American Gene Technology

HIV Cure Program Patent Granted To American Gene Technologies

AGT — Tue, 21 May 2019 13:51:26 +0000

ROCKVILLE, Md., May 21, 2019 (GLOBE NEWSWIRE) -- American Gene Technologies, a leading gene and cell therapy company based in Rockville, Md., was granted a second patent for its unique molecule, methods, and cell process for its HIV program. This patent further protects AGT’s lentiviral vector and proprietary process for generating autologous cell products to treat HIV (“HIV Pre-Immunization and Therapy” US 10,233,464).

AGT’s lentivirus vector AGT103 is a proprietary drug substance used in manufacturing the AGT103-T cell product for an HIV cure. The new patent increases protection for composition of the therapeutic gene cargo in AGT103.

“Improving the breadth of our patents gives AGT better control over technologies critical to our genetic medicine products, and strengthens our ability to defend these patents against challenges,” stated Jeff Galvin, AGT CEO. “This, and other patents surrounding our HIV cure strategy, provide proprietary tools that have value across a range of chronic viral infections in addition to HIV. We look forward to expanding our pipeline into additional infectious diseases.”

AGT has been granted seven patents in the last 17 months, has several additional patents published, and more than 20 patent families represented by filings with the USPTO and international patent offices. AGT’s patent portfolio protects a broad technology platform that is showing efficacy in gene and cell therapy approaches to infectious disease, monogenic disorders, and solid tumor cancers.

About American Gene Technologies (AGT)

American Gene Technologies (AGT) is a gene and cell therapy company with a proprietary gene-delivery platform to rapidly develop gene and cell therapies to cure infectious diseases, cancers, and monogenic disorders. The Company’s mission is to transform people’s lives through genetic medicines that rid the body of disease. The Company expects to take its patented lead candidate for an HIV cure into the clinic in 2019. AGT has received five patents for its unique immuno-oncology approach to stimulate the human body’s natural immune system’s gamma-delta (γδ) T cells to destroy a variety of solid tumors. The Company has also developed a synthetic gene which it expects to cure Phenylketonuria (PKU), a debilitating rare disease. AGT’s treatment for PKU has been granted an Orphan Drug Designation by the Food and Drug Administration (FDA) and it is expected to reach the clinic in 2020.

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AGT Launches Oncology Science Advisory Group to Accelerate Research For A Cancer Cure

AGT — Mon, 25 Mar 2019 16:53:40 +0000

ROCKVILLE, MD, UNITED STATES, March 25, 2019 /EINPresswire.com/ -- American Gene Technologies (AGT), a leading gene and cell therapy biotech company based in Rockville, Md., has established an advisory group for the advancement of immunotherapies that activate gamma-delta (γδ) T cells to attack a variety of tumors including liver, prostate, and breast cancers. This is an initial step in AGT’s long-term immuno-oncology plan.

AGT established the Oncology Science Advisory Group (OSAG) to accelerate AGT’s cancer research program to produce a cure for liver, breast, and other epithelial cancers. The OSAG includes Dr. Miroslav Malkovsky of the University of Wisconsin, Dr. Jean Jacques Fournié of the University of Toulouse Cancer Center, Dr. Marc Bonneville of the Institute Mérieux, Dr. Julie Déchanet-Merville of Bordeaux University and Dr. Yoshimasa Tanaka of Nagasaki University. The group is tasked with reviewing the current status of vector development, in vitro studies and animal testing for gamma-delta (γδ) T cell cancer therapies. The OSAG will advise on critical path studies for AGT’s cancer treatments.

AGT’s OSAG will collaborate with longstanding AGT scientific advisors Dr. Robert Clarke and Dr. Dean Felsher. Dr. Clarke, Dean of Research, Associate Vice President of Georgetown University Medical Center, and Co-director of the Breast Cancer Program at Lombardi Comprehensive Cancer Center, will examine AGT’s efficacy in breast cancer models. Dr. Dean Felsher, Professor of Medicine, Co-Director of the Cancer Nanotechnology Program, Department of Radiology, and Director of Translational Research and Applied Medicine at Stanford Medical School, will provide clinical and research expertise on hepatocellular carcinoma (liver cancer).

AGT’s preclinical animal studies are showing efficacy increasing the activity of gamma delta T-cells, resulting in significant therapeutic outcomes. AGT expects to progress towards an Investigational New Drug (IND) application filing with the U.S. Food and Drug Administration (FDA) for a 2020 Phase 1 study in epithelial cancer.

