Committed to saving lives with better and safer
anti-infective therapies

Stadius Biopharma is developing proprietary fully human antibody therapeutics and a stem cell antibody delivery system for the prophylaxis and treatment of patients with resistant and potentially life threatening bacterial, fungal, and viral infections.

Read More

“Many patients who receive solid or bone marrow transplants or who have been exposed to high dose chemotherapy, the elderly, ICU patients, neonates and HIV/AIDS patients are at risk for life threatening opportunistic infections. Additionally, the development of resistance to anti-infective drugs and the appearance of newly emerging pathogens continue to present significant challenges for the treatment of infectious disease.” – Russell Wilson, Chief Scientific Officer

Developed using novel and differentiable approaches, our products are focused on the prevention and treatment of opportunistic infections in immunocompromised patients.

Our Pipeline

ABOUT US

At Stadius Biopharma, we are researching novel and transformational monoclonal and bispecific antibodies to treat opportunistic pathogens including the delivery of these proteins in man using our patented non-viral gene modified adipose derived mesenchymal stem cell platform to deliver antibodies. Our lead product is focused on treatment of invasive fungal infections in immunocompromised patients.
Fully Human mAbs for the Treatment of Fungal Infections
Stem Cell Platform for Antibody Delivery
Discovery Research

LEADERSHIP

MANAGEMENT TEAM

Dr. Wilson was the founding scientist of Autoimmune Technologies LLC (AIT). He is currently the Acting CEO and CSO of Stadius Biopharma. Previously he was a research biologist at Carnegie Mellon University, an assistant professor of pathology and laboratory medicine at Tulane University Medical School and served on study sections of the Center for Scientific Review of the National Institutes of Health (NIH). Dr. Wilson led the team that developed the highly sensitive detection reagent used in the first emergency use authorized (EUA) rapid test for Ebola virus infection, a test which is also used in the recently 510(k)-approved rapid antigen test for the detection of Ebola. Dr. Wilson was the principal investigator on an NIH/NIAID Phase I/Phase II SBIR Fast-Track grant entitled “Peptide Inhibitors of Influenza Entry” and was the principal investigator on a Phase 2a influenza challenge study funded by an NIH/NIAID contract. Dr. Wilson is experienced in virology, immunology, and molecular cell biology, and his research has focused on the mechanisms by which toxins and viruses gain entry into the cell. He holds degrees in biology from Baylor University and the University of Texas at Dallas and a Ph.D. in molecular and cell biology from the University of Texas at Dallas.

Mr. Phillips serves as CFO for both parent company Autoimmune Technologies LLC (AIT) and Stadius and coordinates fund raising and investor relations and provides general corporate guidance. Mr. Phillips and the family LLC he manages are founding equity investors in AIT. Mr. Phillips also assists in managing a number of other closely-held entities and has commercial banking experience that focused on commercial lending and regional expansion. He holds a degree in political science and history from the University of Colorado-Boulder and an MBA from Tulane University.

Dr. Droege has more than twenty years of industry experience and leadership in clinical operations and management (Phases I-III), pharmaceutical product development, project management, and drug discovery. His experience includes drug (small molecule and biologics) and medical device activities in therapeutic areas such as cardiovascular, renal, analgesia, oncology, in vivo diagnostic imaging, wound healing, and infectious diseases. His expertise includes clinical operations and management, technology assessment and analysis, technical and regulatory strategy development, medical writing (protocols, clinical study reports, investigator brochures, clinical operations, regulatory agency submission documents including IND/NDA preparation, briefing documents, pediatric waiver requests), and regulatory agency meetings (US and ex-US). Previously he was a product and project manager for Corlopam development, an FDA approved antihypertensive, and was the acting director of research for discovery of new in vivo diagnostic imaging agents. Dr. Droege holds a Ph.D. in chemistry from the University of Oregon and was a post-doctoral fellow at Stanford University. He holds 17 patents and applications and more than 50 technical publications.

