Draft:American Gene Technologies
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Private company | |
Industry | |
---|---|
Founded | 2007 |
Founder | Jeff Galvin |
Headquarters | Rockville, Maryland, USA |
Area served | Worldwide |
Key people | |
Number of employees | 50 (2023) |
Subsidiaries | Addimmune
|
Website | www |
American Gene Technologies (AGT) is an American
History
Roscoe Brady MD, PhD
![](http://upload.wikimedia.org/wikipedia/commons/thumb/c/c2/Roscoe_O._Brady.jpg/185px-Roscoe_O._Brady.jpg)
NIH researcher and National Medal of Technology and Innovation recipient Roscoe Brady MD, PhD (1923-2016) is seen as the inspiration for the founding of AGT[4]. Brady conducted research for over 50 years, starting with genetic lipid storage diseases and their metabolic defects, such as Tay-Sachs disease, Niemann-Pick disease, Fabry disease, and Gaucher disease[5].
Later in his career, as gene therapy began to gain momentum, Brady began to focus more on the applications of gene and
Jeff Galvin
Jeff Galvin began his career in Silicon Valley, where he was a founder or executive of a variety of start-up tech companies, many of which were taken public or sold to other public companies[9]. He then retired early to become an investor in high tech and real estate until an opportunity arose with the NIH and Roscoe Brady. After meeting Brady and learning about viral vectors and their potential in the field of medicine and gene therapy, Galvin decided he wanted to come out of retirement to found AGT in 2007 with the goal of using gene therapy to cure humanity's diseases[10]. Galvin decided to found AGT in Rockville, Maryland, because of his belief in the area being an epicenter for cellular and gene therapy technology, leading to the area being referred to by some in the industry as DNA Valley[11]
Year by Year History
2007
Jeff Galvin founds American Gene Technologies in Rockville, Maryland[12].
2008
AGT researchers design and in vitro test multi-gene lentivirus vectors. Many versions were cloned and tested successfully[12].
2009
Formation of AGT's initial Scientific Advisory Board, including leading global scientists such as Fred Nyberg and John Rossi. AGT completes animal testing of AGT1101 for Prostate Cancer, yielding overall positive results. Initial testing of AGT1102 for Pancreatic Cancer is also completed.[12]
2010
AGT scientists design a revised AGT1102 Pancreatic Cancer
2011
Successful development of a lentiviral vector with the capability to carry anti-tumor components that have the potential to limit or inhibit the growth and expansion of hepatocellular carcinoma (HCC) or liver cancer. Over 90% inhibition was seen in the three HCC lines that were tested on. These tests also successfully introduce RNA interference technologies into the AGT viral vectors, indicating their potential to be used in correcting human diseases at a cellular level.[12]
2012
AGT receives NIH funding for two SBIR projects in order to develop gene therapies for Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV). For these projects, AGT developed lentiviral vectors that inhibited the replication of HCV reporter strains in in vitro testing by over 99%[13]. Testing was also completed for over 50 related and intermediate vectors and an anti-HIV RNA inhibitor final construct was improved to prepare for future testing.
2013
AGT secures Series A Preferred venture capital investment based on its success in therapeutic process line development. This capital was used to expand into a new laboratory space and expand its research and development team. Additional in vitro studies on the HIV gene therapy treatment are completed showing high rates of inhibition of HIV replication, with inhibition rates up to 99%.[12]
2014
Initiation of two new programs in collaborations with other leading scientists including a gene therapy program to treat
2015
![](http://upload.wikimedia.org/wikipedia/commons/thumb/1/16/Phenylketonuria_testing.jpg/407px-Phenylketonuria_testing.jpg)
AGT secures
2016
AGT conducts a pre-IND (Investigational New Drug) meeting with the FDA for the product AGT103, which is their HIV gene therapy functional cure. Following this meeting, AGT started their IND development process and began to plan their clinical trials for AGT103. AGT also filed patents for HIV drugs that showed efficacy against the disease in preliminary trials.[12]
2017
AGT collects blood from HIV-infected individuals for testing with the cell manufacturing and the final vector of AGT103. The data from these tests is used in the IND documentation to be submitted to the FDA as well as to validate the protocol of the treatment before clinical trials[15].
2018
AGT receives FDA
2019
AGT secures two patents in order to protect its cancer and HIV assets. AGT announces the launch of their Oncology Science Advisory Group (OSAG), which is used to help accelerate the research for a cancer cure. AGT is invited to the J.P. Morgan Healthcare Conference, which is the largest health care investment meeting in the industry[16]. NIAID and AGT sign a Research Collaboration Agreement for a potential HIV cure.
2020
Headquarters is moved to a larger facility in Rockville, allowing for an expanded lab space. FDA clears AGT for Phase 1 Clinical Trials for their HIV cure program and the first patients are enrolled in the trial. AGT and NIAID publish their peer-reviewed paper on molecular therapy that illustrates positive preclinical data for the potential HIV cure. AGT also secures three more patents for their immuno-oncology asset.[12]
2021
The first patient in the Phase 1 clinical trials is infused with AGT103-T. The
2022
Phase 1 trial results indicate that AGT103-T is not only
2023
AGT launches its new HIV-focused division, Addimmune, to pursue an HIV cure using gene and cell therapies. This builds upon AGT's promising initial results. AGT will now focus on developing gene and cell therapies for other
Research Areas and Technologies
Lentiviral Vectors
AGT is a global leader in the design, development, and use of lentiviral vectors. The
HIV
![](http://upload.wikimedia.org/wikipedia/commons/thumb/7/78/22_AGT-HIV-Page-Cell-Product-Graphic.png/516px-22_AGT-HIV-Page-Cell-Product-Graphic.png)
AGT's former leading product prior to the creation of Addimmune to focus on HIV, was their HIV cure candidate AGT103-T. AGT103-T is a cell therapy technique that delivers CD4 T cells that have been modified to protect against HIV
AGT103-T is currently undergoing clinical trials and completed Phase 1 in 2023. Seven patients have been withdrawn from their ARTs, received AGT103-T, and have had no serious adverse effects. Addimmune hopes to finalize their DARWIN trial and gain approval for another trial later in 2023[22].