To learn more about AGT’s Gamma Delta T Cell Therapy for cancer, ImmunoTox™, click here. For more information on AGT’s liver cancer program, click here.

About American Gene Technologies (AGT)

AGT is an emerging gene and cell therapy company with a platform of proprietary tools and techniques capable of broad applications including: large and orphan indications, infectious disease, immuno-oncology, and monogenic disorders. AGT expects to take its patented candidate for an HIV Cure into the clinic in 2019. It has pioneered a novel immuno-oncology approach of stimulating gamma-delta (γδ) T cells to attack a variety of cancers. Five key patents in AGT’s novel immuno-oncology approach have already been granted. In addition, AGT has a diverse portfolio of patents and patent filings surrounding key tools and components in viral vectors, gene therapy, and regenerative medicine.

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AGT Granted Fifth Patent Protecting Its Immunotherapy Cancer Cure Asset

AGT — Thu, 21 Mar 2019 13:56:35 +0000

ROCKVILLE, MD, UNITED STATES, March 21, 2019 /EINPresswire.com/ -- American Gene Technologies (AGT) recently was awarded a fifth immuno-oncology patent (“Methods and Composition for the Activation of Gamma Delta T cells” US10137144) to protect its lead asset in immunotherapy for cancer. This patent further validates the advances AGT has made towards the treatment of cancer and infectious diseases.

The patent adds protection to AGT’s proprietary methods for activating human gamma-delta (γδ) T cells that will successfully attack a variety of solid tumors as AGT continues to obtain intellectual property surrounding its gene therapy platform for immuno-oncology.

“We are absolutely thrilled with the progress we’ve made towards developing truly novel, efficacious and well-tolerated treatments for cancers,” said Jeffrey A. Galvin, Chief Executive Officer. “These patents highlight AGT’s continued progress toward advanced treatments and cures for cancer and demonstrate the differentiation of our immuno-oncology program.”

About American Gene Technologies (AGT)

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Second Patient Cured of HIV and The Implications for American Gene Technologies’s AGT103-T

AGT — Sat, 09 Mar 2019 15:53:25 +0000

ROCKVILLE, MD, UNITED STATES, March 8, 2019 / American Gene Technologies (AGT) is pleased to see the release of information about a second individual cured of HIV in London--recently reported in the Wall Street Journal and New York Times. The patient was treated with a bone marrow transplant from a CCR5-Δ32 donor. The London Patient remains HIV negative after receiving no antiretroviral therapy for 18 months. The success of utilizing a CCR5-Δ32 donor for both the Berlin (2007) and London (2019) patients provides evidence that a CCR-5 based gene therapy developed by American Gene Technologies could cure any person infected with HIV.

This news supports AGT’s research and development of an HIV cure in the form of a gene therapy product that replicates the effects of the CCR-5 mutation to reconstitute the immune response against HIV, by reducing persistent viral reservoirs and achieving sustained virologic remission in infected individuals in the absence of antiretroviral therapy, similar to the cured “London patient.” AGT’s HIV gene therapy, AGT103-T, is currently in the late stages of Investigational New Drug (IND) enabling, on track for an application submission this year to the U.S. Food and Drug Administration (FDA).

If AGT receives FDA approval for its IND submission to begin a Phase 1 clinical trial, it will begin infusing patients with AGT103-T. In preparation for its submission, final tests are being performed on AGT103-T as part of a non-IND clinical trial in which blood is collected from HIV infected study participants via leukapheresis and ran through an 11-day cell process. The cell process product AGT103-T demonstrates the ability to clear itself of HIV when challenged with the virus and by HIV infected human blood.

About American Gene Technologies (AGT)

AGT is an emerging gene and cell therapeutics company with a proprietary lentiviral platform capable of broad applications including: large and orphan indications, infectious disease, immuno-oncology, and monogenic disorders. AGT forecasts taking its patented candidate for an HIV Cure into the clinic in 2019. It has pioneered a novel immuno-oncology approach of stimulating gamma-delta (γδ) T cells to attack a variety of cancers. Five key patents in AGT’s novel immuno-oncology approach have been granted. AGT has a diverse portfolio of patent filings surrounding key tools and components in viral vectors, gene therapy, and regenerative medicine.

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American Gene Technologies Signs Research Agreement with NIAID for Experimental HIV/AIDS Cure Strategy

AGT — Thu, 14 Feb 2019 15:41:55 +0000

AGT signed Research Collaboration Agreement with National Institute of Allergy and Infectious Diseases for studies on AGT’s cell and gene therapy for HIV/AIDS.