Dr. Chamow has over 30 years of experience in biopharmaceutical product development and is a recognized expert in monoclonal antibodies and Fc fusion proteins. Since 2008 he has served as president of Chamow & Associates, Inc., a consulting group working with biotechnology companies to design and implement development strategies for new therapeutic products. During his career he contributed to the development of three marketed biologics (Avastin, Natrecor, Vectibix). Previously he was Senior Vice President, CMC, at Intradigm Corporation, a private biopharmaceutical company focused on developing RNAi therapeutics (acquired by Silence Therapeutics). Dr. Chamow was Vice President, Process Sciences, at Genitope Corporation and at Abgenix, Inc., (acquired by Amgen), where he built the company’s process sciences department and helped to lead the design and construction of the award-winning Abgenix production facility in Fremont, CA (sold by Amgen to Boehringer-Ingelheim to become its first North American production facility). Before Abgenix, he served as Director of Biopharmaceutical Development at Scios, Inc. (acquired by J&J), and as a scientist and senior scientist in process development at Genentech, Inc. (acquired by Roche). Dr. Chamow was educated at the University of California (UC Santa Cruz, B.A. in biology; UC Davis, Ph.D. in biochemistry), and completed postdoctoral training at the National Institutes of Health. He is author or co-author of more than 50 scientific publications and patents and co-editor of two books (Therapeutic Fc-Fusion Proteins, 2014, and Antibody Fusion Proteins, 1999), both published by Wiley-Blackwell.

Dr. Deshpande is a regulatory affairs professional with over 20 years of experience in pharmaceutical industry. Dr. Deshpande is founder and President of Universal Regulatory Inc., a regulatory affairs consulting firm based in the San Francisco Bay area. Over the years she has held industry positions of increasing responsibility in pharmaceutical development and regulatory affairs, including Acting Head/Vice President of Regulatory Affairs for publicly traded companies and small to mid-size biotechnology firms. As a consultant Dr. Deshpande has worked with more than 75 biotechnology and pharma companies, providing strategic and tactical guidance on product development and regulatory affairs. Her background includes multi-functional expertise in regulatory affairs and pharmaceutical development with knowledge of domestic and international regulatory environments. She has provided regulatory guidance and strategic leadership for several successful marketing authorizations (US, EU), clinical trial applications, and negotiations with global health authorities.  She received her Masters and Ph.D in Pharmaceutical Sciences from West Virginia University and is RAC certified. Dr. Deshpande is a recognized contributor in pharmaceutical community, twice elected by membership of American Association of Pharmaceutical Scientists (AAPS) including Secretary and Chair of the Biotechnology Section. She has served as chairperson and speaker at several workshops, symposia on topics related to regulatory affairs and product development, and professional development topics such as achieving successful careers as women in pharmaceutical sciences.

Ms. Sinatra has over 20 years of experience in the biopharmaceutical industry where she has held various roles of increasing responsibility in both the licensing and commercialization function. She has worked with over 30 different companies in the biopharma space, with a focus on first-in-class-based technologies and products. She has managed more than 10 revenue-generating alliances. She is Principal for Vector Strategic Advisors, a licensing strategy advisory firm and has held executive and director level roles with Attenua, Sutro Biopharma, Telomere Diagnostics, Dynavax Technologies, Abgenix (acquired by Amgen), Matrix (acquired by Chiron), SEQUUS Pharmaceuticals (acquired by JNJ) and Smithkline Beecham. Ms. Sinatra organizes and instructs the Biotechnology Innovation Organization’s Executive Licensing Training program and is a member of the Subcommittee on Next Generation Biotherapeutics. She also volunteers with the California Life Science Institute’s FAST and the University of California at San Francisco’s Start-Up 101 mentoring programs. Ms. Sinatra holds a degree in biology from the State University of New York and pursued post-graduate studies in the department of microbiology at the University of Texas Southwestern Graduate School of Biomedical Sciences.

