MIPS Project Detail:

Profectus BioSciences, Inc.

Cholera Toxin A1 Subunit as an HIV DNA Vaccine Adj

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Company

Profectus BioSciences, Inc.

Baltimore

Baltimore City

County

, Maryland

Founded:

2002

Website:

https://www.profectusbiosciences.com

Company Description:

Profectus is a clinical-stage vaccine development company pioneering evolutionary steps in the design and development of preventive and therapeutic vaccines for infectious diseases, allergy and autoimmunity, and oncolytic vaccines for cancer immunotherapy.

MIPS Project

Cholera Toxin A1 Subunit as an HIV DNA Vaccine Adj

Project #

3905

|

MIPS Round

39 |

Starting Date:

Feb 2007

MIPS Project Challenge:
Profectus sought to test the effectiveness of the Cholera Toxin A1 Subunit as an adjuvant in HIV DNA vaccines.

Project Scope:
Vaccination using plasmid DNA has the potential to provide enhanced safety and efficacy over conventional vaccines, with increased stability and accelerated product development. Unfortunately, successful vaccination of primates with DNA requires multiple inoculations using large doses of plasmid. Adjuvants, genetically encoded into the DNA vaccines, have significantly enhanced the resulting immune responses to encoded vaccine antigens. Profectus found the A1 domain of cholera toxin (CTA1) to be a potent genetic adjuvant that may provide the required dose sparing effect necessary for DNA vaccines to achieve widespread human use. Cholera toxin is a potent adjuvant that works by inducing dendritic cell maturation. A CTA1 fragment enhances the immunogenicity of DNA vaccines in mice. Through MIPS, researchers tested whether CTA1 provides a similar effect in Cynomolgus macaques using a SIVmac239-gag DNA vaccine. If successful, Profectus BioSciences planned to use CTA1 in adjuvant HIV DNA vaccines intended for clinical development.

The data generated from the DNA vaccine study funded by the MIPS grant allowed us to continue testing our HIV/SIV vaccines with follow-on support from NIH SBIR grants. Thanks to these grants, our HIV vaccine (delivered as plasmid DNA) is scheduled to begin phase I human trials with support from NIH. Without the initial support of MIPS, we may not have been able to advance this vaccine concept.

Kenneth Bagley, Staff Scientist

Results:

The project results supported the original hypothesis that CTA1 DNA immunization can be used in rhesus macaques and supported its further development as a means by which immune responses to DNA vaccines could be augmented. The project enabled Profectus to receive a $6.25 million grant from the National Institute of Allergy and Infectious Diseases.

The company has raised $10.29 million in venture funding over two rounds, as well as total of $34.19 million in total funding, including grants, according to Crunchbase.

Profectus vaccines are based on the company’s proprietary VesiculoVax™ and DNA vaccine delivery platforms. The DNA vaccine platform is being harnessed for therapeutic vaccines for immune-mediated disorders, including food allergies and autoimmune disorders. These DNA vaccines rely on the actions of proprietary tolerogenic adjuvants. Used alone, the first-in-class VesiculoVax™-vectored vaccines lead to rapid expansion of B cells to provide protection against emerging infectious diseases of public health and biodefense importance, such as Ebola, Marburg, Chikungunya, Zika, the equine encephalitis viruses, and respiratory syncytial virus. When used as a boost after priming the immune system with best-in-class DNA vaccines, VesiculoVax™-vectored vaccines lead to the expansion of primed T cells into effector cells that are uniquely suited to attacking virally infected cells and cancers. Current programs using this Prime/Boost System of Vaccines (PBS Vax™) strategy include hepatitis B virus (HBV), human papilloma virus (HPV), herpes simplex virus type 2 (HSV-2), universal Influenza and human immunodeficiency virus (HIV).

The prime/boost vaccines also incorporate established and novel, proprietary adjuvants, including IL-12, CTA1 and RALDH2, which is the only known adjuvant that can elicit robust mucosal immunity from systemic immunizations. Partners and collaborators include the Galveston National Laboratory at UTMB, Yale University, the Institute of Human Virology, the Center for HIV/AIDS Vaccine Immunology, the National Cancer Institute, the NIH Division of AIDS, the Bill and Melinda Gates Foundation, the International AIDS Vaccine Initiative, the HIV Vaccines Trials Network, and the AIDS Clinical Trials Group. Profectus has been funded by Cross Atlantic Capital Partners (“XACP”) of Radnor, 3/3 Pennsylvania. XACP’s primary investor is the Pennsylvania Public School Employees’ Retirement System (PSERS).