ROCKVILLE, MD, UNITED STATES, February 14, 2019 /EINPresswire.com/ -- American Gene Technologies (AGT) recently signed a Research Collaboration Agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, for research studies on AGT’s cell and gene therapy for HIV/AIDS. AGT uses its proprietary, genetically modified, autologous cell product (AGT103-T) to reconstitute the immune response against HIV with the goal of reducing persistent viral reservoirs and achieving sustained virologic remission in infected individuals in the absence of antiretroviral therapy. Under this collaboration agreement, NIAID researchers will study the mechanism of action for AGT103-T to define its potential impacts on HIV disease.

“We are thrilled at the prospect of working with HIV experts at NIAID,” commented C. David Pauza, PhD, Chief Science Officer of AGT. “Our collaborative studies will define mechanisms of therapeutic action and give new insights into the nature of HIV reservoirs and immune-mediated viral suppression.”

Under the agreement, AGT will provide genetically modified T-cells created during the development of a cell product for clinical trials. These cell products are highly enriched for HIV-specific CD4 T cells and modified by AGT’s proprietary lentivirus vector to protect cells from HIV-mediated depletion. The collaborative studies will help to characterize these enriched cell products and define their effects on antiviral immunity.

AGT’s prior studies suggested that the enrichment of HIV-specific CD4 T cells in their AGT103-T autologous cell product can provide increased helper and effector activities capable of reducing the HIV burden and improving therapy. The new agreement will allow AGT and NIAID scientists to work together and conduct experimental studies investigating the mechanism of action for AGT103-T and its potential impacts on HIV disease.

About American Gene Technologies (AGT)

AGT is an emerging gene and cell therapeutics company with a proprietary lentiviral platform capable of broad applications including large and orphan indications, infectious disease, immuno-oncology, and monogenic disorders. AGT expects to take its patented candidate for an HIV Cure into the clinic in 2019. It has pioneered a novel immuno-oncology approach of stimulating gamma-delta (γδ) T cells to attack a variety of cancers. Five key patents in AGT’s novel immuno-oncology approach have been granted. AGT has a diverse portfolio of patent filings surrounding key tools and components in viral vectors, gene therapy, and regenerative medicine.

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American Gene Technologies To Attend 2019 J.P. Morgan Healthcare Conference

AGT — Mon, 07 Jan 2019 21:38:38 +0000

ROCKVILLE, MD, UNITED STATES, January 7, 2019 /EINPresswire.com/ -- American Gene Technologies announced today that its Chief Executive Officer, Jeff Galvin, will attend the annual J.P. Morgan Healthcare Conference, held at the Westin St. Francis between January 7-10 in San Francisco, California. American Gene Technologies invitation to attend the conference follows recent discussions with J.P. Morgan and other biotechnology investment firms about AGT’s significant innovations in the industry.

Organized by J.P. Morgan, the J.P. Morgan Healthcare Conference is a four-day conference bringing together emerging fast-growth companies, members of the investment community, industry leaders, and innovative technology creators in healthcare. It is the industry’s largest healthcare investment conference.

Between January 7-10, American Gene Technologies’s CEO Jeff Galvin, CFO Neil Lyons, Norman Rogers, Drew Palin, and Morgan Stevens will also attend the following events in San Francisco: Redefining Early Stage Investments (RESI) Conference, Biotech Showcase, and BIO One-on-One Partnering. In all, they will participate in over 100 meetings.

About American Gene Technologies (AGT):

AGT is an emerging gene and cell therapeutics company with a proprietary lentiviral platform capable of broad applications including: large and orphan indications, infectious disease, immuno-oncology, and monogenic disorders. AGT expects to take its patented, lead candidate for an HIV Cure into the clinic in 2019. It has pioneered a novel immuno-oncology approach of stimulating gamma-delta (γδ) T cells to attack a variety of cancers. Four key patents in AGT’s novel immuno-oncology approach have been granted. AGT has a diverse portfolio of patent filings surrounding key tools and components in viral vectors, gene therapy, and regenerative medicine.