ADVISORS

Dr. Bunnell is the Director of the Tulane Center for Stem Cell Research and Regenerative Medicine and Professor in the Department of Pharmacology in the Tulane University School of Medicine. In addition, he holds the Aron Family Regents Distinguished Chair in Gene Therapy. Dr. Bunnell obtained his Ph.D. in microbiology from the University of Alabama at Birmingham School of Medicine. He then pursued postdoctoral fellowship research at the Howard Hughes Medical Institute in the School of Medicine at the University of Michigan and the National Human Genome Research Institute at the National Institutes of Health in Bethesda. Dr. Bunnell was an assistant professor at the Nationwide Children’s Hospital Research Institute, part of the Ohio State University School of Medicine, prior to joining the faculty at Tulane University in 2002. Dr. Bunnell’s research program is focused on both the basic science and translational applications of adult stem cells isolated from the bone marrow and adipose tissue. Dr. Bunnell investigates use of mesenchymal stem cells (MSCs) isolated from the bone marrow or adipose tissue as a therapeutic intervention for multiple sclerosis, wound repair, lung injury, and bone repair. He is particularly interested the interactions of MSC with the immune system and how the cells elicit robust anti-inflammatory effects in vivo. He is currently working towards human clinical trials for the treatment of osteoarthritis, traumatic brain injury and multiple sclerosis with these cells. He has served as a reviewer of stem cell, regenerative medicine and tissue engineering grants for the National Institutes of Health, Department of Defense, and several state funded programs including Maryland, New York, Virginia, and Pennsylvania. He has also served on grant review panels for several foreign countries including Denmark, Ireland, Poland, Germany, and Spain. Dr. Bunnell serves as an editorial board member for several journals, including Stem Cells, BMC Genomics, and Regenerative Medicine.

Dr. Robinson is Professor of Pediatrics in Infectious Diseases at Tulane University School of Medicine, a position he has held since 1996. He is an internationally recognized immunologist and virologist whose primary interest is developing human monoclonal antibodies against a variety of pathogens for studies of protein structure and for therapy of infectious diseases. Notably, his monoclonal antibodies have proved to be critical reagents in solving the first crystal structures of HIV and Lassa fever virus glycoproteins and a cocktail of his anti-Lassa fever monoclonal antibodies protects non-human primates from lethal Lassa fever. These Lassa antibodies are being further developed as therapeutics in human disease. Dr Robinson received his M.D. from the Tulane University School of Medicine in 1967. After service in the US Navy he completed residency training in pediatrics at the University of Vermont and fellowship training in infectious diseases at Yale University School of Medicine, where he remained on the faculty until 1986. He has since served on faculties of Louisiana State University Health Sciences Center and University of Connecticut before coming to Tulane. Dr. Robinson’s research has led to over 160 peer-reviewed publications in scientific journals.

pipeline

Stadius Pipeline

TECHNOLOGY

Mechanism of Action Using a Dual Targeted Approach

A class of proteins called moonlighting proteins contribute to Candida virulence and pathogenicity through their involvement in mechanisms critical for successful host colonization and infection, such as the adhesion to host cells, interactions with plasma homeostatic proteolytic cascades, responses to stress conditions and molecular mimicry.1 These proteins normally are present within the fungal cell where they are involved with metabolism, however, by unknown mechanisms, they are secreted and associated with the cell wall of the fungal cell where they “moonlight” as virulence factors. The documented knowledge of the roles of these proteins in C. albicans pathogenicity has utility for assisting the design of new therapeutic, diagnostic and preventive strategies against candidiasis.

  • Our research demonstrates that antibodies to two of these proteins Met6 (5-methyltetrahydropteroyltriglutamate-homocysteine S-methyltransferase) and Fba (fructose-1,6-bisphosphate aldolase) specifically bind to peptide epitopes in the full-length Candida proteins and prevent virulence. Both antibodies protect neutropenic A/J mice from lethal challenge with C. albicans. A cocktail containing both anti-Met6 and Fba antibodies protect neutropenic A/J mice from lethal challenge with C. albicans and C. auris. We are currently investigating the development using a bispecific antibody using these antibodies.
  • Our initial studies are focused on the treatment of Candida, with expanded indications for the treatment of aspergillus.
Fba Venn Diagram
Our fully human antibodies are designed to bind to both Fba and Met6. Our strategy is to develop a bispecific antibody to inhibit these targets.

Adipose-derived Mesenchymal Stem Cell Protein Delivery Technology

Adipose-derived stem cells (ADMSCs) provides a promising future in the field of tissue engineering and regenerative medicine. Our patented ADMSC platform has the potential to be used with a number of therapeutic indications where chronic or longer-term administration of antibodies and improved compliance is warranted. This is a new paradigm for the delivery of antibody therapeutics.

Mesenchymal stem cells (MSCs) have the ability to self-renew and to differentiate into one or more specialized cell types. It is, however, the ability of MSCs to maintain and express very large human genomic DNA fragments (>300 kb) as non-integrating episomes that provides a significant advantage over viral vectors and other gene delivery approaches.

