Our Science

NXT Biologics is advancing the development of a Pan-Fungal Vaccine and Pan-Fungal Monoclonal Antibody Therapeutics for the prevention and treatment of fungal infections due to Aspergillus, Candida and Pneumocystis.

Pan-fungal Vaccine. NXT Biologics has developed a recombinant Pan-Fungal protein vaccine that elicits protective antibody responses to fungal infections in pre-clinical, immunosuppressed animal models of infection and immunosuppression. The Pan-Fungal Vaccine was developed from a protein that is common to these and other fungal pathogens and induces durable systemic and mucosal immunity that persists during immunosuppression in pre-clinical models of fungal infections. PNAS NEXUS. Nov 4;1(5):pgac248. PMID: 36712332. PMCID: PMC9802316

Pan-fungal Monoclonal Antibodies. Monoclonal antibody therapeutics are in development for the treatment of life-threatening, invasive fungal Infections. These monoclonal antibodies have the potential to treat multiple fungal pathogens responsible for life-threatening infections, particularly in high-risk, immunocompromised individuals.

Infection Targets

Aspergillosis

Pneumocystis pneumonia (PJP)

Aspergillosis

Globally, Aspergillus contributes to an estimated 3 million infections and 500,000 deaths each year. Invasive aspergillosis (IA) is the most serious Aspergillus infection and causes life-threatening disease in immunosuppressed individuals and individuals with other high-risk co-morbidities such as diabetes, cancer and chronic pulmonary diseases. Increased use of immunosuppressive therapies, including anti-rejection regimens for transplant recipients, chemotherapy and radiation for cancer patients, and anti-inflammatory drugs, is likely contributing to the increased morbidity and mortality associated with invasive fungal infections (Rayens, E. et al. 2021).

Candidiasis

Pneumocystis pneumonia (PJP)

Aspergillosis

Invasive candidiasis is one of the most frequent causes of systemic infections, with an incidence of 3–5 per 100,000 persons in the general population and 1–2% of all medical and surgical intensive care unit admissions. Highest frequency of invasive candidiasis occurs in cancer patients, organ transplantation, hospital-acquired infections.

Mucosal Candida infections can occur in non-immunocompromised individuals.

Mortality due to Invasive Candidiasis remains high at 15% to 35% and the frequency of multi-drug resistant Candida species is increasing.

Pneumocystis pneumonia (PJP)

Approximately 12.5 million people, most of whom have weakened immune systems, are at risk for Pneumocystis jirovecii pneumonia (PJP). Individuals with HIV/AIDS and patients receiving immunosuppressive therapies are at risk for developing PJP.

Globally, Pneumocystis causes an estimated 400,000 cases of HIV-associated PJP and 150,000 deaths per year. Mortality from PJP may be as high as 40% even with treatment, and over 80% in resource-limited settings. In addition to causing life-threatening pneumonia, persistent Pneumocystis colonization and acute pneumonia are associated with chronic obstructive pulmonary disease (COPD) and severe asthma.

Published Research

Rayens, E. Rabacal, W., Willems, H., Kirton, G., Barber, J., Mousa, J., Celia-Sanchez, B., Momany, M., and Norris, KA. 2022. Immunogenicity and protective efficacy of a pan-fungal vaccine in pre-clinical models of aspergillosis, candidiasis and pneumocystosis. PNAS NEXUS. Nov 4;1(5):pgac248. PMID: 36712332. PMCID: PMC9802316

Rayens, E, Rayens, M.K., and Norris, K.A. 2022. Demographic and Socioeconomic Factors Associated with Fungal Infection Risk, United States, 2019. Emerging Infectious Diseases, 28(10):1955-69. PMID: 36149028

Rayens, E. and Norris, K.A. (2022). Prevalence and Healthcare Burden of Fungal Infections in the United States, 2018. Open Forum Infect Dis. 2022 Jan 10;9(1):ofab593. doi: 10.1093/ofid/ofab593. eCollection 2022 Jan.PMID: 35036461

Rayens, E., Norris, K.A. and Cordero, J.F. (2021). Mortality Trends in Risk Conditions and Invasive Mycotic Disease in the United States, 1999-2018. Clin. Infect. Dis. Apr 20:ciab336. doi: 10.1093/cid/ciab336. PMID: 33876235

Rayens, E., Rabacal, W., Kang, S.E., Celia, B.N., Momany, M. and Norris, K.A. (2021). Vaccine-induced Protection in Two Murine Models of Invasive Aspergillosis. Front. Immunol. 12:670578. PMID: 34084170

Rayens E., Noble, B., Vicencio, A., Goldman, D.L., Bunyavanich, S. and Norris, K.A. (2021). Relationship of Pneumocystis antibody responses to paediatric asthma severity. BMJ Open Respir. Res. Mar. 8(1):e000842. PMID: 33762359

Cobos Jimenez, V., Rabacal, W., Rayens, E. and Norris, K.A. (2019). Immunization with Pneumocystis recombinant KEX1 induces robust and durable humoral responses in immunocompromised non-human primates. Hum. Vaccine Immunother. 15(9): 2075-80. PMID: 31348719

Kling, H. and Norris, K. A. (2016). Vaccine-induced Immunogenicity and Protection against Pneumocystis pneumonia in Non-human Primate Model of HIV-Pneumocystis Co-Infection. J. Infect. Dis. 213:1586–95.

Norris, K. A. and Morris, A. (2011). A. Pneumocystis infection and the pathogenesis of chronic obstructive pulmonary disease. Immunologic Research 50, 175-180.

Morris, A. and Norris, K. A. (2012). Colonization by Pneumocystis jirovecii and its role in disease. Clin. Microbiol. Rev. 25:297-317.

Gingo, M. R., Lucht, L., Daly, K.R., Djawe, K., Palella, F.J., Abraham, A.G., Bream, J.H., Witt, M.D., Kingsley, L.A., Norris, K.A., Walzer, P.D., and Morris, A. (2011). Serologic responses to pneumocystis proteins in HIV patients with and without Pneumocystis jirovecii pneumonia. J. Acquir. Immune Defic. Syndr. 57:190-196.

Kling, H.M., Shipley, T.W., and Norris, K.A. (2010). Relationship of Pneumocystis jiroveciI humoral immunity to prevention of colonization and chronic obstructive pulmonary disease in a primate model of HIV infection. Infect. Immun. 78:4320-4330.

Shipley, T.W., Kling, H.M., Morris, A., Patil, S., Kristoff, J.A., Guyach, S.E., Murphy, J.A., Shao, X., Sciurba, F.C., Rogers, R.M., Richard, T., Thompson, P., Montelaro, R.C., Coxson, H.O., Hogg, J.C., and Norris, K.A. (2010). Persistent Pneumocystis colonization leads to the development of chronic obstructive pulmonary disease (COPD) in a non-human primate model of AIDS. J. Infect. Dis. 202:302-12.

Morris, A., Netravali, M., Kling, H.M., Shipley, T.W., Ross, T., Sciurba, F.C. and Norris, K.A. (2008). Relationship of Pneumocystis antibody response to severity of chronic obstructive pulmonary disease. Clin. Infect. Dis. 47: e64-68.

Our Science

Infection Targets

Aspergillosis

Pneumocystis pneumonia (PJP)

Aspergillosis

Candidiasis

Pneumocystis pneumonia (PJP)

Aspergillosis

Pneumocystis pneumonia (PJP)

Pneumocystis pneumonia (PJP)

Pneumocystis pneumonia (PJP)

Published Research

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