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From Treatments to Cures – BIO Partnering Sets the Stage

Theresa Brady
Theresa Brady
September 4, 2019

The fight against HIV has moved off the front pages. Advancements in antiretroviral drugs are allowing people living with HIV to live normal lives. By reducing the “viral load”, these treatments give the immune system a chance to recover and allow the body to fight off infections and certain cancers.

That’s the good news.

Yet managing a disease is not the same as curing it. HIV patients must endure the onerous daily routine of ingesting a combination of therapies that typically include three HIV medicines from at least two different drug classes. And they must do it for the rest of their lives. Compliance is a struggle for patients, but the biggest issue of HIV treatment is the toxicities of the antiretroviral chemotherapeutics that are necessary to suppress the virus. Common daily side effects are nausea, headaches and dizziness, and long-term effects can include early aging, bone density issues (osteoporosis, brittle bones), kidney, liver, and heart disease, and even cancers. Despite preventing AIDS and restoring a relatively normal lifespan, HIV-infected individuals on antiretrovirals still suffer a lower quality of life and increased need for medical interventions.

American Gene Technologies (AGT) of Rockville MD is on a mission to change this reality. For over 10 years this gene therapy company has worked on an underlying platform to bring gene and cell therapy to the broadest number of patients as efficiently and quickly as possible. The company’s first drug candidate moving towards human clinical trials using the innovative technology is a potential cure of HIV.

It is an important milestone for the company and for Jeff Galvin who founded the company in 2008 with $2.5 million of his own money. He grew the company by hiring passionate, committed and smart people and reaching out to the wider biotech community to find investors and strategic partners. Much of this outreach was—and continues to be—done through BIO One-on-One Partnering™ available at BIO events throughout the year.

This is the third in a series recognizing one of BIO’s Triple Crown Partners

“Nearly all of our current discussions with Pharma about licensing began at a BIO partnering meeting,” noted Galvin. “The partnering system is a tremendous opportunity to do critical outreach to people that are likely to want to hear your story and that you can meet face-to-face for that brief speed date that may potentially initiate a relationship.”

AGT is a BIO “Triple Crown Partner”, having completed BIO’s triple crown of partnering meetings: BIO Investor Forum, BIO 1x1@JPM and BIO CEO & Investor Conference.

According to Galvin, AGT is a big believer in the partnering system and has developed its own methodology for how to select people to reach out to, and how to choose people to meet with. “When we contact prospects, we get right to the point, telling them something we believe will attract them and land a meeting. The result? We are pretty jammed during the conference.”

What is AGT’s message when reaching out to investors and strategic partners on the BIO Partnering System? According to the company, AGT has developed a platform that has potential across infectious disease, monogenic disorders, and immuno-oncology.  The near-term opportunity and excitement are over AGT’s progress on an HIV cure, but AGT also expects to submit INDs (investigational new drug documents) to the FDA next year (2020) for two other lead programs: a promising therapeutic for phenylketonuria (PKU) and a unique approach to immuno-oncology that is showing excellent data in animal models.

“Our immuno-oncology approach allows us to stimulate the natural immune system without modifying it. It’s not like CAR-T where you have to go in and modify T-cells to do something new. What we’re doing is modifying the diseased tissue itself. We make one injection of the virus carrying our drug into the primary tumor. It makes the tumor stimulatory to the cells in the body that naturally surveille and eliminate small malignancies and it safely raises them to a level where they can obliterate that solid tumor. Additionally, while the immune cells are in circulation in that stimulated state, they actually get the secondary tumors and the metastasis.”

Galvin’s Silicon Valley background informs his vision for the company. He views gene and cell therapy as the next technology revolution: “It is software for the ‘Human Computer’, the human cell. Gene and cell therapy allow AGT to update the DNA of cells to correct defects, improve their functions, and modify them to mitigate the root causes of many human diseases. Gene and cell therapy have the potential to revolutionize the pharmaceutical industry.”

A revolution cannot be waged alone. AGT will continue to use BIO One-on-One Partnering to look for investors and strategic partners and to maintain its visibility in the biotech community.

“When we are choosing conferences, the well-defined, highly functional BIO partnering system puts BIO events at the top of our list every year”

Registration is now open for the 2019 BIO Investor Forum and BIO One-on-One Partnering™, complimentary for all conference attendees, will open in early-September.

Jeff Galvin, Founder & CEO, American Gene