We have demonstrated that human ADMSCs transfected with episomal vectors that express human monoclonal antibodies to Candida sp. virulence factors produce functional antibodies in vitro and in mice. The company is currently optimizing cell preparation and delivery methods and optimizing expression vectors.

Discovery Research

Stadius has access to patient derived peripheral blood monocytes (PBMCs) from various and unique populations using proprietary approaches. From these, we have been able to isolate neutralizing anti-viral antibodies. These viruses cause significant disease burden in immunocompromised patients, trauma patients, and in certain patients suffering from hematopoietic cancers and carcinomas.

1. A Kozik, et.al. Microorganisms, 14 July 2020

MARKET OPPORTUNITY

Invasive Fungal Infections (IFI) Market

The most common invasive fungal infections are due to invasive candida spp (IC) and invasive aspergillus spp (IA) and are becoming more prevalent as the use of immunosuppressive therapies for the management of malignancy, transplantation, and rheumatology increases.  Improved longevity and the survival of patients with multiple comorbidities and advanced disease is also contributing to increased rates of fungal infection. The presence of multiple risk factors and severe illness makes patients admitted to the ICU particularly vulnerable to these infections.  It is estimated that approximately 1.5M patients admitted to the ICU per year are vulnerable to IFIs.

Mortality rates associated with IC alone have been reported to be about 40% to 60% in ICU patients and 80% to 90% in patients with septic shock. These infections also place a significant financial burden on the health care system because of longer hospital stays, use of expensive therapies, and increased consumption of health care resources.

The most common fungal infections in patients with COVID-19 include aspergillosis or invasive candidiasis, including C.auris, an emerging pathogen. It is estimated that 25% of severe Covid-19 patients have contracted invasive fungal infections, particularly after being treated with immune suppressing drugs, such as dexamethasone or IL-6 inhibitors.2

There have been very few significant treatment developments to fungal infections, and current medications may result in toxicity or drug interactions, and may require renal adjustment with increasing rates of resistance resulting in potentially costly and life-threatening outcomes.

The current U.S. market is estimated to be approximately $3.5B in 2027 with global forecasts reaching approximately $8.2B at a CAGR of 4.5% representing current agents, the majority of which are generic. All recently approved drugs as well as those in development are small molecule agents, many of which are being developed only in oral formulation.

Our differentiated antibody therapeutics are designed to inhibit colonization and invasion using a dual targeted and novel mechanistic approach. With the advent of COVID-19, antibodies are becoming more accepted and acknowledged as a means of treatment for viral infections and other pathogens. Primary market research has indicated a keen interest by physicians for alternatives to current anti-fungal agents. Historically, fully human antibodies have had an excellent safety and distribution profile and are well tolerated, with a very low incidence of allergic reactions.

Worldwide forecast estimate for Invasive Fungal Infections due to Candida and Aspergillosis, 2021
Worldwide forecast estimate for Invasive Fungal Infections due to Candida and Aspergillosis, 2021.

Invasive Candidiasis

The world-wide incidence of IC or candidemia is estimated at 400,000 patients per year. It is the most frequent hospital infection and accounts for up to 15% of bloodstream infections and is the main causative agents in 50-70% of systemic fungal infections. IC presents with high morbidity and mortality in immunosuppressed or immunocompromised populations who have chronic diseases as well as in transplant recipients. Mortality ranges in these patients from 40-70%. Many of these patients are taking drugs to prevent transplant rejection as well as corticosteroids that are immunosuppressive. Other contributors include the overuse of antibiotics in post-surgical patients and trauma patients in the ICU and certain medical and intubation devices where colonization is frequent. It is estimated that 50% of post-surgical procedures in the ICU will get candida peritonitis per year.3

Candida auris: An Emerging Healthcare Threat

Candida auris is an emerging fungus that presents a serious global health threat. It can cause invasive infections associated with up to 40% in-hospital mortality. Most strains of C. auris are resistant to at least one antifungal drug, one-third are resistant to two antifungal drug classes, and some strains are resistant to all three major classes of antifungal drugs. C. auris can spread readily between patients in healthcare facilities. It has caused numerous healthcare-associated outbreaks that have been difficult to control. In some countries, C. auris has emerged as a leading cause of candidemia, accounting for up to 40% of Candida isolates in some hospitals; hospital units have been closed temporarily to stop transmission of C. auris.4

