American Gene Technologies Inc. (AGT) Demonstrates Rationale of its Genetic Approach toward developing a Functional Cure for HIV Infection

ROCKVILLE, Md., Oct. 12, 2017 -- American Gene Technologies International Inc. (“AGT”), a gene therapy and technology company focusing on a lentiviral delivery platform, presented the rationale for its genetic medicine approach toward developing a functional cure for HIV infection. David Pauza, Ph.D., chief scientific officer of AGT, presented the data at the Cell & Gene Meeting on the Mesa on October 5, 2017, in La Jolla, CA.

AGT is developing an ex vivo approach with which HIV-specific T-cells are enriched then transduced with AGT103, an AGT proprietary lentiviral vector that confers protection from HIV. The enriched population of transduced HIV-specific T-cells would then be infused back into the patient.

“Those of us in the HIV treatment community are actively seeking innovative ways to better treat and, if possible, prevent or cure the disease,” said Robert R. Redfield MD, the Robert C. Gallo, MD Endowed Professor in Translational Medicine and Co-Founder & Associate Director, Institute of Human Virology, and Chairman of AGT’s Clinical Advisory Board for HIV.  “AGT’s approach toward a functional cure has great potential to be the standard of care, particularly as gene therapy is becoming mainstream as a therapeutic platform.  I and my colleagues are very excited about the work coming out of AGT and we look forward to the start of the first clinical trial and initial results in 2018.”

AGT anticipates completing development of the cGMP ex vivo transduction process in the fourth quarter of 2017. Trial sites, in Washington, D.C. and Baltimore, have already been recruited. The company expects to file its IND with the Food and Drug Administration during the first quarter of 2018. Interim safety and early efficacy data are expected by the third quarter of 2018.

Presentation material will be available at www.meetingonthemesa.com/webcast, by Friday October 21, 2017, if not sooner.

American Gene Technologies
AGT, is an emerging gene therapy company with a proprietary lentiviral platform capable of broad applications including:  large and orphan indications, immuno-oncology, and monogenic disorders.  AGT will enter the clinic in 2018 with a Phase 1 clinical trial to evaluate AGT103 as a functional cure for HIV. Pre-IND applications for phenylketonuria and hepatocellular carcinoma will follow. 

These therapies demonstrate the breadth of AGT’s unique lentiviral platform and vector technology, including such innovations as a Transient Lentivector™ for temporary expression and an ImmunoTox™ vector for stimulating anti-tumor immunity in immuno-oncology applications. More information can be found at www.americangene.com.

The Cell & Gene Meeting on the Mesa
The Cell & Gene Meeting on the Mesa is a three-day conference organized by Alliance for Regenerative Medicine and UC San Diego Health. It brings together senior executives and top decision-makers in the industry with the scientific community to advance cutting-edge research into cures. The meeting features a nationally recognized Scientific Symposium, attended by leading researchers and clinical experts from around the globe, in conjunction with the industry's premier annual Partnering Forum, the first event of its kind dedicated solely to facilitating connections in this sector. Combined, these meetings attract over 850 attendees, fostering key partnerships through more than 1100 one-on-one meetings while highlighting the significant clinical and commercial progress in the field.

AGT Contact:
C. Neil Lyons, Chief Financial Officer
Phone: (301) 337-2269
Email: [email protected]

Media Contact:
Cari P. Randall, Vice President
The Ruth Group
Phone: (646) 536-7002
Email: [email protected]

Investor Contact:
Robert E. Flamm, Ph.D., Senior Vice President
The Ruth Group
Phone: (646) 536-7017
Email: [email protected]