PKU
AGT's PKU program is a single-dose gene therapy technique in which a lentiviral vector carrying a functional
Immuno-oncology
AGT's
Recognitions
- 2023 NABOE Award for World Changing Business[27].
- 2019, 2021, and 2022 Maryland Tech Council Life Science Company of the Year Finalist[28].
- Jeff Galvin won the 2022 Life Sciences Voice Top Industry Leaders Award[29].
- 2022 BioBuzz Media Award for their "The Cure Chronicles" Series[30].
- 2021 Moxie Award for Healthcare and Biotechnology[31].
- 2021 NOVA Chamber Mid-Atlantic Innovators of the Year[32].
- 2020 BioBuzz Breakthrough Company of the Year[33].
See Also
References
- ^ "American Gene Technologies: A Gene Therapy Biotech Company". American Gene Technologies. Retrieved 2023-07-17.
- ^ "American Gene Technologies | Maryland Business Success Story". business.maryland.gov. Retrieved 2023-07-17.
- PMC 5036358.
- ^ "In Memoriam: Dr. Roscoe Brady". American Gene Technologies. Retrieved 2023-07-17.
- ^ "Brady About Dr Roscoe Brady - Office of NIH History and Stetten Museum". history.nih.gov. Retrieved 2023-07-17.
- PMID 27791045.
- ^ "American Gene Technologies | Maryland Business Success Story". business.maryland.gov. Retrieved 2023-07-17.
- ^ "American Gene Mourns the Passing of Chief Scientific Advisor Roscoe Brady, M.D." American Gene Technologies. Retrieved 2023-07-17.
- ^ "CEO and Founder Jeffrey A. Galvin". American Gene Technologies. Retrieved 2023-07-17.
- ^ "American Gene Technologies® CEO Jeff Galvin Wins Life Sciences Voice Top Industry Leaders Award". PRWeb. Retrieved 2023-07-17.
- ^ "American Gene Technologies | Maryland Business Success Story". business.maryland.gov. Retrieved 2023-07-17.
- ^ a b c d e f g h i j k l "The History of Our Gene Therapy Company". American Gene Technologies. Retrieved 2023-07-17.
- S2CID 231653597.
- ^ Philippidis, Alex (2023-07-07). "AGT Spins Out Addimmune, Focusing on Functional HIV Cure". GEN - Genetic Engineering and Biotechnology News. Retrieved 2023-07-17.
- ^ Research, Center for Drug Evaluation and (2022-11-29). "Investigational New Drug (IND) Application". FDA. Retrieved 2023-07-17.
- ^ "Health Care Conference". www.jpmorgan.com. Retrieved 2023-07-17.
- ^ Keown, Alex (2021-08-03). "AGT's HIV Cure Cell Therapy Clears First Safety Hurdle with DSMB Nod". BioBuzz. Retrieved 2023-07-17.
- PMID 36452901.
- ^ "HIV Treatment: The Basics | NIH". hivinfo.nih.gov. Retrieved 2023-07-17.
- ^ "Lentivirus Vector - an overview | ScienceDirect Topics". www.sciencedirect.com. Retrieved 2023-07-17.
- ^ a b "Our Progress with Gene Technology | AGT". American Gene Technologies. Retrieved 2023-07-17.
- ^ a b c "Our Approach to an HIV Cure | HIV Gene Therapy". American Gene Technologies. Retrieved 2023-07-17.
- ^ a b c "About HIV/AIDS | HIV Basics | HIV/AIDS | CDC". www.cdc.gov. 2022-06-30. Retrieved 2023-07-17.
- ^ "PAH gene: MedlinePlus Genetics". medlineplus.gov. Retrieved 2023-07-17.
- ^ a b c "Immuno-Oncology: AGT's Immunotherapies for Cancer". American Gene Technologies. Retrieved 2023-07-17.
- ^ "Gamma Delta (γδ) T Cells | British Society for Immunology". www.immunology.org. Retrieved 2023-07-17.
- ^ https://twitter.com/americangene/status/1659657731832160262
- ^ "Maryland Tech Council Announces 2022 Industry Awards Finalists". Maryland Tech Council. 2022-03-07. Retrieved 2023-07-17.
- ^ Team, Editorial (2023-07-12). "Top Industry Leaders Award Winner 2022 List". LifeSci Voice. Retrieved 2023-07-17.
- ^ Media, BioBuzz (2022-12-12). "Meet Your 2022 BioBuzz Award Winners". BioBuzz. Retrieved 2023-07-17.
- ^ "Moxie Award 2021 Winners". Moxie Award. Retrieved 2023-07-17.
- ^ https://novachamber.org/wp-content/uploads/2021/05/2021-Innovations-Awards-ReleaseChamber.pdf
- ^ Frew, Chris (2020-12-15). "Meet Your 2020 BioBuzz Award Winners". BioBuzz. Retrieved 2023-07-17.