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American Gene Technologies Granted FDA Orphan Drug Designation For Phenylketonuria

AGT — Thu, 18 Oct 2018 20:44:21 +0000

ROCKVILLE, MD, UNITED STATES, October 18, 2018 /EINPresswire.com/ -- American Gene Technologies (AGT), a leading gene and cell therapy company in the discovery and development of lentiviral vector based therapeutics, announces that the U.S. Food and Drug Administration (FDA) received orphan-drug designation #DRU-2018-6572 for the treatment of phenylketonuria (PKU) using its proprietary, lentiviral vector based technology. PKU is a debilitating inherited disease affecting 1 in 13,500 children born in the U.S. Mandatory screening identifies affected children who can be supported with a strict synthetic diet that does not cure disease. If successful, AGT's lentiviral vector approach will provide a permanent cure, improving quality of life for more than 16,000 people living with PKU in the U.S. alone.

“We are pleased to receive this orphan drug designation from the FDA for AGT’s vector technology to treat PKU. Our technology demonstrates promising potential to address an unmet medical need in treating this rare disease,” said Jeff Galvin, CEO and Founder of AGT. “We believe this orphan designation will enable AGT to formally shape and advance its PKU program.”

About American Gene Technologies (AGT):

AGT is an emerging gene and cell therapeutics company with a proprietary lentiviral platform capable of broad applications including: large and orphan indications, infectious disease, immune-oncology, and monogenic disorders. AGT expects to take its patented, lead candidate for an HIV Cure into the clinic in 2019. It has pioneered a novel immuno-oncology approach of stimulating gamma-delta (γδ) T cells to attack a variety of cancers. Four key patents in AGT’s novel immuno-oncology approach have been granted. AGT has a diverse portfolio of patent filings surrounding key tools and components in viral vectors, gene therapy, and regenerative medicine.

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American Gene Technologies to Present at 2018 Cell and Gene Meeting On The Mesa

AGT — Wed, 26 Sep 2018 18:56:59 +0000

ROCKVILLE, MD, UNITED STATES, September 26, 2018 /EINPresswire.com/ -- American Gene Technologies announced today that its Chief Science Officer C. David Pauza, Ph.D. will present at the annual Partnering Forum, part of the Cell & Gene Meeting on the Mesa to be held October 3-5 in La Jolla, California. Dr. Pauza’s presentation will cover recent progress on AGT’s HIV cure and gamma delta T cell immuno-oncology programs.

Organized by ARM and the Sanford Stem Cell Clinical Center at UC San Diego, the Cell & Gene Meeting on the Mesa is a three-day conference featuring three distinct parts, the program’s two-day Partnering Forum, a Public Forum lecture and a full-day Scientific Symposium. The event’s Partnering Forum on October 3-4 features more than 70 dedicated company presentations in addition to over 90 panelists and featured speakers.

The following are specific details regarding Dr. Pauza’s presentation at the conference:

EVENT: 2018 Cell & Gene Meeting on the Mesa – Partnering Forum

DATE: October 3, 2018

TIME: 5:45pm

LOCATION: La Jolla Ballroom 2, Estancia La Jolla Hotel & Spa, 9700 North Torrey Pines Road, La Jolla, CA 92037

A live video webcast of all company presentations will be available at: http://www.meetingonthemesa.com/webcast and will also be published on the conference website shortly after the event.

Please visit www.meetingonthemesa.com for full information including registration. Complimentary attendance at this event is available for credentialed investors and members of the media only. Investors should contact Laura Parsons at lparsons@alliancerm.org and interested media should contact Lyndsey Scull at lscull@alliancerm.org.

About Chief Science Officer C. David Pauza, Ph.D.:

C. David Pauza, Ph.D. is Chief Science Officer for American Gene Technologies and Professor of Medicine at the University of Maryland Medical School in Baltimore. Prior to joining AGT, Dr. Pauza was Associate Director for the university’s prestigious Institute of Human Virology and Co-Leader of the Greenebaum Cancer Center Program in Viral Oncology. He is an internationally recognized expert in human virology and viral diseases including HIV, arenaviruses, poxviruses and herpesviruses. He has published more than 150 scientific papers and holds 6 US patents.

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David Pauza, PhD
Chief Science Officer

About American Gene Technologies (AGT):

AGT is an emerging gene and cell therapeutics company with a proprietary lentiviral platform capable of broad applications including: large and orphan indications, infectious disease, immune-oncology, and monogenic disorders. AGT expects to take its patented, lead candidate for an HIV Cure into the clinic in 2019. It has pioneered a novel immuno-oncology approach of stimulating gamma-delta (γδ) T cells to attack a variety of cancers. Four key patents in AGT’s novel immuno-oncology approach have been granted. AGT has a diverse portfolio of patent filings surrounding key tools and components in viral vectors, gene therapy, and regenerative medicine.