​Invasive aspergillosis

Over 300,000 patients develop IA per year. IA is estimated to have a 50% mortality rate, even with treatment. It is frequently associated with both solid organ and stem cell transplants, as well as the patients with moderate to severe COPD, and is a major complication of lung cancer. Missed diagnosis is frequent.​

2. https://www.cdc.gov, Updated 2021, Insight Partners 2021
3. Fungal Infection Trust, Updated 2017.
4. The Council of State and Territorial Epidemiologists (CSTE), Committee of Infectious Disease, 2018 and CDC.gov, 2021

NEWS

Upcoming Meetings & Events

Stadius Biopharma will be in attendance at the following:

  • BIO JPM, January 11 – 15, 2021
  • BIO CEO Investor Conference, Feb 16 – 18, 2021 (Presenter)
  • International BIO Partnering Meeting, June 14 – 18, 2021

Press Releases

Stadius Biopharma in the news:

2019

Data supports that antibodies protect mice in lethal models of C. albicans and C. auris, an emerging pathogen

New Orleans (PR Newswire), December 9, 2019 – Stadius Biopharma LLC will present data on its fully human antibodies to Candida at the upcoming Antibody Engineering & Therapeutics meeting December 9 – 13, 2019 in San Diego. The antibodies protect mice from death in lethal mouse models of both C. albicans and C. auris.

Human antibodies to two peptides derived from the C. albicans cell wall associated proteins Fba and MET6 are present in human sera. Six fully human recombinant antibodies have been isolated and preliminary characterizations performed. Two of the antibodies, one to the Fba peptide and one to the MET6 peptide, have been tested in animal models and show protection in lethal mouse models for C. albicans and C. auris. The antibodies may function independently of Fc-mediated host functions. These results demonstrate that anti-peptide antibodies to Fba and to MET6 may be useful as human therapeutics for the prophylaxis and treatment of disseminated candidiasis.

“Our data suggests that human antibodies to peptides derived from conserved sequences of novel virulence factors associated with the Candida albicans cell wall will bind and disrupt the pathology of various species of Candida, including C. auris, a deadly pathogen,” said Russell B. Wilson, Ph.D., the Company’s Chief Science Officer. “This is a novel mechanistic approach for the treatment of invasive candidiasis,” he said.

About Invasive Candidiasis

Invasive Candida infection can present with high morbidity and mortality in immunosuppressed populations and is the most frequent hospital infection, accounting for up to 15% of bloodstream infections. Candida species are the main causative agents in 50–70% of systemic fungal infections.

C. auris has emerged as a life-threatening infection and is increasing in incidence worldwide. There are currently no effective agents. It is a significant threat for patients at risk and potentially the general population (https://www.cdc.gov/fungal/candida-auris/index.html).

Prophylaxis of Candida can range from months to life-long in higher risk groups in solid organ transplant patients. Current oral medications may involve toxicity as well as lack of compliance and recurrence of infection, resulting in potentially costly and life-threatening outcomes.

About Stadius Biopharma

Stadius is a biotechnology company focused on using antibody mining to develop proprietary fully human antibody therapeutics for the prophylaxis and treatment of patients with resistant and potentially life threatening viral, bacterial, and fungal infections which are inadequately addressed by current standard-of-care medicines. The Company is also developing a novel universal donor non-viral gene-modified somatic stem cell platform to deliver antibodies in chronically immunocompromised patients.

Follow Stadius Biopharma on www.stadiusbio.com.

Contact: Investor Inquiries
Michael D. Charbonnet
CEO, Stadius Biopharma LLC
(504) 529-9944
Email: mdc@stadiusbio.com

Media and Licensing Inquiries
Patricia Sinatra, Head of Business Development and Strategy
(504) 529-9944 Email: p.sinatra@stadiusbio.com

PARTNERING

Partnership and Investor Inquiries

We are currently seeking additional Seed/Series A financing. We welcome investors and collaborative biopharmaceutical partners with a strategic interest in the use of protein or cellular therapeutic approaches for the treatment of infectious disease.

If you are interested in exploring a relationship with Stadius Biopharma, please send us an email to busdev@stadiusbio.com.

CONTACT US

For general inquiries, please fill out the form below.

Main Office

826 Union Street, Suite 200
New Orleans, Louisiana 70112
(504) 525-2985

Close Menu