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 viral, bacterial, and fungal infections.

“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 mechanistic approaches, our initial products are focused on the prophylaxis and treatment of patients at high risk for cytomegalovirus infections and candidiasis, with a particular focus on a significant emerging pathogen called Candida auris.

ABOUT US

Stadius Biopharma is working to create novel and transformational monoclonal antibody therapeutics and to deliver these antibodies using both direct dosing and the Company’s patented non-viral gene modified somatic stem cell platform to treat patients. Our unique pipeline includes multiple potentially first-in-class or best-in-class fully human antibodies and antibody cocktails for the prophylaxis and treatment of Candida sp. infections, including C. auris infection, and cytomegalovirus infections in high risk patients.

LEADERSHIP

MANAGEMENT TEAM

Mr. Charbonnet is a founding member of parent company Autoimmune Technologies LLC (AIT) and is also AIT’s CEO. His prior work experience includes CFO and other executive roles at commercial banks and their publicly traded holding companies, and he was a principal in two consulting firms where he advised business clients on capital transactions and large investments. He holds a degree in electrical engineering from Tulane University and an MBA from Boston University. He served as an officer in the Electronic Systems Division of U.S. Air Force Systems Command and is a registered professional engineer.

Dr. Wilson is the founding scientist of parent company Autoimmune Technologies LLC (AIT) and is also AIT’s president and chief scientific officer. 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

Dr. Xin is Associate Professor of Pediatrics, Microbiology, Immunology and Parasitology at Louisiana State University Health Sciences Center. Her research interests include development of a vaccine against disseminated candidiasis caused by all the Candida species of medical significance, development of combination therapies for disseminated candidiasis using monoclonal antibody (mAb) cocktails, determining the protective efficacy of vaccines and therapeutic mAb cocktails in neutropenic mouse model of disseminated candidiasis, and investigating the protective mechanisms of protective peptide-specific mAbs. Dr. Xin graduated from Capital University of Medical Sciences in Beijing. She has a broad background in clinical medicine as an M.D. and received extensive training in biochemistry during her Ph.D. program at LSUHSC. 

pipeline

TECHNOLOGY

Candida Antibodies

Stadius has developed fully human IgG1 monoclonal antibodies to two different virulence factors that are required for lethality in mouse models of disseminated candidiasis. When injected into mice, the antibodies protect the animals from death following lethal injection of Candida albicans and Candida auris. The antibodies bind specifically to two different peptide targets within the cell-wall-associated proteins fructose-bisphosphate aldolase (Fba) and methyltetrahydropteroyltriglutamate homocysteine methyltransferase (MET6). These peptide regions are highly conserved among the Candida species which are human pathogens, including C. auris.

Cytomegalovirus Antibodies

Stadius has developed a pool of proprietary fully human monoclonal antibodies that recognize CMV gH and gB and are potent (low ng/ml) neutralizers of CMV cellular entry and infection. The gH and gB proteins are conserved viral glycoproteins that play a role in binding of CMV to host cells and activation of membrane fusion (gH) and in the fusion of the viral membrane with the host membrane (gB). Sera samples from a unique population were screened for neutralizing activity using an in vitro neutralization assay and the neutralizing antibodies were identified and molecularly cloned from positive donors’ peripheral mononuclear blood cells. The antibodies directly neutralize CMV cellular entry and infection without the need of host factors.

Mesenchymal Stem Cell Antibody Delivery Platform

Stadius is developing its proprietary non-viral gene modified allogeneic stem cell platform for delivering antibodies in chronically immune  compromised patients. The somatic adult adipose-derived mesenchymal stem cells (ADMSCs), which have unique properties to allow prevention of rejection, are transfected with the genetic information required to enable the implanted stem cells to episomally express inside the patient the antibodies needed to prevent or treat infection.

Antibody delivery to patients via this platform is intended to provide continuous protection while reducing the requirement for more frequent dosing. Physician management of circulating stem cells is enabled via apoptosis-mediated kill switches.

The Company’s human ADMSCs transfected with episomal vectors that express human monoclonal antibodies to Candida sp. virulence factors produce functional antibodies in vitro and in mice, and CMV vectors yield neutralizing titers of CMV antibody. The company is currently optimizing cell preparation and delivery methods and optimizing expression vectors.

The ADMSC platform has the potential to be used with a number of therapeutic indications where chronic or longer-term administration of antibodies is warranted.

Additional Research

Stadius is investigating novel antibody approaches for the treatment of HHV6 and Mycobacterium tuberculosis.

  • HHV-6

  • Human Herpesvirus 6 (HHV-6) comprises two closely related herpes viruses known as HHV-6A and HHV-6B. HHV-6B infects nearly 100% of human beings, usually before the age of three. HHV-6 reactivation has been increasingly associated with acute graft-versus-host disease (aGVHD) and allograft rejections in the transplant setting. Consequences of HHV-6 reactivation in liver transplant patients include bone marrow suppression, central nervous system dysfunction, pneumonitis, hepatitis, increased severity of aGVHD, increased incidence of fungal infections, and higher incidence of allograft rejection (source: HHV-6 Foundation).