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Immunotherapy CEO Jeff Galvin Joins The Board of Directors of the Cancer Support Community

AGT — Thu, 06 Sep 2018 16:27:35 +0000

ROCKVILLE, MD, UNITED STATES, September 6, 2018 /EINPresswire.com/ -- Jeff Galvin, a former Silicon Valley CEO, and now a leader in the field of gene and cell therapy to cure cancer and other human diseases, has joined the Board of Directors of the Cancer Support Community (CSC). Galvin’s biotech company, American Gene Technologies International Inc. (AGT), is striving to create the next big revolution in cancer therapies with Gamma Delta T Cell immunotherapy, which uses a method to stimulate the immune system to kill solid cancer tumors.

AGT has four patents on this method with the mission to cure epithelial cancers (10,036,040, 10,023,880, 9,914,938, 9,834,790).

Galvin earned his BA degree in Economics from Harvard in 1981. He has more than 30 years of business and entrepreneurial experience, including founder or executive positions at a variety of Silicon Valley startups. Several of his companies were taken public and/or sold to public companies.

“Jeff Galvin is leveraging his passion, drive, and successful business experience and to revolutionize treatment for cancer and other vexing medical problems facing patients today. It is a privilege to have Jeff join our Board and share his expertise to strengthen our organization,” said Jill Durovsik, Chair of CSC’s Board of Directors.

CSC is the largest professionally led non-profit network of cancer support world-wide with a network of 175 locations, providing $50 million in free support services to patients and families. CSC’s mission is to ensure that “people impacted by cancer are empowered by knowledge, strengthened by action, and sustained by community.”

Kim Thiboldeaux, CEO of CSC, author, and blogger, shared, “We recently completed a study at CSC which found a pressing need among patients and caregivers for information to help them navigate the new world of immunotherapy. We are thrilled to have the leadership and expertise of Jeff Galvin on the Board to support CSC as we empower and educate patients about the many new treatment options available to them.”

Jeff Galvin added, “I’m honored to join CSC’s Board of Directors. It is a privilege to play a role in this important organization, helping to ensure that people impacted by cancer have access to support and knowledge that empowers them to act effectively in making their treatment plans and decisions.”

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Jeffrey A. Galvin
CEO and Founder

About American Gene Technologies (AGT):

AGT is an emerging gene and cell therapeutics company with a proprietary lentiviral platform capable of broad applications including: large and orphan indications, infectious disease, immune-oncology, and monogenic disorders. AGT expects to take its patented, lead candidate for an HIV Cure into the clinic in 2019. It has pioneered a novel immuno-oncology approach of stimulating gamma-delta (γδ) T cells to attack a variety of cancers. Four key patents in AGT’s novel immuno-oncology approach have been granted. AGT has a diverse portfolio of patent filings surrounding key tools and components in viral vectors, gene therapy, and regenerative medicine.

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American Gene Technologies (AGT) Granted Three New Patents in its HIV Cure and Immuno-oncology Programs

AGT — Wed, 22 Aug 2018 19:01:49 +0000

ROCKVILLE, MD, UNITED STATES, August 22, 2018 /EINPresswire.com/ -- AGT announces the receipt of three foundational patents. Two new patents focus on the immuno-oncology program and add to AGT’s broad protection for its unique process of activating gamma delta T cells to attack solid tumors (“Methods and Composition for the Activation of Gamma Delta T cells” US10023880 and US10036040). The third patent is AGT’s first in its HIV Cure program and protects a lentiviral vector and proprietary process for generating autologous cell products for treating HIV (“HIV Pre-Immunization and Therapy” US10036038).

Jeff Galvin, Founder and CEO commented: “These patents add to our substantial intellectual property portfolio and highlight AGT’s continued progress toward advanced treatments and cures in cancers and infectious diseases.”

The HIV Cure program is moving rapidly toward a Phase 1 clinical trial and AGT’s work with gamma delta T cells is showing promising data in animal models as AGT develops a broad immuno-oncology platform.

About American Gene Technologies (AGT):

AGT is an emerging gene and cell therapeutics company with a proprietary lentiviral platform capable of broad applications including: large and orphan indications, infectious disease, immune-oncology, and monogenic disorders. AGT expects to take its patented, lead candidate for an HIV Cure into the clinic in 2019. It has pioneered a novel immuno-oncology approach of stimulating gamma-delta (γδ) T cells to attack a variety of cancers. Four key patents in AGT’s novel immuno-oncology approach have been granted. AGT has a diverse portfolio of patent filings surrounding key tools and components in viral vectors, gene therapy, and regenerative medicine.

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