AGT Newsletter Volume 9

This month, AGT saw tremendous progress with the FDA. FDA time and attention to our project has seemed to increase while agency review responses to our submissions have narrowed to unambiguous guidance, helping the HIV cure enter clinical trials. The recent response from the FDA was concise, and it presented a short list of specific items to...

This month, AGT saw tremendous progress with the FDA. FDA time and attention to our project has seemed to increase while agency review responses to our submissions have narrowed to unambiguous guidance, helping the HIV cure enter clinical trials.

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The recent response from the FDA was concise, and it presented a short list of specific items to implement and report; items that AGT is well-prepared to provide. The previous "fuzziness" in the review process was completely clarified, and the FDA provided focused feedback that greatly enhanced our discussions.

AGT now feels positioned to respond to the shortlist of items the FDA requested. We should be able to fully comply in a Complete Response to Hold (CRH) submission within the next 30 days. We can't say for sure what the FDA's next response will be, but we believe that we will provide the full set of data they requested and positively respond to the guidance in their May 20th review-committee letter. The FDA and AGT now seem aligned and in-sync regarding how to assure safety for patients and provide the greatest chance of a successful outcome to AGT's human trial of our HIV cell therapy cure!

We have captured sufficient patent landscape (see four new patents below) necessary to begin publishing articles in peer-reviewed journals about our HIV cure program.

An article published May 3rd in Molecular Therapy is the most extensive, scientifically-detailed information we have ever released on our autologous cell therapy designed to cure HIV.

With our phase 1 clinical trial approaching, we hope that the release of this article will assist in educating and informing scientists, doctors, and the HIV+ community on the results of the years of work leading up to this point, and our confidence in an HIV cure. Articles like this one are an essential contribution to scientific research and discovery on HIV, and we are proud to do our part to contribute to the industry’s understanding of this insidious virus. https://www.cell.com/molecular-therapy-family/methods/fulltext/S2329-0501(20)30084-X#figures

The pandemic hasn’t affected the R&D progress of AGT’s programs, however, regulatory slowdowns that began earlier, have persisted and continued to lag for the gene and cell therapy industry. The addition of special programs and reviews at the FDA for Covid treatments and vaccines may have slightly exacerbated this issue. However, the gene and cell therapy industry is mostly a victim of its own success: becoming the hottest technology in pharmaceuticals and on Wall Street over these past few years. “Herd mentality” pervading institutional investors and investment banks has inspired (and funded) the creation of many new companies pursuing monogenic diseases utilizing a variety of gene editing approaches, and this has strained resources (especially FDA review) for everyone. The industry is flourishing, and the FDA has experienced the rapid surge of IND applications. We continue to interact and meet with teams from the FDA since they began working from home, and everything seems to be continuing to progress (and improve) on their end.

Potential partners are currently reviewing our PKU program. A partnership in PKU would not only accelerate AGT‘s drug candidate into the clinic, but would also offer sustainable capital for all of AGT’s lead programs (including HIV and immuno-oncology). A large pharma partnership could provide external validation of our platform, creating momentum to build new collaborations with other large pharmaceutical companies. In the short-term, upfront cash from a partnering deal could merit the closing of our 2020 financing early with non-dilutive capital.

AGT’s new address, 9713 Key West Ave., Suite 500, Rockville, MD 20850, puts us at the center of the booming life science research arena. Considered the heart of DNA Valley, this area is rich with opportunities for biotech growth due to its proximity to the FDA, NIH, NCI, NIAID, local partnership opportunities, and one of the country’s most dense populations of PhDs and STEM-educated workers.

This video explains the ins and outs of cell therapy. Dr. C. David Pauza, Chief Science Officer of American Gene Technologies, explains how one tiny dot on a cell, a virus, can kill a person, but this dot can be changed from the infectious root of disease into curative genetic medicine. Watch Here

What is an ”AGT person”? AGT has a corporate culture that provides a place for smart, motivated, hardworking persons to pursue their passion to help others by developing innovative pharmaceuticals that ”swing for the fences” and provide new hope for millions of patients. Learn more in this video.

Irene Tennant, the head of clinical development and regulatory affairs at AGT, speaks about her role in the development of gene and cell therapies to treat human diseases. She works to progress potential therapies into the clinic, and ultimately to the bedsides of patients in need. Watch Here

In this article, he shares a perspective on the industry: “in the same manner that the personal computing industry grew and developed business models that fit the way products were sourced, constructed and delivered, a business model for biopharma is taking shape.”

Jeff has been personally committed to engaging the public by sharing the power of gene and cell therapy and what it means for the future of healthcare: curing diseases vs. treating them. Industry publications like BioSpace are recognizing the impact of gene and cell therapy and how leaders like Jeff Galvin will help shape the future of medicine. Read the article here.

AGT’s is headquartered in Maryland, where we are fortunate to have the strong, caring leadership of Governor Larry Hogan at the helm in these uncertain times. He and many other government officials and public servants throughout Maryland have risen to the challenge of the pandemic, tirelessly working to control the outbreak, preserve our economy, and plot a course back towards normal.

AGT’s is headquartered in Maryland, where we are fortunate to have the strong, caring leadership of Governor Larry Hogan at the helm in these uncertain times. He and many other government officials and public servants throughout Maryland have risen to the challenge of the pandemic, tirelessly working to control the outbreak, preserve our economy, and plot a course back towards normal.

We reached out to send a thank you to Governor Hogan that attracted many positive comments from Marylanders. We're confident of Maryland's future knowing that dedicated Maryland leaders continue to place public safety at the top of their priorities. Thank you to leaders, front-line workers, healthcare professionals, public servants, scientific experts, and all Marylanders who are working together to serve their neighbors and community during this immense global challenge.

Source: www.americangene.com