  • Mycobacterium Tuberculosis

  • Mycobacterium tuberculosis is the species that causes infectious tuberculosis. M. tuberculosis has unusually waxy walls, is slow-growing, and is among the most difficult bacteria to treat in man. It is highly aerobic, which is one of the main reasons it colonizes the lung. According to the World Health Organization, a total of 1.5 million people died from TB in 2018. The disease is one of the top ten causes of death and the leading cause from a single infectious agent, surpassing HIV/AIDS.

MARKET OPPORTUNITY

Invasive Candidiasis and C. Auris

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

Candida auris has emerged as a life threatening infection and is increasing in incidence worldwide. There are currently no effective agents. Recent announcements by the CDC indicate that C. auris it is a significant threat for patients at risk and potentially the general population.

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

CMV Market

Over 50% of individuals in the U.S. over 40 years of age have been exposed to CMV and carry it without symptoms. It can re-activate in patients with weakened immune systems with the potential for multi-organ involvement. It’s transmitted through normal body fluids, including breast milk and saliva. Over time, individuals can become re-infected with different strains of CMV, further complicating prophylaxis and treatment.

CMV is the most frequent infectious complication following solid organ transplantation and bone marrow transplantation. It is responsible for both direct and indirect effects that can result in significant morbidity, including loss of the transplant, and mortality.

CMV is a major primary pathogen in neonates with one in three infected at birth and results in clinical abnormalities including neurological sequela in 10% to 15% of infected infants.

Experts recommend that CMV antiviral prophylaxis or preemptive therapy be used for the prevention of CMV replication and disease after solid organ transplantation. Virtually all patients are given CMV-antivirals before transplant surgery and one to two years following transplantation, and many lung transplant patients are treated for life.

Current agents may present with significant renal and hepatocellular toxicity and it is documented that there is a need for newer, more effective protective and therapeutic vaccines.

NEWS

Upcoming Meetings & Events

Stadius Biopharma will be in attendance at the following:

  • Antibody Engineering & Therapeutics US meeting, San Diego, CA.  December 9-13, 2019
  • Biotech Showcase, San Francisco, CA, January 13 – 15, 2019
  • Biotechnology Innovation Meeting, San Diego, CA,  January 8 – 11. 2020

Press Releases

Stadius Biopharma in the news:

2019

New Orleans (PR Newswire), December 9, 2019 – Autoimmune Technologies LLC, a biotechnology company developing diagnostics and therapies for non-infectious and infectious disease, has established a new subsidiary, Stadius Biopharma LLC, to focus on proprietary anti-infective antibody therapeutics for diseases that are inadequately addressed by current standard-of-care medicines. “Within this standalone entity we’ll concentrate on our unique fully human antibodies and our stem cell antibody delivery platform to treat opportunistic viral, bacterial, and fungal infections,” said Michael Charbonnet, who will serve as CEO of the newly formed business unit in addition to his continuing responsibilities for the parent company. Current Stadius antibody targets include invasive candidiasis and cytomegalovirus (CMV) infection. “Our antibodies bind and disrupt the function of conserved sequences of novel virulence factors associated with pathology of various species of Candida,” said CSO Russell Wilson. “Candida auris is an emerging fungus that presents a serious global health threat, and we’re encouraged by our initial preclinical data that indicates activity against C. auris as well as C. albicans, which is prevalent in high risk patients,” he said. The CDC is monitoring the spread of C. auris colonization and infection in the United States. C. auris is associated with a high rate of morbidity and mortality and is resistant to current standard of care antifungal treatments. Healthy individuals unknowingly colonized with C. auris or other Candida species and can spread the fungal cells to surfaces in hospitals, long-term-care facilities, and other healthcare environments, where they pose a threat to people with weakened immune systems. Also under development are antibody therapeutics to CMV infection. More than 50% of individuals in the U.S. over 40 years of age have been exposed to CMV and carry it without symptoms. It can re-activate in patients with subpar immune systems with the potential for multi-organ involvement, and it can be transmitted through body fluids such as breast milk and saliva. Over time, individuals can become re-infected with different strains of CMV, further complicating prophylaxis and treatment. CMV is the most frequent infectious complication following both solid organ transplantation and bone marrow transplantation. The company is also developing its proprietary non-viral gene modified allogeneic stem cell platform for delivering antibodies in chronically immune compromised patients. The somatic adipose-derived mesenchymal stem cells, which have unique properties to allow prevention of rejection, are transfected with the genetic information needed to enable the implanted stem cells to produce inside the patient the antibodies needed to prevent or treat infection. Antibody delivery to patients via this platform is intended to provide continuous protection while reducing the requirement for more frequent dosing. 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

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

Corporate Partnerships

Stadius intends to maximize the value of the promising drug and cell therapy candidates generated by its novel discovery research programs through licensing and collaborative opportunities. The Company is currently seeking partners that have a strategic interest in infectious disease, transplantation, or novel cellular therapeutic approaches.

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

830 Union Street, Suite 200
New Orleans, Louisiana 70112
(504) 529-9944

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