus Erythematosus is a complex, multi-faceted autoimmune disease that shares commonalities with several other immune disorders, including rheumatoid arthritis. Lupus is characterized by the immune system's attack on its own tissues, leading to widespread inflammation and tissue damage. Predominantly affecting women, hallmark symptoms include a distinctive butterfly-shaped facial rash, fever, fatigue, and joint pain. The disease can affect multiple systems, such as the skin, joints, kidneys, heart, lungs, blood vessels, and nervous system, manifesting in a wide range of symptoms that vary from person to person.

Unmet Need

The current standard of care for Lupus has significant room for growth. Today, care involves a combination of medications tailored to each patient's severity and specific symptoms of the disease. The first-line treatment generally includes non-steroidal anti-inflammatory drugs (NSAIDs) for joint pain and swelling and antimalarial drugs like hydroxychloroquine, which are used for skin and joint issues as well as to reduce flares. Glucocorticoids are also commonly prescribed to reduce inflammation. For more severe cases, especially those involving organs like the kidneys, stronger and potentially toxic immunosuppressive drugs are used. Only one approved targeted biologic, belimumab (Benlysta®), has been approved to treat active, autoantibody-positive Systemic Lupus Erythematosus when there is high disease activity. While Benlysta® works well in 25% of advanced Lupus patients, considerable unmet needs remain. Benlysta® was previously developed by Fab's management team and is considered a breakthrough therapy in the field.

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Being Female Matters

The biology driving a heightened female immune response

The female sex is associated with an enhanced function of both innate and adaptive immune pathways, resulting in better immune defense and increased autoimmune disease susceptibility. The IncRNA molecule Xist, present in every female cell and central to the proper regulation of the X chromosomes, can sometimes inadvertently create protein complexes strongly associated with developing an autoimmune response.⁷

Decades of ignoring female biology ends here

Fab Biopharma is pioneering drug discovery from a female perspective by actively prioritizing female patient samples and animal models and designing clinical trials with predominantly female subjects for diseases prevalent primarily in women. It is also undertaking additional R&D projects exploring genetic markers, including the Xist ribonucleoprotein complex.

Fab’s goal is to reduce sex-based scientific bias including in formative cellular biology studies and landmark clinical trials. From use of predominantly male cell lines and male animal models to the historic limiting of clinical trial participation to primarily males, sex-based bias has greatly contributed to the lack of understanding of and efficacious treatments for predominantly female autoimmune diseases.⁸

The Team

Applying Our Expertise to a Global Need

Fab Biopharma’s leadership team is comprised of biopharma industry leaders with specialist expertise in drug discovery and development, clinical development, commercial strategy, and intellectual property. Together, they have a tremendous track record of success, including involvement in the development of two blockbuster biologic drugs, Enbrel® and Benlysta®.

Gardiner Smith

Co-Founder, Executive Officer

Gardiner Smith is the CEO of Fab Biopharma, leading the company since January 2021. With over two decades of experience in the biopharma industry, he has previously held executive roles at Glaxo, Human Genome Sciences, Memory Pharma, Aspreva and AgeneBio. Gardiner holds a Bachelor’s degree in Chemistry from the University of North Carolina at Chapel Hill and a JD from North Carolina Central University. He is a member of the U.S. Patent Bar.

Chia Chia Sun

Co-Founder, Chief Commercial Officer

Chia Chia Sun is the Chief Commercial Officer at FAB Biopharma, leveraging over 20 years of experience in women’s health, personal care, and biotechnology. Previously the CEO of Damiva Inc., she has a robust background in clinical trial management and corporate finance. Chia Chia has served in leadership roles at Azanta and TenX Biopharma. She holds an MBA in Corporate Finance from the University of Toronto’s Rotman School of Management and an MSc in Experimental Medicine and Bioethics from McGill University, bringing multifaceted expertise to her commercial strategies.

Bill Freimuth

Co-Founder, Consultant

Bill Freimuth is the Head of Clinical and Regulatory at FAB Biopharma, bringing 28 years of experience in translational medicine and clinical development for autoimmune and infectious diseases. He has led pivotal clinical trials and regulatory submissions for therapies targeting HIV and SLE. With a PhD in Immunology and an MD specializing in Internal Medicine and Rheumatology, Bill’s extensive background includes senior roles at Pfizer and Human Genome Sciences, where he contributed to significant therapeutic advancements and regulatory approvals.

Reiner Gentz

Co-Founder, Chief Scientific Officer

Reiner Gentz is the Chief Scientific Officer at FAB Biopharma, with over 25 years of expertise in protein development, cGMP manufacturing, and regulatory compliance. He holds a PhD in Molecular Biology and has a distinguished career developing therapeutic proteins, antibodies, and vaccines. Reiner has held senior positions at Human Genome Sciences and founded Gentz Biopharmaceutical Consulting LLC. He has played key roles in developing groundbreaking biologics, including the first FDA-approved drug for lupus, Benlysta®, and has extensive experience designing advanced biopharmaceutical facilities.